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23. März 2010 06:00 UND
Dynavax berichtet über positive Entdeckungen von ausführlicher Sicherheits-Analyse von HEPLISAV TM
Vergleichbares Sicherheits-Profil zu anerkanntem Handelsimpfstoff; Kein Beweis für erhöhtes Risiko von Autoimmunität
BERKELEY, CA--(Marketwire - 23. März 2010) - Dynavax Technologies Corporation (Nasdaq: DVAX) wird anwesend zum ersten Mal eine ausführliche Analyse von Sicherheitsdaten für HEPLISAV™, ein erwachsener Untersuchungsimpfstoff der Hepatitis B, einschließlich zwei Hauptentdeckungen:
* Das Sicherheitsprofil von HEPLISAV war mit dem von Engerix-B®, einer von zwei z.Z. genehmigten Impfstoffen für die Verhinderung der Infektion der Hepatitis B vergleichbar und
* Es gibt keinen Unterschied bezüglich der autoimmunen nachteiligen Ereignisse oder der Labormarkierungen von Autoimmunität zwischen den Themen, die mit HEPLISAV geimpft werden und Engerix-B.
Die Resultate neun schlossen die klinischen Studien ab, die HEPLISAV mit Engerix-B vergleichen und eine Analyse von ungefähr 9.300 Blutproben von den Themen, die mit HEPLISAV oder Engerix-B geimpft werden, wird bei der der Droge-Informations-dritten Oligonucleotides-gegründeten Therapeutik-Konferenz Verbindung (Durchmessers) in Bethesda, MD am 24. März 2010 dargestellt. Die Sicherheitsdaten wurden ursprünglich für Unterordnung zur FDA als Teil der umfangreichen Unterlagen vorbereitet, die die Basis bildeten, nach der klinische Entwicklung HEPLISAVS spätem 2009 wurde wieder aufnehmen lassen.
Diese Daten zeigen, dass es keinen Unterschied zwischen dem HEPLISAV und den Engerix-B Gruppen im Vorkommen der autoimmunen nachteiligen Ereignisse (AEs) gab, mit 7 autoimmunes AEs in 2.500 Themen, die mit HEPLISAV, eine Rate von 0.28%, gegen 4 autoimmunes AEs in 930 Themen immunisiert werden, die mit Engerix-B, eine Rate von 0.43% immunisiert werden. Zusätzlich waren alle weiteren Analysen, die, einschließlich AEs möglicherweise verbunden ist mit Autoimmunität, Anti-doppelte angeschwemmte DNA-Antikörper und ANCA Antikörper dargestellt wurden, zwischen den zwei Gruppen nisht zu unterscheidend.
„Unsere zurückblickende Analyse der klinischer und Laborsicherheit von 2.500 HEPLISAV-geimpften Themen in neun klinischen Studien lieferte keinen Beweis eines erhöhten Risikos des Autoimmunkrankheits. Diese vollständige Analyse ist mit der FDA besprochen worden und, dass das Sicherheitsprofil von HEPLISAV zu dem von Engerix-B kein unterschiedliches ist, einen der sichersten Impfstoffe auf dem Markt heute,“ angezeigter Dr. Tyler Martin, leitender Oberarzt zeigt.
Engerix-B® ist ein eingetragenes Warenzeichen von GlaxoSmithKline.
Bericht der vorher berichteten Phase 3 HEPLISAV Daten
Dr. Martin wiederholte auch einige frühere klinische Studien, die HEPLISAV mit Engerix-B verglichen, und vorausgesetzt Beweis der erhöhten Leistung HEPLISAVS:
* Die 2004 Studie der Phase 3 von 412 Themen altern 40-70 Jahre altes gefunden:
o 99% seroprotection für HEPLISAV gegen 25% für Engerix-B nach der zweiten Dosis;
o Haltbare Antikörperniveaus, die ein Jahr nach der ersten Dosis blieben; und
o Größerer Schutz in den ältesten Themen studierte, spezifisch zwischen 56-70 Lebensjahren.
* Die 2008 Studie der Phase 3 „PHAST“ von mehr als 2.400 Themen bei 21 Aufstellungsorten in Kanada und in Deutschland stellte dar:
o 98% von Themen, die zwei Dosen HEPLISAV (n=1,819) empfingen entwickelte schützende Antikörper zu Hepatitis B, gegen 81% von Themen, die drei Dosen Engerix-B (n=608) empfingen;
o Die Nichtunterlegenheit von HEPLISAV verglichen mit Engerix-B; und
o Ein bedeutender Unterschied in Wirksamkeit (97% gegen 75% in den weniger entgegenkommenden Bevölkerungen, nämlich im vorbehaltlichen Gruppenalter 40-55 Jahre alt) ausgedrückt.
* Die Studie 2007 Phase 1 bei 75 chronischen Niere-Krankheitpatienten gezeigt:
o Schneller, erhöhter Schutz gegen Vireninfektion der Hepatitis B mit wenigen Dosen (96% von den Patienten, die 3 Dosen HEPLISAV erzieltes seroprotection an Monat 7, verglichen bis 88% von den Patienten empfangen 8 Dosen Engerix-B empfangen);
o Eine schnelle Antwort von 83% gegen das 44% seroprotection zwei Monate nach der zweiten Dosis;
o Hohe und haltbare Antikörper Niveaus und seroprotection; und
o Verbessertes seroprotection in einer immunocompromised Bevölkerung.
Über HEPLISAV
HEPLISAV ist ein erwachsener Untersuchungsimpfstoff der Hepatitis B. Der vaccine Anwärter wird in Zweiphasen3 Studien ausgewertet, die auf befriedigende licensure Anforderungen in den US, im Kanada und im Europa gerichtet werden. In einem abgeschlossenen Angelversuch der phase 3 zeigte HEPLISAV erhöhten, schnellen Schutz mit wenigen Dosen als gegenwärtige genehmigte Impfstoffe. Dynavax hat weltweite Handelsrechte zu HEPLISAV und entwickelt den Impfstoff für die großen, hochwertigen Bevölkerungen, die gegenwärtigen genehmigten Impfstoffen weniger entgegenkommend sind, einschließlich Einzelpersonen mit chronischer Nierekrankheit. HEPLISAV kombiniert Oberflächenantigen der Hepatitis B mit einem Eigentümer Abgabe-wie dem Agonisten des Empfängers 9, der als ISS bekannt ist, um die immune Antwort zu erhöhen.
Über Impfstoffe der Hepatitis-B
Zurzeit verfügbare Impfstoffe der Hepatitis B erfordern drei Dosen in sechs Monaten, volle Immunisierungsfähigkeit in den gesunden geduldigen Bevölkerungen zu erzielen. Weil Befolgung dieser vaccine Regierung niedrig ist, sind neue Impfstoffe erforderlich, erhöhten Schutz in einem kürzeren Zeitrahmen zu bieten. Außerdem sprechen zurzeit verfügbare Impfstoffe nicht völlig die Notwendigkeiten einiger geduldiger Bevölkerungen, einschließlich die mit chronischer Nierekrankheit, HIV oder chronischer Leberkrankheit an. Insbesondere fordern Patienten mit enthaltenen Immunsystemen schnellen und erhöhten Schutz, irgendeinen, weil sie herkömmlichen vaccine Regierungen weniger entgegenkommend sind, oder weil sie am hohen Risiko der Infektion sind.
Über Dynavax
Dynavax Technologies Corporation, eine Klinischstadium biopharmaceutical Firma, entdeckt und entwickelt neue Produkte, um Infektionskrankheiten zu verhindern und zu behandeln. Der Blei-Produktanwärter der Firma ist HEPLISAV, ein erwachsener Untersuchungsimpfstoff der Hepatitis B, der entworfen ist, um Schutz wenigen Dosen als gegenwärtige genehmigte Impfstoffe schnell und mit zu erhöhen. Für mehr Informationsbesuch www.dynavax.com.
Vorausschauende Aussagen
Dieses Pressekommuniqué enthält „vorausschauende Aussagen,“, dass abhängig von einigen Risiken und Ungewissheiten seien Sie. Tatsächliche Resultate können von denen materiell sich unterscheiden, die in diesem Pressekommuniqué wegen der Risiken und die Ungewissheiten zugehörig sind in unserem Geschäft festgelegt werden und umfassen, ob die Vergleichbarkeitdaten, die in den zurückblickenden Analysen vorgelegt werden, in anderen klinischen Studien wiederholt werden, erfolgreiches klinisches und regelnde Entwicklung und Zustimmung von HEPLISAV können in einer fristgerechten Weise oder ohne bedeutende zusätzliche Studien oder Schwierigkeiten oder Verzögerungen in der Entwicklung oder in der Studieeneinschreibung auftreten, ob die Studien Ausrichtung für Kommerzialisierung von HEPLISAV stützen können; die Resultate der klinischen Studien und die Auswirkung jener Resultate auf die Einführung und die Beendigung der folgenden Versuche und der Ausgaben, die im regelnden Prozess entstehen; die Fähigkeit der Firma, zusätzliche Finanzierung zu erhalten, um die Entwicklung und die Kommerzialisierung von HEPLISAV und von seinen anderen Betrieben, mögliche Ansprüche zu stützen gegen die Firma basiert auf den Patentrechten von anderen; und anderes riskiert ausführliches im „Risiko-Faktor“ Abschnitt unserer gegenwärtigen periodischen Reports mit der sek. Wir nehmen uns keine Verpflichtung, hierin zu verbessern oder die Updateinformationen, zum von Ereignissen oder von Umständen zukünftig zu reflektieren auf, selbst wenn neue Informationen vorhanden werden. Informationen über Dynavaxs Web site bei www.dynavax.com werden nicht durch Hinweis in den gegenwärtigen periodischen Reports der Firma mit der sek enthalten.
Dynavax berichtet über positive Entdeckungen von ausführlicher Sicherheits-Analyse von HEPLISAV TM
Vergleichbares Sicherheits-Profil zu anerkanntem Handelsimpfstoff; Kein Beweis für erhöhtes Risiko von Autoimmunität
BERKELEY, CA--(Marketwire - 23. März 2010) - Dynavax Technologies Corporation (Nasdaq: DVAX) wird anwesend zum ersten Mal eine ausführliche Analyse von Sicherheitsdaten für HEPLISAV™, ein erwachsener Untersuchungsimpfstoff der Hepatitis B, einschließlich zwei Hauptentdeckungen:
* Das Sicherheitsprofil von HEPLISAV war mit dem von Engerix-B®, einer von zwei z.Z. genehmigten Impfstoffen für die Verhinderung der Infektion der Hepatitis B vergleichbar und
* Es gibt keinen Unterschied bezüglich der autoimmunen nachteiligen Ereignisse oder der Labormarkierungen von Autoimmunität zwischen den Themen, die mit HEPLISAV geimpft werden und Engerix-B.
Die Resultate neun schlossen die klinischen Studien ab, die HEPLISAV mit Engerix-B vergleichen und eine Analyse von ungefähr 9.300 Blutproben von den Themen, die mit HEPLISAV oder Engerix-B geimpft werden, wird bei der der Droge-Informations-dritten Oligonucleotides-gegründeten Therapeutik-Konferenz Verbindung (Durchmessers) in Bethesda, MD am 24. März 2010 dargestellt. Die Sicherheitsdaten wurden ursprünglich für Unterordnung zur FDA als Teil der umfangreichen Unterlagen vorbereitet, die die Basis bildeten, nach der klinische Entwicklung HEPLISAVS spätem 2009 wurde wieder aufnehmen lassen.
Diese Daten zeigen, dass es keinen Unterschied zwischen dem HEPLISAV und den Engerix-B Gruppen im Vorkommen der autoimmunen nachteiligen Ereignisse (AEs) gab, mit 7 autoimmunes AEs in 2.500 Themen, die mit HEPLISAV, eine Rate von 0.28%, gegen 4 autoimmunes AEs in 930 Themen immunisiert werden, die mit Engerix-B, eine Rate von 0.43% immunisiert werden. Zusätzlich waren alle weiteren Analysen, die, einschließlich AEs möglicherweise verbunden ist mit Autoimmunität, Anti-doppelte angeschwemmte DNA-Antikörper und ANCA Antikörper dargestellt wurden, zwischen den zwei Gruppen nisht zu unterscheidend.
„Unsere zurückblickende Analyse der klinischer und Laborsicherheit von 2.500 HEPLISAV-geimpften Themen in neun klinischen Studien lieferte keinen Beweis eines erhöhten Risikos des Autoimmunkrankheits. Diese vollständige Analyse ist mit der FDA besprochen worden und, dass das Sicherheitsprofil von HEPLISAV zu dem von Engerix-B kein unterschiedliches ist, einen der sichersten Impfstoffe auf dem Markt heute,“ angezeigter Dr. Tyler Martin, leitender Oberarzt zeigt.
Engerix-B® ist ein eingetragenes Warenzeichen von GlaxoSmithKline.
Bericht der vorher berichteten Phase 3 HEPLISAV Daten
Dr. Martin wiederholte auch einige frühere klinische Studien, die HEPLISAV mit Engerix-B verglichen, und vorausgesetzt Beweis der erhöhten Leistung HEPLISAVS:
* Die 2004 Studie der Phase 3 von 412 Themen altern 40-70 Jahre altes gefunden:
o 99% seroprotection für HEPLISAV gegen 25% für Engerix-B nach der zweiten Dosis;
o Haltbare Antikörperniveaus, die ein Jahr nach der ersten Dosis blieben; und
o Größerer Schutz in den ältesten Themen studierte, spezifisch zwischen 56-70 Lebensjahren.
* Die 2008 Studie der Phase 3 „PHAST“ von mehr als 2.400 Themen bei 21 Aufstellungsorten in Kanada und in Deutschland stellte dar:
o 98% von Themen, die zwei Dosen HEPLISAV (n=1,819) empfingen entwickelte schützende Antikörper zu Hepatitis B, gegen 81% von Themen, die drei Dosen Engerix-B (n=608) empfingen;
o Die Nichtunterlegenheit von HEPLISAV verglichen mit Engerix-B; und
o Ein bedeutender Unterschied in Wirksamkeit (97% gegen 75% in den weniger entgegenkommenden Bevölkerungen, nämlich im vorbehaltlichen Gruppenalter 40-55 Jahre alt) ausgedrückt.
* Die Studie 2007 Phase 1 bei 75 chronischen Niere-Krankheitpatienten gezeigt:
o Schneller, erhöhter Schutz gegen Vireninfektion der Hepatitis B mit wenigen Dosen (96% von den Patienten, die 3 Dosen HEPLISAV erzieltes seroprotection an Monat 7, verglichen bis 88% von den Patienten empfangen 8 Dosen Engerix-B empfangen);
o Eine schnelle Antwort von 83% gegen das 44% seroprotection zwei Monate nach der zweiten Dosis;
o Hohe und haltbare Antikörper Niveaus und seroprotection; und
o Verbessertes seroprotection in einer immunocompromised Bevölkerung.
Über HEPLISAV
HEPLISAV ist ein erwachsener Untersuchungsimpfstoff der Hepatitis B. Der vaccine Anwärter wird in Zweiphasen3 Studien ausgewertet, die auf befriedigende licensure Anforderungen in den US, im Kanada und im Europa gerichtet werden. In einem abgeschlossenen Angelversuch der phase 3 zeigte HEPLISAV erhöhten, schnellen Schutz mit wenigen Dosen als gegenwärtige genehmigte Impfstoffe. Dynavax hat weltweite Handelsrechte zu HEPLISAV und entwickelt den Impfstoff für die großen, hochwertigen Bevölkerungen, die gegenwärtigen genehmigten Impfstoffen weniger entgegenkommend sind, einschließlich Einzelpersonen mit chronischer Nierekrankheit. HEPLISAV kombiniert Oberflächenantigen der Hepatitis B mit einem Eigentümer Abgabe-wie dem Agonisten des Empfängers 9, der als ISS bekannt ist, um die immune Antwort zu erhöhen.
Über Impfstoffe der Hepatitis-B
Zurzeit verfügbare Impfstoffe der Hepatitis B erfordern drei Dosen in sechs Monaten, volle Immunisierungsfähigkeit in den gesunden geduldigen Bevölkerungen zu erzielen. Weil Befolgung dieser vaccine Regierung niedrig ist, sind neue Impfstoffe erforderlich, erhöhten Schutz in einem kürzeren Zeitrahmen zu bieten. Außerdem sprechen zurzeit verfügbare Impfstoffe nicht völlig die Notwendigkeiten einiger geduldiger Bevölkerungen, einschließlich die mit chronischer Nierekrankheit, HIV oder chronischer Leberkrankheit an. Insbesondere fordern Patienten mit enthaltenen Immunsystemen schnellen und erhöhten Schutz, irgendeinen, weil sie herkömmlichen vaccine Regierungen weniger entgegenkommend sind, oder weil sie am hohen Risiko der Infektion sind.
Über Dynavax
Dynavax Technologies Corporation, eine Klinischstadium biopharmaceutical Firma, entdeckt und entwickelt neue Produkte, um Infektionskrankheiten zu verhindern und zu behandeln. Der Blei-Produktanwärter der Firma ist HEPLISAV, ein erwachsener Untersuchungsimpfstoff der Hepatitis B, der entworfen ist, um Schutz wenigen Dosen als gegenwärtige genehmigte Impfstoffe schnell und mit zu erhöhen. Für mehr Informationsbesuch www.dynavax.com.
Vorausschauende Aussagen
Dieses Pressekommuniqué enthält „vorausschauende Aussagen,“, dass abhängig von einigen Risiken und Ungewissheiten seien Sie. Tatsächliche Resultate können von denen materiell sich unterscheiden, die in diesem Pressekommuniqué wegen der Risiken und die Ungewissheiten zugehörig sind in unserem Geschäft festgelegt werden und umfassen, ob die Vergleichbarkeitdaten, die in den zurückblickenden Analysen vorgelegt werden, in anderen klinischen Studien wiederholt werden, erfolgreiches klinisches und regelnde Entwicklung und Zustimmung von HEPLISAV können in einer fristgerechten Weise oder ohne bedeutende zusätzliche Studien oder Schwierigkeiten oder Verzögerungen in der Entwicklung oder in der Studieeneinschreibung auftreten, ob die Studien Ausrichtung für Kommerzialisierung von HEPLISAV stützen können; die Resultate der klinischen Studien und die Auswirkung jener Resultate auf die Einführung und die Beendigung der folgenden Versuche und der Ausgaben, die im regelnden Prozess entstehen; die Fähigkeit der Firma, zusätzliche Finanzierung zu erhalten, um die Entwicklung und die Kommerzialisierung von HEPLISAV und von seinen anderen Betrieben, mögliche Ansprüche zu stützen gegen die Firma basiert auf den Patentrechten von anderen; und anderes riskiert ausführliches im „Risiko-Faktor“ Abschnitt unserer gegenwärtigen periodischen Reports mit der sek. Wir nehmen uns keine Verpflichtung, hierin zu verbessern oder die Updateinformationen, zum von Ereignissen oder von Umständen zukünftig zu reflektieren auf, selbst wenn neue Informationen vorhanden werden. Informationen über Dynavaxs Web site bei www.dynavax.com werden nicht durch Hinweis in den gegenwärtigen periodischen Reports der Firma mit der sek enthalten.
Eigentlich müßte es jetzt Angebote für eine Partnerschaft hageln! 
Guten Morgen 
Ich wünsche uns einen dunkelgrünen Tag!
Ich wünsche uns einen dunkelgrünen Tag!
Ich wollte heute eigentlich die 2$ sehn! 
Trading Spotlight
DYNAVAX TECHNOLOGIES CORPORATION
2929 Seventh Street, Suite 100
Berkeley, California 94710
NOTICE OF 2010 ANNUAL MEETING OF STOCKHOLDERS
May 12, 2010
Dear Stockholder:
You are cordially invited to attend the 2010 Annual Meeting of Stockholders of Dynavax Technologies Corporation, a Delaware corporation, or the Company. The meeting will be held on May 12, 2010 at 10:00 a.m. Pacific Time, at the Company’s executive offices 2929 Seventh Street, Suite 100, Berkeley, California 94710 for the following purposes:
1. To elect our nominees for Class I directors to hold office until the 2013 Annual Meeting of Stockholders or until their respective successors are duly elected and qualified.
2. To ratify the selection by the Board of Directors of Ernst & Young LLP as the independent registered public accounting firm of the Company for its fiscal year ending December 31, 2010.
3. To conduct any other business properly brought before the meeting or any adjournment(s) thereof.
These items of business are more fully described in the Proxy Statement accompanying this Notice.
The record date for the 2010 Annual Meeting is March 17, 2010. Only stockholders of record at the close of business on that date may vote at the meeting or any adjournment thereof.
http://investors.dynavax.com/secfiling.cfm?filingID=1193125-…
2929 Seventh Street, Suite 100
Berkeley, California 94710
NOTICE OF 2010 ANNUAL MEETING OF STOCKHOLDERS
May 12, 2010
Dear Stockholder:
You are cordially invited to attend the 2010 Annual Meeting of Stockholders of Dynavax Technologies Corporation, a Delaware corporation, or the Company. The meeting will be held on May 12, 2010 at 10:00 a.m. Pacific Time, at the Company’s executive offices 2929 Seventh Street, Suite 100, Berkeley, California 94710 for the following purposes:
1. To elect our nominees for Class I directors to hold office until the 2013 Annual Meeting of Stockholders or until their respective successors are duly elected and qualified.
2. To ratify the selection by the Board of Directors of Ernst & Young LLP as the independent registered public accounting firm of the Company for its fiscal year ending December 31, 2010.
3. To conduct any other business properly brought before the meeting or any adjournment(s) thereof.
These items of business are more fully described in the Proxy Statement accompanying this Notice.
The record date for the 2010 Annual Meeting is March 17, 2010. Only stockholders of record at the close of business on that date may vote at the meeting or any adjournment thereof.
http://investors.dynavax.com/secfiling.cfm?filingID=1193125-…
Wird Zeit für News!
Lausiges Volumen! 
Test!
Heute ist ja garnix los! 
Events & Presentations
2010 Annual Meeting of Stockholders
May 12, 2010
10:00 AM PT
2929 Seventh Street, Suite 100
Berkeley , AL 94710
US
2010 Annual Meeting of Stockholders
May 12, 2010
10:00 AM PT
2929 Seventh Street, Suite 100
Berkeley , AL 94710
US
Aus dem Yahoo!
New job listing Dynavax Europe 1-Apr-10 06:08 pm
http://www.dynavax.com/careers/careers_europe.html
Ramping up for commercial production, IMO
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks…
New job listing Dynavax Europe 1-Apr-10 06:08 pm
http://www.dynavax.com/careers/careers_europe.html
Ramping up for commercial production, IMO
http://messages.finance.yahoo.com/Stocks_%28A_to_Z%29/Stocks…
WOW! Das sieht doch nicht schlecht aus!
http://files.shareholder.com/downloads/DVAX/753965771x0x3631…
http://files.shareholder.com/downloads/DVAX/753965771x0x3631…
Die Amis sind wohl noch zu Tisch!
Kommt heute was? 
Exhibit No.
Description
EX-5.1
Opinion of Cooley Godward Kronish LLP.
Glen Y. Sato
(650) 843-5502
gsato@cooley.com
April 5, 2010
Dynavax Technologies Corporation
2929 Seventh Street, Suite 100
Berkeley, CA 94710
RE: Dynavax Technologies Corporation
Ladies and Gentlemen:
You have requested our opinion with respect to certain matters in connection with the sale by Dynavax Technologies Corporation (the “ Company ”) of 1,281,100 shares of the Company’s Common Stock (the “ Shares ”) under the Equity Distribution Agreement dated as of August 17, 2009 by and between the Company and Wedbush Morgan Securities, Inc. (the “ Agreement ”).
In connection with this opinion, we have examined and relied upon the representations and warranties as to factual matters contained in and made pursuant to the Agreement by the various parties and originals or copies certified to our satisfaction, of such records, documents, certificates, opinions, memoranda and other instruments as in our judgment are necessary or appropriate to enable us to render the opinion expressed below.
In rendering this opinion, we have assumed: the genuineness and authenticity of all signatures on original documents; the authenticity of all documents submitted to us as originals; the conformity to originals of all documents submitted to us as copies; the accuracy, completeness and authenticity of certificates of public officials; and the due authorization, execution and delivery of all documents, where authorization, execution and delivery are prerequisites to the effectiveness of such documents. We have also assumed that all individuals executing and delivering documents had the legal capacity to so execute and deliver.
On the basis of the foregoing, in reliance thereon and with the foregoing qualification, we are of the opinion that the Shares have been duly authorized and validly issued and are outstanding, fully paid and nonassessable.
Very truly yours,
C OOLEY G ODWARD K RONISH LLP
By: /s/ Glen Y. Sato
Glen Y. Sato
FIVE PALO ALTO SQUARE, 3000 EL CAMINO REAL, PALO ALTO, CA 94306-2155 T: (650) 843-5000 F: (650) 849-7400 WWW.COOLEY.COM
http://investors.dynavax.com/secfiling.cfm?filingID=1181431-…
Description
EX-5.1
Opinion of Cooley Godward Kronish LLP.
Glen Y. Sato
(650) 843-5502
gsato@cooley.com
April 5, 2010
Dynavax Technologies Corporation
2929 Seventh Street, Suite 100
Berkeley, CA 94710
RE: Dynavax Technologies Corporation
Ladies and Gentlemen:
You have requested our opinion with respect to certain matters in connection with the sale by Dynavax Technologies Corporation (the “ Company ”) of 1,281,100 shares of the Company’s Common Stock (the “ Shares ”) under the Equity Distribution Agreement dated as of August 17, 2009 by and between the Company and Wedbush Morgan Securities, Inc. (the “ Agreement ”).
In connection with this opinion, we have examined and relied upon the representations and warranties as to factual matters contained in and made pursuant to the Agreement by the various parties and originals or copies certified to our satisfaction, of such records, documents, certificates, opinions, memoranda and other instruments as in our judgment are necessary or appropriate to enable us to render the opinion expressed below.
In rendering this opinion, we have assumed: the genuineness and authenticity of all signatures on original documents; the authenticity of all documents submitted to us as originals; the conformity to originals of all documents submitted to us as copies; the accuracy, completeness and authenticity of certificates of public officials; and the due authorization, execution and delivery of all documents, where authorization, execution and delivery are prerequisites to the effectiveness of such documents. We have also assumed that all individuals executing and delivering documents had the legal capacity to so execute and deliver.
On the basis of the foregoing, in reliance thereon and with the foregoing qualification, we are of the opinion that the Shares have been duly authorized and validly issued and are outstanding, fully paid and nonassessable.
Very truly yours,
C OOLEY G ODWARD K RONISH LLP
By: /s/ Glen Y. Sato
Glen Y. Sato
FIVE PALO ALTO SQUARE, 3000 EL CAMINO REAL, PALO ALTO, CA 94306-2155 T: (650) 843-5000 F: (650) 849-7400 WWW.COOLEY.COM
http://investors.dynavax.com/secfiling.cfm?filingID=1181431-…
Guten Morgen 
Ich wünsche uns einen grünen Tag!
Ich wünsche uns einen grünen Tag!
Gibt es hier bald News oder müssen wir auf die Q1- Zahlen warten?
UPCOMING EVENTS
Date Event
26-Apr-10 Earnings announcement
Date Event
26-Apr-10 Earnings announcement
Es kommt wieder Bewegung rein!
Dynavax Announces New Employment Inducement Awards
BERKELEY, CA, Apr 09, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) reported that equity awards were made to two new employees under the Company's 2010 Employment Inducement Award Plan ("the 2010 Plan"). The employees are focused on clinical and commercial development. Dynavax's Board of Directors adopted the 2010 Plan to grant equity awards as a material inducement to new employees. NASDAQ Marketplace Rule 5635(c)(4) requires a public announcement to be issued when awards are made under the 2010 Plan. The employees were granted options to purchase an aggregate of 235,000 shares of the Company's common stock, a portion of which vest over four years and the remainder upon achievement of specified performance objectives. No officers received any awards under this plan. The exercise price for the option shares granted is $1.36, which was the closing price of Dynavax common stock on the date of grant.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies Corporation
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=457…
Dynavax Announces New Employment Inducement Awards
BERKELEY, CA, Apr 09, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) reported that equity awards were made to two new employees under the Company's 2010 Employment Inducement Award Plan ("the 2010 Plan"). The employees are focused on clinical and commercial development. Dynavax's Board of Directors adopted the 2010 Plan to grant equity awards as a material inducement to new employees. NASDAQ Marketplace Rule 5635(c)(4) requires a public announcement to be issued when awards are made under the 2010 Plan. The employees were granted options to purchase an aggregate of 235,000 shares of the Company's common stock, a portion of which vest over four years and the remainder upon achievement of specified performance objectives. No officers received any awards under this plan. The exercise price for the option shares granted is $1.36, which was the closing price of Dynavax common stock on the date of grant.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies Corporation
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=457…
Dynavax Raises $44 Million Through Public Offering of Common Stock and Warrants
Transaction Expected to Close April 16, 2010
BERKELEY, CA, Apr 13, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the pricing of an underwritten offering resulting in gross proceeds of $44 million, before deducting estimated offering expenses. 30,293,000 units are being sold at a per unit price of $1.4525. Each unit consists of one share of common stock and one warrant to purchase 0.5 of a share of common stock. Each warrant has an exercise price of $1.50 per share and is exercisable for a period of five years from the date of issuance.
The institutional investors participating in the offering included Federated Kaufmann Funds, Great Point Partners and Vivo Ventures.
As a result of the offering, pursuant to the terms of the Company's Amended and Restated Purchase Option Agreement with Symphony Capital Partners, LP (Symphony) entered into in November 2009, Symphony and certain related investors will receive an additional 1.1 million shares of common stock and new warrants to purchase 7 million shares of common stock having the same terms as the warrants sold in the offering. The warrants to purchase 2 million shares of common stock previously issued to Symphony and its related investors in connection with the Amended and Restated Purchase Option Agreement will be cancelled.
Dynavax intends to use the net proceeds from the sale of the common stock and warrants for general corporate purposes and to further advance the development of the Company's lead product candidate, HEPLISAV(TM), including Phase 3 studies to support registration in the U.S., Canada and European Union.
Wedbush PacGrow Life Sciences served as the sole underwriter for the offering. The securities described above are being offered by Dynavax pursuant to a registration statement previously filed and declared effective by the Securities and Exchange Commission (File No. 333-165663). The offering is expected to close on or about April 16, 2010, subject to customary closing conditions.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. Copies of the prospectus supplement and accompanying base prospectus relating to this offering may be obtained at the Securities and Exchange Commission's website at http://www.sec.gov.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward-Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
Contacts:
Jennifer Lew
Vice President, Finance
510-665-7217
Email Contact
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=458…
Ich will heute noch die 1,50$ sehn!
Na also! Es geht doch!
Trade Detail
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
19:25 $ 1.54 1,200
19:19 $ 1.54 600
19:13 $ 1.54 1,000
19:13 $ 1.51 1,000
19:13 $ 1.54 200
19:13 $ 1.52 200
18:46 $ 1.51 1,000
18:45 $ 1.51 3,000
18:41 $ 1.51 1,000
18:06 $ 1.47 500
17:50 $ 1.48 200
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
Trade Detail
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
19:25 $ 1.54 1,200
19:19 $ 1.54 600
19:13 $ 1.54 1,000
19:13 $ 1.51 1,000
19:13 $ 1.54 200
19:13 $ 1.52 200
18:46 $ 1.51 1,000
18:45 $ 1.51 3,000
18:41 $ 1.51 1,000
18:06 $ 1.47 500
17:50 $ 1.48 200
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
Should I Buy DVAX Stock ?
No Top 5 DVAX owner is selling their shares!
Dynavax Technologies Corp (DVAX) group of the top 5 most profitable owners are earning an average return of 24.04 %. The best return for a group of top 5 for Medical-Drugs stocks are 654.80 % they own PFE, while the average return is 38.34 %. That return ranks 68th out of 198 stocks.
The smartest group owning it is below average at picking profitable stocks!
Their confidence is indicated by an activity score of 3.7. The highest confidence score is 5.0 for GCAN.OB, while the average is 2.64. That activity score ranks 25th.
No Top 5 is selling their DVAX shares! With a positive outlook.
B vf Inc Il the largest current or previous position didn't change anything. Federated Investors Inc the second largest current or previous position didn't change anything. Hughes Howard Medical Institute the largest current or previous position is new
No consensus among the 3 largest owners.
Traded by 49 funds and institutions. The most for Medical-Drugs stocks is 2658 for PFE, while the average is 163.35. DVAX ranks 84th.
Less owners then the average Medical-Drugs stock.
Total owner confidence for Dynavax Technologies Corp (DVAX) is an activity score of 2.80. The best score for Medical-Drugs stocks is 5.00 for VNLSY.OB, while the average is 2.69. DVAX score ranks 101st.
Confidence is higher than average. With a negative outlook.
There are 11 funds buying DVAX. The most bought Medical-Drugs stock is PFE with 1513 s buying shares, the average buying is 53.33. Likewise there are 14 selling DVAX. The most sold Medical-Drugs stock is WYE with 1318, the average is 74.94. Btw, the most newly add Medical-Drugs stock is PFE and the most dumped is WYE.
http://www.mffais.com/dvax
No Top 5 DVAX owner is selling their shares!
Dynavax Technologies Corp (DVAX) group of the top 5 most profitable owners are earning an average return of 24.04 %. The best return for a group of top 5 for Medical-Drugs stocks are 654.80 % they own PFE, while the average return is 38.34 %. That return ranks 68th out of 198 stocks.
The smartest group owning it is below average at picking profitable stocks!
Their confidence is indicated by an activity score of 3.7. The highest confidence score is 5.0 for GCAN.OB, while the average is 2.64. That activity score ranks 25th.
No Top 5 is selling their DVAX shares! With a positive outlook.
B vf Inc Il the largest current or previous position didn't change anything. Federated Investors Inc the second largest current or previous position didn't change anything. Hughes Howard Medical Institute the largest current or previous position is new
No consensus among the 3 largest owners.
Traded by 49 funds and institutions. The most for Medical-Drugs stocks is 2658 for PFE, while the average is 163.35. DVAX ranks 84th.
Less owners then the average Medical-Drugs stock.
Total owner confidence for Dynavax Technologies Corp (DVAX) is an activity score of 2.80. The best score for Medical-Drugs stocks is 5.00 for VNLSY.OB, while the average is 2.69. DVAX score ranks 101st.
Confidence is higher than average. With a negative outlook.
There are 11 funds buying DVAX. The most bought Medical-Drugs stock is PFE with 1513 s buying shares, the average buying is 53.33. Likewise there are 14 selling DVAX. The most sold Medical-Drugs stock is WYE with 1318, the average is 74.94. Btw, the most newly add Medical-Drugs stock is PFE and the most dumped is WYE.
http://www.mffais.com/dvax
Ich glaub den Affen brauch ich heute nicht! 
Hours Trading
Pre-Market Charts | After Hours Charts
Apr. 14, 2010 Market Close: $ 1.45
After Hours
Last: $ 1.78 After Hours
High: $ 2.66
After Hours
Volume: 1,292,818 After Hours
Low: $ 1.45
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
Dynavax's Chronic Kidney Disease Study Confirms HEPLISAV's Enhanced Seroprotection Against HBV Infection
Phase 2 Data Presented at National Kidney Foundation
BERKELEY, CA, Apr 14, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today presented Phase 2 clinical data that demonstrate HEPLISAV(TM)'s immunogenicity and rapid protection in patients with chronic kidney disease. In a poster session at the National Kidney Foundation Spring Clinical Meeting in Orlando, FL, Dynavax results showed that two doses of HEPLISAV protected 100% of the dialysis and pre-dialysis patients measured at week 24 in the Phase 2 study.
"Chronic Kidney Disease patients undergoing hemodialysis are at high risk of HBV infection, are hyporesponsive to current HBV vaccines, and have a worse prognosis if infected with HBV," commented Tyler Martin, M.D., Dynavax's Chief Medical Officer. "These results demonstrate that HEPLISAV can effectively protect this susceptible patient population."
At its initiation, the Phase 2 single blind study in chronic kidney disease patients called for the comparison of two different HEPLISAV regimens, a single-dose vaccine and a double-dose vaccine, at 0, 1, and 6 months. A total of 41 subjects with progressive loss of renal function and between 40-70 years of age were enrolled. The vast majority of patients had received only the first two immunizations when the study was prematurely discontinued due to an FDA-imposed clinical hold on HEPLISAV. The clinical hold was subsequently removed. In the poster entitled, "Safety and Immunogenicity of a Novel hepatitis B Vaccine Adjuvanted with Immunostimulatory Sequence (ISS) in Renal Predialysis and Dialysis Patients," Dynavax presented safety and immunogenicity data for time points 4 weeks after the first immunization and 8 and 20 weeks after the second immunization.
HEPLISAV is currently being evaluated in a Phase 3 study in subjects with chronic kidney disease at multiple centers in the U.S., Canada and Germany. An additional Phase 3 study in subjects over the age of 40 is being conducted to demonstrate lot-to-lot consistency and complete the safety database for HEPLISAV. Dynavax anticipates submitting the initial BLA for HEPLISAV in 2011.
For a copy of the poster presentation, please visit http://investors.dynavax.com/newsevents.cfm.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Hepatitis B Vaccines
Currently available hepatitis B vaccines require three doses over six months to achieve full immunogenicity in healthy patient populations. Because compliance with this vaccine regimen is low, new vaccines are needed to provide increased protection in a shorter timeframe. Furthermore, currently available vaccines do not fully address the needs of several patient populations, including those with chronic kidney disease, HIV or chronic liver disease. In particular, patients with compromised immune systems require both rapid and enhanced protection, either because they are less responsive to conventional vaccine regimens or because they are at high risk of infection.
Chronic Kidney Disease Market
The chronic kidney disease market is large and growing rapidly. In 2006, there were approximately 750,000 end-stage renal disease (ESRD) patients in the United States and the five major European markets; approximately 150,000 new patients are diagnosed each year. Vaccination against HBV is widely recommended for these patients. However, an estimated 35% of immunocompromised ESRD patients do not respond to vaccination, and 20% require boosters. Since patients are usually vaccinated at dialysis centers, this is a highly concentrated, renewable market that can be served by cost-effective, targeted sales and distribution networks.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide more rapid and increased protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward-Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties, including the anticipated BLA submission date for HEPLISAV. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the reported results can be replicated in larger studies, whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV, the potential size and value of the chronic kidney disease market addressable with HEPLISAV, the commercial potential for HEPLISAV, and the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=459…
Phase 2 Data Presented at National Kidney Foundation
BERKELEY, CA, Apr 14, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today presented Phase 2 clinical data that demonstrate HEPLISAV(TM)'s immunogenicity and rapid protection in patients with chronic kidney disease. In a poster session at the National Kidney Foundation Spring Clinical Meeting in Orlando, FL, Dynavax results showed that two doses of HEPLISAV protected 100% of the dialysis and pre-dialysis patients measured at week 24 in the Phase 2 study.
"Chronic Kidney Disease patients undergoing hemodialysis are at high risk of HBV infection, are hyporesponsive to current HBV vaccines, and have a worse prognosis if infected with HBV," commented Tyler Martin, M.D., Dynavax's Chief Medical Officer. "These results demonstrate that HEPLISAV can effectively protect this susceptible patient population."
At its initiation, the Phase 2 single blind study in chronic kidney disease patients called for the comparison of two different HEPLISAV regimens, a single-dose vaccine and a double-dose vaccine, at 0, 1, and 6 months. A total of 41 subjects with progressive loss of renal function and between 40-70 years of age were enrolled. The vast majority of patients had received only the first two immunizations when the study was prematurely discontinued due to an FDA-imposed clinical hold on HEPLISAV. The clinical hold was subsequently removed. In the poster entitled, "Safety and Immunogenicity of a Novel hepatitis B Vaccine Adjuvanted with Immunostimulatory Sequence (ISS) in Renal Predialysis and Dialysis Patients," Dynavax presented safety and immunogenicity data for time points 4 weeks after the first immunization and 8 and 20 weeks after the second immunization.
HEPLISAV is currently being evaluated in a Phase 3 study in subjects with chronic kidney disease at multiple centers in the U.S., Canada and Germany. An additional Phase 3 study in subjects over the age of 40 is being conducted to demonstrate lot-to-lot consistency and complete the safety database for HEPLISAV. Dynavax anticipates submitting the initial BLA for HEPLISAV in 2011.
For a copy of the poster presentation, please visit http://investors.dynavax.com/newsevents.cfm.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Hepatitis B Vaccines
Currently available hepatitis B vaccines require three doses over six months to achieve full immunogenicity in healthy patient populations. Because compliance with this vaccine regimen is low, new vaccines are needed to provide increased protection in a shorter timeframe. Furthermore, currently available vaccines do not fully address the needs of several patient populations, including those with chronic kidney disease, HIV or chronic liver disease. In particular, patients with compromised immune systems require both rapid and enhanced protection, either because they are less responsive to conventional vaccine regimens or because they are at high risk of infection.
Chronic Kidney Disease Market
The chronic kidney disease market is large and growing rapidly. In 2006, there were approximately 750,000 end-stage renal disease (ESRD) patients in the United States and the five major European markets; approximately 150,000 new patients are diagnosed each year. Vaccination against HBV is widely recommended for these patients. However, an estimated 35% of immunocompromised ESRD patients do not respond to vaccination, and 20% require boosters. Since patients are usually vaccinated at dialysis centers, this is a highly concentrated, renewable market that can be served by cost-effective, targeted sales and distribution networks.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide more rapid and increased protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward-Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties, including the anticipated BLA submission date for HEPLISAV. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the reported results can be replicated in larger studies, whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV, the potential size and value of the chronic kidney disease market addressable with HEPLISAV, the commercial potential for HEPLISAV, and the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=459…
Antwort auf Beitrag Nr.: 39.337.906 von Lucky72 am 15.04.10 07:08:50Gut!
Antwort auf Beitrag Nr.: 39.337.906 von Lucky72 am 15.04.10 07:08:50Das sind vielleicht idioten anstatt erst die News zu bringen und dann erst die KE ,machen die es genau andersrum .
Deine gelegenheit zu verkaufen lucky die wird auf jedenfall wieder zurück kommen .
KE zu 1,45 $ !!!
Deine gelegenheit zu verkaufen lucky die wird auf jedenfall wieder zurück kommen .
KE zu 1,45 $ !!!
Antwort auf Beitrag Nr.: 39.340.203 von BrauchGeld am 15.04.10 12:51:50Brauchgeld, kannst DVAX ja shorten von 1,82 bis 1,50 USD.
Antwort auf Beitrag Nr.: 39.340.203 von BrauchGeld am 15.04.10 12:51:50Ich halte meine Teile ganz fest!
Der Kurs nimmt wohl erst Anlauf!
Guten Morgen
Ich wünsche uns einen dunkelgrünen Tag!
Ich wünsche uns einen dunkelgrünen Tag!
Was geht den jetzt ab?
SL fischen?!
SL fischen?!
Ist das langweilig!!! 
Wo bleibt die Hep C News aus Wien!
Zur Info! 
Pipeline :: Hepatitis C
Data from a Phase 1b trial and from an in vitro study of SD-101’s mechanism of action show that SD-101 is 1) well tolerated and safe and 2) induces both IFN-lambda and IFN-alpha at concentrations producing antiviral activity. The data will be presented at the 45th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria in April 2010. We believe these studies differentiate SD-101 from standard-of-care as well as emerging treatments for chronic HCV infection. SD-101 hepatitis C therapy utilizes a novel second-generation Toll-like Receptor 9 (TLR9) agonist and may offer a more effective therapeutic option for patients chronically infected with the hepatitis C virus (HCV).
Data from the Phase 1b study of SD-101 in treatment-naïve, genotype 1 HCV patients show:
* A safety and tolerability profile that compares favorably to that of IFN-alpha, at all four doses tested;
* A dose-dependent antiviral response, with 100% of patients at the highest dose experiencing a greater than one (1) log reduction in viral load; and
* The potency of SD-101 as confirmed by biomarker analysis in patients. The biomarker data point to substantial, dose-related increases in the expression of key antiviral genes (MX-B and ISG-54k) and genes indicating enhanced immunity (IP-10 and MCP-1).
The Phase 1b study evaluated four dose levels of SD-101 in 34 chronically infected, treatment-naïve, genotype 1 HCV patients. SD-101 was administered as a monotherapy once weekly, for four weeks, in doses from 0.1 to 5.0 milligrams per week.
The in vitro data from a study of the drug in human blood cells demonstrate that compared to first-generation TLR9 agonists, SD-101 stimulates 20-fold higher levels of both IFN-alpha and IFN-lambda, two classes of IFNs with potent activity against HCV.
Commercial Opportunity
With the completed acquisition of Symphony Dynamo in January 2010, Dynavax has full development and commercialization rights to SD-101. As such, SD-101 is now part of the portfolio of development programs that are available for partnership.
According to the World Health Organization, there are 170 million people worldwide chronically infected with HCV. We estimate the current worldwide market for HCV therapeutics is over $3 billion annually. While there is no vaccine available to prevent HCV, current therapy includes pegylated interferon alpha and the antiviral drug ribavirin. Both of these therapies may cause significant side effects and are only effective in treating half of all patients infected with HCV.
Our HCV therapy is designed to be used in combination with oral antivirals -- including standard-of care and emerging therapies -- to stop HCV viral replication and induce a long-lasting T-cell immune response.
http://www.dynavax.com/hepatitis_ct.html
Pipeline :: Hepatitis C
Data from a Phase 1b trial and from an in vitro study of SD-101’s mechanism of action show that SD-101 is 1) well tolerated and safe and 2) induces both IFN-lambda and IFN-alpha at concentrations producing antiviral activity. The data will be presented at the 45th Annual Meeting of the European Association for the Study of the Liver in Vienna, Austria in April 2010. We believe these studies differentiate SD-101 from standard-of-care as well as emerging treatments for chronic HCV infection. SD-101 hepatitis C therapy utilizes a novel second-generation Toll-like Receptor 9 (TLR9) agonist and may offer a more effective therapeutic option for patients chronically infected with the hepatitis C virus (HCV).
Data from the Phase 1b study of SD-101 in treatment-naïve, genotype 1 HCV patients show:
* A safety and tolerability profile that compares favorably to that of IFN-alpha, at all four doses tested;
* A dose-dependent antiviral response, with 100% of patients at the highest dose experiencing a greater than one (1) log reduction in viral load; and
* The potency of SD-101 as confirmed by biomarker analysis in patients. The biomarker data point to substantial, dose-related increases in the expression of key antiviral genes (MX-B and ISG-54k) and genes indicating enhanced immunity (IP-10 and MCP-1).
The Phase 1b study evaluated four dose levels of SD-101 in 34 chronically infected, treatment-naïve, genotype 1 HCV patients. SD-101 was administered as a monotherapy once weekly, for four weeks, in doses from 0.1 to 5.0 milligrams per week.
The in vitro data from a study of the drug in human blood cells demonstrate that compared to first-generation TLR9 agonists, SD-101 stimulates 20-fold higher levels of both IFN-alpha and IFN-lambda, two classes of IFNs with potent activity against HCV.
Commercial Opportunity
With the completed acquisition of Symphony Dynamo in January 2010, Dynavax has full development and commercialization rights to SD-101. As such, SD-101 is now part of the portfolio of development programs that are available for partnership.
According to the World Health Organization, there are 170 million people worldwide chronically infected with HCV. We estimate the current worldwide market for HCV therapeutics is over $3 billion annually. While there is no vaccine available to prevent HCV, current therapy includes pegylated interferon alpha and the antiviral drug ribavirin. Both of these therapies may cause significant side effects and are only effective in treating half of all patients infected with HCV.
Our HCV therapy is designed to be used in combination with oral antivirals -- including standard-of care and emerging therapies -- to stop HCV viral replication and induce a long-lasting T-cell immune response.
http://www.dynavax.com/hepatitis_ct.html
Guten Morgen 
Keine News???!!!
Keine News???!!!
Shared power to vote or to direct the vote:
Reporting Person
Shares
Vivo Ventures VI, LLC
6,269,235
Vivo Ventures Fund VI, L.P.
6,223,641
Vivo Ventures VI Affiliates Fund, L.P.
45,594
Vivo Ventures V, LLC
1,476,765
Vivo Ventures Fund V, L.P.
1,459,635
Vivo Ventures V Affiliates Fund, L.P.
17,130
http://investors.dynavax.com/secfiling.cfm?filingID=1019687-…
Last Trade: 1.41
Trade Time: 1:54PM EDT
Change: Up 0.01 (0.71%)
Prev Close: 1.40
Open: 1.41
Bid: 1.40 x 95500
Ask: 1.41 x 5400
1y Target Est: 2.60
Trade Time: 1:54PM EDT
Change: Up 0.01 (0.71%)
Prev Close: 1.40
Open: 1.41
Bid: 1.40 x 95500
Ask: 1.41 x 5400
1y Target Est: 2.60
Dynavax Reports Positive Data on Universal Flu Vaccine Candidate
Key Biological Effects Confirmed
BERKELEY, CA, Apr 26, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today presented preclinical data that confirms the expected immunogenicity and mechanistic effects of its Universal Flu vaccine. In addition to the demonstrated ability of Dynavax's vaccine to generate cytotoxic T-cells and cytotoxic antibodies, the data presented today at the Thirteenth Annual Conference on Vaccine Research in Baltimore, MD, show that the universal components of Dynavax's vaccine enhance the efficacy of a standard flu vaccine by increasing antibody production directed at virus neutralization. These data are key indicators of immunogenicity and the potential for dose-sparing in the event of a pandemic. Dynavax's Universal Flu vaccine is uniquely designed to combine a TLR9 agonist and two conserved antigens, NP and M2e, with a standard trivalent flu vaccine.
"The vaccine candidate presented at the Vaccine Research conference represents the final formulation that we intend to take into the clinic. We have now confirmed the key biological effects of this molecule, and are on-track to begin clinical development imminently," noted Dino Dina, M.D., President and CEO.
Dynavax plans to initiate Phase 1 clinical development of its Universal Flu vaccine by mid-year 2010 at centers that are members of the Vaccine Testing and Evaluation Units (VTEUs) of the National Institute for Allergy and Infectious Disease (NIAID/NIH). A GLP toxicity study has demonstrated that this Universal Flu vaccine candidate is well-tolerated, and clinical material for the upcoming trial has been manufactured.
Dynavax's research and development program has been partially funded by grants from the National Institutes of Health (NIH). Dynavax has a worldwide supply and option agreement with Novartis Vaccines and Diagnostics, Inc. for the Universal Flu vaccine program.
About Dynavax's Universal Flu Vaccine
Standard annual flu vaccines are designed to provide protection against the three strains of the influenza virus that are predicted to be most prevalent in an upcoming flu season. As such, these vaccines do not provide protection against divergent strains that emerge unexpectedly.
Dynavax's novel Universal Flu vaccine is designed to offer protection against divergent strains as well as increase the efficacy and potentially reduce the dose of standard flu vaccine. This unique approach is based on combining two highly conserved antigens and Dynavax's proprietary second-generation TLR9 agonist with standard flu vaccines:
-- Two highly conserved antigens NP and M2e offer protection against divergent strains
Dynavax's Universal Flu vaccine includes two conserved antigens, NP and M2e, which are present in all flu strains. NP, or nucleoprotein, is highly conserved across human and animal strains, while M2e, the extracellular domain of the matrix 2 protein, is conserved but with some variations among species. NP provides cytotoxic T-cell protection and M2e offers protective antibodies for protection against divergent strains.
-- Dynavax's proprietary second-generation TLR9 agonist to enhance efficacy and enable dose-sparing
The conserved antigens NP and M2e are linked to Dynavax's proprietary second-generation TLR9 agonist. This approach has demonstrated the potential to boost the immune response and enable dose sparing, which could extend the quantity of standard flu vaccine available during a pandemic.
-- Standard flu vaccine
Dynavax's Universal Flu vaccine combines the conserved antigens NP and M2e with the Company's proprietary TLR9 agonist and the standard vaccine, which provides neutralizing antibodies. The Company's proprietary component (NP/M2e-ISS) could be combined with any standard flu vaccine, including standard trivalent influenza vaccine (TIV), and vaccines against emerging strains such as H5N1 or H1N1.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," including statements related to our Universal Flu vaccine, including the anticipated timing and investigators for the initial clinical trial and the composition and potential of the vaccine. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the reported results can be replicated in human trials, difficulties or delays in discovery or development, initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our Novartis agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=463…
Der Fels in der Brandung!
Dynavax to start human studies of flu vaccine
Associated Press, 04.27.10, 12:21 PM EDT
NEW YORK -- Shares of Dynavax Technologies Corp. rose Tuesday after the drug developer said it is ready to begin human clinical trials of a vaccine that is intended to provide protection against many flu strains.
The Berkeley, Calif., company said it identified the formulation of the vaccine that it wants to use in human testing. Dynavax plans to start the first clinical trial by midyear.
Article Controls
The main goal of early stage clinical testing is demonstrating that a drug candidate is safe.
Dynavax said standard flu vaccines are designed to protect against the three flu strains that are expected to be the most common in the next flu season. Those vaccines don't provide immunization against strains that develop unexpectedly after the vaccine is created, the company said. The shot could also improve the effectiveness of flu vaccines and possibly allow physicians to use smaller doses, Dynavax said.
The company presented data on the vaccine candidate and discussed its plans at a vaccine research conference in Baltimore. In midday trading, its shares rose 6 cents, or 4.2 percent, to $1.50. Earlier in the day they traded as high as $1.54.
Dynavax Technologies ( DVAX - news - people ) said it has a worldwide supply agreement with the vaccines unit of Swiss drugmaker Novartis ( NVS - news - people ) AG. Its research has received funding from the National Institutes of Health.
http://www.forbes.com/feeds/ap/2010/04/27/business-health-ca…
Associated Press, 04.27.10, 12:21 PM EDT
NEW YORK -- Shares of Dynavax Technologies Corp. rose Tuesday after the drug developer said it is ready to begin human clinical trials of a vaccine that is intended to provide protection against many flu strains.
The Berkeley, Calif., company said it identified the formulation of the vaccine that it wants to use in human testing. Dynavax plans to start the first clinical trial by midyear.
Article Controls
The main goal of early stage clinical testing is demonstrating that a drug candidate is safe.
Dynavax said standard flu vaccines are designed to protect against the three flu strains that are expected to be the most common in the next flu season. Those vaccines don't provide immunization against strains that develop unexpectedly after the vaccine is created, the company said. The shot could also improve the effectiveness of flu vaccines and possibly allow physicians to use smaller doses, Dynavax said.
The company presented data on the vaccine candidate and discussed its plans at a vaccine research conference in Baltimore. In midday trading, its shares rose 6 cents, or 4.2 percent, to $1.50. Earlier in the day they traded as high as $1.54.
Dynavax Technologies ( DVAX - news - people ) said it has a worldwide supply agreement with the vaccines unit of Swiss drugmaker Novartis ( NVS - news - people ) AG. Its research has received funding from the National Institutes of Health.
http://www.forbes.com/feeds/ap/2010/04/27/business-health-ca…
Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue Immunizations
Safety Assessment of First Group of Immunized Subjects Complete
BERKELEY, CA, Apr 27, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 trials for HEPLISAV(TM) has assessed subject safety data for 1,548 subjects that received their first injection and 1,225 subjects that received a second injection, and determined that the studies may continue without modification of the existing protocols.
HEPLISAV is an innovative vaccine designed to protect against hepatitis B infection. The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials evaluating HEPLISAV, one trial in adults 40 years and older, and a second trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=463…
Wer kauft da??
Antwort auf Beitrag Nr.: 39.421.360 von Lucky72 am 28.04.10 21:32:47Lucky,
das war tatsächlich ein riesiger Trade
21:28:24 1,5700 690981
Man durfte ja schon seit längerem das Gefühl haben, dass hier ein Grosser abverkauft. Ständig positive News und immer fällt das Kurs auf die 1,40 USD zurück.
Ich stand schon kurz vorm Schmeissen, warte jetzt aber doch noch mal ab (long DVAX).
Könnte mir vorstellen, dass es jetzt hoch geht...
Gruß
KJ
das war tatsächlich ein riesiger Trade
21:28:24 1,5700 690981
Man durfte ja schon seit längerem das Gefühl haben, dass hier ein Grosser abverkauft. Ständig positive News und immer fällt das Kurs auf die 1,40 USD zurück.
Ich stand schon kurz vorm Schmeissen, warte jetzt aber doch noch mal ab (long DVAX).
Könnte mir vorstellen, dass es jetzt hoch geht...
Gruß
KJ
Antwort auf Beitrag Nr.: 39.422.694 von KillingJoke am 29.04.10 08:24:23Ich sehe aber nicht das hier jemand abverkauft!
Im Gegenteil, Vivo Ventures hat sich schnell mal 4.2Mille ins Depot gelegt!
http://data.cnbc.com/quotes/DVAX/tab/8
Im Gegenteil, Vivo Ventures hat sich schnell mal 4.2Mille ins Depot gelegt!
http://data.cnbc.com/quotes/DVAX/tab/8
Antwort auf Beitrag Nr.: 39.428.422 von Lucky72 am 29.04.10 20:38:57Lucky,
die Liste unter http://data.cnbc.com/quotes/DVAX/tab/8 zeigt schön das Größen-Verhältnis des Trades von 690K. Nur 8 Shareholder halten überhaupt mehr.
Wer ge- oder verkauft hat, sehen wir erst mit den nächsten Filings.
die Liste unter http://data.cnbc.com/quotes/DVAX/tab/8 zeigt schön das Größen-Verhältnis des Trades von 690K. Nur 8 Shareholder halten überhaupt mehr.
Wer ge- oder verkauft hat, sehen wir erst mit den nächsten Filings.
Ziiiieeeeh!!!!
Was geht den heute ab?????
Nächster Halt bei 2$?!
Der Kurs nimmt nochmal Anlauf!
Antwort auf Beitrag Nr.: 39.448.130 von Lucky72 am 03.05.10 21:29:21Oder Gewinnmitnahmen??
Was für eine geile Aktie!!!
Dow 10,926.77 -2.02%
Nasdaq 2,424.25 -2.98%
Healthcare -1.08%
DVAX 1.73 1.76%
Nasdaq 2,424.25 -2.98%
Healthcare -1.08%
DVAX 1.73 1.76%
Wird langsam Zeit das die Zahlen kommen!
Ist das langweilig!!!
Dynavax Reports 2010 First Quarter Financial Results
Conference Call and Webcast Today at 4:30 pm EDT
BERKELEY, CA, May 06, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the first quarter ended March 31, 2010, including $30.1 million in cash and cash equivalents. Total cash for the first quarter 2010 does not include $41 million in net proceeds from the public offering completed on April 16, 2010.
"With the completion of the recent financing, we are poised to achieve our most critical goals, including completion of the Phase 3 study required for submitting our BLA for HEPLISAV(TM), initiating clinical development for our Universal Flu and TLR autoimmune products, and positioning hepatitis B and C therapeutics for out-licensing," noted Dino Dina, M.D., President and CEO.
The tables included as part of this press release provide a reconciliation of GAAP revenues and operating expenses to pro forma revenues and operating expenses.
Conference Call
Dynavax will webcast a conference call today at 4:30 p.m. EDT (1:30 p.m. PDT). The live and archived webcast can be accessed by visiting the investor relations section of the Company's Web site at http://investors.dynavax.com/newsevents.cfm.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties, including statements relating to clinical trials and BLA submission. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
- tables to follow -
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=467…
Dynavax Completes Over 2000 First Immunizations in Phase 3 Study
HEPLISAV Study to Finish in 12 Months
Press Release Source: Dynavax Technologies On Thursday May 6, 2010, 4:00 pm
BERKELEY, CA--(Marketwire - 05/06/10) - Dynavax Technologies Corporation (NASDAQ
VAX - News) today reported completing the first immunizations of over 2,000 subjects enrolled in its large-scale Phase 3 study of HEPLISAV™. This starts a 12-month follow-up on these subjects and sets the study's completion for May 2011. Dynavax said this event supports its goal of a BLA submission for HEPLISAV in the second half of 2011.About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Hepatitis B Vaccines
Currently available hepatitis B vaccines require three doses over six months to achieve full immunogenicity in healthy patient populations. Because compliance with this vaccine regimen is low, new vaccines are needed to provide increased protection with fewer doses in a shorter timeframe. Furthermore, currently available vaccines do not fully address the needs of several patient populations, including those with chronic kidney disease, HIV or chronic liver disease. In particular, patients with compromised immune systems require both rapid and enhanced protection, either because they are less responsive to conventional vaccine regimens or because they are at high risk of infection.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties, including statements relating to clinical trials, and BLA and other regulatory submissions. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
http://finance.yahoo.com/news/Dynavax-Completes-Over-2000-iw…
Lausiges Volumen!
Heute noch 1,80$???
Heute noch 1,90$???
[
b]Federated ...11.6M[/b] $17,936,846
Symphony Capital LLC 9.1M $13,124,575
Biotechnology ...6.2M $9,600,700
Vivo Ventures ...4.2M $5,851,286
Auriana (Lawrence E)3.0M $2,520,000
Howard Hughes ...1.2M $1,588,600
Renaissance ...1.1M $1,591,624
William Harris ...967.6K $1,373,992
Dimensional Fund ...594.3K $772,610
InterWest Partners 584.3K $782,993
b]Federated ...11.6M[/b] $17,936,846
Symphony Capital LLC 9.1M $13,124,575
Biotechnology ...6.2M $9,600,700
Vivo Ventures ...4.2M $5,851,286
Auriana (Lawrence E)3.0M $2,520,000
Howard Hughes ...1.2M $1,588,600
Renaissance ...1.1M $1,591,624
William Harris ...967.6K $1,373,992
Dimensional Fund ...594.3K $772,610
InterWest Partners 584.3K $782,993
Guten Morgen
Das wird heute ein dunkelgrüner Tag!
Das wird heute ein dunkelgrüner Tag!
Pre-Market Charts | After Hours Charts May 12, 2010 Market Close: $ 1.88
After Hours Quote and Chart
After Hours
Last: $ 2.03
High: $ 2.10
After Hours
Volume: 228,181 After Hours
Low: $ 1.87
After Hours Quote and Chart
After Hours
Last: $ 2.03
High: $ 2.10
After Hours
Volume: 228,181 After Hours
Low: $ 1.87
Dynavax (DVAX) Shares Jump as Wedbush Issues After-Hours Upgrade
More News related to Upgrades
May 12, 2010 5:06 PM EDT
Shares of Dynavax Technologies (Nasdaq: DVAX) have surged about 4% in tonight\'s after-hours session as an analyst at Wedbush has assumed and upgraded the stock from Neutral to Outperform and also boosted the firm\'s price target from $2.60 to $6.
The firm said its thesis is based on \"conviction that Heplisav, Dynavax\' lead product candidate, will garner regulatory approvals in the US and EU before year-end 2012.\" Wedbush also said it believes shares of Dynavax are \"depressed in value as a consequence of the clinical hold debacle with Heplisav in 2008-2009.\"
Shares of Dynavax last traded at $1.95, now up about 4% from today\'s close at $1.88.
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases.
http://www.streetinsider.com/Upgrades/Dynavax+%28DVAX%29+Sha…
Der Kurs hält sich super!
Würde mich nicht wundern wenn wir heute noch die 2,30$ sehn!
Kannst Du was Dynavax sagen?
Was sie machen, Verschuldung, Cash, MK, wo die Fantasie liegt und warum die Aktie jetzt auf Outperform gesetzt wurde, etc...
Danke
Was sie machen, Verschuldung, Cash, MK, wo die Fantasie liegt und warum die Aktie jetzt auf Outperform gesetzt wurde, etc...
Danke
Antwort auf Beitrag Nr.: 39.518.772 von VaJo am 14.05.10 10:05:41Hier sind die Zahlen für Q1 / 2010
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=467…
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=467…
Antwort auf Beitrag Nr.: 39.518.772 von VaJo am 14.05.10 10:05:41Dynavax shares rise after analyst raises rating
NEW YORK
Shares of Dynavax Technologies moved higher Thursday as a Wedbush analyst upgraded the stock, saying its hepatitis B vaccine candidate will become a standard treatment for the disease.
Analyst Y. Katherine Xu said Heplisav will be approved in the U.S. and the European Union by the end of 2012 and become the primary hepatitis B vaccine by 2018, with $500 million in sales that year.
Xu raised her rating on the stock to "Outperform" from "Neutral," and increased her price target to $6 per share from $2.60.
The analyst said shares of the Berkeley, Calif., company are still trading at a low price because of doubts over Heplisav's approval. Studies of the drug were halted for 18 months after one patient in a clinical trial was diagnosed with a blood vessel inflammation. Regulators removed a hold on the drug in September, allowing human testing to resume.
Xu said the company has done "exhaustive" safety work on Heplisav and that it is superior to current treatments. She said it is very likely the drug will be approved.
Shares of Dynavax Technologies Corp. rose 13 cents, or 6.9 percent to $2.01 in afternoon trading.
http://www.businessweek.com/ap/financialnews/D9FM3B6O0.htm
NEW YORK
Shares of Dynavax Technologies moved higher Thursday as a Wedbush analyst upgraded the stock, saying its hepatitis B vaccine candidate will become a standard treatment for the disease.
Analyst Y. Katherine Xu said Heplisav will be approved in the U.S. and the European Union by the end of 2012 and become the primary hepatitis B vaccine by 2018, with $500 million in sales that year.
Xu raised her rating on the stock to "Outperform" from "Neutral," and increased her price target to $6 per share from $2.60.
The analyst said shares of the Berkeley, Calif., company are still trading at a low price because of doubts over Heplisav's approval. Studies of the drug were halted for 18 months after one patient in a clinical trial was diagnosed with a blood vessel inflammation. Regulators removed a hold on the drug in September, allowing human testing to resume.
Xu said the company has done "exhaustive" safety work on Heplisav and that it is superior to current treatments. She said it is very likely the drug will be approved.
Shares of Dynavax Technologies Corp. rose 13 cents, or 6.9 percent to $2.01 in afternoon trading.
http://www.businessweek.com/ap/financialnews/D9FM3B6O0.htm
Ist das heute langweilig!
Antwort auf Beitrag Nr.: 39.524.240 von Lucky72 am 14.05.10 21:23:54und bald sind sie pleite
Antwort auf Beitrag Nr.: 39.525.154 von Hoffnungstraeger am 15.05.10 00:39:11Seh ich auch so
Antwort auf Beitrag Nr.: 39.527.570 von VaJo am 16.05.10 10:15:40Dann geht doch short!
Es wird langsam wieder Zeit für News!
Guten Morgen
Seit 6.Mai keine News!
Zum Glück ist der Euro auch abgekackt!
WOW!!!
Dynavax ist jetzt auf Platz 14!!!
Ranking | Company (Ticker) | Potential Upside
14 Dynavax Technologies Corporation (NASDAQ DVAX) 261.4%
http://www.nasd100.com/2010/05/top-us-healthcare-stocks-with…
Dynavax ist jetzt auf Platz 14!!!
Ranking | Company (Ticker) | Potential Upside
14 Dynavax Technologies Corporation (NASDAQ DVAX) 261.4%
http://www.nasd100.com/2010/05/top-us-healthcare-stocks-with…
Na also es geht doch!
Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue Immunizations
Second Safety Assessment Complete
BERKELEY, CA, May 27, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 trials for HEPLISAV(TM) has completed the second of its planned safety assessments. The evaluation included data from 2,264 subjects that received their first injection, 1,611 of whom received their first and second injections. The DSMB determined that the studies may continue without modification.
HEPLISAV is an innovative vaccine designed to protect against hepatitis B infection. The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials evaluating HEPLISAV, one trial in adults 40 years and older, and a second trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=473…
Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue Immunizations
Second Safety Assessment Complete
BERKELEY, CA, May 27, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 trials for HEPLISAV(TM) has completed the second of its planned safety assessments. The evaluation included data from 2,264 subjects that received their first injection, 1,611 of whom received their first and second injections. The DSMB determined that the studies may continue without modification.
HEPLISAV is an innovative vaccine designed to protect against hepatitis B infection. The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials evaluating HEPLISAV, one trial in adults 40 years and older, and a second trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=473…
Antwort auf Beitrag Nr.: 39.552.388 von Lucky72 am 20.05.10 08:29:38
Der Chart sieht nach "GOLDEN CROSS" aus!!!
Der Chart sieht nach "GOLDEN CROSS" aus!!!
Antwort auf Beitrag Nr.: 39.606.093 von Lucky72 am 30.05.10 20:04:51Dynavax mit negativem buchwert,au Backe !!
buchwert,au Backe !!
Antwort auf Beitrag Nr.: 39.609.950 von Zukertort am 31.05.10 17:27:49-30%
Guten Morgen
Ich wünsche allen einen dunkelgrünen Tag!
Ich wünsche allen einen dunkelgrünen Tag!
Es wird langsam Zeit für News!
Was ist heute los?????
Antwort auf Beitrag Nr.: 39.678.473 von Lucky72 am 14.06.10 16:04:28news konnte ich auch nicht finden, aber es gibt eine Erwähnung bei Smartrend.
http://www.mysmartrend.com/news-briefs/news-watch/look-share…
http://www.mysmartrend.com/news-briefs/news-watch/look-share…
Antwort auf Beitrag Nr.: 39.678.623 von randnotiz am 14.06.10 16:24:55Hab ich schon gelesen!
Aber wer kauft deshalb 45k zu 1,85$?
Aber wer kauft deshalb 45k zu 1,85$?
Antwort auf Beitrag Nr.: 39.678.689 von Lucky72 am 14.06.10 16:36:39mir ist egal wer da kauft.
dvax ist noch mein einziger steuerfreier Posten, würde mir wünschen, dass sie mit Heplisav in absehbarer Zeit zu einem Durchbruch kommen.
Die Pipeline ist ja ansonsten eher im Frühstadium.
dvax ist noch mein einziger steuerfreier Posten, würde mir wünschen, dass sie mit Heplisav in absehbarer Zeit zu einem Durchbruch kommen.
Die Pipeline ist ja ansonsten eher im Frühstadium.
Antwort auf Beitrag Nr.: 39.678.863 von randnotiz am 14.06.10 17:03:06Nur schade das der Euro nicht weiter abkackt!
Antwort auf Beitrag Nr.: 39.680.467 von Lucky72 am 14.06.10 21:37:27bis wohin könnte er denn abrutschen? hab leider keine Ahnung von Devisengeschichten
Antwort auf Beitrag Nr.: 39.682.628 von randnotiz am 15.06.10 10:58:19Na,1 : 1!
Geht es jetzt los?
Antwort auf Beitrag Nr.: 39.687.208 von Lucky72 am 15.06.10 21:24:55Lucky! weisst Du wo der nächste Widerstand nach 2$ ist ? das sollte doch mal langsam zu packen sein.
wurden nicht letztes Jahr sogar 10$ prognostiziert?
und seitdem gab es einige gute Nachrichten...
wurden nicht letztes Jahr sogar 10$ prognostiziert?
und seitdem gab es einige gute Nachrichten...
Antwort auf Beitrag Nr.: 39.687.518 von randnotiz am 15.06.10 22:01:17Kursziel ist 6$!
http://www.businessweek.com/ap/financialnews/D9FM3B6O0.htm
http://www.businessweek.com/ap/financialnews/D9FM3B6O0.htm
Antwort auf Beitrag Nr.: 39.687.650 von Lucky72 am 15.06.10 22:16:45ok,danke, also 2012 wirds spannend.
Hi all,
Gruß in die Runde, leider kann ich mich nicht immer um alle Diskusionsforen kümmern... Hab ja auch noch andere "Schätzchen im Depot"...
Bin aber in DVAX seit geraumer Zeit investiert....
Ich weiss nicht ob ihr es schon wußtet,
INDEXAUFNAHME !!
DVAX wir in den RUSSEL 3000
aufgenommen:
Siehe: http://www.russell.com/indexes/membership/reconstitution/Rec…
Gruß
masel
Gruß in die Runde, leider kann ich mich nicht immer um alle Diskusionsforen kümmern... Hab ja auch noch andere "Schätzchen im Depot"...
Bin aber in DVAX seit geraumer Zeit investiert....
Ich weiss nicht ob ihr es schon wußtet,
INDEXAUFNAHME !!
DVAX wir in den RUSSEL 3000
aufgenommen:
Siehe: http://www.russell.com/indexes/membership/reconstitution/Rec…
Gruß
masel
Antwort auf Beitrag Nr.: 39.688.287 von Massel am 16.06.10 07:22:47möge sich die zukünftige Anlegerschaft doch davon inspirieren lassen
NEEWWWS!!!!!
NATURE Publishes New Dynavax Findings on Novel Role of TLRs in Lupus
BERKELEY, CA, Jun 16, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported in NATURE new data that may explain the resistance of lupus patients to glucocorticoid treatment. In the June 16, 2010 issue of NATURE, Dynavax scientists show that activation of cells of the innate immune system by two key receptors, TLR7 and TLR9, can cause glucocorticoid resistance in lupus patients. The data also demonstrate that this resistance can be reversed by Dynavax's novel TLR7/TLR9 inhibitors in human blood cells and animal models of lupus.
Glucocorticoids are widely used for the treatment of many autoimmune and inflammatory conditions, but the high doses required for effective treatment of lupus lead to significant side-effects. In the article entitled, "TLR Recognition of Self Nucleic Acids Hampers Glucocorticoid Activity in Lupus," researchers from Dynavax and their collaborators show that patients' own RNA and DNA can cause a key cell type to become resistant to the killing effects of glucocorticoids. This response to self RNA and DNA operates via two key receptors, TLR7 and TLR9, which are the targets of a novel inhibitory drug being developed by Dynavax.
"Our findings reveal a novel potential for TLR inhibitors to permit effective glucocorticoid therapy with lower, better-tolerated doses," commented Robert Coffman, Ph.D., Chief Scientific Officer of Dynavax. "There is an urgent need for new therapies for lupus and we look forward to advancing our lead TLR inhibitor, DV1179, into clinical trials later this year."
This work was conducted in collaboration with investigators at the Baylor Institute for Immunology Research, the Texas Scottish Rite Hospital and the University of Texas Southwestern Medical Center, all in Dallas, TX; the National Institutes of Health in Bethesda, MD; and the Institut Curie in Paris, France. The research was supported in part by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Allergy and Infectious Diseases, the Alliance for Lupus Research and the Mary Kirkland Center for Lupus Research.
About Dynavax's TLR Inhibitors
Dynavax's TLR inhibitors are a novel class of oligonucleotides, called immunoregulatory sequences (IRS), that specifically inhibit the TLR-induced inflammatory response associated with autoimmune and inflammatory diseases. Preclinical data from animal model studies show Dynavax's TLR inhibitors block induction of IFN-alpha and also reduce symptoms in multiple autoimmune disease animal models, such as lupus, inflammatory skin disorders, and rheumatoid arthritis. Dynavax is developing its TLR inhibitors under a worldwide strategic alliance with GlaxoSmithKline (GSK), whereby GSK has an exclusive option to obtain a license to the program.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties, including statements about data for the Company's IRS, their potential benefits and initiation of clinical trials. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the reported results can be replicated in human trials, difficulties or delays in discovery or development, initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our GSK collaborative agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=480…
NATURE Publishes New Dynavax Findings on Novel Role of TLRs in Lupus
BERKELEY, CA, Jun 16, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported in NATURE new data that may explain the resistance of lupus patients to glucocorticoid treatment. In the June 16, 2010 issue of NATURE, Dynavax scientists show that activation of cells of the innate immune system by two key receptors, TLR7 and TLR9, can cause glucocorticoid resistance in lupus patients. The data also demonstrate that this resistance can be reversed by Dynavax's novel TLR7/TLR9 inhibitors in human blood cells and animal models of lupus.
Glucocorticoids are widely used for the treatment of many autoimmune and inflammatory conditions, but the high doses required for effective treatment of lupus lead to significant side-effects. In the article entitled, "TLR Recognition of Self Nucleic Acids Hampers Glucocorticoid Activity in Lupus," researchers from Dynavax and their collaborators show that patients' own RNA and DNA can cause a key cell type to become resistant to the killing effects of glucocorticoids. This response to self RNA and DNA operates via two key receptors, TLR7 and TLR9, which are the targets of a novel inhibitory drug being developed by Dynavax.
"Our findings reveal a novel potential for TLR inhibitors to permit effective glucocorticoid therapy with lower, better-tolerated doses," commented Robert Coffman, Ph.D., Chief Scientific Officer of Dynavax. "There is an urgent need for new therapies for lupus and we look forward to advancing our lead TLR inhibitor, DV1179, into clinical trials later this year."
This work was conducted in collaboration with investigators at the Baylor Institute for Immunology Research, the Texas Scottish Rite Hospital and the University of Texas Southwestern Medical Center, all in Dallas, TX; the National Institutes of Health in Bethesda, MD; and the Institut Curie in Paris, France. The research was supported in part by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Allergy and Infectious Diseases, the Alliance for Lupus Research and the Mary Kirkland Center for Lupus Research.
About Dynavax's TLR Inhibitors
Dynavax's TLR inhibitors are a novel class of oligonucleotides, called immunoregulatory sequences (IRS), that specifically inhibit the TLR-induced inflammatory response associated with autoimmune and inflammatory diseases. Preclinical data from animal model studies show Dynavax's TLR inhibitors block induction of IFN-alpha and also reduce symptoms in multiple autoimmune disease animal models, such as lupus, inflammatory skin disorders, and rheumatoid arthritis. Dynavax is developing its TLR inhibitors under a worldwide strategic alliance with GlaxoSmithKline (GSK), whereby GSK has an exclusive option to obtain a license to the program.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties, including statements about data for the Company's IRS, their potential benefits and initiation of clinical trials. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the reported results can be replicated in human trials, difficulties or delays in discovery or development, initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our GSK collaborative agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=480…
PRESS RELEASE
June 16, 2010, 1:19 p.m. EDT · Recommend · Post:
NATURE Publishes New Dynavax Findings on Novel Role of TLRs in Lupus
BERKELEY, CA, Jun 16, 2010 (MARKETWIRE via COMTEX) -- Dynavax Technologies Corporation (DVAX 1.97, -0.01, -0.51%) today reported in NATURE new data that may explain the resistance of lupus patients to glucocorticoid treatment. In the June 16, 2010 issue of NATURE, Dynavax scientists show that activation of cells of the innate immune system by two key receptors, TLR7 and TLR9, can cause glucocorticoid resistance in lupus patients. The data also demonstrate that this resistance can be reversed by Dynavax's novel TLR7/TLR9 inhibitors in human blood cells and animal models of lupus.
Glucocorticoids are widely used for the treatment of many autoimmune and inflammatory conditions, but the high doses required for effective treatment of lupus lead to significant side-effects. In the article entitled, "TLR Recognition of Self Nucleic Acids Hampers Glucocorticoid Activity in Lupus," researchers from Dynavax and their collaborators show that patients' own RNA and DNA can cause a key cell type to become resistant to the killing effects of glucocorticoids. This response to self RNA and DNA operates via two key receptors, TLR7 and TLR9, which are the targets of a novel inhibitory drug being developed by Dynavax.
"Our findings reveal a novel potential for TLR inhibitors to permit effective glucocorticoid therapy with lower, better-tolerated doses," commented Robert Coffman, Ph.D., Chief Scientific Officer of Dynavax. "There is an urgent need for new therapies for lupus and we look forward to advancing our lead TLR inhibitor, DV1179, into clinical trials later this year."
This work was conducted in collaboration with investigators at the Baylor Institute for Immunology Research, the Texas Scottish Rite Hospital and the University of Texas Southwestern Medical Center, all in Dallas, TX; the National Institutes of Health in Bethesda, MD; and the Institut Curie in Paris, France. The research was supported in part by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Allergy and Infectious Diseases, the Alliance for Lupus Research and the Mary Kirkland Center for Lupus Research.
About Dynavax's TLR Inhibitors
Dynavax's TLR inhibitors are a novel class of oligonucleotides, called immunoregulatory sequences (IRS), that specifically inhibit the TLR-induced inflammatory response associated with autoimmune and inflammatory diseases. Preclinical data from animal model studies show Dynavax's TLR inhibitors block induction of IFN-alpha and also reduce symptoms in multiple autoimmune disease animal models, such as lupus, inflammatory skin disorders, and rheumatoid arthritis. Dynavax is developing its TLR inhibitors under a worldwide strategic alliance with GlaxoSmithKline (GSK), whereby GSK has an exclusive option to obtain a license to the program.
June 16, 2010, 1:19 p.m. EDT · Recommend · Post:
NATURE Publishes New Dynavax Findings on Novel Role of TLRs in Lupus
BERKELEY, CA, Jun 16, 2010 (MARKETWIRE via COMTEX) -- Dynavax Technologies Corporation (DVAX 1.97, -0.01, -0.51%) today reported in NATURE new data that may explain the resistance of lupus patients to glucocorticoid treatment. In the June 16, 2010 issue of NATURE, Dynavax scientists show that activation of cells of the innate immune system by two key receptors, TLR7 and TLR9, can cause glucocorticoid resistance in lupus patients. The data also demonstrate that this resistance can be reversed by Dynavax's novel TLR7/TLR9 inhibitors in human blood cells and animal models of lupus.
Glucocorticoids are widely used for the treatment of many autoimmune and inflammatory conditions, but the high doses required for effective treatment of lupus lead to significant side-effects. In the article entitled, "TLR Recognition of Self Nucleic Acids Hampers Glucocorticoid Activity in Lupus," researchers from Dynavax and their collaborators show that patients' own RNA and DNA can cause a key cell type to become resistant to the killing effects of glucocorticoids. This response to self RNA and DNA operates via two key receptors, TLR7 and TLR9, which are the targets of a novel inhibitory drug being developed by Dynavax.
"Our findings reveal a novel potential for TLR inhibitors to permit effective glucocorticoid therapy with lower, better-tolerated doses," commented Robert Coffman, Ph.D., Chief Scientific Officer of Dynavax. "There is an urgent need for new therapies for lupus and we look forward to advancing our lead TLR inhibitor, DV1179, into clinical trials later this year."
This work was conducted in collaboration with investigators at the Baylor Institute for Immunology Research, the Texas Scottish Rite Hospital and the University of Texas Southwestern Medical Center, all in Dallas, TX; the National Institutes of Health in Bethesda, MD; and the Institut Curie in Paris, France. The research was supported in part by grants from the National Institute of Arthritis and Musculoskeletal and Skin Diseases, the National Institute of Allergy and Infectious Diseases, the Alliance for Lupus Research and the Mary Kirkland Center for Lupus Research.
About Dynavax's TLR Inhibitors
Dynavax's TLR inhibitors are a novel class of oligonucleotides, called immunoregulatory sequences (IRS), that specifically inhibit the TLR-induced inflammatory response associated with autoimmune and inflammatory diseases. Preclinical data from animal model studies show Dynavax's TLR inhibitors block induction of IFN-alpha and also reduce symptoms in multiple autoimmune disease animal models, such as lupus, inflammatory skin disorders, and rheumatoid arthritis. Dynavax is developing its TLR inhibitors under a worldwide strategic alliance with GlaxoSmithKline (GSK), whereby GSK has an exclusive option to obtain a license to the program.
Dynavax Technologies
Corporation (Nasdaq: DVAX) berichtete heute in den neuen Daten der NATUR, die den Widerstand der Lupuspatienten Glukocorticoidbehandlung erklären können. In der 16. Juni 2010-Ausgabe der NATUR, zeigen Dynavax Wissenschaftler diese Aktivierung der Zellen des angeborenen Immunsystems durch zwei Schlüsselempfänger, TLR7 und TLR9, kann Glukocorticoidwiderstand bei Lupuspatienten verursachen. Die Daten zeigen auch, dass dieser Widerstand durch Dynavaxs neue Hemmnisse TLR7/TLR9 in den menschlichen Blutzellen und in den Tiermodellen von Lupus aufgehoben werden kann.
Glucocorticoids sind für die Behandlung vieler autoimmunen und entzündlichen Bedingungen am meisten benutzt, aber die hohen Dosen, die für wirkungsvolle Behandlung von Lupus erfordert werden, führen zu bedeutende Nebenwirkungen. Im betitelten Artikel, „TLR Anerkennung der Selbstnukleinsäure-Fessel-Glukocorticoidtätigkeit im Lupus,“ Forscher von Dynavax und ihre Mitarbeiter zeigen, dass eigene RNS und DNA der Patienten eine Schlüsselzellenart veranlassen können, gegen die Tötungeffekte von glucocorticoids beständig zu werden. Diese Antwort zur Selbst-RNS und zu DNA funktioniert über zwei Schlüsselempfänger, TLR7 und TLR9, die die Ziele einer neuen hemmenden Droge sind, die von Dynavax sich entwickelt wird.
„Unsere Entdeckungen decken ein neues Potenzial auf, damit TLR Hemmnisse wirkungsvolle Glukocorticoidtherapie mit den untereren, gut-zugelassenen Dosen,“ kommentierter Robert Coffman, Ph.D., wissenschaftlicher hauptsächlichoffizier von Dynavax ermöglichen. „Es gibt ein dringendes Bedürfnis an den neuen Therapien für Lupus und wir freuen uns, unser Hemmnis des Bleis TLR, DV1179, in klinische Studien im Laufe dieses Jahres voranzubringen.“
Diese Arbeit wurde gemeinsam mit Forschern am Baylor Institut für Immunitätsforschung-Forschung, am Texas-schottischen Ritus-Krankenhaus und an der Universität des Texas-südwestlichen Gesundheitszentrums, alles in Dallas, TX durchgeführt; die nationalen Institute der Gesundheit in Bethesda, MD; und das Institut Curie in Paris, Frankreich. Die Forschung wurde in Teil durch Bewilligungen vom nationalen Institut von Arthritis und Musculoskeletal und Haut-Krankheiten, das nationale Institut der Allergie und der Infektionskrankheiten, das Bündnis für Lupus-Forschung und die Mitte Mary-Kirkland für Lupus-Forschung gestützt.
Über Dynavaxs TLR Hemmnisse
Dynavaxs TLR Hemmnisse sind eine neue Kategorie Oligonucleotides, genannt immunoregulatory Reihenfolgen (IRS), die spezifisch die TLR-verursachte entzündliche Antwort hemmen, die mit den autoimmunen und entzündlichen Krankheiten verbunden ist. Präklinische Daten tierischen vorbildlichen Studienerscheinen Dynavaxs TLR von den Hemmnissen blockieren Induktion des IFN-Alphas und verringern auch Symptome in den mehrfachen Autoimmunkrankheittiermodellen, wie Lupus, entzündlichen Hautstörungen und rheumatischer Arthritis
. Dynavax entwickelt seine TLR Hemmnisse unter einem weltweiten strategischen Bündnis mit GlaxoSmithKline (GSK), hingegen GSK eine exklusive Wahl hat, zum einer Lizenz zum Programm zu erreichen.
Über Dynavax
Dynavax Technologies Corporation, eine Klinischstadium biopharmaceutical Firma, entdeckt und entwickelt neue Produkte, um Infektionskrankheiten zu verhindern und zu behandeln. Der Blei-Produktanwärter der Firma ist HEPLISAV™, ein erwachsener Untersuchungsimpfstoff der Hepatitis B, der entworfen ist, um Schutz wenigen Dosen als gegenwärtige genehmigte Impfstoffe schnell und mit zu erhöhen. Für mehr Informationsbesuch www.dynavax.com.
Corporation (Nasdaq: DVAX) berichtete heute in den neuen Daten der NATUR, die den Widerstand der Lupuspatienten Glukocorticoidbehandlung erklären können. In der 16. Juni 2010-Ausgabe der NATUR, zeigen Dynavax Wissenschaftler diese Aktivierung der Zellen des angeborenen Immunsystems durch zwei Schlüsselempfänger, TLR7 und TLR9, kann Glukocorticoidwiderstand bei Lupuspatienten verursachen. Die Daten zeigen auch, dass dieser Widerstand durch Dynavaxs neue Hemmnisse TLR7/TLR9 in den menschlichen Blutzellen und in den Tiermodellen von Lupus aufgehoben werden kann.
Glucocorticoids sind für die Behandlung vieler autoimmunen und entzündlichen Bedingungen am meisten benutzt, aber die hohen Dosen, die für wirkungsvolle Behandlung von Lupus erfordert werden, führen zu bedeutende Nebenwirkungen. Im betitelten Artikel, „TLR Anerkennung der Selbstnukleinsäure-Fessel-Glukocorticoidtätigkeit im Lupus,“ Forscher von Dynavax und ihre Mitarbeiter zeigen, dass eigene RNS und DNA der Patienten eine Schlüsselzellenart veranlassen können, gegen die Tötungeffekte von glucocorticoids beständig zu werden. Diese Antwort zur Selbst-RNS und zu DNA funktioniert über zwei Schlüsselempfänger, TLR7 und TLR9, die die Ziele einer neuen hemmenden Droge sind, die von Dynavax sich entwickelt wird.
„Unsere Entdeckungen decken ein neues Potenzial auf, damit TLR Hemmnisse wirkungsvolle Glukocorticoidtherapie mit den untereren, gut-zugelassenen Dosen,“ kommentierter Robert Coffman, Ph.D., wissenschaftlicher hauptsächlichoffizier von Dynavax ermöglichen. „Es gibt ein dringendes Bedürfnis an den neuen Therapien für Lupus und wir freuen uns, unser Hemmnis des Bleis TLR, DV1179, in klinische Studien im Laufe dieses Jahres voranzubringen.“
Diese Arbeit wurde gemeinsam mit Forschern am Baylor Institut für Immunitätsforschung-Forschung, am Texas-schottischen Ritus-Krankenhaus und an der Universität des Texas-südwestlichen Gesundheitszentrums, alles in Dallas, TX durchgeführt; die nationalen Institute der Gesundheit in Bethesda, MD; und das Institut Curie in Paris, Frankreich. Die Forschung wurde in Teil durch Bewilligungen vom nationalen Institut von Arthritis und Musculoskeletal und Haut-Krankheiten, das nationale Institut der Allergie und der Infektionskrankheiten, das Bündnis für Lupus-Forschung und die Mitte Mary-Kirkland für Lupus-Forschung gestützt.
Über Dynavaxs TLR Hemmnisse
Dynavaxs TLR Hemmnisse sind eine neue Kategorie Oligonucleotides, genannt immunoregulatory Reihenfolgen (IRS), die spezifisch die TLR-verursachte entzündliche Antwort hemmen, die mit den autoimmunen und entzündlichen Krankheiten verbunden ist. Präklinische Daten tierischen vorbildlichen Studienerscheinen Dynavaxs TLR von den Hemmnissen blockieren Induktion des IFN-Alphas und verringern auch Symptome in den mehrfachen Autoimmunkrankheittiermodellen, wie Lupus, entzündlichen Hautstörungen und rheumatischer Arthritis
. Dynavax entwickelt seine TLR Hemmnisse unter einem weltweiten strategischen Bündnis mit GlaxoSmithKline (GSK), hingegen GSK eine exklusive Wahl hat, zum einer Lizenz zum Programm zu erreichen.
Über Dynavax
Dynavax Technologies Corporation, eine Klinischstadium biopharmaceutical Firma, entdeckt und entwickelt neue Produkte, um Infektionskrankheiten zu verhindern und zu behandeln. Der Blei-Produktanwärter der Firma ist HEPLISAV™, ein erwachsener Untersuchungsimpfstoff der Hepatitis B, der entworfen ist, um Schutz wenigen Dosen als gegenwärtige genehmigte Impfstoffe schnell und mit zu erhöhen. Für mehr Informationsbesuch www.dynavax.com.
Antwort auf Beitrag Nr.: 39.693.343 von randnotiz am 16.06.10 19:26:49Jetzt aber aufi auf`n Berg!
Antwort auf Beitrag Nr.: 39.693.398 von Lucky72 am 16.06.10 19:38:09die 2$ erweisen sich aber als sehr hartnäckig,
egal wird schon!
egal wird schon!
Antwort auf Beitrag Nr.: 39.693.490 von randnotiz am 16.06.10 19:51:23
Den Amis die Vormittag verkauft haben ist bestimmt der Burger im Hals stecken geblieben!
Den Amis die Vormittag verkauft haben ist bestimmt der Burger im Hals stecken geblieben!
Antwort auf Beitrag Nr.: 39.693.490 von randnotiz am 16.06.10 19:51:23Welche 2$?
Time & Sales
Price Size Exch Time
1.95 800 NGS 16:00:01
1.99 169 NGS 15:59:58
1.99 900 NGS 15:59:58
1.99 500 NGS 15:59:58
1.99 500 NYE 15:59:57
1.99 100 BATS 15:59:57
1.99 100 BATS 15:59:57
1.99 200 BATS 15:59:57
1.99 500 NGS 15:59:57
Price Size Exch Time
1.95 800 NGS 16:00:01
1.99 169 NGS 15:59:58
1.99 900 NGS 15:59:58
1.99 500 NGS 15:59:58
1.99 500 NYE 15:59:57
1.99 100 BATS 15:59:57
1.99 100 BATS 15:59:57
1.99 200 BATS 15:59:57
1.99 500 NGS 15:59:57
Antwort auf Beitrag Nr.: 39.693.551 von Lucky72 am 16.06.10 19:59:47immer das gleiche, erst hochziehen, dann Gewinne mitnehmen.
sieht aber trotzdem nach gesundem Anstieg aus, die Zocker halten sich
noch zurück
sieht aber trotzdem nach gesundem Anstieg aus, die Zocker halten sich
noch zurück
Antwort auf Beitrag Nr.: 39.694.527 von randnotiz am 16.06.10 22:22:18Das sehe ich auch so!
Nur schade das der Chart jetzt wieder einen "Roten" drin hat!
Und das wegen lausigen 800 Aktien!
http://stockcharts.com/h-sc/ui?s=DVAX&p=D&yr=0&mn=3&dy=0&id=…
Nur schade das der Chart jetzt wieder einen "Roten" drin hat!
Und das wegen lausigen 800 Aktien!
http://stockcharts.com/h-sc/ui?s=DVAX&p=D&yr=0&mn=3&dy=0&id=…
Antwort auf Beitrag Nr.: 39.694.610 von Lucky72 am 16.06.10 22:36:46dafür siehts after hours bis jetzt wieder versöhnlich aus, mit 3690 Stück auf
1.98 $.
1.98 $.
Keine "Wischiwaschinews" und der Kurs hält trotzdem!
Antwort auf Beitrag Nr.: 39.701.170 von Lucky72 am 17.06.10 20:33:32nur so am Rande
http://www.barchart.com/opinions/stocks/DVAX
http://www.barchart.com/opinions/stocks/DVAX
Antwort auf Beitrag Nr.: 39.703.653 von randnotiz am 18.06.10 11:04:50Super Link! Danke!
Ich hoffe die Amis kennen den auch!
Ich hoffe die Amis kennen den auch!
Ein neuer "Big Boy" ist eingestiegen!
Mutual Fund Holders: DVAX
AST Federated Aggressive Growth Portfolio 2.24 M
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Mutual Fund Holders: DVAX
AST Federated Aggressive Growth Portfolio 2.24 M
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Antwort auf Beitrag Nr.: 39.706.159 von Lucky72 am 18.06.10 17:28:30scheint sich ja wirklich zu einem substantiellen Wert zu entwickeln.
leider ist mffais.com nicht aktuell, aber bis 31.03 sieht man dort auch überwiegend Zukäufe.
wünsche ein entspanntes Wochenende
leider ist mffais.com nicht aktuell, aber bis 31.03 sieht man dort auch überwiegend Zukäufe.
wünsche ein entspanntes Wochenende
Antwort auf Beitrag Nr.: 39.707.002 von randnotiz am 18.06.10 20:18:18leider ist mffais.com nicht aktuell,
Nein, aber die Seite von CNBC!
http://data.cnbc.com/quotes/DVAX/tab/8
Nein, aber die Seite von CNBC!
http://data.cnbc.com/quotes/DVAX/tab/8
Antwort auf Beitrag Nr.: 39.707.306 von Lucky72 am 18.06.10 21:23:26ok! die Seite kenn ich. so neu ist der"big boy" aber nicht, er hat ein bisschen
aufgestockt, oder?
http://www.mffais.com/stock-owner/advanced-series-trust---as…
(8.Zeile)
übrigens steht auf cnbc noch was von 0,2% europäischen Aktionären,
damit sind bestimmt wir beide gemeint
aufgestockt, oder?
http://www.mffais.com/stock-owner/advanced-series-trust---as…
(8.Zeile)
übrigens steht auf cnbc noch was von 0,2% europäischen Aktionären,
damit sind bestimmt wir beide gemeint
Antwort auf Beitrag Nr.: 39.708.281 von randnotiz am 19.06.10 11:46:35Sieht nicht schlecht aus für uns!
Dynavax Technologies Corporatio
(NasdaqCM: DVAX)
After Hours: 1.92 Up 0.0008 (0.04%) 4:28PM EDT
Last Trade: 1.92
Trade Time: Jun 18
Change: Down 0.04 (2.04%)
Prev Close: 1.96
Open: 1.98
Bid: 1.77 x 100
Ask: 5.41 x 5000
1y Target Est: 6.00
Ich hoffe das ist ein Zeichen in welche Richtung es geht!
http://finance.yahoo.com/q?s=DVAX
Dynavax Technologies Corporatio
(NasdaqCM: DVAX)
After Hours: 1.92 Up 0.0008 (0.04%) 4:28PM EDT
Last Trade: 1.92
Trade Time: Jun 18
Change: Down 0.04 (2.04%)
Prev Close: 1.96
Open: 1.98
Bid: 1.77 x 100
Ask: 5.41 x 5000
1y Target Est: 6.00
Ich hoffe das ist ein Zeichen in welche Richtung es geht!
http://finance.yahoo.com/q?s=DVAX
Nur zur Info!
Hepatitis-B-Impfstoff kommt aus Hellerhof
Das Düsseldorfer Unter-nehmen Rhein Biotech GmbH, mit Hauptsitz in Düsseldorf-Hellerhof, hat die GMP-Zertifizierung für die Produktion eines neuartigen Hepatitis-B-Impfstoffes erhalten. Die Rhein Biotech hat für ihre US-Mutterfirma, Dynavax Technologies (USA, Berkeley CA), ein Herstell-verfahren für den Impfstoff im kommerziellen Maßstab entwickelt. Dies teilt jetzt die städtische Wirtschaftsförderung mit. Im Pilotmaßstab wurden bereits seit 2006 klinische Prüfmuster des neuen Impfstoffes am Standort Düsseldorf hergestellt. Die jetzt erhaltene Zertifizierung, die für die Produktion des Impfstoffes sowohl für den europäischen als auch den US-amerikanischen Markt notwendig ist, stärkt den Produktionsstandort Düsseldorf-Hellerhof.
Damit erfährt der Life Science Standort Düsseldorf eine erneute Bestätigung. Wie eine jüngste Untersuchung ergab, ist der Life Science Cluster Bioriver, der sich von Bonn über Düsseldorf bis Aachen erstreckt, der bedeutendste in Deutschland und innerhalb dieses Clusters wiederum ist die Landeshauptstadt führend, was die Anzahl der Unternehmen und die Anzahl der Arbeitsplätze in Biotech-Unternehmen anbelangt.
Beigeordneter Wilfried Kruse, in seiner Funktion als Wirtschaftsdezernent auch Vorstandsmitglied von Bioriver: "Rhein Biotech ist seit fast 20 Jahren in unserem Gewerbegebiet Hellerhof angesiedelt und die Wirtschaftsförderer immer wieder in engem Kontakt mit dem Unternehmen, auch gerade bei Fragen der nun anstehenden Standorterweiterung. Diese Zertifizierung ist ein großer Erfolg, auch für die Stadt als Life Science Standort, sichert er doch den Produktionsstandort Hellerhof für Rhein Biotech nachhaltig".
Hintergrund: Hepatitisimpfstoff Heplisav
Heplisav ist ein neuartiger Hepatitis-B-Impfstoff, der derzeit noch in der klinischen Erprobung ist (Phase 3 der klinischen Prüfung, siehe unten). Heplisav zeigte in der Phase 2-Prüfung eine deutlich raschere Schutzwirkung als bisher auf dem Markt befindliche Vakzine. Die weltweiten Rechte für die kommerzielle Verwertung von Heplisav liegen bei Dynavax Technologies, der US-Mutterfirma von Rhein Biotech.
Der Vorteil gegenüber herkömmlichen Hepatitis-B-Impfstoffen liegt darin, dass besonders Patienten mit chronischen Nierenerkrankungen und Patienten mit eingeschränkter Immunabwehr, die eine schnelle und anhaltende Schutzwirkung benötigen, darauf besser ansprechen. Bei bisherigen Impfstoffe sind drei Impfungen über einen Zeitraum von sechs Monaten erforderlich, um einen ausreichenden Impfschutz zu erzielen. Erfahrungsgemäß ist jedoch die Mitwirkung des Patienten im Sinne einer korrekten Einhaltung der empfohlenen Impfung und Impfabstände sehr gering. Heplisav dagegen benötigt lediglich zwei Impfdosen in einem Zeitrahmen von nur einem Monat und bietet damit ein praktikableres Impfschema. Damit verspricht man sich einen besseren Schutz der Patienten, die aufgrund ihres hohen Infektionsrisikos gerade gegen Hepatitis B besonders geschützt werden müssen.
Hintergrund: Dynavax
Dynavax Technology Corporation ist ein biopharmazeutisches Unternehmen mit Hauptsitz in Berkeley, Kalifornien, USA. Unternehmensziel ist die Erforschung und die Entwicklung neuer Produkte zur Vorbeugung und Behandlung von Infektionskrankheiten. Voraussichtlicher Bestseller wird Heplisav, das mit weniger Dosen schneller einen Impfschutz vermitteln kann als die bisher am Markt erhältlichen Impfstoffe.
Hintergrund: Rhein Biotech GmbH
Die seit 25 Jahren am Markt befindliche Rhein Biotech ist ein Spin-off der für ihre Unternehmensausgründungen bekannten Heinrich-Heine- Universität Düsseldorf. Rhein Biotech wurde 1985 gegründet und ist mit deutschem Hauptquartier in Düsseldorf, im Gewerbepark Hellerhof, Eichsfelder Straße 11, ansässig. Rhein Biotech ist seit 2006 Tochterunternehmen von Dynavax. Die Rhein Biotech GmbH hat bereits in der Vergangenheit prophylaktische Impfstoffe entwickelt und weltweit lizensiert. Neben der Heplisav-Impfstoffproduktion arbeitet das Düsseldorfer Unternehmen an der Entwicklung innovativer therapeutischer Impfstoffe (Behandlung von Patienten mit chronischer Hepatitis B)
Nachricht vom 14.1.10 20:59
http://www.unser-duesseldorf.de/barrierearm/index.php?site=n…
Hepatitis-B-Impfstoff kommt aus Hellerhof
Das Düsseldorfer Unter-nehmen Rhein Biotech GmbH, mit Hauptsitz in Düsseldorf-Hellerhof, hat die GMP-Zertifizierung für die Produktion eines neuartigen Hepatitis-B-Impfstoffes erhalten. Die Rhein Biotech hat für ihre US-Mutterfirma, Dynavax Technologies (USA, Berkeley CA), ein Herstell-verfahren für den Impfstoff im kommerziellen Maßstab entwickelt. Dies teilt jetzt die städtische Wirtschaftsförderung mit. Im Pilotmaßstab wurden bereits seit 2006 klinische Prüfmuster des neuen Impfstoffes am Standort Düsseldorf hergestellt. Die jetzt erhaltene Zertifizierung, die für die Produktion des Impfstoffes sowohl für den europäischen als auch den US-amerikanischen Markt notwendig ist, stärkt den Produktionsstandort Düsseldorf-Hellerhof.
Damit erfährt der Life Science Standort Düsseldorf eine erneute Bestätigung. Wie eine jüngste Untersuchung ergab, ist der Life Science Cluster Bioriver, der sich von Bonn über Düsseldorf bis Aachen erstreckt, der bedeutendste in Deutschland und innerhalb dieses Clusters wiederum ist die Landeshauptstadt führend, was die Anzahl der Unternehmen und die Anzahl der Arbeitsplätze in Biotech-Unternehmen anbelangt.
Beigeordneter Wilfried Kruse, in seiner Funktion als Wirtschaftsdezernent auch Vorstandsmitglied von Bioriver: "Rhein Biotech ist seit fast 20 Jahren in unserem Gewerbegebiet Hellerhof angesiedelt und die Wirtschaftsförderer immer wieder in engem Kontakt mit dem Unternehmen, auch gerade bei Fragen der nun anstehenden Standorterweiterung. Diese Zertifizierung ist ein großer Erfolg, auch für die Stadt als Life Science Standort, sichert er doch den Produktionsstandort Hellerhof für Rhein Biotech nachhaltig".
Hintergrund: Hepatitisimpfstoff Heplisav
Heplisav ist ein neuartiger Hepatitis-B-Impfstoff, der derzeit noch in der klinischen Erprobung ist (Phase 3 der klinischen Prüfung, siehe unten). Heplisav zeigte in der Phase 2-Prüfung eine deutlich raschere Schutzwirkung als bisher auf dem Markt befindliche Vakzine. Die weltweiten Rechte für die kommerzielle Verwertung von Heplisav liegen bei Dynavax Technologies, der US-Mutterfirma von Rhein Biotech.
Der Vorteil gegenüber herkömmlichen Hepatitis-B-Impfstoffen liegt darin, dass besonders Patienten mit chronischen Nierenerkrankungen und Patienten mit eingeschränkter Immunabwehr, die eine schnelle und anhaltende Schutzwirkung benötigen, darauf besser ansprechen. Bei bisherigen Impfstoffe sind drei Impfungen über einen Zeitraum von sechs Monaten erforderlich, um einen ausreichenden Impfschutz zu erzielen. Erfahrungsgemäß ist jedoch die Mitwirkung des Patienten im Sinne einer korrekten Einhaltung der empfohlenen Impfung und Impfabstände sehr gering. Heplisav dagegen benötigt lediglich zwei Impfdosen in einem Zeitrahmen von nur einem Monat und bietet damit ein praktikableres Impfschema. Damit verspricht man sich einen besseren Schutz der Patienten, die aufgrund ihres hohen Infektionsrisikos gerade gegen Hepatitis B besonders geschützt werden müssen.
Hintergrund: Dynavax
Dynavax Technology Corporation ist ein biopharmazeutisches Unternehmen mit Hauptsitz in Berkeley, Kalifornien, USA. Unternehmensziel ist die Erforschung und die Entwicklung neuer Produkte zur Vorbeugung und Behandlung von Infektionskrankheiten. Voraussichtlicher Bestseller wird Heplisav, das mit weniger Dosen schneller einen Impfschutz vermitteln kann als die bisher am Markt erhältlichen Impfstoffe.
Hintergrund: Rhein Biotech GmbH
Die seit 25 Jahren am Markt befindliche Rhein Biotech ist ein Spin-off der für ihre Unternehmensausgründungen bekannten Heinrich-Heine- Universität Düsseldorf. Rhein Biotech wurde 1985 gegründet und ist mit deutschem Hauptquartier in Düsseldorf, im Gewerbepark Hellerhof, Eichsfelder Straße 11, ansässig. Rhein Biotech ist seit 2006 Tochterunternehmen von Dynavax. Die Rhein Biotech GmbH hat bereits in der Vergangenheit prophylaktische Impfstoffe entwickelt und weltweit lizensiert. Neben der Heplisav-Impfstoffproduktion arbeitet das Düsseldorfer Unternehmen an der Entwicklung innovativer therapeutischer Impfstoffe (Behandlung von Patienten mit chronischer Hepatitis B)
Nachricht vom 14.1.10 20:59
http://www.unser-duesseldorf.de/barrierearm/index.php?site=n…
Antwort auf Beitrag Nr.: 39.710.335 von Lucky72 am 20.06.10 12:55:18das wird doch wohl kein Witzbold sein !
ask aktuell 2,38x200
Tendenz ist sehr hoffnungsvoll
ask aktuell 2,38x200
Tendenz ist sehr hoffnungsvoll
Keine News!
Ist was im Busch?!
Gleich knallts!
Na dann kanns morgen weiter UUUUPPPP gehn!
After Hours Charts Jun. 24, 2010 Market Close: $ 2.05
After Hours Quote and Chart
After Hours Last: $ 2.0394
After Hours High: $ 2.10
After Hours Volume: 3,678,135
After Hours Low: $ 1.90
After Hours Charts Jun. 24, 2010 Market Close: $ 2.05
After Hours Quote and Chart
After Hours Last: $ 2.0394
After Hours High: $ 2.10
After Hours Volume: 3,678,135
After Hours Low: $ 1.90
Antwort auf Beitrag Nr.: 39.743.324 von Lucky72 am 27.06.10 20:26:44auch hier sehr optimistisch.
http://www.barchart.com/opinions/stocks/DVAX
möchte in den nächsten Wochen endlich die 3 vor dem Komma sehen
http://www.barchart.com/opinions/stocks/DVAX
möchte in den nächsten Wochen endlich die 3 vor dem Komma sehen
Antwort auf Beitrag Nr.: 39.745.324 von randnotiz am 28.06.10 12:58:22Das kann auch schneller gehn!
Top Purchases Today
Fidelity Capital Trust - Fidelity Stock Selector bought 2,951,400 shares of Dynavax Technologies Corp (DVAX), prior they they did not have any shares. Buying DVAX and selling these other Medical-Drugs industry stocks: Auxilium Pharmaceuticals Inc (AUXL) Osi Pharmaceuticals Inc (OSIP) .
http://www.mffais.com/stock/dynavax-technologies-corp.html
@Dino
Wird lagsam Zeit für News!
Wird lagsam Zeit für News!
Fidelity Securities Fund - Otc Portfolio bought 1,004,179 shares of Dynavax Technologies Corp (DVAX), prior they did not have any shares.
http://www.mffais.com/stock/dynavax-technologies-corp.html
Antwort auf Beitrag Nr.: 39.759.929 von Lucky72 am 30.06.10 20:37:44alles sehr schön. leider übt sich der Gesamtmarkt in Hysterie.
Aufwärtstrend ist aber noch intakt. Sehe ich das richtig?
(verfüge leider nur über primitive Kenntnisse der Chartdeutung)
Aufwärtstrend ist aber noch intakt. Sehe ich das richtig?
(verfüge leider nur über primitive Kenntnisse der Chartdeutung)
Antwort auf Beitrag Nr.: 39.760.323 von randnotiz am 30.06.10 21:46:01Noch ist alles im grünen Bereich!
Wird aber höchste Zeit für News!
Antwort auf Beitrag Nr.: 39.760.473 von Lucky72 am 30.06.10 22:05:56danke!
selbst wenn keine news kommt; bis zu den Q2 Zahlen sind es ja nur noch knapp 4 Wochen.
selbst wenn keine news kommt; bis zu den Q2 Zahlen sind es ja nur noch knapp 4 Wochen.
Antwort auf Beitrag Nr.: 39.760.666 von randnotiz am 30.06.10 22:43:30WOW!!!!
Federated Kaufmann Small Cap Fund 6.33 M
Federated Kaufmann Fund 2.75 M
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Federated Kaufmann Small Cap Fund 6.33 M
Federated Kaufmann Fund 2.75 M
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Lausiges Volumen!
Es warten wohl alle auf News!
Es warten wohl alle auf News!
Antwort auf Beitrag Nr.: 39.771.513 von Lucky72 am 02.07.10 20:53:33was will man erwarten bei diesem Marktumfeld, DVAX hält sich sehr gut.
vielleicht ringt sich ja nochmal ein sogenannter Analyst zu einem upgrade durch
vielleicht ringt sich ja nochmal ein sogenannter Analyst zu einem upgrade durch
Antwort auf Beitrag Nr.: 39.771.792 von randnotiz am 02.07.10 21:58:52Das Warten macht mich langsam fix und fertig!
Ich hoffe nur die Fonds bekommen mehr Infos über HEPLISAV!
Ich hoffe nur die Fonds bekommen mehr Infos über HEPLISAV!
Antwort auf Beitrag Nr.: 39.771.942 von Lucky72 am 02.07.10 22:41:08die wird auch weiter fallen , denn auch diese firma wird keine substanz entwickeln, alles nur ein hyp und weg mit ihr
Antwort auf Beitrag Nr.: 39.772.154 von Hoffnungstraeger am 03.07.10 00:20:40fühle mich geehrt, dass nun auch endlich der Geistesadel den Weg in den Thread gefunden hat.
übrigens: hype, nicht hyp
übrigens: hype, nicht hyp
Dynavax Awarded NIH Grant to Explore Feasibility of Universal Papilloma Virus Vaccine
BERKELEY, CA, Jul 06, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the award of a $600,000 grant from the National Institutes of Health (NIH) to explore the feasibility of developing a universal vaccine to prevent infection by human papilloma virus (HPV). In contrast to the two approved HPV vaccines that target approximately 70 percent of HPV strains, Dynavax's goal is to develop a vaccine that provides immunity to nearly all cancer-causing strains of HPV. Each year, 470,000 cervical cancers are diagnosed worldwide, and 250,000 deaths are due to cervical cancers.
About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=485…
Dynavax Initiates First Human Trial in Universal Flu Vaccine Program
BERKELEY, CA, Jul 07, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today the first human clinical trial in its Universal Flu vaccine program. The Phase 1 trial, which began vaccinating subjects in late June, will assess the safety and immunogenicity of N8295, the novel component of Dynavax's Universal Flu vaccine candidate. Approximately 40 subjects, divided into three dose groups, will receive two immunizations of N8295, one month apart. N8295 is a fusion protein comprised of NP and M2e, two highly conserved influenza antigens covalently linked to Dynavax's proprietary second-generation TLR9 agonist. Dynavax expects to report data by year-end 2010.
Novartis Vaccines and Diagnostics, Inc. is committed to supply influenza vaccine for Dynavax's clinical trials under a worldwide supply and option agreement signed in 2008. Novartis has an option to negotiate a joint development and commercialization agreement for Dynavax's Universal Flu vaccine and is obligated to provide commercial supplies of its vaccine once clinical proof-of-concept has been established. A clinical study to demonstrate proof-of-concept data is planned for 2011.
Dynavax's Universal Flu Vaccine is designed to offer protection against divergent influenza strains as well as to increase the efficacy of a standard trivalent inactivated influenza vaccine. Preclinical data have confirmed the expected immunogenicity and mechanistic effects of the vaccine candidate's novel components. The production of cytotoxic T-cells by NP and cytotoxic antibodies by M2e have been demonstrated in preclinical studies, as has an increase in neutralizing antibodies provided by a co-administered inactivated influenza vaccine. A GLP toxicity study demonstrated that this Universal Flu vaccine candidate is well-tolerated.
About Dynavax's Universal Flu Vaccine
Standard annual flu vaccines are designed to provide protection against the three strains of the influenza virus that are predicted to be most prevalent in an upcoming flu season. As such, these vaccines do not provide protection against divergent strains that emerge unexpectedly.
Dynavax's novel Universal Flu vaccine is designed to offer protection against divergent strains as well as increase the efficacy and potentially reduce the dose of standard flu vaccine. This unique approach is based on combining two highly conserved antigens and Dynavax's proprietary second-generation TLR9 agonist with standard flu vaccines:
-- Two highly conserved antigens NP and M2e offer protection against
divergent strains
Dynavax's Universal Flu vaccine includes two conserved antigens, NP and M2e, which are present in all flu strains. NP, or nucleoprotein, is highly conserved across human and animal strains, while M2e, the extracellular domain of the matrix protein, is conserved but with some variations among species. NP provides cytotoxic T-cell protection and M2e offers protective antibodies for protection against divergent strains. Conventional flu vaccines do not induce a response to these antigens.
-- Standard flu vaccine
Dynavax's Universal Flu vaccine combines the conserved antigens NP and M2e linked to the Company's proprietary TLR9 agonist and the standard trivalent flu vaccine to produce neutralizing antibodies. The Company's proprietary component (N8295) could be combined with any standard flu vaccine, including standard trivalent influenza vaccine (TIV) and emerging strains such as H5N1 or H1N1.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward-looking Statements
This press release contains "forward-looking statements," including statements related to the anticipated timing for the availability of data from the initial clinical trial in our universal flu vaccine program and for the proof-of-concept clinical study and the potential features of the vaccine. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether results of completed studies can be replicated in human studies, difficulties or delays in discovery or development, initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our Novartis agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=485…
BERKELEY, CA, Jul 07, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today the first human clinical trial in its Universal Flu vaccine program. The Phase 1 trial, which began vaccinating subjects in late June, will assess the safety and immunogenicity of N8295, the novel component of Dynavax's Universal Flu vaccine candidate. Approximately 40 subjects, divided into three dose groups, will receive two immunizations of N8295, one month apart. N8295 is a fusion protein comprised of NP and M2e, two highly conserved influenza antigens covalently linked to Dynavax's proprietary second-generation TLR9 agonist. Dynavax expects to report data by year-end 2010.
Novartis Vaccines and Diagnostics, Inc. is committed to supply influenza vaccine for Dynavax's clinical trials under a worldwide supply and option agreement signed in 2008. Novartis has an option to negotiate a joint development and commercialization agreement for Dynavax's Universal Flu vaccine and is obligated to provide commercial supplies of its vaccine once clinical proof-of-concept has been established. A clinical study to demonstrate proof-of-concept data is planned for 2011.
Dynavax's Universal Flu Vaccine is designed to offer protection against divergent influenza strains as well as to increase the efficacy of a standard trivalent inactivated influenza vaccine. Preclinical data have confirmed the expected immunogenicity and mechanistic effects of the vaccine candidate's novel components. The production of cytotoxic T-cells by NP and cytotoxic antibodies by M2e have been demonstrated in preclinical studies, as has an increase in neutralizing antibodies provided by a co-administered inactivated influenza vaccine. A GLP toxicity study demonstrated that this Universal Flu vaccine candidate is well-tolerated.
About Dynavax's Universal Flu Vaccine
Standard annual flu vaccines are designed to provide protection against the three strains of the influenza virus that are predicted to be most prevalent in an upcoming flu season. As such, these vaccines do not provide protection against divergent strains that emerge unexpectedly.
Dynavax's novel Universal Flu vaccine is designed to offer protection against divergent strains as well as increase the efficacy and potentially reduce the dose of standard flu vaccine. This unique approach is based on combining two highly conserved antigens and Dynavax's proprietary second-generation TLR9 agonist with standard flu vaccines:
-- Two highly conserved antigens NP and M2e offer protection against
divergent strains
Dynavax's Universal Flu vaccine includes two conserved antigens, NP and M2e, which are present in all flu strains. NP, or nucleoprotein, is highly conserved across human and animal strains, while M2e, the extracellular domain of the matrix protein, is conserved but with some variations among species. NP provides cytotoxic T-cell protection and M2e offers protective antibodies for protection against divergent strains. Conventional flu vaccines do not induce a response to these antigens.
-- Standard flu vaccine
Dynavax's Universal Flu vaccine combines the conserved antigens NP and M2e linked to the Company's proprietary TLR9 agonist and the standard trivalent flu vaccine to produce neutralizing antibodies. The Company's proprietary component (N8295) could be combined with any standard flu vaccine, including standard trivalent influenza vaccine (TIV) and emerging strains such as H5N1 or H1N1.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward-looking Statements
This press release contains "forward-looking statements," including statements related to the anticipated timing for the availability of data from the initial clinical trial in our universal flu vaccine program and for the proof-of-concept clinical study and the potential features of the vaccine. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether results of completed studies can be replicated in human studies, difficulties or delays in discovery or development, initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our Novartis agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=485…
New Research Uncovers Why Many With Lupus Are Resistant to Traditional Treatments
Findings Could Lead to Lower Doses of Medication for Lupus Patients, Reducing Serious Side Effects
DALLAS, July 12 /PRNewswire-USNewswire/ -- Two immune system proteins could be the culprit behind many lupus patients' resistance to widely used steroid treatments, scientists with the Baylor Research Institute (BRI) in Dallas announced today. It is estimated that more than 5 million people suffer from lupus worldwide.
Currently, those with lupus and other autoimmune diseases, commonly treat the condition with corticosteroids to suppress their overactive immune system and prevent it from attacking healthy tissues which can result in symptoms such as inflammation, pain and organ damage.
These steroid treatments work by killing certain immune system cells, including plasmacytoid dendritic cells (PDCs) that overproduce type 1 interferons, an immune system substance that contributes to lupus and other autoimmune diseases. However, unlike other conditions, steroid treatments are not as effective against these cells in those with lupus.
By largely studying children with systemic lupus erythematosus (SLE), BRI scientists in collaboration with scientists at Dynavax in Berkeley, CA, were able to solve the mystery behind the resistance. They determined that two immune system proteins known as toll-receptor 7 (TLR7) and toll-receptor 9 (TLR9), cause an activation of PDCs—the very cells steroids target—negating the effects of treatment. BRI scientists reported their findings in the June issue of the journal Nature.
"We have long known that these receptors played a critical role in lupus, but until now, we didn't know they were directly interfering with the effects of steroid treatments," says Virginia Pascual, M.D., one of the principal investigators of the study and a researcher at Baylor Institute for Immunology Research, a component of BRI. "By blocking TLR7 and TLR9 function, we may have found a safer way to treat this debilitating disease."
Currently, large doses of corticosteroids are required to treat lupus, but can cause serious damage to the organs and create other side effects such as weight gain, cataracts, hypertension, brittle bones and thin skin. In children, corticosteroids can also cause stunted growth. In addition, patients must take other strong immunosuppressants which can leave them vulnerable to infections.
"The ultimate goal is to reduce the amount of steroids these patients take because they carry a risk of serious side effects. Our work suggests that if we can somehow block these proteins from carrying out their mission, steroid treatments will be more effective and we may be able to significantly lower the doses," explains Dr. Pascual.
While Dr. Pascual's research focused mainly on children, she says there is no reason to believe these findings would not be true for adults with lupus as well.
"There are limited treatment options for this disease and the ones that do exist are very hard on the body. It is a complicated condition that is difficult to treat so there is an urgent need for this type of research," says Michael Ramsay, M.D., president of BRI. "Not only have Dr. Pascual and her team made a huge contribution to medical research, but they have given hope to the millions of people who suffer from lupus."
Dr. Ramsay adds that blocking agents for TLR7 and TLR9 are already in development and could be ready for clinical studies soon.
Funding for this study was provided by the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a part of the Department of Health and Human Services' National Institutes of Health (NIH); the Alliance for Lupus Research, the Mary Kirkland Center for Lupus Research and a Small Business Innovation Research Grant.
About Lupus
Systemic lupus erythematosus (SLE) is an autoimmune disease which occurs when the body's immune system begins attacking healthy tissues. As a result, those with the disease often experience inflammation which causes swelling, pain and tissue damage throughout the body and in severe cases, serious organ damage. The exact cause is unknown, but it is thought to be largely genetic. Lupus primarily affects young women with a peak occurrence between the ages of 15-40. According to the Lupus Foundation of America, more than five million people suffer from lupus worldwide.
About Dynavax Technologies
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. For more information, visit www.dynavax.com.
About Baylor Research Institute
Baylor Research Institute (BRI) is a leading research center focused on bringing clinical research findings from the laboratory and making them accessible to patient populations of all types. This concept of "bench-to-bedside" makes the patient the top priority as BRI works to understand the origin of a disease, identify potential treatments or preventative therapies and enroll patients in research trials. With more than 900 active research projects by 300 investigators in 20 medical specialties, the institute is nationally and internationally recognized for developing therapies that advance the care and well-being of our community through basic science, translational research, continuity across therapeutic areas and clinical trials.
As part of Dallas-based Baylor Health Care System, and supported by leading clinicians and world-class scientists, BRI specializes in several key areas including: immunology and its clinical indications (such as cancer), auto-immune diseases, rheumatology, and dermatology as well as transplantation, metabolic diseases, cardiovascular disease, infectious diseases and oncology. Research in these areas is bringing the latest discoveries from the laboratory to patient populations across the country and around the world.
http://www.prnewswire.com/news-releases/new-research-uncover…
SL fischen!
Dynavax Technologies Corporation
$ 1.99
DVAX
-0.05
Short Interest (Shares Short)
3,167,300
Days To Cover (Short Interest Ratio)
2.6
Short Percent of Float
0.39 %
Short Interest - Prior
476,800
Short % Increase / Decrease
564.28 %
Short Squeeze Ranking™
1
http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…
$ 1.99
DVAX
-0.05
Short Interest (Shares Short)
3,167,300
Days To Cover (Short Interest Ratio)
2.6
Short Percent of Float
0.39 %
Short Interest - Prior
476,800
Short % Increase / Decrease
564.28 %
Short Squeeze Ranking™
1
http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…
Ich will heute noch die 2,10$ sehn!
"The trend is your friend"
Antwort auf Beitrag Nr.: 39.816.935 von Hoffnungstraeger am 14.07.10 00:22:14Du meinst sicher 6,0$!
Antwort auf Beitrag Nr.: 39.816.574 von Lucky72 am 13.07.10 22:54:32hoffentlich geht es nach den Q2-Zahlen so weiter!
@Hoffnungstraeger da Dir sicherlich niemand das Wasser reichen kann, wäre es ein großer
Zugewinn den Hintergrund Deiner Kursprognose zu erfahren.
@Hoffnungstraeger da Dir sicherlich niemand das Wasser reichen kann, wäre es ein großer
Zugewinn den Hintergrund Deiner Kursprognose zu erfahren.
Antwort auf Beitrag Nr.: 39.818.935 von randnotiz am 14.07.10 12:18:26ich dachte eher an die 10,-
Die "Big Boys" saugen den ganzen Free Float auf!
http://www.dailyfinance.com/company/dynavax-technologies-cor…
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Guten Morgen!
Ich wünsche allen einen dunkelgrünen Tag!
Ich wünsche allen einen dunkelgrünen Tag!
Die Ruhe vor dem Sturm?!
Jetzt wirds aber höchste Zeit für News!
Auf gehts!
Gibt es hier keine News?
Was ist mit HEPLISAV?
Was ist mit HEPLISAV?
Es gibt News!!!
Dynavax Appoints Daniel Kisner, M.D. to Board of Directors
BERKELEY, CA, Jul 22, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today the appointment of Daniel Kisner, M.D. to its Board of Directors. The addition of Dr. Kisner to the Dynavax Board brings its membership to 10.
Dr. Kisner most recently served as a Partner at Aberdare Ventures and prior to that as President and CEO of Caliper Technologies, leading its evolution from a start-up focused on microfluidic lab-on-a-chip technology to a publicly-traded, commercial organization. Prior to Caliper, he was the President and COO of Isis Pharmaceuticals, Inc.
Previously, Dr. Kisner was Division Vice President of Pharmaceutical Development for Abbott Laboratories and Vice President of Clinical Research and Development at SmithKline Beckman Pharmaceuticals. In addition, he held a tenured position in the Division of Oncology at the University of Texas, San Antonio School of Medicine and is certified by the American Board of Internal Medicine in Internal Medicine and Medical Oncology.
Dr. Kisner serves as Chairman of the Board for Tekmira Pharmaceuticals, and he sits on the boards of several private companies. He holds a BA from Rutgers University and an M.D. from Georgetown University. He is a Venture Partner at Aberdare Ventures, a San Francisco, CA-based venture capital firm.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President, Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=491…
Dynavax Appoints Daniel Kisner, M.D. to Board of Directors
BERKELEY, CA, Jul 22, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today the appointment of Daniel Kisner, M.D. to its Board of Directors. The addition of Dr. Kisner to the Dynavax Board brings its membership to 10.
Dr. Kisner most recently served as a Partner at Aberdare Ventures and prior to that as President and CEO of Caliper Technologies, leading its evolution from a start-up focused on microfluidic lab-on-a-chip technology to a publicly-traded, commercial organization. Prior to Caliper, he was the President and COO of Isis Pharmaceuticals, Inc.
Previously, Dr. Kisner was Division Vice President of Pharmaceutical Development for Abbott Laboratories and Vice President of Clinical Research and Development at SmithKline Beckman Pharmaceuticals. In addition, he held a tenured position in the Division of Oncology at the University of Texas, San Antonio School of Medicine and is certified by the American Board of Internal Medicine in Internal Medicine and Medical Oncology.
Dr. Kisner serves as Chairman of the Board for Tekmira Pharmaceuticals, and he sits on the boards of several private companies. He holds a BA from Rutgers University and an M.D. from Georgetown University. He is a Venture Partner at Aberdare Ventures, a San Francisco, CA-based venture capital firm.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President, Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=491…
Dynavax Reports New Employment Inducement Awards
BERKELEY, CA, Jul 23, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) reported that equity awards were made to two new employees under the Company's 2010 Employment Inducement Award Plan ("the 2010 Plan"). The employees were granted options to purchase an aggregate of 13,000 shares of the Company's common stock at an exercise price of $1.96 per share, the closing price of Dynavax common stock on the date of grant. Dynavax's Board of Directors adopted the 2010 Plan to grant equity awards as a material inducement to new employees. NASDAQ Marketplace Rule 5635(c)(4) requires a public announcement to be issued when awards are made under the 2010 Plan.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies Corporation
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=491…
BERKELEY, CA, Jul 23, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) reported that equity awards were made to two new employees under the Company's 2010 Employment Inducement Award Plan ("the 2010 Plan"). The employees were granted options to purchase an aggregate of 13,000 shares of the Company's common stock at an exercise price of $1.96 per share, the closing price of Dynavax common stock on the date of grant. Dynavax's Board of Directors adopted the 2010 Plan to grant equity awards as a material inducement to new employees. NASDAQ Marketplace Rule 5635(c)(4) requires a public announcement to be issued when awards are made under the 2010 Plan.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies Corporation
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=491…
Guten Morgen!
Ich wünsche uns einen dunkelgrünen Tag!
Ich wünsche uns einen dunkelgrünen Tag!
Hier richts nach gegrillten Shorty!
Antwort auf Beitrag Nr.: 39.876.894 von Lucky72 am 26.07.10 15:50:25smartrend ist auch positiv gestimmt, dann kann es ja nun mal richtig aufwärts gehen
http://www.mysmartrend.com/news-briefs/news-watch/earnings-a…
http://www.mysmartrend.com/news-briefs/news-watch/earnings-a…
Antwort auf Beitrag Nr.: 39.877.301 von randnotiz am 26.07.10 16:40:17Wenn das so weiter geht könnten wir heute noch die 2,3$ sehn!
Sag ich doch, 2,30$!
Antwort auf Beitrag Nr.: 39.879.075 von Lucky72 am 26.07.10 21:09:18nächster Widerstand laut barchart bei 2,34$
http://www.barchart.com/quotes/stocks/DVAX
http://www.barchart.com/quotes/stocks/DVAX
Dynavax Technologies Corporation
$ 2.27
DVAX
0.19
Short Interest (Shares Short)
2,754,300
Days To Cover (Short Interest Ratio)
5.0
Short Percent of Float
0.39 %
Short Interest - Prior
3,167,300
Short % Increase / Decrease
-13.04 %
Short Squeeze Ranking™
0
% From 52-Wk High ($ 3.35 )
-32.24 %
% From 52-Wk Low ($ 1.11 )
104.50 %
% From 200-Day MA ($ 1.58 )
43.67 %
% From 50-Day MA ($ 1.89 )
20.11 %
Price % Change (52-Week)
19.47 %
Shares Float
63,580,000
Total Shares Outstanding
86,573,335
% Owned by Insiders
40.52 %
% Owned by Institutions
6.70 %
Market Cap.
$ 196,521,469
Trading Volume - Today
1,262,608
Trading Volume - Average
545,700
Trading Volume - Today vs. Average
15.22 %
Earnings Per Share
-1.06
PE Ratio
Record Date
2010-JulyB
Sector
Healthcare
Industry
Drug Manufacturers - Other
Exchange
NAS
http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…
$ 2.27
DVAX
0.19
Short Interest (Shares Short)
2,754,300
Days To Cover (Short Interest Ratio)
5.0
Short Percent of Float
0.39 %
Short Interest - Prior
3,167,300
Short % Increase / Decrease
-13.04 %
Short Squeeze Ranking™
0
% From 52-Wk High ($ 3.35 )
-32.24 %
% From 52-Wk Low ($ 1.11 )
104.50 %
% From 200-Day MA ($ 1.58 )
43.67 %
% From 50-Day MA ($ 1.89 )
20.11 %
Price % Change (52-Week)
19.47 %
Shares Float
63,580,000
Total Shares Outstanding
86,573,335
% Owned by Insiders
40.52 %
% Owned by Institutions
6.70 %
Market Cap.
$ 196,521,469
Trading Volume - Today
1,262,608
Trading Volume - Average
545,700
Trading Volume - Today vs. Average
15.22 %
Earnings Per Share
-1.06
PE Ratio
Record Date
2010-JulyB
Sector
Healthcare
Industry
Drug Manufacturers - Other
Exchange
NAS
http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…
Dynavax Completes Enrollment and First Immunizations in Universal Flu Vaccine Study
BERKELEY, CA, Jul 27, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported completing enrollment and the first immunizations of 39 subjects enrolled in its Phase 1 study of the company's Universal Flu vaccine. Safety and immunogenicity data from this study are anticipated in the fourth quarter of this year.
The Phase 1 trial began vaccinating subjects in late June to assess the safety and immunogenicity of N8295, the novel component of Dynavax's Universal Flu vaccine candidate. Since that time, 39 subjects were divided into three dose groups. All subjects have received the first of two immunizations of N8295; all subjects will complete their second immunizations one month after the first. N8295 is a fusion protein comprised of NP and M2e, two highly conserved influenza antigens covalently linked to Dynavax's proprietary second-generation TLR9 agonist.
Dynavax's Universal Flu Vaccine is designed to offer protection against divergent influenza strains as well as to increase the efficacy of a standard trivalent inactivated influenza vaccine. Preclinical data have confirmed the expected immunogenicity and mechanistic effects of the vaccine candidate's novel components. The production of cytotoxic T-cells by NP and cytotoxic antibodies by M2e have been demonstrated in preclinical studies, as has an increase in neutralizing antibodies provided by a co-administered inactivated influenza vaccine. A GLP toxicity study demonstrated that this Universal Flu vaccine candidate is well-tolerated.
Novartis Vaccines and Diagnostics, Inc. is committed to supply influenza vaccine for Dynavax's clinical trials under a worldwide supply and option agreement signed in 2008. Novartis has an option to negotiate a joint development and commercialization agreement for Dynavax's Universal Flu vaccine and is obligated to provide commercial supplies of its vaccine once clinical proof-of-concept has been established. A clinical study to demonstrate proof-of-concept data is planned for 2011.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward-looking Statements
This press release contains "forward-looking statements," including statements related to the anticipated timing for the availability of data from the initial clinical trial in our universal flu vaccine program and for the proof-of-concept clinical study and the potential features of the vaccine. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether results of completed studies can be replicated in human studies, difficulties or delays in discovery or development, initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our Novartis agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=492…
Dynavax Promotes J. Tyler Martin, M.D. to President
BERKELEY, CA, Jul 27, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the promotion of J. Tyler Martin, M.D. to the newly-created position of President and the appointment of Dr. Martin to the company's Board of Directors. Dr. Martin joined Dynavax as Chief Medical Officer in February 2009.
"Tyler has made many significant contributions to advancing the Company's programs since joining us a little more than a year ago, including leading the successful effort to remove the clinical hold on HEPLISAV(TM), reinitiating clinical development and moving our novel Universal Flu vaccine product candidate into the clinic. We look forward to his continuing achievements in his new role," said Dino Dina, M.D., Chief Executive Officer.
Dr. Martin has 20 years of experience in the biotechnology industry. Prior to joining Dynavax, Dr. Martin was President of Humabs Llc and before that he was Vice President, Development at Chiron. In his seven years at Chiron, Dr. Martin led the team responsible for the development of the novel vaccine adjuvant MF59, the first vaccine adjuvant licensed by regulatory agencies since alum, and approved as FLUAD influenza vaccine in Europe. He has also held senior development and research positions at Sangamo, Inc., Valentis, Inc. and SyStemix/GTI. Dr. Martin received a B.S. in Chemistry and an M.D. from the University of Nebraska. He completed his fellowship in pediatric infectious diseases and molecular microbiology at Washington University in St. Louis.
About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=492…
BERKELEY, CA, Jul 27, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the promotion of J. Tyler Martin, M.D. to the newly-created position of President and the appointment of Dr. Martin to the company's Board of Directors. Dr. Martin joined Dynavax as Chief Medical Officer in February 2009.
"Tyler has made many significant contributions to advancing the Company's programs since joining us a little more than a year ago, including leading the successful effort to remove the clinical hold on HEPLISAV(TM), reinitiating clinical development and moving our novel Universal Flu vaccine product candidate into the clinic. We look forward to his continuing achievements in his new role," said Dino Dina, M.D., Chief Executive Officer.
Dr. Martin has 20 years of experience in the biotechnology industry. Prior to joining Dynavax, Dr. Martin was President of Humabs Llc and before that he was Vice President, Development at Chiron. In his seven years at Chiron, Dr. Martin led the team responsible for the development of the novel vaccine adjuvant MF59, the first vaccine adjuvant licensed by regulatory agencies since alum, and approved as FLUAD influenza vaccine in Europe. He has also held senior development and research positions at Sangamo, Inc., Valentis, Inc. and SyStemix/GTI. Dr. Martin received a B.S. in Chemistry and an M.D. from the University of Nebraska. He completed his fellowship in pediatric infectious diseases and molecular microbiology at Washington University in St. Louis.
About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=492…
Ist das heute langweilig! 
Dynavax to Present at the Wedbush Life Sciences Conference
BERKELEY, CA, Jul 29, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the Wedbush Life Sciences Best Ideas Conference 2010 on Tuesday, August 3, 2010 at 8:00 am Eastern Time (5:00 am Pacific Time) at the Le Parker Meridien Hotel in New York.
Dynavax plans to present a corporate overview. To access the live webcast and the subsequent archived recording of the presentation, please log onto Dynavax's website at http://investors.dynavax.com/newsevents.cfm.
About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=493…
moin Lucky!
kommen nun die Q2 Zahlen am Montag? weißt Du evtl mehr?
kommen nun die Q2 Zahlen am Montag? weißt Du evtl mehr?
Antwort auf Beitrag Nr.: 39.905.352 von randnotiz am 30.07.10 17:34:00Mahlzeit Randnotiz!
Auf der HP steht noch nix!
Hab nur das gefunden
08/02/2010 * 18:00 Q2 2010 Dynavax Earnings Release
This event time is tentative
http://www.dailyfinance.com/event/dynavax-technologies-corpo…
Auf der HP steht noch nix!
Hab nur das gefunden
08/02/2010 * 18:00 Q2 2010 Dynavax Earnings Release
This event time is tentative
http://www.dailyfinance.com/event/dynavax-technologies-corpo…
Die Drückerkolonne ist wieder unterwegs!
Antwort auf Beitrag Nr.: 39.905.352 von randnotiz am 30.07.10 17:34:00Die Zahlen sind schon da!!!!!!
Dynavax Reports 2010 Second Quarter Financial Results
BERKELEY, CA, Jul 30, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the second quarter ended June 30, 2010, including $57.4 million in cash and cash equivalents. This compared to $30.1 million at March 31, 2010. In April, the Company completed a financing which resulted in net proceeds of $41 million. The $13.7 million cash usage for the second quarter primarily reflected accelerated enrollment and immunization of over 2,400 subjects in the HEPLISAVTM Phase 3 lot-to-lot consistency and safety study and to a lesser extent, planned investment in early clinical development of the Company's universal flu vaccine and autoimmune program.
Total revenues for the second quarter 2010 were $2.2 million, compared to $15.9 million reported for the second quarter in 2009, of which $13.0 million was non-cash deferred revenue recognized following the termination of the Merck collaboration.
Total operating expenses for the second quarter 2010 were $18.5 million, versus $17.3 million reported for the first quarter 2010, driven by intensified clinical and manufacturing activities for HEPLISAV. Total operating expenses for the second quarter 2009 were $13.0 million prior to restarting the HEPLISAV clinical program in September 2009.
One-time events affected the net loss for the first half of 2010 and 2009. Net loss for the second quarter 2010 was $28.0 million, or $0.34 per share, which included non-operating expense of $11 million resulting from the issuance of common stock and warrants to Symphony in connection with the Company's April 2010 financing. Net income for the second quarter 2009 was $4.1 million, or $0.10 per share, reflecting the non-cash deferred revenue of $13 million described above.
The tables included as part of this press release provide a reconciliation of GAAP revenues and operating expenses to pro forma revenues and operating expenses.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties. Future actual operating and financial results may differ materially due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment and whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. Past financial results are not necessarily indicative of future financial performance. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
- tables to follow -
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=495…
Dynavax Reports 2010 Second Quarter Financial Results
BERKELEY, CA, Jul 30, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the second quarter ended June 30, 2010, including $57.4 million in cash and cash equivalents. This compared to $30.1 million at March 31, 2010. In April, the Company completed a financing which resulted in net proceeds of $41 million. The $13.7 million cash usage for the second quarter primarily reflected accelerated enrollment and immunization of over 2,400 subjects in the HEPLISAVTM Phase 3 lot-to-lot consistency and safety study and to a lesser extent, planned investment in early clinical development of the Company's universal flu vaccine and autoimmune program.
Total revenues for the second quarter 2010 were $2.2 million, compared to $15.9 million reported for the second quarter in 2009, of which $13.0 million was non-cash deferred revenue recognized following the termination of the Merck collaboration.
Total operating expenses for the second quarter 2010 were $18.5 million, versus $17.3 million reported for the first quarter 2010, driven by intensified clinical and manufacturing activities for HEPLISAV. Total operating expenses for the second quarter 2009 were $13.0 million prior to restarting the HEPLISAV clinical program in September 2009.
One-time events affected the net loss for the first half of 2010 and 2009. Net loss for the second quarter 2010 was $28.0 million, or $0.34 per share, which included non-operating expense of $11 million resulting from the issuance of common stock and warrants to Symphony in connection with the Company's April 2010 financing. Net income for the second quarter 2009 was $4.1 million, or $0.10 per share, reflecting the non-cash deferred revenue of $13 million described above.
The tables included as part of this press release provide a reconciliation of GAAP revenues and operating expenses to pro forma revenues and operating expenses.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties. Future actual operating and financial results may differ materially due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment and whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. Past financial results are not necessarily indicative of future financial performance. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
- tables to follow -
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=495…
Also Abverkauf sieht für mich anders aus!
Jul. 30, 2010 Market Close: $ 2.21
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
19:40 $ 2.15 1,000
16:31 $ 2.07 600
16:30 $ 2.17 600
16:30 $ 2.16 400
16:30 $ 2.15 400
16:24 $ 2.21 504
16:18 $ 2.2085 5,900
16:10 $ 2.2065 6,013
16:05 $ 2.2021 5,800
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
Jul. 30, 2010 Market Close: $ 2.21
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
19:40 $ 2.15 1,000
16:31 $ 2.07 600
16:30 $ 2.17 600
16:30 $ 2.16 400
16:30 $ 2.15 400
16:24 $ 2.21 504
16:18 $ 2.2085 5,900
16:10 $ 2.2065 6,013
16:05 $ 2.2021 5,800
http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
Dynavax meldet 2010 Zweites Quartal-Finanzergebnisse
BERKELEY, CA, 30. Juli 2010 (MARKETWIRE über COMTEX Nachrichten-Netz) -- Dynavax Technologies Corporation (Nasdaq: DVAX) meldete heute Finanzergebnisse während des Zweiten Quartals beendetes 30. Juni 2010, einschließlich $57.4 Million in den Bargeld- und Bargeldäquivalenten. Dieses verglich bis $30.1 Million bei 31. März 2010. Im April schloß die Firma eine Finanzierung ab, die Nettoerträge von $41 Million ergab. Der Verbrauch des Bargeldes $13.7 Million während des Zweiten Quartals reflektierte hauptsächlich beschleunigte Einschreibung und Immunisierung von über 2.400 Themen in der HEPLISAVTM Phase 3 Los-zulos Übereinstimmungs- und Sicherheitsstudie und in geringerem Ausmaß, geplante Investition in der frühen klinischen Entwicklung des Universalgrippeimpfstoffs der Firma und autoimmunes Programm.
Gesamteinkommen während des Zweiten Quartals 2010 waren $2.2 Million, verglichen bis $15.9 Million berichtet während des Zweiten Quartals 2009, von dem $13.0 Million die bargeldlosen Ertragsabgrenzungen war, die nach dem Endpunkt der Merck-Zusammenarbeit erkannt wurden.
Gesamtbetriebskosten während des Zweiten Quartals 2010 waren $18.5 Million, gegen $17.3 Million berichtet für das erste Viertel 2010, gefahren durch verstärkte klinische und Herstellungstätigkeiten für HEPLISAV. Gesamtbetriebskosten während des Zweiten Quartals 2009 waren $13.0 Million vor dem Wiederbeginnen des HEPLISAV klinischen Programms im September 2009.
Einmalige Ereignisse beeinflußten den Reinverlust für die erste Hälfte von 2010 und von 2009. Reinverlust während des Zweiten Quartals 2010 war $28.0 Million oder $0.34 pro Anteil, der inoperative Unkosten von $11 Million umfaßte, resultierend von die Austeilung von Stammaktien und die Ermächtigungen zu Symphonie in Zusammenhang mit der April 2010-Finanzierung der Firma. Reineinkommen während des Zweiten Quartals 2009 war $4.1 Million oder $0.10 pro den Anteil und reflektierte die bargeldlosen Ertragsabgrenzungen von $13 Million oben beschrieben.
Die Tabellen, die als Teil dieses Pressekommuniqués eingeschlossen sind, stellen eine Versöhnung der GAAP Einkommen und der Betriebskosten zu den Proformaeinkommen und zu den Betriebskosten zur Verfügung.
Über HEPLISAV
HEPLISAV ist ein erwachsener Untersuchungsimpfstoff der Hepatitis B. Der vaccine Anwärter wird in Zweiphasen3 Studien ausgewertet, die auf befriedigende licensure Anforderungen in US, in Kanada und in Europa gerichtet werden. In einem abgeschlossenen Angelversuch der phase 3 zeigte HEPLISAV erhöhten, schnellen Schutz mit wenigen Dosen als gegenwärtige genehmigte Impfstoffe. Dynavax hat weltweite Handelsrechte zu HEPLISAV und entwickelt den Impfstoff für die großen, hochwertigen Bevölkerungen, die gegenwärtigen genehmigten Impfstoffen weniger entgegenkommend sind, einschließlich Einzelpersonen mit chronischer Nierekrankheit. HEPLISAV kombiniert Oberflächenantigen der Hepatitis B mit einem Eigentümer Abgabe-wie dem Agonisten des Empfängers 9, der als ISS bekannt ist, um die immune Antwort zu erhöhen.
Über Dynavax
Dynavax Technologies Corporation, eine Klinischstadium biopharmaceutical Firma, entdeckt und entwickelt neue Produkte, um Infektionskrankheiten zu verhindern und zu behandeln. Der Blei-Produktanwärter der Firma ist HEPLISAV, ein erwachsener Untersuchungsimpfstoff der Hepatitis B, der entworfen ist, um Schutz wenigen Dosen als gegenwärtige genehmigte Impfstoffe schnell und mit zu erhöhen. Für mehr Informationsbesuch www.dynavax.com.
Vorausschauende Aussagen
Dieses Pressekommuniqué enthält „vorausschauende Aussagen,“, dass abhängig von einigen Risiken und Ungewissheiten seien Sie. Zukünftiger tatsächlicher Betrieb und Finanzergebnisse können sich unterscheiden materiell wegen der Risiken und die Ungewissheiten, die in unserem Geschäft zugehörig sind und umfassen, ob erfolgreiche klinische und regelnde Entwicklung und Zustimmung von HEPLISAV in einer fristgerechten Weise oder ohne bedeutende zusätzliche Studien oder Schwierigkeiten oder Verzögerungen in der Entwicklung oder in der Studieeneinschreibung auftreten können und ob die Studien Ausrichtung für Kommerzialisierung von HEPLISAV stützen können; die Resultate der klinischen Studien und die Auswirkung jener Resultate auf die Einführung und die Beendigung der folgenden Versuche und der Ausgaben, die im regelnden Prozess entstehen; die Fähigkeit der Firma, zusätzliche Finanzierung zu erhalten, um die Entwicklung und die Kommerzialisierung von HEPLISAV und von seinen anderen Betrieben, mögliche Ansprüche zu stützen gegen die Firma basiert auf den Patentrechten von anderen; und anderes riskiert ausführliches im „Risiko-Faktor“ Abschnitt unserer gegenwärtigen periodischen Reports mit der sek. Letzte Finanzergebnisse sind nicht notwendigerweise von der zukünftigen Finanzleistung hinweisend. Wir nehmen uns keine Verpflichtung, hierin zu verbessern oder die Updateinformationen, zum von Ereignissen oder von Umständen zukünftig zu reflektieren auf, selbst wenn neue Informationen vorhanden werden. Informationen über Dynavaxs Web site bei www.dynavax.com werden nicht durch Hinweis in den gegenwärtigen periodischen Reports der Firma mit der sek enthalten.
- Tabellen zum zu folgen -
BERKELEY, CA, 30. Juli 2010 (MARKETWIRE über COMTEX Nachrichten-Netz) -- Dynavax Technologies Corporation (Nasdaq: DVAX) meldete heute Finanzergebnisse während des Zweiten Quartals beendetes 30. Juni 2010, einschließlich $57.4 Million in den Bargeld- und Bargeldäquivalenten. Dieses verglich bis $30.1 Million bei 31. März 2010. Im April schloß die Firma eine Finanzierung ab, die Nettoerträge von $41 Million ergab. Der Verbrauch des Bargeldes $13.7 Million während des Zweiten Quartals reflektierte hauptsächlich beschleunigte Einschreibung und Immunisierung von über 2.400 Themen in der HEPLISAVTM Phase 3 Los-zulos Übereinstimmungs- und Sicherheitsstudie und in geringerem Ausmaß, geplante Investition in der frühen klinischen Entwicklung des Universalgrippeimpfstoffs der Firma und autoimmunes Programm.
Gesamteinkommen während des Zweiten Quartals 2010 waren $2.2 Million, verglichen bis $15.9 Million berichtet während des Zweiten Quartals 2009, von dem $13.0 Million die bargeldlosen Ertragsabgrenzungen war, die nach dem Endpunkt der Merck-Zusammenarbeit erkannt wurden.
Gesamtbetriebskosten während des Zweiten Quartals 2010 waren $18.5 Million, gegen $17.3 Million berichtet für das erste Viertel 2010, gefahren durch verstärkte klinische und Herstellungstätigkeiten für HEPLISAV. Gesamtbetriebskosten während des Zweiten Quartals 2009 waren $13.0 Million vor dem Wiederbeginnen des HEPLISAV klinischen Programms im September 2009.
Einmalige Ereignisse beeinflußten den Reinverlust für die erste Hälfte von 2010 und von 2009. Reinverlust während des Zweiten Quartals 2010 war $28.0 Million oder $0.34 pro Anteil, der inoperative Unkosten von $11 Million umfaßte, resultierend von die Austeilung von Stammaktien und die Ermächtigungen zu Symphonie in Zusammenhang mit der April 2010-Finanzierung der Firma. Reineinkommen während des Zweiten Quartals 2009 war $4.1 Million oder $0.10 pro den Anteil und reflektierte die bargeldlosen Ertragsabgrenzungen von $13 Million oben beschrieben.
Die Tabellen, die als Teil dieses Pressekommuniqués eingeschlossen sind, stellen eine Versöhnung der GAAP Einkommen und der Betriebskosten zu den Proformaeinkommen und zu den Betriebskosten zur Verfügung.
Über HEPLISAV
HEPLISAV ist ein erwachsener Untersuchungsimpfstoff der Hepatitis B. Der vaccine Anwärter wird in Zweiphasen3 Studien ausgewertet, die auf befriedigende licensure Anforderungen in US, in Kanada und in Europa gerichtet werden. In einem abgeschlossenen Angelversuch der phase 3 zeigte HEPLISAV erhöhten, schnellen Schutz mit wenigen Dosen als gegenwärtige genehmigte Impfstoffe. Dynavax hat weltweite Handelsrechte zu HEPLISAV und entwickelt den Impfstoff für die großen, hochwertigen Bevölkerungen, die gegenwärtigen genehmigten Impfstoffen weniger entgegenkommend sind, einschließlich Einzelpersonen mit chronischer Nierekrankheit. HEPLISAV kombiniert Oberflächenantigen der Hepatitis B mit einem Eigentümer Abgabe-wie dem Agonisten des Empfängers 9, der als ISS bekannt ist, um die immune Antwort zu erhöhen.
Über Dynavax
Dynavax Technologies Corporation, eine Klinischstadium biopharmaceutical Firma, entdeckt und entwickelt neue Produkte, um Infektionskrankheiten zu verhindern und zu behandeln. Der Blei-Produktanwärter der Firma ist HEPLISAV, ein erwachsener Untersuchungsimpfstoff der Hepatitis B, der entworfen ist, um Schutz wenigen Dosen als gegenwärtige genehmigte Impfstoffe schnell und mit zu erhöhen. Für mehr Informationsbesuch www.dynavax.com.
Vorausschauende Aussagen
Dieses Pressekommuniqué enthält „vorausschauende Aussagen,“, dass abhängig von einigen Risiken und Ungewissheiten seien Sie. Zukünftiger tatsächlicher Betrieb und Finanzergebnisse können sich unterscheiden materiell wegen der Risiken und die Ungewissheiten, die in unserem Geschäft zugehörig sind und umfassen, ob erfolgreiche klinische und regelnde Entwicklung und Zustimmung von HEPLISAV in einer fristgerechten Weise oder ohne bedeutende zusätzliche Studien oder Schwierigkeiten oder Verzögerungen in der Entwicklung oder in der Studieeneinschreibung auftreten können und ob die Studien Ausrichtung für Kommerzialisierung von HEPLISAV stützen können; die Resultate der klinischen Studien und die Auswirkung jener Resultate auf die Einführung und die Beendigung der folgenden Versuche und der Ausgaben, die im regelnden Prozess entstehen; die Fähigkeit der Firma, zusätzliche Finanzierung zu erhalten, um die Entwicklung und die Kommerzialisierung von HEPLISAV und von seinen anderen Betrieben, mögliche Ansprüche zu stützen gegen die Firma basiert auf den Patentrechten von anderen; und anderes riskiert ausführliches im „Risiko-Faktor“ Abschnitt unserer gegenwärtigen periodischen Reports mit der sek. Letzte Finanzergebnisse sind nicht notwendigerweise von der zukünftigen Finanzleistung hinweisend. Wir nehmen uns keine Verpflichtung, hierin zu verbessern oder die Updateinformationen, zum von Ereignissen oder von Umständen zukünftig zu reflektieren auf, selbst wenn neue Informationen vorhanden werden. Informationen über Dynavaxs Web site bei www.dynavax.com werden nicht durch Hinweis in den gegenwärtigen periodischen Reports der Firma mit der sek enthalten.
- Tabellen zum zu folgen -
Antwort auf Beitrag Nr.: 39.907.206 von Lucky72 am 31.07.10 07:57:41danke, hab ich doch glatt übersehen.
die Verluste sind etwas höher als erwartet. die Schätzungen beliefen sich, glaube ich
auf -0,13$/Aktie.
naja...wird schon!!
die Verluste sind etwas höher als erwartet. die Schätzungen beliefen sich, glaube ich
auf -0,13$/Aktie.
naja...wird schon!!
Antwort auf Beitrag Nr.: 39.907.772 von randnotiz am 31.07.10 13:36:23Also ich mach mir da keine Sorgen!
70% der Aktien werden von Institutions, Fonds und Insidern gehalten!
Wenn morgen ein Rücksetzer kommen sollte, werden sie wohl versuchen den Rest auch noch aufzusammeln!
(Nur meien Meinung)
Meine Aktien bekommen sie aber nicht!
70% der Aktien werden von Institutions, Fonds und Insidern gehalten!
Wenn morgen ein Rücksetzer kommen sollte, werden sie wohl versuchen den Rest auch noch aufzusammeln!
(Nur meien Meinung)
Meine Aktien bekommen sie aber nicht!
Mal schaun ob wir heute noch "Grün" sehn!
Kommt heute was?
Dynavax to Present at the Wedbush Life Sciences Conference
BERKELEY, CA, Jul 29, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the Wedbush Life Sciences Best Ideas Conference 2010 on Tuesday, August 3, 2010 at 8:00 am Eastern Time (5:00 am Pacific Time) at the Le Parker Meridien Hotel in New York.
Dynavax plans to present a corporate overview. To access the live webcast and the subsequent archived recording of the presentation, please log onto Dynavax's website at http://investors.dynavax.com/newsevents.cfm.
About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
Dynavax to Present at the Wedbush Life Sciences Conference
BERKELEY, CA, Jul 29, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the Wedbush Life Sciences Best Ideas Conference 2010 on Tuesday, August 3, 2010 at 8:00 am Eastern Time (5:00 am Pacific Time) at the Le Parker Meridien Hotel in New York.
Dynavax plans to present a corporate overview. To access the live webcast and the subsequent archived recording of the presentation, please log onto Dynavax's website at http://investors.dynavax.com/newsevents.cfm.
About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
"The trend is your friend"
Vanguard Group, Inc. hat sich nochmal 765,968 ins Depot gelegt!
http://www.dailyfinance.com/company/dynavax-technologies-cor…" target="_blank" rel="nofollow ugc noopener">http://www.dailyfinance.com/company/dynavax-technologies-cor…
http://www.dailyfinance.com/company/dynavax-technologies-cor…" target="_blank" rel="nofollow ugc noopener">http://www.dailyfinance.com/company/dynavax-technologies-cor…
Guten Morgen
Es wird langsam Zeit für einen FDA Update!
Es wird langsam Zeit für einen FDA Update!
Da hat wohl einer zuviel "Feuerwasser" getrunken!
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
16:56 $ 2.26 200
16:56 $ 2.26 200
16:56 $ 2.26 100
16:19 $ 1.99 1,600
16:05 $ 2.0031 700
Read more: http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
16:56 $ 2.26 200
16:56 $ 2.26 200
16:56 $ 2.26 100
16:19 $ 1.99 1,600
16:05 $ 2.0031 700
Read more: http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…
WOW!
Da sind heute 0,2% der gesamten Aktien gehandelt worden!!!
Da sind heute 0,2% der gesamten Aktien gehandelt worden!!!
Fidelity Management & Research legen sich 3.42 M ins Depot!
Jetzt werden schon insgesamt 73,3% der OS von Large Block Holder gehalten!
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Jetzt werden schon insgesamt 73,3% der OS von Large Block Holder gehalten!
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Der Markt ist heute wieder richtig abgekackt!
Und Dynavax brav hinterher!
Und Dynavax brav hinterher!
@Dino
Wir brauchen NEWS!
Wir brauchen NEWS!
Keine News!
Super "Management"!
Super "Management"!
WOW!
84,34% der OS werden von "Big Boys" gehalten!
http://www.dailyfinance.com/company/dynavax-technologies-cor…
84,34% der OS werden von "Big Boys" gehalten!
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Ich such schon mal die Raketenbilder raus!
Seit drei Wochen keine News!!
Antwort auf Beitrag Nr.: 40.007.474 von Lucky72 am 18.08.10 19:22:21Jetzt sind es 85,28% der OS!
Steigt nächst Woche die...
Steigt nächst Woche die...
Antwort auf Beitrag Nr.: 40.025.505 von Lucky72 am 21.08.10 22:10:42die big boys werden schon wissen, was sie tun. das Managment hält sich allerdings sehr zurück
mit Insiderkäufen.
http://www.insidercow.com/
mit Insiderkäufen.
http://www.insidercow.com/
Das wird wohl heute wieder Nix mit News!
Seit vier Wochen keine News!
Tolle Leistung vom Management!
Tolle Leistung vom Management!
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
(e) Compensation Arrangements of Certain Officers
On August 25, 2010, the Board of Directors (the "Board") of Dynavax Technologies Corporation ("Dynavax" or the "Company") modified the compensation for J. Tyler Martin, M.D. to reflect Dr. Martin's July 2010 promotion to President of the Company. As a result, Dr. Martin's cash-based compensation was increased to an annual base salary of $375,000 and an annual target incentive of 55% of his base salary, payable if corporate and individual goals are achieved. In addition, the Board granted Dr. Martin an option to purchase 517,244 shares of Dynavax Common Stock at an exercise price of $1.72, which represents the closing stock price on the date of grant. The stock option award will vest in equal annual installments through the fourth anniversary of the date of grant, subject to Dr. Martin's continuous service with the Company through each applicable vesting date.
Management Continuity and Severance Agreements
Also on August 25, 2010, the Board amended the terms of the Management Continuity and Severance Agreements (the "Agreements") for each of Dr. Martin and Dino Dina, M.D., the Company's Chief Executive Officer. The Agreements provide severance payments and benefits to executives upon termination of employment under certain circumstances, including a change of control of the Company. The Board amended the Agreements for each of Drs. Martin and Dina as follows:
Dr. Martin. In the event of an "involuntary" termination without "cause", for "good reason" (as such terms are defined in the Agreements), Dr. Martin will receive (i) a lump-sum cash payment equal to twelve (12) months of his then effective annual base salary, (ii) continuing health care coverage for twelve (12) months upon his election of COBRA continuation coverage, and (iii) an additional twelve (12) months vesting of unvested options to purchase Dynavax Common Stock, with an exercisability period of three (3) months.
In the event of a "change in control" of Dynavax (as such term is defined in the Agreements), Dr. Martin will receive two (2) years additional vesting of unvested options to purchase Dynavax Common Stock. Further, if Dr. Martin's employment is terminated for any reason, including voluntary resignation, within two (2) years of a change in control, he will also receive (i) a lump-sum cash payment equal to eighteen (18) months of his then effective annual base salary, (ii) a lump-sum cash payment equal to his target incentive bonus, (iii) continuing health care coverage for eighteen (18) months upon the his election of COBRA continuation coverage, and (iv) a three-year exercise period of all vested options to purchase Dynavax Common Stock, but not to exceed the expiration date of any option.
Dr. Dina. In the event of an "involuntary" termination of employment without "cause", for "good reason", Dr. Dina will receive (i) a lump-sum cash payment equal to twenty-four (24) months of the his then effective annual base salary, (ii) continuing health care coverage for twenty-four (24) months upon the his election of COBRA continuation coverage, and (iii) vesting of all unvested options to purchase Dynavax Common Stock, with an exercisability period of three (3) years, but not to exceed the expiration date of any option.
In the event of a "change in control" of Dynavax, Dr. Dina will receive vesting of all unvested options to purchase shares of Dynavax Common Stock. Further, if Dr. Dina's employment is terminated for any reason, including voluntary resignation, within two (2) years of a "change in control," he will also receive (i) a lump-sum cash payment equal to twenty-four (24) months of the his then effective annual base salary, (ii) a lump-sum cash payment equal to his target incentive bonus, (iii) continuing health care coverage for twenty-four (24) months upon his election of COBRA continuation coverage, and (iv) a three-year exercise period of all options to purchase Dynavax Common Stock following termination of employment, but not to exceed the expiration date of any option.
Although Drs. Martin and Dina are each in agreement with the material terms set forth above, the summary above is qualified in its entirety by the final Agreements, which will be filed following execution by the respective parties.
http://investors.dynavax.com/secfiling.cfm?filingID=1181431-…
(e) Compensation Arrangements of Certain Officers
On August 25, 2010, the Board of Directors (the "Board") of Dynavax Technologies Corporation ("Dynavax" or the "Company") modified the compensation for J. Tyler Martin, M.D. to reflect Dr. Martin's July 2010 promotion to President of the Company. As a result, Dr. Martin's cash-based compensation was increased to an annual base salary of $375,000 and an annual target incentive of 55% of his base salary, payable if corporate and individual goals are achieved. In addition, the Board granted Dr. Martin an option to purchase 517,244 shares of Dynavax Common Stock at an exercise price of $1.72, which represents the closing stock price on the date of grant. The stock option award will vest in equal annual installments through the fourth anniversary of the date of grant, subject to Dr. Martin's continuous service with the Company through each applicable vesting date.
Management Continuity and Severance Agreements
Also on August 25, 2010, the Board amended the terms of the Management Continuity and Severance Agreements (the "Agreements") for each of Dr. Martin and Dino Dina, M.D., the Company's Chief Executive Officer. The Agreements provide severance payments and benefits to executives upon termination of employment under certain circumstances, including a change of control of the Company. The Board amended the Agreements for each of Drs. Martin and Dina as follows:
Dr. Martin. In the event of an "involuntary" termination without "cause", for "good reason" (as such terms are defined in the Agreements), Dr. Martin will receive (i) a lump-sum cash payment equal to twelve (12) months of his then effective annual base salary, (ii) continuing health care coverage for twelve (12) months upon his election of COBRA continuation coverage, and (iii) an additional twelve (12) months vesting of unvested options to purchase Dynavax Common Stock, with an exercisability period of three (3) months.
In the event of a "change in control" of Dynavax (as such term is defined in the Agreements), Dr. Martin will receive two (2) years additional vesting of unvested options to purchase Dynavax Common Stock. Further, if Dr. Martin's employment is terminated for any reason, including voluntary resignation, within two (2) years of a change in control, he will also receive (i) a lump-sum cash payment equal to eighteen (18) months of his then effective annual base salary, (ii) a lump-sum cash payment equal to his target incentive bonus, (iii) continuing health care coverage for eighteen (18) months upon the his election of COBRA continuation coverage, and (iv) a three-year exercise period of all vested options to purchase Dynavax Common Stock, but not to exceed the expiration date of any option.
Dr. Dina. In the event of an "involuntary" termination of employment without "cause", for "good reason", Dr. Dina will receive (i) a lump-sum cash payment equal to twenty-four (24) months of the his then effective annual base salary, (ii) continuing health care coverage for twenty-four (24) months upon the his election of COBRA continuation coverage, and (iii) vesting of all unvested options to purchase Dynavax Common Stock, with an exercisability period of three (3) years, but not to exceed the expiration date of any option.
In the event of a "change in control" of Dynavax, Dr. Dina will receive vesting of all unvested options to purchase shares of Dynavax Common Stock. Further, if Dr. Dina's employment is terminated for any reason, including voluntary resignation, within two (2) years of a "change in control," he will also receive (i) a lump-sum cash payment equal to twenty-four (24) months of the his then effective annual base salary, (ii) a lump-sum cash payment equal to his target incentive bonus, (iii) continuing health care coverage for twenty-four (24) months upon his election of COBRA continuation coverage, and (iv) a three-year exercise period of all options to purchase Dynavax Common Stock following termination of employment, but not to exceed the expiration date of any option.
Although Drs. Martin and Dina are each in agreement with the material terms set forth above, the summary above is qualified in its entirety by the final Agreements, which will be filed following execution by the respective parties.
http://investors.dynavax.com/secfiling.cfm?filingID=1181431-…
WOW!
Heute sind schon 120K Aktien gehandelt worden!
Heute sind schon 120K Aktien gehandelt worden!
Guten Morgen
Wer ist Melissa Malhame???
Ms Melissa Malhame,
Senior Director
Dynavax Technologies
Melissa Malhame., MBA is the Sr. Director of Marketing and Product Management at Dynavax Technologies. Ms. Malhame holds a MBA from Cornell University's Johnson Graduate School of Management in marketing and general management. Melissa has worked during the past fifteen years in various vaccine marketing, sales and business development positions of increasing responsibility with Merck Vaccine Division, and Dynavax Technologies. Her responsibilities have included Market Research and Business Development, Promotion Management, Physician and Institutional Sales and Product Management with Merck. At Dynavax Melissa has had responsibility as Project Leader of their lead Phase 3 hepatitis B vaccine, HEPLISAV, including the negotiation and management of a collaboration between Dynavax and Merck for development of the vaccine.
Day Two - Tuesday 5 October 2010 3.15pm
Moving forward with Heplisav™ – a new chapter in phase trials and strategy
* Identifying next steps after recent pivotal trials data demonstrating clinical benefit
* Planned Phase III registration trial and Phase III lot-to-lot consistency trial
* What is on the horizon for US registration trials and European development strategies?
Ms Melissa Malhame,
Senior Director,
Dynavax Technologies
http://www.terrapinn.com/2010/wvcl/SPK-ms-melissa-MALHAME.st…
Wer ist Melissa Malhame???
Ms Melissa Malhame,
Senior Director
Dynavax Technologies
Melissa Malhame., MBA is the Sr. Director of Marketing and Product Management at Dynavax Technologies. Ms. Malhame holds a MBA from Cornell University's Johnson Graduate School of Management in marketing and general management. Melissa has worked during the past fifteen years in various vaccine marketing, sales and business development positions of increasing responsibility with Merck Vaccine Division, and Dynavax Technologies. Her responsibilities have included Market Research and Business Development, Promotion Management, Physician and Institutional Sales and Product Management with Merck. At Dynavax Melissa has had responsibility as Project Leader of their lead Phase 3 hepatitis B vaccine, HEPLISAV, including the negotiation and management of a collaboration between Dynavax and Merck for development of the vaccine.
Day Two - Tuesday 5 October 2010 3.15pm
Moving forward with Heplisav™ – a new chapter in phase trials and strategy
* Identifying next steps after recent pivotal trials data demonstrating clinical benefit
* Planned Phase III registration trial and Phase III lot-to-lot consistency trial
* What is on the horizon for US registration trials and European development strategies?
Ms Melissa Malhame,
Senior Director,
Dynavax Technologies
http://www.terrapinn.com/2010/wvcl/SPK-ms-melissa-MALHAME.st…
NEWS!
NIAID Grant to Fund Dynavax Research on Hepatitis B Vaccination and Individual Variations in Human Responsiveness
BERKELEY, CA, Aug 31, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today a grant from the National Institute of Allergy and Infectious Diseases (NIAID) to take a systems biology approach to study the differences between individuals that do or do not respond to vaccination against the Hepatitis B virus. This study will be one of several projects covered in a five-year, $17.6 million grant to Dr. Jacques Banchereau of the Baylor Institute of Immunology Research in Dallas as part of the Human Immune Phenotyping Centers program.
According to Dynavax's Chief Scientific Officer, Robert L. Coffman, Ph.D., "HEPLISAV(TM), our investigational hepatitis B vaccine candidate, has already demonstrated an ability to protect certain patients, for example, the elderly and chronically ill, who are normally less- or non-responsive to conventional vaccines. With this grant, we have the opportunity to study the underlying mechanisms that affect a target population's ability to respond to immunization."
About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=503…
NIAID Grant to Fund Dynavax Research on Hepatitis B Vaccination and Individual Variations in Human Responsiveness
BERKELEY, CA, Aug 31, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today a grant from the National Institute of Allergy and Infectious Diseases (NIAID) to take a systems biology approach to study the differences between individuals that do or do not respond to vaccination against the Hepatitis B virus. This study will be one of several projects covered in a five-year, $17.6 million grant to Dr. Jacques Banchereau of the Baylor Institute of Immunology Research in Dallas as part of the Human Immune Phenotyping Centers program.
According to Dynavax's Chief Scientific Officer, Robert L. Coffman, Ph.D., "HEPLISAV(TM), our investigational hepatitis B vaccine candidate, has already demonstrated an ability to protect certain patients, for example, the elderly and chronically ill, who are normally less- or non-responsive to conventional vaccines. With this grant, we have the opportunity to study the underlying mechanisms that affect a target population's ability to respond to immunization."
About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=503…
WOW! Die News hat eingeschlagen wie eine Bombe!
1.62$
-0.08 (-4.71%)
1.62$
-0.08 (-4.71%)
87,53% der OS werden jetzt schon von den "Big Boys" gehalten!
Die Beiden sind neu!
iShares Russell 2000 Index Fund 935,041
iShares Russell 2000 Growth Index Fund 437,958
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Die Beiden sind neu!
iShares Russell 2000 Index Fund 935,041
iShares Russell 2000 Growth Index Fund 437,958
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Guten Morgen
Ich wünsche uns einen dunkelgrünen Tag!
Ich wünsche uns einen dunkelgrünen Tag!
Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis
This study is not yet open for participant recruitment.
Verified by Dynavax Technologies Corporation, September 2010
First Received: September 2, 2010
Estimated Enrollment: 150
Study Start Date: October 2010
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
http://clinicaltrials.gov/ct2/show/NCT01195246?term=HEPLISAV…
Super, ich kann wieder posten.
Danke
Danke
Wird Zeit für News!
Ob das dem Kurs hilft?
Dynavax to Present at the UBS Global Life Sciences Conference
BERKELEY, CA, Sep 16, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that its Chief Business Officer, Michael Ostrach, plans to make a formal presentation at UBS Global Life Sciences Conference 2010 on Monday, September 20, 2010 at 2:00 pm Eastern Time (11:00 am Pacific Time) at the Grand Hyatt Hotel in New York City, NY.
Mr. Ostrach will present a corporate overview, which will be webcast. To access the live webcast and the subsequent archived recording of the presentation, please log onto Dynavax's website at http://investors.dynavax.com/newsevents.cfm.
About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=508…
Dynavax to Present at the UBS Global Life Sciences Conference
BERKELEY, CA, Sep 16, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that its Chief Business Officer, Michael Ostrach, plans to make a formal presentation at UBS Global Life Sciences Conference 2010 on Monday, September 20, 2010 at 2:00 pm Eastern Time (11:00 am Pacific Time) at the Grand Hyatt Hotel in New York City, NY.
Mr. Ostrach will present a corporate overview, which will be webcast. To access the live webcast and the subsequent archived recording of the presentation, please log onto Dynavax's website at http://investors.dynavax.com/newsevents.cfm.
About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=508…
WOW! Die News hat eingeschlagen wie eine Bombe!
Wie Yahoo Finance auf "Strong Buy" kommt ist mir schleierhaft!
"Big Boys" sammeln weiter!
Jetzt schon 88,83% der OS!!!!
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Jetzt schon 88,83% der OS!!!!
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Form 8-K for DYNAVAX TECHNOLOGIES CORP
20-Sep-2010
Entry into a Material Definitive Agreement, Termination of a Material D
Item 1.01 Entry into a Material Definitive Agreement.
On September 20, 2010, Dynavax Technologies Corporation, a Delaware corporation ("Dynavax" or the "Company"), entered into a Common Stock Purchase Agreement (the "Purchase Agreement") with Aspire Capital Fund, LLC, an Illinois limited liability company ("Aspire Capital"), which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $30.0 million of shares of Dynavax common stock (the "Purchase Shares") over the term of the Purchase Agreement. Under the Purchase Agreement, the Company agreed to pay Aspire Capital a commitment fee equal to 4% of $30 million in consideration for Aspire Capital's obligation to purchase up to $30 million of Dynavax common stock. Dynavax paid this commitment fee by issuance of 600,000 shares of its common stock valued at $2.00 per share. The Company did not pay any additional expense reimbursement or any placement agent fees in connection with the transaction. In accordance with the terms of the Purchase Agreement, the Company sold 1,000,000 shares of common stock (the "Initial Purchase Shares") to Aspire Capital at a purchase price of $2.00 per share, for an aggregate purchase price of $2,000,000.
Summary of terms of Purchase Agreement
On any Business Day on which the closing sale price of the Company's common stock exceeds $1.00, over the 25-month term of the Purchase Agreement, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice (each, a "Purchase Notice") directing Aspire Capital to purchase up to 150,000 Purchase Shares per Business Day (defined in the Purchase Agreement as any day on which the Principal Market is open for trading including any day on which the Principal Market is open for trading for a period of time less than the customary time). The Company and Aspire Capital may mutually agree to increase the number of shares that may be sold per Business Day to as much as an additional 1,000,000 Purchase Shares per Business Day. The purchase price per Purchase Share (the "Purchase Price") is the lower of (i) the lowest sale price for the common stock on the date of sale or (ii) the arithmetic average of the three lowest closing sale prices for the common stock during the 12 consecutive Business Days ending on the Business Day immediately preceding the purchase date of those securities.
The number of Purchase Shares covered by and timing of each Purchase Notice are determined in the Company's sole discretion, and the applicable Purchase Price will be determined prior to delivery of any Purchase Notice. The Company may deliver multiple Purchase Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed. The number of shares that may be sold under the Purchase Agreement is limited to 19.99% of the Company's outstanding shares on September 20, 2010, the date of the Purchase Agreement, absent stockholder approval. There are no trading volume requirements or restrictions under the Purchase Agreement. Aspire Capital has no right to require any sales by the Company, but is obligated to make purchases as directed in accordance with the Purchase Agreement.
The Purchase Agreement contains customary representations, warranties, covenants, closing conditions and indemnification and termination provisions. The Purchase Agreement may be terminated by the Company at any time, at its discretion, without any cost or penalty. Aspire Capital has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of Dynavax common stock. The Company did not pay any additional amounts to reimburse or otherwise compensate Aspire Capital in connection with the transaction. There are no limitations on use of proceeds, financial or business covenants, restrictions on future fundings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement.
The Company's net proceeds will depend on the Purchase Price and frequency of the Company's sales of Purchase Shares to Aspire Capital; provided, however, that the maximum aggregate proceeds from sales of Purchase Shares is $30 million under the terms of the Purchase Agreement. The Company's delivery of Purchase Notices will be made subject to market conditions, in light of the Company's capital needs from time to time and under the limitations contained in the Purchase Agreement. The Company expects to use proceeds from sales of Purchase Shares for general corporate purposes and working capital requirements.
Registration Rights
In connection with the Purchase Agreement, the Company also entered into a Registration Rights Agreement (the "Registration Rights Agreement") with Aspire Capital, dated September 20, 2010. The Registration Rights Agreement provides, among other things, that the Company will register the sales of the Commitment Shares and the Purchase Shares (collectively, the "Securities") to Aspire Capital. In accordance with the Registration Rights Agreement, the sale of the Securities to Aspire Capital is being made under the Company's Registration Statement on Form S-3 (No. 333-165663), filed with the Securities and Exchange Commission on March 24, 2010, as amended and supplemented from time to time (the "Registration Statement"). The Company further agreed to keep the Registration Statement effective and to indemnify Aspire Capital for certain liabilities in connection with the sale of the Securities under the terms of the Registration Rights Agreement.
The foregoing description of the Purchase Agreement and the Registration Rights Agreement is not a complete description of all the terms of those agreements. For a complete description of all the terms, we refer you to the full text of the Purchase Agreement and Registration Rights Agreement, copies of which are filed herewith as Exhibits 10.53 and 4.18, respectively, to this Current Report on Form 8-K and are incorporated herein by reference. This Current Report on Form 8-K also incorporates by reference the Purchase Agreement and Registration Rights Agreement into the Registration Statement.
Item 1.02 Termination of a Material Definitive Agreement.
On September 14, 2010, the Company terminated that certain Equity Distribution Agreement dated as of August 19, 2009 between the Company and Wedbush Morgan Securities, Inc. pursuant to Section 12(a) thereof.
This Current Report on Form 8-K contains "forward-looking" statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, including statements related to the potential future sale of shares of our common stock under the Purchase Agreement and the use of proceeds from such sales. Forward-looking statements are generally identified by use of the term "expect," "may," "will" and similar expressions. While we believe our plans, intentions and expectations reflected in those forward-looking statements are reasonable, these plans, intentions or expectations may not be achieved. Our actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements. For information about the factors that could cause such differences, please refer to our Annual Report on Form 10-K for the year ended December 31, 2009, including the information discussed under the caption "Item 1 Business," "Item 1A. Risk Factors" and "Item 7 Management's Discussion and Analysis of Financial Condition and Results of Operations," and our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2010 and June 30, 2010, as well as the Company's various other filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We assume no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
Item 8.01 Other Events.
On September 20, 2010, the Company issued a press release announcing that it has entered into the Purchase Agreement with Aspire Capital. A copy of the press release is filed as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
http://biz.yahoo.com/e/100920/dvax8-k.html
20-Sep-2010
Entry into a Material Definitive Agreement, Termination of a Material D
Item 1.01 Entry into a Material Definitive Agreement.
On September 20, 2010, Dynavax Technologies Corporation, a Delaware corporation ("Dynavax" or the "Company"), entered into a Common Stock Purchase Agreement (the "Purchase Agreement") with Aspire Capital Fund, LLC, an Illinois limited liability company ("Aspire Capital"), which provides that, upon the terms and subject to the conditions and limitations set forth therein, Aspire Capital is committed to purchase up to an aggregate of $30.0 million of shares of Dynavax common stock (the "Purchase Shares") over the term of the Purchase Agreement. Under the Purchase Agreement, the Company agreed to pay Aspire Capital a commitment fee equal to 4% of $30 million in consideration for Aspire Capital's obligation to purchase up to $30 million of Dynavax common stock. Dynavax paid this commitment fee by issuance of 600,000 shares of its common stock valued at $2.00 per share. The Company did not pay any additional expense reimbursement or any placement agent fees in connection with the transaction. In accordance with the terms of the Purchase Agreement, the Company sold 1,000,000 shares of common stock (the "Initial Purchase Shares") to Aspire Capital at a purchase price of $2.00 per share, for an aggregate purchase price of $2,000,000.
Summary of terms of Purchase Agreement
On any Business Day on which the closing sale price of the Company's common stock exceeds $1.00, over the 25-month term of the Purchase Agreement, the Company has the right, in its sole discretion, to present Aspire Capital with a purchase notice (each, a "Purchase Notice") directing Aspire Capital to purchase up to 150,000 Purchase Shares per Business Day (defined in the Purchase Agreement as any day on which the Principal Market is open for trading including any day on which the Principal Market is open for trading for a period of time less than the customary time). The Company and Aspire Capital may mutually agree to increase the number of shares that may be sold per Business Day to as much as an additional 1,000,000 Purchase Shares per Business Day. The purchase price per Purchase Share (the "Purchase Price") is the lower of (i) the lowest sale price for the common stock on the date of sale or (ii) the arithmetic average of the three lowest closing sale prices for the common stock during the 12 consecutive Business Days ending on the Business Day immediately preceding the purchase date of those securities.
The number of Purchase Shares covered by and timing of each Purchase Notice are determined in the Company's sole discretion, and the applicable Purchase Price will be determined prior to delivery of any Purchase Notice. The Company may deliver multiple Purchase Notices to Aspire Capital from time to time during the term of the Purchase Agreement, so long as the most recent purchase has been completed. The number of shares that may be sold under the Purchase Agreement is limited to 19.99% of the Company's outstanding shares on September 20, 2010, the date of the Purchase Agreement, absent stockholder approval. There are no trading volume requirements or restrictions under the Purchase Agreement. Aspire Capital has no right to require any sales by the Company, but is obligated to make purchases as directed in accordance with the Purchase Agreement.
The Purchase Agreement contains customary representations, warranties, covenants, closing conditions and indemnification and termination provisions. The Purchase Agreement may be terminated by the Company at any time, at its discretion, without any cost or penalty. Aspire Capital has covenanted not to cause or engage in any manner whatsoever, any direct or indirect short selling or hedging of Dynavax common stock. The Company did not pay any additional amounts to reimburse or otherwise compensate Aspire Capital in connection with the transaction. There are no limitations on use of proceeds, financial or business covenants, restrictions on future fundings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement.
The Company's net proceeds will depend on the Purchase Price and frequency of the Company's sales of Purchase Shares to Aspire Capital; provided, however, that the maximum aggregate proceeds from sales of Purchase Shares is $30 million under the terms of the Purchase Agreement. The Company's delivery of Purchase Notices will be made subject to market conditions, in light of the Company's capital needs from time to time and under the limitations contained in the Purchase Agreement. The Company expects to use proceeds from sales of Purchase Shares for general corporate purposes and working capital requirements.
Registration Rights
In connection with the Purchase Agreement, the Company also entered into a Registration Rights Agreement (the "Registration Rights Agreement") with Aspire Capital, dated September 20, 2010. The Registration Rights Agreement provides, among other things, that the Company will register the sales of the Commitment Shares and the Purchase Shares (collectively, the "Securities") to Aspire Capital. In accordance with the Registration Rights Agreement, the sale of the Securities to Aspire Capital is being made under the Company's Registration Statement on Form S-3 (No. 333-165663), filed with the Securities and Exchange Commission on March 24, 2010, as amended and supplemented from time to time (the "Registration Statement"). The Company further agreed to keep the Registration Statement effective and to indemnify Aspire Capital for certain liabilities in connection with the sale of the Securities under the terms of the Registration Rights Agreement.
The foregoing description of the Purchase Agreement and the Registration Rights Agreement is not a complete description of all the terms of those agreements. For a complete description of all the terms, we refer you to the full text of the Purchase Agreement and Registration Rights Agreement, copies of which are filed herewith as Exhibits 10.53 and 4.18, respectively, to this Current Report on Form 8-K and are incorporated herein by reference. This Current Report on Form 8-K also incorporates by reference the Purchase Agreement and Registration Rights Agreement into the Registration Statement.
Item 1.02 Termination of a Material Definitive Agreement.
On September 14, 2010, the Company terminated that certain Equity Distribution Agreement dated as of August 19, 2009 between the Company and Wedbush Morgan Securities, Inc. pursuant to Section 12(a) thereof.
This Current Report on Form 8-K contains "forward-looking" statements within the meaning of Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, including statements related to the potential future sale of shares of our common stock under the Purchase Agreement and the use of proceeds from such sales. Forward-looking statements are generally identified by use of the term "expect," "may," "will" and similar expressions. While we believe our plans, intentions and expectations reflected in those forward-looking statements are reasonable, these plans, intentions or expectations may not be achieved. Our actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements. For information about the factors that could cause such differences, please refer to our Annual Report on Form 10-K for the year ended December 31, 2009, including the information discussed under the caption "Item 1 Business," "Item 1A. Risk Factors" and "Item 7 Management's Discussion and Analysis of Financial Condition and Results of Operations," and our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2010 and June 30, 2010, as well as the Company's various other filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We assume no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
Item 8.01 Other Events.
On September 20, 2010, the Company issued a press release announcing that it has entered into the Purchase Agreement with Aspire Capital. A copy of the press release is filed as Exhibit 99.1 to this Current Report and is incorporated herein by reference.
http://biz.yahoo.com/e/100920/dvax8-k.html
Dynavax Announces $30 Million At-The-Market Common Stock Purchase Agreement
Aspire Capital Makes Initial Investment of $2 Million at $2.00 per Share
BERKELEY, CA, Sep 20, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that Aspire Capital Fund, LLC, an Illinois limited liability company, has purchased 1,000,000 shares of Dynavax common stock at $2.00 per share, representing a 23% premium to the closing market price on September 17, 2010. The investment was made in connection with a $30 million At-The-Market common stock purchase agreement under which Aspire Capital has committed to purchase up to an additional $28 million of Dynavax common stock over the next 25 months.
During the term of the purchase agreement, Dynavax will control the timing and amount of any sales of its common stock to Aspire Capital. Aspire Capital has no right to require any sales by the Company but is obligated to make purchases as the Company directs in accordance with the purchase agreement, which may be terminated by Dynavax at any time. Dynavax will use net proceeds from any sales of its stock to complete the Company's development activities for its lead program, HEPLISAV(TM), an investigational hepatitis B vaccine, and for other general corporate purposes. Under the purchase agreement, the Company agreed to pay Aspire Capital a commitment fee equal to 4% of $30 million in consideration for Aspire Capital's obligation to purchase up to $30 million of Dynavax common stock. Dynavax paid this commitment fee by issuance of 600,000 shares of its common stock valued at $2.00 per share. The Company did not pay any additional expense reimbursement or any placement agent fees in connection with the transaction. A more detailed description of the transaction agreements with Aspire Capital is set forth in the Company's current report on Form 8-K, filed today with the U.S. Securities and Exchange Commission.
According to Dino Dina, M.D., Dynavax's Chief Executive Officer, "The agreement with Aspire Capital provides us the ability to raise equity capital when we choose at opportunistic prices. The financing is designed to complement potential corporate partnership discussions and provide flexibility as we assess multiple value-enhancing strategic opportunities. Equally important, Aspire Capital's decision to make an equity investment in Dynavax at a premium to the current market price signals confidence in our prospects for market-oriented initiatives and our ability to deliver results, including the BLA for HEPLISAV that is targeted for the second half of 2011."
"Dynavax has made considerable progress on the path to commercializing HEPLISAV and we believe Dynavax is on track to deliver a novel product to an important and expanding market," noted Steven G. Martin, Managing Member, Aspire Capital Partners, LLC.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and developing the vaccine for immunization of large, high-value populations that are at risk, less responsive to current licensed vaccines, and for which vaccination recommendations are in place, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
About Aspire Capital Fund, LLC
Aspire Capital Fund, LLC is an institutional investor based in Chicago, Illinois, with a fundamental investment approach. Aspire Capital invests in a wide range of companies and industries emphasizing life sciences, energy and technology.
Forward Looking Statements
This press release contains "forward-looking" statements, including statements related to the potential future sale of shares of our common stock under the Purchase Agreement and the use of proceeds from such sales. Forward-looking statements are generally identified by use of the term "expect," "may," "will" and similar expressions. While we believe our plans, intentions and expectations reflected in those forward-looking statements are reasonable, these plans, intentions or expectations may not be achieved. Our actual results, performance or achievements could differ materially from those contemplated, expressed or implied by the forward-looking statements. For information about the factors that could cause such differences, please refer to our Annual Report on Form 10-K for the year ended December 31, 2009, including the information discussed under the caption "Item 1 Business," "Item 1A. Risk Factors" and "Item 7 Management's Discussion and Analysis of Financial Condition and Results of Operations," and our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2010 and June 30, 2010, as well as the Company's various other filings with the SEC. Given these uncertainties, you should not place undue reliance on these forward-looking statements. We assume no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=509…
Guten Morgen
Ich wünsche uns einen dunkelgrünen Tag!
Ich wünsche uns einen dunkelgrünen Tag!
endlich mal wieder eine richtige news. ich will ja nicht nach den Sternen greifen, aber sollte Heplisav
jemals auf den Markt kommen, dann ist das hier auf jeden Fall ein tenbagger...
jemals auf den Markt kommen, dann ist das hier auf jeden Fall ein tenbagger...
Dynavax Begins Phase 1b Study for Universal Flu Vaccine
Phase 1a Study of Novel Flu Component Completed
BERKELEY, CA, Sep 23, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it has begun to immunize subjects in a Phase 1b clinical trial of its Universal Flu Vaccine candidate. The study will evaluate the safety of the combination of N8295, the novel component of Dynavax's Universal Flu vaccine candidate, and Novartis' investigational H5N1 avian influenza vaccine. N8295 is a fusion protein comprised of NP and M2e, two highly conserved influenza antigens covalently linked to Dynavax's proprietary second-generation TLR9 agonist.
The Phase 1b study is being initiated six months ahead of schedule based on preliminary Phase 1a safety data on N8295 alone. In an ongoing Phase 1a trial initiated during the second quarter of 2010, no dose limiting toxicities were identified. The trial is assessing three dose levels of N8295, and all immunizations have been completed. Follow-up data will be available by year-end 2010.
Establishing the safety -- first, of the novel component, N8295, and now, of the combination -- is key to the continued development of Dynavax's Universal Flu Vaccine. By assessing N8295 in combination with H5N1 vaccine, Dynavax expects to improve its understanding of the immunologic properties of the company's universal flu vaccine candidate in the absence of pre-existing immunity to the H5N1 flu strain in human subjects. With additional positive data from both the Phase 1a and 1b studies, Dynavax plans to design a proof-of-concept study to generate data that could trigger Novartis' option on joint development and commercialization of the product.
"Our success in moving forward to a Phase 1b study ahead of plan was a result of the positive preliminary data produced in the first safety study. Equally important, however, was close coordination of Novartis with our team and its commitment to supply H5N1 vaccine to meet the accelerated schedule," said Tyler Martin, Dynavax President and Chief Medical Officer.
Principal Investigator, Dr. John E. Ervin, will conduct the study at The Center for Pharmaceutical Research in Kansas City, MO. A total of 15 subjects will be divided into three different dose groups of N8295, each dose of which will be combined with the same amount of H5N1 vaccine. All subjects will receive two immunizations, separated by one month. Preliminary data is expected to be available early in 2011. Subjects will continue to be monitored for approximately one year.
Dynavax's Universal Flu Vaccine is designed to offer protection against divergent influenza strains as well as to increase the efficacy of an inactivated influenza vaccine. Preclinical data have confirmed the expected immunogenicity and mechanistic effects of the vaccine candidate's novel components. The production of cytotoxic T-cells by NP and cytotoxic antibodies by M2e have been demonstrated in preclinical studies, as has an increase in neutralizing antibodies provided by a co-administered inactivated influenza vaccine. A GLP toxicity study demonstrated that this Universal Flu vaccine candidate is well-tolerated.
Under a 2008 agreement Novartis Vaccines and Diagnostics is providing Dynavax with influenza vaccine for both clinical trial use and potential vaccine sales. Novartis has an exclusive option to negotiate a Joint Development and Commercialization agreement with Dynavax pending proof-of-concept data.
About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward-looking Statements This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties, including statements related to the anticipated timing and design of clinical trials of our universal flu vaccine candidate, the nature and availability of data from the clinical trials and the features of the vaccine. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether results of completed studies can be replicated in human studies, difficulties or delays in initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our Novartis agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=510…
@Dino
Wir brauchen eine HEPLISAV News!!!
Wir brauchen eine HEPLISAV News!!!
Antwort auf Beitrag Nr.: 40.201.840 von Lucky72 am 23.09.10 22:03:47http://www.marketwatch.com/story/dynavaxs-two-phase-3-heplis…
Antwort auf Beitrag Nr.: 40.224.587 von randnotiz am 28.09.10 15:52:21
Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue
Third Safety Assessment Complete
BERKELEY, CA, Sep 28, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 trials for HEPLISAV(TM) has completed the third of its planned safety assessments. The DSMB determined that the studies may continue without protocol modification. The Phase 3 lot-to-lot consistency trial was fully enrolled in May 2010; the Phase 3 chronic kidney disease study is expected to complete enrollment within the next few months.
The evaluation included data from 2717 subjects. Of the subjects enrolled in the Phase 3 lot-to-lot consistency study, all are at least two months past their final HEPLISAV injections. Furthermore, the first subjects enrolled in the Phase 3 chronic kidney disease study are now 12 months past their first dose.
Tyler Martin, M.D., President and Chief Medical Officer, commented, "The DSMB's recommendation that both Phase 3 trials continue without protocol modification is consistent with our expectation. Generally, one expects adverse events related to study drugs to occur in temporal proximity to the exposure. With 100% of subjects in the Phase 3 lot-to-lot consistency study now two months past the last HEPLISAV vaccination, our confidence in the safety of this product is reinforced."
Dino Dina, M.D., Chief Executive Officer, added, "We have clearly advanced past a key milestone in both studies and are working to stay on our projected timeline for making regulatory submissions before the end of 2011. We have demonstrated HEPLISAV's efficacy in multiple prior trials and expect these trials to demonstrate efficacy in line with our previous results. The first of these Phase 3 trials was designed to confirm the consistency of our lots and to provide us a safety database that will be acceptable to the regulatory authorities in the U.S. and in Europe; the second was designed to demonstrate a regimen specifically for CKD patients."
HEPLISAV is an innovative investigational vaccine designed to protect against hepatitis B infection. The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials evaluating HEPLISAV, the first a lot-to-lot consistency trial in adults 40 years and older, and the second a trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.
Conference Call
Dynavax will webcast a conference call today at 4:10 p.m. EDT (1:10 p.m. PDT). The live and archived webcast can be accessed by visiting the investor relations section of the Company's website at http://investors.dynavax.com/newsevents.cfm.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=511…
Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue
Third Safety Assessment Complete
BERKELEY, CA, Sep 28, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 trials for HEPLISAV(TM) has completed the third of its planned safety assessments. The DSMB determined that the studies may continue without protocol modification. The Phase 3 lot-to-lot consistency trial was fully enrolled in May 2010; the Phase 3 chronic kidney disease study is expected to complete enrollment within the next few months.
The evaluation included data from 2717 subjects. Of the subjects enrolled in the Phase 3 lot-to-lot consistency study, all are at least two months past their final HEPLISAV injections. Furthermore, the first subjects enrolled in the Phase 3 chronic kidney disease study are now 12 months past their first dose.
Tyler Martin, M.D., President and Chief Medical Officer, commented, "The DSMB's recommendation that both Phase 3 trials continue without protocol modification is consistent with our expectation. Generally, one expects adverse events related to study drugs to occur in temporal proximity to the exposure. With 100% of subjects in the Phase 3 lot-to-lot consistency study now two months past the last HEPLISAV vaccination, our confidence in the safety of this product is reinforced."
Dino Dina, M.D., Chief Executive Officer, added, "We have clearly advanced past a key milestone in both studies and are working to stay on our projected timeline for making regulatory submissions before the end of 2011. We have demonstrated HEPLISAV's efficacy in multiple prior trials and expect these trials to demonstrate efficacy in line with our previous results. The first of these Phase 3 trials was designed to confirm the consistency of our lots and to provide us a safety database that will be acceptable to the regulatory authorities in the U.S. and in Europe; the second was designed to demonstrate a regimen specifically for CKD patients."
HEPLISAV is an innovative investigational vaccine designed to protect against hepatitis B infection. The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials evaluating HEPLISAV, the first a lot-to-lot consistency trial in adults 40 years and older, and the second a trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.
Conference Call
Dynavax will webcast a conference call today at 4:10 p.m. EDT (1:10 p.m. PDT). The live and archived webcast can be accessed by visiting the investor relations section of the Company's website at http://investors.dynavax.com/newsevents.cfm.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=511…
Dynavax's HEPLISAV Demonstrates Superior Seroprotection in Diabetics Compared to Engerix-B
Late-Breaker AASLD Abstract and New Diabetic Data Published Online
BERKELEY, CA, Oct 04, 2010 (MARKETWIRE via COMTEX News Network) -- In an abstract published today on the website of the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Dynavax Technologies Corporation (NASDAQ: DVAX) reported that its novel hepatitis B vaccine candidate, HEPLISAV(TM), given as two doses over four weeks demonstrated superior seroprotection in persons with diabetes mellitus compared to Engerix-B given as three doses over 24 weeks. The subset analysis of 62 adults with diabetes in Dynavax's previously reported Phase 3 multicenter study (PHAST or Phase 3 HEPLISAV Short-regimen Trial), showed that at 12 weeks, 84 percent of adult diabetics treated with HEPLISAV achieved seroprotection as compared to 0 percent of adult diabetics treated with Engerix-B. At week 28, 93 percent of the HEPLISAV-treated group versus 35 percent in the Engerix-B group achieved seroprotection. HEPLISAV's significantly higher rate of seroprotection was achieved without further immunization past four weeks while the Engerix-B group received a third immunization at 24 weeks. A poster presentation (LB-17) entitled, "Immunogenicity of Two Doses of Investigational HEPLISAV(TM) Compared to Three Doses of Licensed Hepatitis B Vaccine (ENGERIX-B(R)) in Diabetics", will be made in a late-breaker session on November 1, 2010 at the AASLD in Boston, Massachusetts.
According to Dr. Tyler Martin, President and Chief Medical Officer of Dynavax, "Diabetics are at risk for hepatitis B infection, and once infected, their disease frequently results in more severe chronic illness. The situation is complicated by the fact that patients with diabetes commonly do not respond well to currently licensed hepatitis B vaccines. The data we will report at the AASLD meeting is particularly exciting as our technology clearly represents a potential breakthrough in immunization regimens as well as a means of significantly expanding the number of individuals for whom protection against hepatitis B will be possible.
"It is well known that epidemic outbreaks of hepatitis B have occurred over the last several years in long-term care facilities. However, vaccination against the disease has been limited because patients in this setting simply do not respond to vaccination as well as healthy, younger adults in the general population. The Center for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has been studying the issue for quite some time, and later this month will consider a new recommendation for hepatitis B vaccination of adults with diabetes," Dr. Martin continued.
Dynavax first reported the results of its PHAST multi-center, observer-blinded Phase 3 study in August 2008. Of the 2101 subjects in the overall per protocol study population, the seroprotection rate of the HEPLISAV-treated group was 95 percent at week 12 and 81 percent at week 28 in the Engerix-B group, indicating non-inferiority/superiority of HEPLISAV over Engerix-B. HEPLISAV is Dynavax's novel hepatitis B vaccine candidate, a TLR9 agonist; Engerix-B is a commercially available hepatitis B vaccine.
Engerix-B(R) is a registered trademark of GlaxoSmithKline
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," including the potential for use of HEPLISAV that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the reported results can be replicated in prospective studies, whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=513…
AMENDMENT NO. 3
RESEARCH COLLABORATION AND LICENSE AGREEMENT
This A MENDMENT N O . 3 (the “ Amendment ”) is effective as of September 30, 2010 (the “ Amendment Effective Date ”), by and between AstraZeneca AB, a company incorporated in Sweden under no. 556011-7482 with offices at S-151 85 Södertälje, Sweden (“ AstraZeneca ”) and Dynavax Technologies Corporation, a Delaware corporation with offices at 2929 Seventh Street, Suite 100, Berkeley, California 94710-2753, USA (“ Dynavax ”). AstraZeneca and Dynavax are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
R ECITALS
W HEREAS , the Parties are party to the Research Collaboration and License Agreement entered into as of September 1, 2006, as amended (the “ Agreement ”), whereby the Parties entered into an agreement for the discovery and development of TLR-9 agonist-based therapies for the treatment of asthma and chronic obstructive pulmonary disease;
W HEREAS , the Parties now desire to amend the Agreement to amend Section 19.3.
N OW , T HEREFORE , the Parties, intending to be legally bound, hereby agree as follows:
1.1 Definitions. Terms used with initial capitals herein and not defined below shall have the meanings ascribed to them in the Agreement.
1.2 Amendments. The following provisions of the Agreement are amended as set forth below.
(a) Section 19.3 . Section 19.3 of the Agreement is hereby amended to read in full as follows:
“ Regents Indemnity; AstraZeneca . In addition to any other remedy available to AstraZeneca, Dynavax shall indemnify defend and hold harmless AstraZeneca, its Affiliates, Distributors, Sublicensees and its and their respective directors, officers and employees in full and on demand, from and against any and all Losses incurred by them to the extent resulting from or arising out of or in connection with any breach by Dynavax of its obligations pursuant to the Regents Agreement referenced in Section 10.5, excluding any breach directly arising from breach of this Agreement by AstraZeneca.”
1.3 Governing Law. This Amendment shall be governed by and construed under the substantive laws of the State of Delaware, excluding any conflict of law rule or principle that might otherwise refer construction or interpretation of this Amendment to the substantive law of another jurisdiction.
1.4 Continuing Effect. The Agreement, as hereby amended, remains in full force and effect.
I N W ITNESS W HEREOF , each of the Parties have agreed to and accepted the foregoing Amendment and have caused this Amendment to be signed by their duly authorized representatives on the Amendment Effective Date.
D YNAVAX T ECHNOLOGIES C ORPORATION A STRA Z ENECA AB
By: /s/ Michael S. Ostrach By: /s/ Anders Buren
Name: Michael S. Ostrach Name: Anders Buren
Title: Vice President Title: Authorized Signatory
http://investors.dynavax.com/secfiling.cfm?filingID=1181431-…
RESEARCH COLLABORATION AND LICENSE AGREEMENT
This A MENDMENT N O . 3 (the “ Amendment ”) is effective as of September 30, 2010 (the “ Amendment Effective Date ”), by and between AstraZeneca AB, a company incorporated in Sweden under no. 556011-7482 with offices at S-151 85 Södertälje, Sweden (“ AstraZeneca ”) and Dynavax Technologies Corporation, a Delaware corporation with offices at 2929 Seventh Street, Suite 100, Berkeley, California 94710-2753, USA (“ Dynavax ”). AstraZeneca and Dynavax are sometimes referred to herein individually as a “Party” and collectively as the “Parties.”
R ECITALS
W HEREAS , the Parties are party to the Research Collaboration and License Agreement entered into as of September 1, 2006, as amended (the “ Agreement ”), whereby the Parties entered into an agreement for the discovery and development of TLR-9 agonist-based therapies for the treatment of asthma and chronic obstructive pulmonary disease;
W HEREAS , the Parties now desire to amend the Agreement to amend Section 19.3.
N OW , T HEREFORE , the Parties, intending to be legally bound, hereby agree as follows:
1.1 Definitions. Terms used with initial capitals herein and not defined below shall have the meanings ascribed to them in the Agreement.
1.2 Amendments. The following provisions of the Agreement are amended as set forth below.
(a) Section 19.3 . Section 19.3 of the Agreement is hereby amended to read in full as follows:
“ Regents Indemnity; AstraZeneca . In addition to any other remedy available to AstraZeneca, Dynavax shall indemnify defend and hold harmless AstraZeneca, its Affiliates, Distributors, Sublicensees and its and their respective directors, officers and employees in full and on demand, from and against any and all Losses incurred by them to the extent resulting from or arising out of or in connection with any breach by Dynavax of its obligations pursuant to the Regents Agreement referenced in Section 10.5, excluding any breach directly arising from breach of this Agreement by AstraZeneca.”
1.3 Governing Law. This Amendment shall be governed by and construed under the substantive laws of the State of Delaware, excluding any conflict of law rule or principle that might otherwise refer construction or interpretation of this Amendment to the substantive law of another jurisdiction.
1.4 Continuing Effect. The Agreement, as hereby amended, remains in full force and effect.
I N W ITNESS W HEREOF , each of the Parties have agreed to and accepted the foregoing Amendment and have caused this Amendment to be signed by their duly authorized representatives on the Amendment Effective Date.
D YNAVAX T ECHNOLOGIES C ORPORATION A STRA Z ENECA AB
By: /s/ Michael S. Ostrach By: /s/ Anders Buren
Name: Michael S. Ostrach Name: Anders Buren
Title: Vice President Title: Authorized Signatory
http://investors.dynavax.com/secfiling.cfm?filingID=1181431-…
S-3 DYNAVAX TECHNOLOGIES CORP, 2929 SEVENTH STREET, SUITE 100, BERKELEY,
CA, 94710, 5108485100 -
0 ($100,000,000.00) Unallocated (Universal) Shelf, (File 333-169576 -
Sep. 24) (BR. 01A)
http://www.sec.gov/news/digest/2010/dig092710-sar.txt
Ist schon geil wie die "Big Boys" die ganzen Aktien aufsaugen!
Zur Zeit sind über 90% der OS in festen Händen!
http://www.dailyfinance.com/company/dynavax-technologies-cor…
http://www.dailyfinance.com/company/dynavax-technologies-cor…
$100,000,000
Common Stock
Preferred Stock
Debt Securities
Warrants
Units
From time to time, we may offer, issue and sell up to $100,000,000 of any combination of the securities described in this prospectus, either individually or in units. We may also offer securities as may be issuable upon conversion, redemption, repurchase, exchange or exercise of any securities registered hereunder, including under any applicable anti-dilution provisions.
We will provide the specific terms of these offerings and securities in one or more supplements to this prospectus. We may also authorize one or more free writing prospectuses to be provided to you in connection with these offerings. The prospectus supplement and any related free writing prospectus may also add, update or change information contained in this prospectus. You should carefully read this prospectus, the applicable prospectus supplement and any related free writing prospectus, as well as any documents incorporated by reference, before buying any of the securities being offered.
Our common stock is listed on the NASDAQ Capital Market under the symbol “DVAX.” The last reported sale price of our common stock on September 23, 2010 was $1.74 per share. The applicable prospectus supplement will contain information, where applicable, as to any other listing, if any, on the NASDAQ Capital Market or any securities market or other exchange of the securities covered by the applicable prospectus supplement.
Investing in our securities involves a high degree of risk. You should review carefully the risks and uncertainties described under the heading “ Risk Factors ” contained in the applicable prospectus supplement and any related free writing prospectus, and under similar headings in the other documents that are incorporated by reference into this prospectus.
This prospectus may not be used to consummate a sale of any securities unless accompanied by a prospectus supplement.
The securities may be sold directly by us to investors, through agents designated from time to time or to or through underwriters or dealers, on a continuous or delayed basis. For additional information on the methods of sale, you should refer to the section entitled “Plan of Distribution” in this prospectus. If any agents or underwriters are involved in the sale of any securities with respect to which this prospectus is being delivered, the names of such agents or underwriters and any applicable fees, commissions, discounts and over-allotment options will be set forth in a prospectus supplement. The price to the public of such securities and the net proceeds that we expect to receive from such sale will also be set forth in a prospectus supplement.
Neither the Securities and Exchange Commission nor any state securities commission has approved or disapproved of these securities or determined if this prospectus is truthful or complete. Any representation to the contrary is a criminal offense.
The date of this prospectus is October 6, 2010.
http://investors.dynavax.com/secfiling.cfm?filingID=1193125-…
Dr Robert L. Coffman,
VP & CSO
Dynavax
Dr. Coffman has been the Vice President and Chief Scientific Officer of Dynavax since December 2000. Dr. Coffman joined Dynavax from the DNAX Research Institute where he had been since 1981, most recently as Distinguished Research Fellow. Prior to that, he was a postdoctoral fellow at Stanford University Medical School. Dr. Coffman has made fundamental discoveries about the regulation of immune responses in allergic and infectious diseases. He shared the William S. Coley Award for Research in Immunology for discovery of the Th1 and Th2 subsets of T lymphocytes, the two major types of T cells that control most immune responses. Dr. Coffman received his Ph.D. from the University of California, San Diego and his A.B. from Indiana University. In 2006, Dr. Coffman was elected to the National Academy of Sciences.
Appearing:
Conference Day Two – Wednesday 8 December 2010
4.30pm
Combining NP, M2e and Immunostimulatory Sequence (ISS) for the Dynavax Universal Influenza Vaccine
* Vaccine composition: Why and how we have included two conserved influenza antigens in this vaccine
* Contributions of each component of the vaccine demonstrated in preclinical results
* Recent results
Dr Robert L. Coffman,
VP & CSO,
Dynavax
http://www.terrapinn.com/2010/flu/SPK-dr-robertl-COFFMAN.stm
VP & CSO
Dynavax
Dr. Coffman has been the Vice President and Chief Scientific Officer of Dynavax since December 2000. Dr. Coffman joined Dynavax from the DNAX Research Institute where he had been since 1981, most recently as Distinguished Research Fellow. Prior to that, he was a postdoctoral fellow at Stanford University Medical School. Dr. Coffman has made fundamental discoveries about the regulation of immune responses in allergic and infectious diseases. He shared the William S. Coley Award for Research in Immunology for discovery of the Th1 and Th2 subsets of T lymphocytes, the two major types of T cells that control most immune responses. Dr. Coffman received his Ph.D. from the University of California, San Diego and his A.B. from Indiana University. In 2006, Dr. Coffman was elected to the National Academy of Sciences.
Appearing:
Conference Day Two – Wednesday 8 December 2010
4.30pm
Combining NP, M2e and Immunostimulatory Sequence (ISS) for the Dynavax Universal Influenza Vaccine
* Vaccine composition: Why and how we have included two conserved influenza antigens in this vaccine
* Contributions of each component of the vaccine demonstrated in preclinical results
* Recent results
Dr Robert L. Coffman,
VP & CSO,
Dynavax
http://www.terrapinn.com/2010/flu/SPK-dr-robertl-COFFMAN.stm
Dynavax to Report New HEPLISAV(TM) Data in Diabetics
BERKELEY, CA, Oct 11, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today said that Dr. William L. Heyward, Vice President, Clinical Development, will make an oral presentation of new data from a subset of diabetes subjects evaluated as part of the company's previously reported multicenter, observer-blinded phase 3 study. The PHAST (Phase 3 HeplisAv Short-regimen Trial) study compared two doses of HEPLISAV (20ug HBsAg combined with 3000ug 1018 immunostimulatory sequence, Dynavax's Toll-like receptor agonist) given at 0 and 4 weeks (placebo at 24 weeks) to three doses of Engerix-B given at 0, 4 and 24 weeks. The presentation will be made in a late-breaker session on October 23, 2010 at the Annual Meeting of the Infectious Diseases Society of America (IDSA) in Vancouver, British Columbia.
The Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices (ACIP) has been studying the hepatitis B infection rates among diabetics and in long-term care facilities for quite some time. Later this month, ACIP will consider a recommendation for hepatitis B vaccination of adults with diabetes. Diabetics are at risk for hepatitis B infection and once infected, their disease frequently results in more severe chronic illness. Multiple outbreaks of hepatitis B among diabetics have occurred over the last several years in long-term care facilities, but prevention by vaccine has been complicated by the fact that diabetics are not routinely immunized and commonly do not respond well to currently licensed hepatitis B vaccines.
Dynavax first reported the results of its PHAST multi-center, observer-blinded Phase 3 study in August 2008. Of the 2101 subjects in the overall per protocol study population, the seroprotection rate of the HEPLISAV-treated group was 95 percent at week 12 and 81 percent at week 28 in the Engerix-B group, indicating noninferiority/superiority of HEPLISAV over Engerix-B. HEPLISAV is Dynavax's novel hepatitis B vaccine candidate, a TLR9 agonist; Engerix-B is a commercially available hepatitis B vaccine.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in U.S., Canada and Europe. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
Engerix-B(R) is a registered trademark of GlaxoSmithKline
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the company's current periodic reports with the SEC.
Contact:
Michael Ostrach
Vice President and Chief Business Officer
510-665-7257
Email Contact
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=516…
Lausiges Volumen!
Warten wohl alle auf Q3 Zahlen!
Warten wohl alle auf Q3 Zahlen!
#
Thursday, October 14, 2010
#
Dynavax management to meet with Jefferies
12:46:21 PM | Theflyonthewall.com
http://www.dailyfinance.com/headlines/dynavax-technologies-c…
Thursday, October 14, 2010
#
Dynavax management to meet with Jefferies
12:46:21 PM | Theflyonthewall.com
http://www.dailyfinance.com/headlines/dynavax-technologies-c…
Wo bleiben die Q3 Zahlen?
Langweilig!!!! 
Antwort auf Beitrag Nr.: 40.374.557 von randnotiz am 22.10.10 15:49:08Nur leider hilft die "News" dem Kurs nicht!
Antwort auf Beitrag Nr.: 40.376.985 von Lucky72 am 22.10.10 21:21:39oder der Kurs nimmt evtl schlechte Q3 Ergebnisse vorweg. die müssten doch eigentlich die kommende Woche erscheinen!?
Antwort auf Beitrag Nr.: 40.378.455 von randnotiz am 23.10.10 13:07:05Die Q3 Zahlen sind schon seit 18.10 überfällig!
Die Meetings am Wochenende waren auch fürn Ar...!
Antwort auf Beitrag Nr.: 40.378.455 von randnotiz am 23.10.10 13:07:05
das versteh ich nicht. in den letzten zwei monaten stieg der kurs von 1,6 usd auf 1,9 usd ! wo ist da das problemchen?
das versteh ich nicht. in den letzten zwei monaten stieg der kurs von 1,6 usd auf 1,9 usd ! wo ist da das problemchen?
Antwort auf Beitrag Nr.: 40.386.105 von Lucky72 am 25.10.10 18:48:44lestztes mal sind sie am 30.07 erschienen, könnte also noch bis Freitag dauern.
@pokemon, das Problemchen ist,daß sich der Kurs im Verhältnis zum Newsflow sehr neutral verhält.
kann jedenfalls nicht erkennen, daß hier die Zukunft gehandelt wird.
@pokemon, das Problemchen ist,daß sich der Kurs im Verhältnis zum Newsflow sehr neutral verhält.
kann jedenfalls nicht erkennen, daß hier die Zukunft gehandelt wird.
Das wird heut wieder nix! 
Dynavax Announces Proposed Public Offering of Common Stock
BERKELEY, CA, Oct 27, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it intends to offer and sell shares of its common stock in an underwritten public offering. Jefferies & Company, Inc. is acting as sole book-running manager of the offering. Wedbush PacGrow Life Sciences and Cowen and Company, LLC are acting as co-managers for the offering. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
The securities described above are being offered by Dynavax pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), which the SEC declared effective on October 4, 2010. A preliminary prospectus supplement related to the offering will be filed with the SEC and will be available on the SEC's website located at http://www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Equity Syndicate Prospectus Department, Jefferies & Company, 520 Madison Avenue, 12th Floor, New York, NY, 10022, at 877-547-6340, and at Prospectus_Department@Jefferies.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Dynavax Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=523…
Item 2.02 Results of Operations and Financial Condition.
Based on preliminary financial data, we expect to report consolidated revenues, operating expenses and net loss for the three months ended September 30, 2010 of approximately $11.6 million, $18.4 million and $5.0 million, respectively, and consolidated cash and cash equivalents and marketable securities as of September 30, 2010 of approximately $47.2 million. Our financial statements for the three months ended September 30, 2010 are not yet available, and the estimates above are based on management estimates. In the course of preparing our financial statements for the three months ended September 30, 2010 to be filed with the U.S. Securities and Exchange Commission, we may make adjustments to the amounts from which we derived the estimates above.
The information with respect to Item 2.02 in this current report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information with respect to Item 2.02 in this current report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Dynavax, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
http://investors.dynavax.com/secfiling.cfm?filingID=1193125-…
Based on preliminary financial data, we expect to report consolidated revenues, operating expenses and net loss for the three months ended September 30, 2010 of approximately $11.6 million, $18.4 million and $5.0 million, respectively, and consolidated cash and cash equivalents and marketable securities as of September 30, 2010 of approximately $47.2 million. Our financial statements for the three months ended September 30, 2010 are not yet available, and the estimates above are based on management estimates. In the course of preparing our financial statements for the three months ended September 30, 2010 to be filed with the U.S. Securities and Exchange Commission, we may make adjustments to the amounts from which we derived the estimates above.
The information with respect to Item 2.02 in this current report shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section or Sections 11 and 12(a)(2) of the Securities Act of 1933, as amended. The information with respect to Item 2.02 in this current report shall not be incorporated by reference into any filing with the U.S. Securities and Exchange Commission made by Dynavax, whether made before or after the date hereof, regardless of any general incorporation language in such filing.
http://investors.dynavax.com/secfiling.cfm?filingID=1193125-…
Net loss for the second quarter 2010 was $28.0 million, or $0.34 per share
Dynavax expects a loss of about $5 million for the third quarter, which ended September.
$5 million : 88,344,444 share = 0,056$/share
Könnte schlimmer sein!!!!
Dynavax expects a loss of about $5 million for the third quarter, which ended September.
$5 million : 88,344,444 share = 0,056$/share
Könnte schlimmer sein!!!!
Dynavax Prices Public Offering of Common Stock
BERKELEY, CA, Oct 28, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the pricing of an underwritten public offering of 23,000,000 shares of its common stock at a price to the public of $1.70 per share. The gross proceeds to Dynavax from this offering are expected to be approximately $39.1 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Dynavax. Jefferies & Company, Inc. is acting as sole book-running manager for the offering. Wedbush PacGrow Life Sciences and Cowen and Company, LLC are acting as co-managers for the offering. Dynavax has granted the underwriters a 30-day option to purchase up to an aggregate of 3,450,000 additional shares of common stock to cover over-allotments, if any. The offering is expected to close on or about November 2, 2010, subject to customary closing conditions.
Dynavax anticipates using the net proceeds from the offering to fund its development activities for its lead program, HEPLISAV(TM), a Phase 3 investigational hepatitis B vaccine, and for other general corporate purposes, including working capital.
The securities described above are being offered by Dynavax pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), which the SEC declared effective on October 4, 2010. A preliminary prospectus supplement related to the offering has been filed with the SEC and is available on the SEC's website located at http://www.sec.gov. Copies of the final prospectus supplement relating to these securities, when available, may be obtained from Equity Syndicate Prospectus Department, Jefferies & Company, 520 Madison Avenue, 12th Floor, New York, NY, 10022, at 877-547-6340, and at Prospectus_Department@Jefferies.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=524…
BERKELEY, CA, Oct 28, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the pricing of an underwritten public offering of 23,000,000 shares of its common stock at a price to the public of $1.70 per share. The gross proceeds to Dynavax from this offering are expected to be approximately $39.1 million, before deducting underwriting discounts and commissions and other estimated offering expenses payable by Dynavax. Jefferies & Company, Inc. is acting as sole book-running manager for the offering. Wedbush PacGrow Life Sciences and Cowen and Company, LLC are acting as co-managers for the offering. Dynavax has granted the underwriters a 30-day option to purchase up to an aggregate of 3,450,000 additional shares of common stock to cover over-allotments, if any. The offering is expected to close on or about November 2, 2010, subject to customary closing conditions.
Dynavax anticipates using the net proceeds from the offering to fund its development activities for its lead program, HEPLISAV(TM), a Phase 3 investigational hepatitis B vaccine, and for other general corporate purposes, including working capital.
The securities described above are being offered by Dynavax pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), which the SEC declared effective on October 4, 2010. A preliminary prospectus supplement related to the offering has been filed with the SEC and is available on the SEC's website located at http://www.sec.gov. Copies of the final prospectus supplement relating to these securities, when available, may be obtained from Equity Syndicate Prospectus Department, Jefferies & Company, 520 Madison Avenue, 12th Floor, New York, NY, 10022, at 877-547-6340, and at Prospectus_Department@Jefferies.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=524…
Pre market wollten alle raus!
Jetzt wollen alle wieder rein!
Echt komisch diese Ammis!
Jetzt wollen alle wieder rein!
Echt komisch diese Ammis!
Kommt heute noch was?!
Dynavax to Host Analyst & Investor Day Webcast October 29, 2010
BERKELEY, CA, Oct 21, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it will webcast its first Analyst & Investor Day on Friday, October 29, 2010, from 8:00 - 11:00 am Eastern Time.
Presentation and discussions will focus on hepatitis B: epidemiology, unmet needs, and public/individual health Impacts, as well as the regulatory landscape and new market opportunities.
Guest speakers at the event will include:
-- William Schaffner, M.D., Professor & Chairman, Department of
Preventive Medicine, Division of Infectious Diseases, Vanderbilt
University School of Medicine.
-- Florian Schoedel, M.D., PhD, formerly Merck VP, Infectious
Diseases / Vaccines Clinical Research.
-- Peter Patriarca, M.D., formerly, FDA Director, Division of Viral
Products, Office of Vaccines Research & Review in the Center for
Biologics Evaluation & Research (CBER).
-- Stanley Plotkin, M.D., Emeritus Professor of Pediatrics and
Microbiology, University of Pennsylvania.
Presentations by Dynavax's Dr. Tyler Martin, President and Chief Medical Officer; Dr. Robert Coffman, Chief Scientific Officer; Brant Biehn, Chief Commercial Officer; and Dr. Dino Dina, Chief Executive Officer will also be broadcast. To access the live webcast and the subsequent archived audio recording of the presentation, please log onto Dynavax's website at http://investors.dynavax.com/newsevents.cfm.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Shari Annes
Investor Relations
510-665-7211
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=521…
Dynavax to Host Analyst & Investor Day Webcast October 29, 2010
BERKELEY, CA, Oct 21, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it will webcast its first Analyst & Investor Day on Friday, October 29, 2010, from 8:00 - 11:00 am Eastern Time.
Presentation and discussions will focus on hepatitis B: epidemiology, unmet needs, and public/individual health Impacts, as well as the regulatory landscape and new market opportunities.
Guest speakers at the event will include:
-- William Schaffner, M.D., Professor & Chairman, Department of
Preventive Medicine, Division of Infectious Diseases, Vanderbilt
University School of Medicine.
-- Florian Schoedel, M.D., PhD, formerly Merck VP, Infectious
Diseases / Vaccines Clinical Research.
-- Peter Patriarca, M.D., formerly, FDA Director, Division of Viral
Products, Office of Vaccines Research & Review in the Center for
Biologics Evaluation & Research (CBER).
-- Stanley Plotkin, M.D., Emeritus Professor of Pediatrics and
Microbiology, University of Pennsylvania.
Presentations by Dynavax's Dr. Tyler Martin, President and Chief Medical Officer; Dr. Robert Coffman, Chief Scientific Officer; Brant Biehn, Chief Commercial Officer; and Dr. Dino Dina, Chief Executive Officer will also be broadcast. To access the live webcast and the subsequent archived audio recording of the presentation, please log onto Dynavax's website at http://investors.dynavax.com/newsevents.cfm.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The company's lead product candidate is HEPLISAV, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Shari Annes
Investor Relations
510-665-7211
Email Contact
SOURCE: Dynavax Technologies
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=521…
Nicht vergessen!
Dynavax's HEPLISAV Demonstrates Superior Seroprotection in Diabetics Compared to Engerix-B
Late-Breaker AASLD Abstract and New Diabetic Data Published Online
BERKELEY, CA, Oct 04, 2010 (MARKETWIRE via COMTEX News Network) -- In an abstract published today on the website of the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Dynavax Technologies Corporation (NASDAQ: DVAX) reported that its novel hepatitis B vaccine candidate, HEPLISAV(TM), given as two doses over four weeks demonstrated superior seroprotection in persons with diabetes mellitus compared to Engerix-B given as three doses over 24 weeks. The subset analysis of 62 adults with diabetes in Dynavax's previously reported Phase 3 multicenter study (PHAST or Phase 3 HEPLISAV Short-regimen Trial), showed that at 12 weeks, 84 percent of adult diabetics treated with HEPLISAV achieved seroprotection as compared to 0 percent of adult diabetics treated with Engerix-B. At week 28, 93 percent of the HEPLISAV-treated group versus 35 percent in the Engerix-B group achieved seroprotection. HEPLISAV's significantly higher rate of seroprotection was achieved without further immunization past four weeks while the Engerix-B group received a third immunization at 24 weeks. A poster presentation (LB-17) entitled, "Immunogenicity of Two Doses of Investigational HEPLISAV(TM) Compared to Three Doses of Licensed Hepatitis B Vaccine (ENGERIX-B(R)) in Diabetics", will be made in a late-breaker session on November 1, 2010 at the AASLD in Boston, Massachusetts.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=513…
Dynavax's HEPLISAV Demonstrates Superior Seroprotection in Diabetics Compared to Engerix-B
Late-Breaker AASLD Abstract and New Diabetic Data Published Online
BERKELEY, CA, Oct 04, 2010 (MARKETWIRE via COMTEX News Network) -- In an abstract published today on the website of the 61st Annual Meeting of the American Association for the Study of Liver Diseases (AASLD), Dynavax Technologies Corporation (NASDAQ: DVAX) reported that its novel hepatitis B vaccine candidate, HEPLISAV(TM), given as two doses over four weeks demonstrated superior seroprotection in persons with diabetes mellitus compared to Engerix-B given as three doses over 24 weeks. The subset analysis of 62 adults with diabetes in Dynavax's previously reported Phase 3 multicenter study (PHAST or Phase 3 HEPLISAV Short-regimen Trial), showed that at 12 weeks, 84 percent of adult diabetics treated with HEPLISAV achieved seroprotection as compared to 0 percent of adult diabetics treated with Engerix-B. At week 28, 93 percent of the HEPLISAV-treated group versus 35 percent in the Engerix-B group achieved seroprotection. HEPLISAV's significantly higher rate of seroprotection was achieved without further immunization past four weeks while the Engerix-B group received a third immunization at 24 weeks. A poster presentation (LB-17) entitled, "Immunogenicity of Two Doses of Investigational HEPLISAV(TM) Compared to Three Doses of Licensed Hepatitis B Vaccine (ENGERIX-B(R)) in Diabetics", will be made in a late-breaker session on November 1, 2010 at the AASLD in Boston, Massachusetts.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=513…
Antwort auf Beitrag Nr.: 40.424.776 von Lucky72 am 31.10.10 21:47:04Monday, November 1
4:45 - 6:15 pm Late-breaking Abstracts
http://www.aasld.org/lm/program/Pages/default.aspx
4:45 - 6:15 pm Late-breaking Abstracts
http://www.aasld.org/lm/program/Pages/default.aspx
WOW!
01.11.2010 14:56:09 1,8100 100
01.11.2010 14:56:09 1,8100 500
01.11.2010 14:56:09 1,8100 300
01.11.2010 14:55:37 1,8200 250.000
01.11.2010 14:54:48 1,8100 100
01.11.2010 14:48:46 1,8200 100
01.11.2010 14:48:46 1,8200 100
01.11.2010 14:48:46 1,8200 300
01.11.2010 14:48:46 1,8200 400
01.11.2010 14:48:46 1,8200 100
01.11.2010 14:48:46 1,8200 200
01.11.2010 14:48:46 1,8200 2.000
01.11.2010 14:48:46 1,8300 200
01.11.2010 14:48:46 1,8300 700
01.11.2010 14:48:43 1,8300 100
01.11.2010 14:48:43 1,8300 300
01.11.2010 14:48:43 1,8300 100
01.11.2010 14:48:15 1,8200 100
01.11.2010 14:48:03 1,8300 100
01.11.2010 14:47:48 1,8250 200.000
01.11.2010 14:45:47 1,8260 2.000
01.11.2010 14:56:09 1,8100 100
01.11.2010 14:56:09 1,8100 500
01.11.2010 14:56:09 1,8100 300
01.11.2010 14:55:37 1,8200 250.000
01.11.2010 14:54:48 1,8100 100
01.11.2010 14:48:46 1,8200 100
01.11.2010 14:48:46 1,8200 100
01.11.2010 14:48:46 1,8200 300
01.11.2010 14:48:46 1,8200 400
01.11.2010 14:48:46 1,8200 100
01.11.2010 14:48:46 1,8200 200
01.11.2010 14:48:46 1,8200 2.000
01.11.2010 14:48:46 1,8300 200
01.11.2010 14:48:46 1,8300 700
01.11.2010 14:48:43 1,8300 100
01.11.2010 14:48:43 1,8300 300
01.11.2010 14:48:43 1,8300 100
01.11.2010 14:48:15 1,8200 100
01.11.2010 14:48:03 1,8300 100
01.11.2010 14:47:48 1,8250 200.000
01.11.2010 14:45:47 1,8260 2.000
Dynavax to Present at the Oppenheimer Healthcare Conference
BERKELEY, CA, Nov 01, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the Oppenheimer 21st Annual Healthcare Conference on Tuesday, November 2, 2010 at 10:15 am EDT (7:15 am PDT) at the Waldorf Astoria Hotel in New York.
Michael Ostrach, Chief Business Officer of Dynavax, will provide a corporate overview presentation. To access the live webcast and the subsequent archived recording of the presentation, please log onto Dynavax's website at http://investors.dynavax.com/newsevents.cfm.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=525…
BERKELEY, CA, Nov 01, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the Oppenheimer 21st Annual Healthcare Conference on Tuesday, November 2, 2010 at 10:15 am EDT (7:15 am PDT) at the Waldorf Astoria Hotel in New York.
Michael Ostrach, Chief Business Officer of Dynavax, will provide a corporate overview presentation. To access the live webcast and the subsequent archived recording of the presentation, please log onto Dynavax's website at http://investors.dynavax.com/newsevents.cfm.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV(TM), a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=525…
Eigentlich wollte ich heute die 2$ sehn!
Dynavax Announces Exercise in Full of Overallotment Option and Closing of Public Offering of Common Stock
Raises $42.0 Million in Net Proceeds
BERKELEY, CA, Nov 02, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the completion of a public offering of 26,450,000 shares of its common stock, including 3,450,000 shares sold pursuant to the full exercise of an overallotment option previously granted to the underwriters. All of the shares were offered by Dynavax. The net proceeds to Dynavax from this offering, after deducting underwriting discounts and commissions and other estimated offering expenses, were approximately $42.0 million.
Dynavax anticipates using the net proceeds from the offering to fund its development activities for its lead program, HEPLISAV(TM), a Phase 3 investigational hepatitis B vaccine, and for other general corporate purposes, including working capital.
Jefferies & Company, Inc. acted as sole book-running manager for the offering. Wedbush PacGrow Life Sciences and Cowen and Company, LLC acted as co-managers for the offering.
The securities described above were offered by Dynavax pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), which the SEC declared effective on October 4, 2010. A final prospectus supplement related to the offering has been filed with the SEC and is available on the SEC's website located at http://www.sec.gov. Copies of the final prospectus supplement relating to these securities may be obtained from Equity Syndicate Prospectus Department, Jefferies & Company, 520 Madison Avenue, 12th Floor, New York, NY, 10022, at 877-547-6340, and at Prospectus_Department@Jefferies.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=526…
Raises $42.0 Million in Net Proceeds
BERKELEY, CA, Nov 02, 2010 (MARKETWIRE via COMTEX News Network) -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the completion of a public offering of 26,450,000 shares of its common stock, including 3,450,000 shares sold pursuant to the full exercise of an overallotment option previously granted to the underwriters. All of the shares were offered by Dynavax. The net proceeds to Dynavax from this offering, after deducting underwriting discounts and commissions and other estimated offering expenses, were approximately $42.0 million.
Dynavax anticipates using the net proceeds from the offering to fund its development activities for its lead program, HEPLISAV(TM), a Phase 3 investigational hepatitis B vaccine, and for other general corporate purposes, including working capital.
Jefferies & Company, Inc. acted as sole book-running manager for the offering. Wedbush PacGrow Life Sciences and Cowen and Company, LLC acted as co-managers for the offering.
The securities described above were offered by Dynavax pursuant to a shelf registration statement previously filed with the Securities and Exchange Commission (the "SEC"), which the SEC declared effective on October 4, 2010. A final prospectus supplement related to the offering has been filed with the SEC and is available on the SEC's website located at http://www.sec.gov. Copies of the final prospectus supplement relating to these securities may be obtained from Equity Syndicate Prospectus Department, Jefferies & Company, 520 Madison Avenue, 12th Floor, New York, NY, 10022, at 877-547-6340, and at Prospectus_Department@Jefferies.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=526…
Dynavax Reports 2010 Third Quarter Financial Results
BERKELEY, CA -- (MARKET WIRE) -- 11/04/10 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the third quarter ended September 30, 2010, including $47.2 million in cash, cash equivalents and marketable securities. This compared to $57.4 million at June 30, 2010. In November 2010, the Company received $42.7 million from the successful completion of a public offering and a grant covering certain research costs, resulting in current cash, cash equivalents and marketable securities in excess of $83 million as of the date of this release.
In particular, the $47.2 million in reported cash at September 30, 2010 does not reflect the net proceeds of $42.0 million from the Company's public offering and $0.7 million in grants under The Patient Protection and Affordable Care Act of 2010 covering research and development costs from 2009 and 2010 for three of the Company's qualified therapeutic discovery projects including HEPLISAV?. The $10.2 million net cash usage reported for the third quarter 2010 included a $2.0 million initial purchase of the Company's common stock by Aspire Capital Fund, LLC that the Company received upon executing its September 2010 financing arrangement.
Total revenues of $11.6 million for the third quarter 2010 included recognition of the $10.0 million upfront payment received from AstraZeneca in 2006 following the recent amendment of our collaboration agreement. This compared to $2.9 million reported for the third quarter in 2009.
Total operating expenses of $18.4 million for the third quarter 2010, driven by continued clinical and manufacturing activities for HEPLISAV, were consistent with the $18.5 million reported for the second quarter 2010. Total operating expenses for the third quarter 2009 of $13.6 million were lower prior to restarting the HEPLISAV clinical program in September 2009.
The tables included as part of this press release provide a reconciliation of GAAP revenues and operating expenses to pro forma revenues and operating expenses.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
- tables to follow -
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=527…
Dynavax cuts Q3 loss to $5M
Date: Thursday, November 4, 2010, 5:50pm PDT
Dynavax Technologies Corp. lost $5 million in the September quarter, an improvement over the $10.7 million it lost in the same quarter a year earlier.
The Berkeley business (NASDAQ: DVAX) had $11.6 million in revenue in the quarter, up from revenue of $2.9 million a year earlier.
That works out to a loss of 6 cents a share in the most recent quarter, compared with a loss of 24 cents a share a year ago. But Dynavax had more than twice as many shares outstanding this time around -- 86.8 million vs 40.2 million.
For the nine months ended September, however, Dynavax reported a loss of $42.2 million on sales of $22.2 million, compared with a loss of $3.5 million on sales of $38.1 million in the first nine months of 2009.
The company is testing Heplisav, a vaccine against hepatitis B.
After paying underwriters and other costs, Dynavax was left with about $36.5 million from its recent $42 million stock sale.
Dino Dina, M.D., is CEO of Dynavax.
http://www.bizjournals.com/sanfrancisco/news/2010/11/04/dyna…
Date: Thursday, November 4, 2010, 5:50pm PDT
Dynavax Technologies Corp. lost $5 million in the September quarter, an improvement over the $10.7 million it lost in the same quarter a year earlier.
The Berkeley business (NASDAQ: DVAX) had $11.6 million in revenue in the quarter, up from revenue of $2.9 million a year earlier.
That works out to a loss of 6 cents a share in the most recent quarter, compared with a loss of 24 cents a share a year ago. But Dynavax had more than twice as many shares outstanding this time around -- 86.8 million vs 40.2 million.
For the nine months ended September, however, Dynavax reported a loss of $42.2 million on sales of $22.2 million, compared with a loss of $3.5 million on sales of $38.1 million in the first nine months of 2009.
The company is testing Heplisav, a vaccine against hepatitis B.
After paying underwriters and other costs, Dynavax was left with about $36.5 million from its recent $42 million stock sale.
Dino Dina, M.D., is CEO of Dynavax.
http://www.bizjournals.com/sanfrancisco/news/2010/11/04/dyna…
Wer kauft in Frankfurt zu 1,61€?
Datum / Zeit Kurs Volumen
05.11.2010 09:14:16 1,6100 4.000
Datum / Zeit Kurs Volumen
05.11.2010 09:14:16 1,6100 4.000
Jefferies Starts Dynavax Technologies (DVAX) at Buy
November 8, 2010 7:20 AM EST
Jefferies initiates coverage on Dynavax Technologies (Nasdaq: DVAX) with a Buy rating and $4 price target.
The firm states, "We believe Heplisav offers efficacy and convenience benefits that will make it a preferred choice for high-risk adult patients who are poor responders to current HBV vaccines. We see diabetics as a new major market opportunity for Heplisav that has not been fully captured in the valuation."
http://www.streetinsider.com/New+Coverage/Jefferies+Starts+D…
Item 5.02. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers
On November 3, 2010, Stephen F. Tuck, Ph.D., joined Dynavax Technologies Corporation ("Dynavax" or the "Company") as the Company's Vice President, Global Technical Operations. Dr. Tuck, age 48, was an independent consultant to biotechnology and pharmaceutical clients from 2007 to 2010, which included Dynavax. From 1997 until 2007, Dr. Tuck was an employee of Dynavax where he held a series of positions with increasing responsibility and ultimately served as our Vice President of Biopharmaceutical Development. Prior to joining Dynavax in November 1997, Dr. Tuck was employed by Chiron Corporation, where he had served in various capacities in the Technical Affairs and Process Development departments. At Chiron, Dr. Tuck was involved in the development of Fluad(R), a novel adjuvanted influenza vaccine, various subunit vaccines, adjuvants and protein therapeutics. Prior to joining Chiron, Dr. Tuck was a post-doctoral fellow at Johns Hopkins University School of Medicine and the University of California, San Francisco. He has over 20 years of experience in pharmaceutical chemistry. Dr. Tuck received his Ph.D. and B.Sc. from Imperial College, University of London.
Under the terms of his at-will offer letter, Dr. Tuck will be paid an annual salary of $325,000. Dr. Tuck is also eligible to earn annual incentive compensation of up to 50% of his annual salary. In addition, for starting work not later than November 3, 2010, Dr. Tuck will receive a sign-on bonus of $50,000, subject to repayment if he voluntarily terminates his employment prior to the first anniversary of his start date. In addition, subject to board approval, the Company will grant Dr. Tuck two stock options to purchase 125,000 shares and 50,000 shares, respectively, of the Company's Common Stock. The first option will vest in four equal annual installments. The second option will vest upon achievement of certain performance goals prior to the end of 2012. The options will have an exercise price not less than the fair market value of the underlying stock on the date of grant. In addition, subject to board approval, the Company will grant Dr. Tuck a restricted stock unit award for 75,000 shares of the Company's Common Stock, which will vest based on the achievement of certain performance milestones. All compensation offered to Dr. Tuck is subject to applicable tax withholdings.
Dr. Tuck has entered into the Company's standard form of a Management Continuity and Severance Agreement, dated as of November 3, 2010 (the "Agreement"). The form of the Agreement was filed with the Securities and Exchange Commission ("SEC") as exhibit 10.38 to the Company's Form 10-K, as filed with the SEC on March 6, 2009. The Agreement provides severance payments and benefits to Dr. Tuck upon an involuntary termination of employment, as well as certain change in control benefits. If Dr. Tuck's employment is involuntarily terminated other than following a change in control, Dr. Tuck will receive (i) a lump-sum cash payment equal to six months of the executive's then effective annual base salary, (ii) a payment that may be used toward the cost of health care continuation coverage for up to six months, and (iii) six months accelerated vesting of unvested options to purchase Dynavax Common Stock. If Dr. Tuck's employment is involuntarily terminated within twenty-four months following a change in control, Dr. Tuck will receive (i) a lump-sum cash payment equal to twelve months of the executive's then effective annual base salary, (ii) a lump-sum cash payment equal to his target bonus, (iii) a payment that may be used toward the cost of health care continuation coverage for up to twelve months, and (iv) the ability to exercise his then outstanding vested options to purchase Dynavax Common Stock for up to three years following his termination. In addition, if, in connection with a change in control, Dr. Tuck is offered and accepts a position with the acquirer, or is not offered a comparable position with the acquirer, then, as of immediately prior to the closing of the change in control, his then outstanding but unvested options to purchase Dynavax Common Stock will become vested as to the number of shares underlying each such option that would have vested, in the ordinary course, in the following two years.
http://biz.yahoo.com/e/101108/dvax8-k.html
On November 3, 2010, Stephen F. Tuck, Ph.D., joined Dynavax Technologies Corporation ("Dynavax" or the "Company") as the Company's Vice President, Global Technical Operations. Dr. Tuck, age 48, was an independent consultant to biotechnology and pharmaceutical clients from 2007 to 2010, which included Dynavax. From 1997 until 2007, Dr. Tuck was an employee of Dynavax where he held a series of positions with increasing responsibility and ultimately served as our Vice President of Biopharmaceutical Development. Prior to joining Dynavax in November 1997, Dr. Tuck was employed by Chiron Corporation, where he had served in various capacities in the Technical Affairs and Process Development departments. At Chiron, Dr. Tuck was involved in the development of Fluad(R), a novel adjuvanted influenza vaccine, various subunit vaccines, adjuvants and protein therapeutics. Prior to joining Chiron, Dr. Tuck was a post-doctoral fellow at Johns Hopkins University School of Medicine and the University of California, San Francisco. He has over 20 years of experience in pharmaceutical chemistry. Dr. Tuck received his Ph.D. and B.Sc. from Imperial College, University of London.
Under the terms of his at-will offer letter, Dr. Tuck will be paid an annual salary of $325,000. Dr. Tuck is also eligible to earn annual incentive compensation of up to 50% of his annual salary. In addition, for starting work not later than November 3, 2010, Dr. Tuck will receive a sign-on bonus of $50,000, subject to repayment if he voluntarily terminates his employment prior to the first anniversary of his start date. In addition, subject to board approval, the Company will grant Dr. Tuck two stock options to purchase 125,000 shares and 50,000 shares, respectively, of the Company's Common Stock. The first option will vest in four equal annual installments. The second option will vest upon achievement of certain performance goals prior to the end of 2012. The options will have an exercise price not less than the fair market value of the underlying stock on the date of grant. In addition, subject to board approval, the Company will grant Dr. Tuck a restricted stock unit award for 75,000 shares of the Company's Common Stock, which will vest based on the achievement of certain performance milestones. All compensation offered to Dr. Tuck is subject to applicable tax withholdings.
Dr. Tuck has entered into the Company's standard form of a Management Continuity and Severance Agreement, dated as of November 3, 2010 (the "Agreement"). The form of the Agreement was filed with the Securities and Exchange Commission ("SEC") as exhibit 10.38 to the Company's Form 10-K, as filed with the SEC on March 6, 2009. The Agreement provides severance payments and benefits to Dr. Tuck upon an involuntary termination of employment, as well as certain change in control benefits. If Dr. Tuck's employment is involuntarily terminated other than following a change in control, Dr. Tuck will receive (i) a lump-sum cash payment equal to six months of the executive's then effective annual base salary, (ii) a payment that may be used toward the cost of health care continuation coverage for up to six months, and (iii) six months accelerated vesting of unvested options to purchase Dynavax Common Stock. If Dr. Tuck's employment is involuntarily terminated within twenty-four months following a change in control, Dr. Tuck will receive (i) a lump-sum cash payment equal to twelve months of the executive's then effective annual base salary, (ii) a lump-sum cash payment equal to his target bonus, (iii) a payment that may be used toward the cost of health care continuation coverage for up to twelve months, and (iv) the ability to exercise his then outstanding vested options to purchase Dynavax Common Stock for up to three years following his termination. In addition, if, in connection with a change in control, Dr. Tuck is offered and accepts a position with the acquirer, or is not offered a comparable position with the acquirer, then, as of immediately prior to the closing of the change in control, his then outstanding but unvested options to purchase Dynavax Common Stock will become vested as to the number of shares underlying each such option that would have vested, in the ordinary course, in the following two years.
http://biz.yahoo.com/e/101108/dvax8-k.html
Dynavax Technologies Corporation (DVAX) rated Outperform with price target $8 by Wedbush
Posted on: Tuesday, Nov 9, 2010 9:25 AM ET by Wedbush
Wedbush rated Outperform Dynavax Technologies Corporation (NASDAQ: DVAX) on 11/09/2010. Previously Wedbush rated Outperform Dynavax Technologies Corporation (NASDAQ: DVAX) on
05/13/2010., when the stock price was $2.04. Since then, Dynavax Technologies Corporation has gained 3.92% as of 11/08/2010's recent price of $2.12. If you would have followed the previous Wedbush 's recommendation on DVAX, you would have gained 3.92% of your investment in 179 days.
http://www.gainerstoday.com/Gains-Stock-78072-DVAX
by Wedbush Posted on: Tuesday, Nov 9, 2010 9:25 AM ET by Wedbush
Wedbush rated Outperform Dynavax Technologies Corporation (NASDAQ: DVAX) on 11/09/2010. Previously Wedbush rated Outperform Dynavax Technologies Corporation (NASDAQ: DVAX) on
05/13/2010., when the stock price was $2.04. Since then, Dynavax Technologies Corporation has gained 3.92% as of 11/08/2010's recent price of $2.12. If you would have followed the previous Wedbush 's recommendation on DVAX, you would have gained 3.92% of your investment in 179 days.
http://www.gainerstoday.com/Gains-Stock-78072-DVAX
Eigentlich wollte ich heute die 2,28$ sehn!
Short Interest (Shares Short) 2,576,200
Days To Cover (Short Interest Ratio) 3.3
Short Interest - Prior 2,327,400
http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…
Days To Cover (Short Interest Ratio) 3.3
Short Interest - Prior 2,327,400
http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…
"Hepatitis B: Why Should I Care?"
A presentation by Dr. William Schaffner
Chairman Department of Preventative Medicine
Vanderbilt University
http://investors.dynavax.com/wmv_16732.cfm
A presentation by Dr. William Schaffner
Chairman Department of Preventative Medicine
Vanderbilt University
http://investors.dynavax.com/wmv_16732.cfm
@DINO
Wir brauchen NEWS!
Wir brauchen NEWS!
Dynavax Reports New Employment Inducement Awards
BERKELEY, CA -- (MARKET WIRE) -- 11/12/10 -- Dynavax Technologies Corporation (NASDAQ: DVAX) reported that the Company's independent compensation committee approved the granting of equity awards to 11 new employees under the Company's 2010 Employment Inducement Award Plan ("the 2010 Plan") as a material inducement for each individual to become an employee of the Company. The employees were granted a total of 15 options to purchase an aggregate of 174,500 shares of the Company's common stock at an exercise price of $1.98 per share, the closing price of Dynavax common stock on the date of grant, and a total of two restricted stock unit awards covering 75,000 shares of the Company's common stock. Dynavax's Board of Directors adopted the 2010 Plan to grant equity awards as a material inducement to new employees. NASDAQ Marketplace Rule 5635(c)(4) requires a public announcement to be issued when awards are made under the 2010 Plan.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=530…
BERKELEY, CA -- (MARKET WIRE) -- 11/12/10 -- Dynavax Technologies Corporation (NASDAQ: DVAX) reported that the Company's independent compensation committee approved the granting of equity awards to 11 new employees under the Company's 2010 Employment Inducement Award Plan ("the 2010 Plan") as a material inducement for each individual to become an employee of the Company. The employees were granted a total of 15 options to purchase an aggregate of 174,500 shares of the Company's common stock at an exercise price of $1.98 per share, the closing price of Dynavax common stock on the date of grant, and a total of two restricted stock unit awards covering 75,000 shares of the Company's common stock. Dynavax's Board of Directors adopted the 2010 Plan to grant equity awards as a material inducement to new employees. NASDAQ Marketplace Rule 5635(c)(4) requires a public announcement to be issued when awards are made under the 2010 Plan.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Contact:
Michael Ostrach
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=530…
KE oder Giftpille????
PRELIMINARY COPY—SUBJECT TO COMPLETION
DYNAVAX TECHNOLOGIES CORPORATION
2929 Seventh Street, Suite 100
Berkeley, California 94710
NOTICE OF SPECIAL MEETING OF STOCKHOLDERS
To Be Held On January 5, 2011
Dear Stockholder:
Notice is hereby given that a Special Meeting of Stockholders of Dynavax Technologies Corporation, a Delaware corporation (the “Company”), will be held on January 5, 2011 at 9:00 a.m. local time at the Company’s executive offices at 2929 Seventh Street, Suite 100, Berkeley, California 94710. The Company is conducting this Special Meeting for the following purposes:
1. To approve an amendment to the Company’s Sixth Amended and Restated Certificate of Incorporation to increase the authorized number of shares of common stock from 150,000,000 to 250,000,000 shares.
2. To approve the Dynavax Technologies Corporation 2011 Equity Incentive Plan.
These items of business are more fully described in the Proxy Statement accompanying this Notice.
The record date for the Special Meeting is November 5, 2010. Only stockholders of record at the close of business on that date may vote at the meeting or any adjournment or postponement thereof. In accordance with Delaware law, for ten days prior to the Special Meeting, a list of stockholders of record will be available for inspection in the office of the Corporate Secretary, Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, California 94710. The list of stockholders will also be available at the Special Meeting.
http://investors.dynavax.com/secfiling.cfm?filingID=1193125-…
PRELIMINARY COPY—SUBJECT TO COMPLETION
DYNAVAX TECHNOLOGIES CORPORATION
2929 Seventh Street, Suite 100
Berkeley, California 94710
NOTICE OF SPECIAL MEETING OF STOCKHOLDERS
To Be Held On January 5, 2011
Dear Stockholder:
Notice is hereby given that a Special Meeting of Stockholders of Dynavax Technologies Corporation, a Delaware corporation (the “Company”), will be held on January 5, 2011 at 9:00 a.m. local time at the Company’s executive offices at 2929 Seventh Street, Suite 100, Berkeley, California 94710. The Company is conducting this Special Meeting for the following purposes:
1. To approve an amendment to the Company’s Sixth Amended and Restated Certificate of Incorporation to increase the authorized number of shares of common stock from 150,000,000 to 250,000,000 shares.
2. To approve the Dynavax Technologies Corporation 2011 Equity Incentive Plan.
These items of business are more fully described in the Proxy Statement accompanying this Notice.
The record date for the Special Meeting is November 5, 2010. Only stockholders of record at the close of business on that date may vote at the meeting or any adjournment or postponement thereof. In accordance with Delaware law, for ten days prior to the Special Meeting, a list of stockholders of record will be available for inspection in the office of the Corporate Secretary, Dynavax Technologies Corporation, 2929 Seventh Street, Suite 100, Berkeley, California 94710. The list of stockholders will also be available at the Special Meeting.
http://investors.dynavax.com/secfiling.cfm?filingID=1193125-…
Mein Schlusskurstipp für heute liegt bei 2,02$!
SK 1,92$
Knapp daneben ist auch vorbei!
Knapp daneben ist auch vorbei!
Wer kauft 1Mio???
Datum / Zeit Kurs Volumen
23.11.2010 21:52:40 1,9300 2.500
23.11.2010 21:52:16 1,9200 200
23.11.2010 21:52:15 1,9300 200
23.11.2010 21:51:58 1,9300 1 Mio.
23.11.2010 21:51:31 1,9300 200
23.11.2010 21:50:45 1,9300 200
23.11.2010 21:49:16 1,9300 200
Datum / Zeit Kurs Volumen
23.11.2010 21:52:40 1,9300 2.500
23.11.2010 21:52:16 1,9200 200
23.11.2010 21:52:15 1,9300 200
23.11.2010 21:51:58 1,9300 1 Mio.
23.11.2010 21:51:31 1,9300 200
23.11.2010 21:50:45 1,9300 200
23.11.2010 21:49:16 1,9300 200
Antwort auf Beitrag Nr.: 40.504.778 von Lucky72 am 11.11.10 18:29:04Nicht schlecht für einen Freitag!
Dynavax Technologies Corporation
$ 2.14
DVAX
0.12
Short Interest (Shares Short) 2,344,000
Days To Cover (Short Interest Ratio) 2.6
Short Interest - Prior 2,576,200
Record Date 2010-NovB
$ 2.14
DVAX
0.12
Short Interest (Shares Short) 2,344,000
Days To Cover (Short Interest Ratio) 2.6
Short Interest - Prior 2,576,200
Record Date 2010-NovB
Antwort auf Beitrag Nr.: 40.535.253 von Lucky72 am 17.11.10 08:07:13Siehn nach einer "GIFTPILLE" aus!
Die "Big Boys" halten auch ihre Aktien!
http://www.dailyfinance.com/company/dynavax-technologies-cor…
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Vielleicht knallt der Kurs nächst Woche durch die Decke!
Antwort auf Beitrag Nr.: 40.603.927 von Lucky72 am 28.11.10 10:33:59Das heißt wenn GSK langsam merkt das ihnen die Felle wegschwimmen!
increase the authorized number of shares of common stock from 150,000,000 to 250,000,000 shares.
Und trotzdem steigt der Kurs weiter!
Da ist doch was im Busch!
Und trotzdem steigt der Kurs weiter!
Da ist doch was im Busch!
Wird langsam Zeit für Ergebnisse!
Pipeline :: Hepatitis B Vaccine
HEPLISAV™ Hepatitis B vaccine
Our lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine that is designed to elicit enhanced protection more rapidly and with fewer doses than current licensed vaccines. Our global strategy is to develop HEPLISAV for populations that are less responsive to current licensed vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and others.
We have two ongoing Phase 3 completion trials: one in chronic kidney disease patients and a lot-to-lot consistency trial in adults over 40 years of age. The lot-to-lot trial is a large-scale trial designed to demonstrate the lot-to-lot consistency of commercial vaccine and to complete the safety database for HEPLISAV. Both studies are directed toward fulfilling licensure requirements in the U.S., Canada and Europe. Patient enrollment and immunization has been completed for the lot-to-lot consistency trial, and the trial is expected to complete in May 2011. Dynavax has worldwide commercial rights to HEPLISAV, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 (TLR9) agonist to enhance the immune response.
Clinical Results
Over 2,500 individuals have been vaccinated with HEPLISAV to date. Phase 3 data from our PHAST clinical trial demonstrate subjects over 40 years of age receiving two doses of HEPLISAV over one month achieved a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over six months.
Commercial Opportunity
The total worldwide market for adult hepatitis B vaccines is estimated at over $500 million annually. Current vaccines leave unmet needs for more rapid and increased protection, particularly for less responsive, underserved populations.
Chronic Kidney Disease Market – A high-value segment, the chronic kidney disease market is large, growing rapidly, and is widely recommended for vaccination. In 2006, there were approximately 750,000 end-stage renal disease (ESRD) patients in the United States and the 5 major European markets and approximately 150,000 new patients are added annually. Approximately 35% of these immunocompromised ESRD patients do not respond to vaccination and 20% require boosters. As vaccination for these patients occurs regularly at dialysis centers, this is a highly concentrated, renewable market that can be served by cost-effective, targeted sales distribution networks.
HEPLISAV is a trademark of Dynavax Technologies Corporation
HEPLISAV™ Hepatitis B vaccine
Our lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine that is designed to elicit enhanced protection more rapidly and with fewer doses than current licensed vaccines. Our global strategy is to develop HEPLISAV for populations that are less responsive to current licensed vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and others.
We have two ongoing Phase 3 completion trials: one in chronic kidney disease patients and a lot-to-lot consistency trial in adults over 40 years of age. The lot-to-lot trial is a large-scale trial designed to demonstrate the lot-to-lot consistency of commercial vaccine and to complete the safety database for HEPLISAV. Both studies are directed toward fulfilling licensure requirements in the U.S., Canada and Europe. Patient enrollment and immunization has been completed for the lot-to-lot consistency trial, and the trial is expected to complete in May 2011. Dynavax has worldwide commercial rights to HEPLISAV, which combines hepatitis B surface antigen (HBsAg) with a proprietary Toll-like Receptor 9 (TLR9) agonist to enhance the immune response.
Clinical Results
Over 2,500 individuals have been vaccinated with HEPLISAV to date. Phase 3 data from our PHAST clinical trial demonstrate subjects over 40 years of age receiving two doses of HEPLISAV over one month achieved a seroprotection rate of 92%, compared to 75% of subjects receiving 3 doses of a licensed vaccine over six months.
Commercial Opportunity
The total worldwide market for adult hepatitis B vaccines is estimated at over $500 million annually. Current vaccines leave unmet needs for more rapid and increased protection, particularly for less responsive, underserved populations.
Chronic Kidney Disease Market – A high-value segment, the chronic kidney disease market is large, growing rapidly, and is widely recommended for vaccination. In 2006, there were approximately 750,000 end-stage renal disease (ESRD) patients in the United States and the 5 major European markets and approximately 150,000 new patients are added annually. Approximately 35% of these immunocompromised ESRD patients do not respond to vaccination and 20% require boosters. As vaccination for these patients occurs regularly at dialysis centers, this is a highly concentrated, renewable market that can be served by cost-effective, targeted sales distribution networks.
HEPLISAV is a trademark of Dynavax Technologies Corporation
Antwort auf Beitrag Nr.: 40.603.926 von Lucky72 am 28.11.10 10:32:55Zum Vergleich!
http://data.cnbc.com/quotes/DVAX/tab/8
http://data.cnbc.com/quotes/DVAX/tab/8
Ich hoffe das Dynavax abgeht wie HGSI!
Dynavax Technologies Corporation (DVAX) rated Outperform with price target $8 by Wedbush
Posted on: Tuesday, Nov 9, 2010 9:25 AM ET by Wedbush
Wedbush rated Outperform Dynavax Technologies Corporation (NASDAQ: DVAX) on 11/09/2010. Previously Wedbush rated Outperform Dynavax Technologies Corporation (NASDAQ: DVAX) on
05/13/2010., when the stock price was $2.04. Since then, Dynavax Technologies Corporation has gained 4.90% as of 11/26/2010's recent price of $2.14. If you would have followed the previous Wedbush 's recommendation on DVAX, you would have gained 4.9% of your investment in 197 days.
http://www.gainerstoday.com/Gains-Stock-78072-DVAX
by WedbushPosted on: Tuesday, Nov 9, 2010 9:25 AM ET by Wedbush
Wedbush rated Outperform Dynavax Technologies Corporation (NASDAQ: DVAX) on 11/09/2010. Previously Wedbush rated Outperform Dynavax Technologies Corporation (NASDAQ: DVAX) on
05/13/2010., when the stock price was $2.04. Since then, Dynavax Technologies Corporation has gained 4.90% as of 11/26/2010's recent price of $2.14. If you would have followed the previous Wedbush 's recommendation on DVAX, you would have gained 4.9% of your investment in 197 days.
http://www.gainerstoday.com/Gains-Stock-78072-DVAX
Das Orakel postet auch ein "BUY CONFIRMED"!
http://www.americanbulls.com/StockPage.asp?CompanyTicker=DVA…
http://www.americanbulls.com/StockPage.asp?CompanyTicker=DVA…
Antwort auf Beitrag Nr.: 40.605.170 von Lucky72 am 28.11.10 19:54:38Ist aber nur ein "Orakel"!!!
Ob das was zu sagen hat kann jeder selbst entscheiden!
Ob das was zu sagen hat kann jeder selbst entscheiden!
Journal of Experimental Medicine Publishes New Dynavax Findings on the Role of TLRS in Cutaneous Lupus
BERKELEY, CA -- (MARKET WIRE) -- 11/29/10 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported in the JOURNAL OF EXPERIMENTAL MEDICINE (JEM) new data that suggests an important role of the key innate immune receptors TLR7 and TLR9 in cutaneous lupus and related skin conditions. In the issue of JEM (Volume 207, Number 13), which was published online today and will appear in print December 20, 2010, Dynavax scientists report development of a novel mouse model for evaluating skin conditions similar to cutaneous lupus. Using that model, Dynavax show that its inhibitor of TLR7 and TLR9 prevents and reverses disease in this model, suggesting therapeutic application of the inhibitor for the treatment of cutaneous lupus and related skin conditions.
"This work demonstrates the central role of two innate immune receptors, TLR7 and TLR9, in the inflammatory response to skin injury and shows how injury can lead to chronic disease in mice predisposed to develop lupus. It also significantly extends the list of diseases for which an inhibitor of TLR7 and TLR9 may provide benefit," commented Robert Coffman, Ph.D., Chief Scientific Officer of Dynavax.
The work was partly supported by a Small Business Innovation Research (SBIR) grant from the National Institute of Allergy and Infectious Diseases (NIAID) intended to advance Dynavax's oligonucleotide-based Toll-like Receptor (TLR) inhibitors for the treatment of inflammatory skin diseases including cutaneous lupus and dermatomyositis.
About Dynavax's TLR Inhibitors
Dynavax's TLR inhibitors are a novel class of oligonucleotides, called immunoregulatory sequences (IRS), that specifically inhibit the TLR-induced inflammatory response associated with autoimmune and inflammatory diseases. Preclinical data from animal model studies show Dynavax's TLR inhibitors block induction of IFN-alpha and also reduce symptoms in animal models of multiple autoimmune diseases, such as lupus, inflammatory skin disorders, and rheumatoid arthritis. Dynavax is developing its TLR inhibitors under a worldwide strategic alliance with GlaxoSmithKline (GSK), whereby GSK has an exclusive option to obtain a license to the program.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV™, an investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties, including statements about data for the Company's IRS. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether the reported results can be replicated in human trials, difficulties or delays in discovery or development, initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving our GSK collaborative agreement objectives; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
Contact:
Robert L. Coffman, Ph.D.
Vice President and Chief Scientific Officer
510-665-7224
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=533…
Lausiges Volumen!
Das wird heute nischt!
Das wird heute nischt!
Dynavax Reports Phase 1a Safety and Immunogenicity Results for Universal Flu Vaccine
Detailed Phase 1a and 1b Results to Be Reported at WHO Meeting in February 2011
BERKELEY, CA -- (MARKET WIRE) -- 12/07/10 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported safety and immunogenicity data from its Phase 1a clinical trial of N8295, one of two key components of its Universal Flu Vaccine candidate. N8295 is a fusion protein comprised of NP and M2e, two highly conserved influenza antigens covalently linked to Dynavax's proprietary second-generation TLR9 agonist. The trial assessed three dose levels of N8295 in a total study population of 39 subjects. The Phase 1a data showed:
* All doses were very safe and generally well tolerated;
* No dose limiting toxicities;
* Positive antibody responses to M2e; and
* Positive T-cell mediated responses to NP.
Based on preliminary safety data, Dynavax initiated a Phase 1b study in September 2010 to evaluate the safety of the combination of N8295, the novel component of Dynavax's Universal Flu vaccine candidate, and an investigational H5N1 avian influenza vaccine. Detailed results of the Phase 1a and 1b studies will be reported at the World Health Organization 7th Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials in Geneva, Switzerland in February 2011.
Dr. J. Tyler Martin, M.D., Dynavax President and Chief Medical Officer, said, "Now that we have completed the safety assessment of the novel component, N8295, we are eager to assess the combination of N8295 with an avian flu vaccine. Those data are expected to improve our understanding of the immunologic properties of our universal flu vaccine candidate in the absence of pre-existing immunity to the H5N1 flu strain in human subjects. These are key achievements in the continued development of Dynavax's Universal Flu Vaccine as they should allow us to design a proof-of-concept study."
Dynavax's Universal Flu Vaccine is designed to offer protection against divergent influenza strains as well as to increase the efficacy of a conventional influenza vaccine. Preclinical data have confirmed the expected immunogenicity and mechanistic effects of the vaccine candidate's novel components. The production of cytotoxic T-cells by NP and cytotoxic antibodies by M2e have been demonstrated in preclinical studies, as has an increase in neutralizing antibodies provided by a co-administered conventional influenza vaccine. A GLP toxicity study demonstrated that this Universal Flu vaccine candidate is well-tolerated.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly and with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward-looking Statements
This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties, including statements related to the anticipated timing and nature of data from clinical trials of our universal flu vaccine candidate and the features of the vaccine. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether results of completed studies can be replicated in human studies with greater numbers of subjects, difficulties or delays in initiation and completion of preclinical or clinical studies, the results of those studies and the impact of those results on the initiation and completion of subsequent studies and issues arising in the regulatory process; achieving the objectives under our collaborative agreement; our ability to obtain additional financing to support our operations; and other risks detailed in the "Risk Factors" section of our current periodic reports filed with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=535…
Guten Morgen!
Ich wünsche allen einen dunkelgrünen Tag!
Ich wünsche allen einen dunkelgrünen Tag!
Ist was im Busch??
Die geht ja ab wie ein Zäpfchen!
Guten Morgen!
Ich hoffe es geht heute weiter UP!
Ich hoffe es geht heute weiter UP!
Keine News!
Morgen knallt es!
Da wollten noch einige am Freitag rein, und haben sogar 2,39$ bezahlt!
Vielleicht kommt es zu einer Übernahme bevor im Januar die "Giftpille" gesetzt wird!
Neues 52 Wochen Hoch!!!!!
# Range 2.12 - 2.39
# 52 week 1.19 - 2.39
# Open 2.32
# Vol / Avg. 1.16M/1.04M
# Range 2.12 - 2.39
# 52 week 1.19 - 2.39
# Open 2.32
# Vol / Avg. 1.16M/1.04M
Alle Postings sind nur meine Meinung, und keine Empfehlung für Kauf/Verkauf!
Wo bleibt die NEWS?
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
16:26 $ 2.80 5,000
16:26 $ 2.80 2,000
16:26 $ 2.80 100
16:25 $ 2.80 300
16:24 $ 2.85 100
16:24 $ 2.85 200
16:24 $ 2.4403 843
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16:23 $ 2.44 402
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16:23 $ 2.75 888
16:23 $ 2.80 1,000
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16:22 $ 2.69 1,500
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16:20 $ 2.65 5,000
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16:17 $ 2.48 2,500
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16:16 $ 2.50 400
16:16 $ 2.48 100
16:11 $ 2.3704 2,000
16:11 $ 2.48 100
16:06 $ 2.3625 26,200
Guten Morgen!
Ich wünsche allen einen grünen Tag!
Ich wünsche allen einen grünen Tag!
Neuer Chart!
Eigentlich wollte ich heute die 3$ sehn!
Aber ohne News wird das wohl nix!
Aber ohne News wird das wohl nix!
Tja, die Aktie ist nix für schwache Nerven!
Research on Vertex Pharmaceuticals Incorporated and Dynavax Technologies Corporation - FDA Making Life Easier for 'Drug Manufacturers - Other' Sector
JOHANNESBURG, SOUTH AFRICA--(Marketwire - 12/17/10) - www.stockcall.com/ offers investors comprehensive research on the drug manufacturers - other industry and has completed analytical research on Vertex Pharmaceuticals Incorporated (NASDAQ:VRTX - News) and Dynavax Technologies Corporation (NASDAQ
VAX - News). Register with us today at www.stockcall.com/ to have free access to these researches.The FDA has proven to be more lenient recently as a panel recommended approval of a new obesity drug Contrave. This comes after over a decade has passed since the last drug targeting weight-loss was approved. This should give hope to other drug companies as the market for obesity drugs in the United States is potentially enormous. Currently, 68% of adults are considered overweight, 24% of which are considered obese.
www.stockcall.com/ is an online platform where investors doing their due-diligence on the drug manufacturers - other industry can have easy and free access to our analyst research and opinions on Vertex Pharmaceuticals Incorporated and Dynavax Technologies Corporation; investors and shareholders of these companies can simply register for a complimentary membership at https://stockcall.com/development/stockcall/page.php?name=re…
Another piece of good FDA related news is their current consideration of a proposal that would allow for faster generic drug reviews. With the growing amount of generic manufacturers moving overseas, the FDA has had a hard time keeping up with inspections. To remedy this, they are considering the payment of fees by manufacturers that would expedite the entire process. Visit www.stockcall.com/ to see how companies in this industry have grown over the past years and how they are expected to perform in the future.
While the FDA has been more cordial toward the Drug Manufacturers- Other sector lately, the Federal Trade Commission has been cracking down on pay-for-delay settlements in which brand name drug makers pay generic makers to delay release of their generic version so that the brand named drug maker can continue charging monopoly prices. This practice has been deemed anti-competitive by the FTC due to its harmful effect on consumer pocket books. Register now at https://stockcall.com/development/stockcall/page.php?name=re… to have free access to our reports on the drug manufacturers - other industry.
Taking a look at the financial results delivered during the third quarter by some of the industry players, Vertex Pharmaceuticals Incorporated posted wider loss this quarter due to R&D expenses on its potential blockbuster treatment for hepatitis C which is still in experimental stage. Net loss came in at $209 million on revenue of $23.8 million. On the other hand, Dynavax Technologies Corporation saw its loss for the quarter shrunk to $5 million on revenue of $11.6 million. Investors can register for free to access the research reports on Vertex Pharmaceuticals Incorporated and Dynavax Technologies Corporation at www.stockcall.com/VRTX171210.pdf or www.stockcall.com/DVAX171210.pdf.
About StockCall.com
StockCall.com is a financial website where investors can have easy, precise and comprehensive research and opinions on stocks making the headlines.
http://finance.yahoo.com/news/Research-on-Vertex-iw-38517022…
WOW!!
Ich weiß nur eins, so lange die Insider und Funds weiter kaufen, verkaufe ich nicht!
Antwort auf Beitrag Nr.: 40.852.362 von pokemon am 13.01.11 07:53:22Jep, und ich hoffe das bleibt so!
Zitat von Lucky72: Dynavax Technologies Corporation (DVAX) rated Outperform with price target $8
Posted on: Tuesday, Nov 9, 2010 9:25 AM ET by Wedbush
Wedbush rated Outperform Dynavax Technologies Corporation (NASDAQ: DVAX) on 11/09/2010. Previously Wedbush rated Outperform Dynavax Technologies Corporation (NASDAQ: DVAX) on
05/13/2010., when the stock price was $2.04. Since then, Dynavax Technologies Corporation has gained 3.92% as of 11/08/2010's recent price of $2.12. If you would have followed the previous Wedbush 's recommendation on DVAX, you would have gained 3.92% of your investment in 179 days.
http://www.gainerstoday.com/Gains-Stock-78072-DVAX
Trend ist noch OK!
Zitat von Lucky72: Ich heiz schon mal den Grill an!
Short Interest (Shares Short) 4,028,900
Short Interest - Prior 2,048,400
Days To Cover (Short Interest Ratio) 2.5
http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…
20 Short Seller Targets Under $5
The following is a list of stocks under $5 that have seen a sharp increase in shares shorted over the last three months.
To create the list, we started with a universe of about 150 stocks with prices below $5.00. We then narrowed down the list to only focus on those companies that have seen a significant increase in shares shorted between 9/30 - 12/31.
Is this growing pessimism justified, or will short covering provide support to these names? What do you think? Full details below.
Short trends data sourced from AOL Money, moving average and current short float data sourced from Finviz. Note that all short trends described occurred between 9/30 and 12/31.
6. Dynavax Technologies Corporation (DVAX): Drug Manufacturer. Market cap of $383.73M. Price at $3.31. Shares shorted have increased from 2.5M to 4.0M over the last three months. Short float at 1.78%, which implies a short ratio of 1.86 days. The stock has gained 112.82% over the last year.
http://seekingalpha.com/article/246731-20-short-seller-targe…
Warum kackt der Kurs so ab????!!!
Eigentlich wollte ich heute die 3,30$ sehn!
@Dino
Raus mit der News!
Raus mit der News!
Guten Morgen!
Ich hoffe es geht heute wieder UP!
Ich hoffe es geht heute wieder UP!
Zitat von Lucky72: Ich heiz schon mal den Grill an!
Short Interest (Shares Short) 4,028,900
Short Interest - Prior 2,048,400
Days To Cover (Short Interest Ratio) 2.5
http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…
Jetzt sind schon 6,298,400 Shares Short!!!!
Kein Wunder das der Kurs runter gegangen ist!
Seit drei Wochen keine News!
Antwort auf Beitrag Nr.: 40.845.556 von Lucky72 am 12.01.11 11:01:04Neuer Update!!!!
Jetzt werden schon 99,4% von den Instis gehalten!
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Jetzt werden schon 99,4% von den Instis gehalten!
http://www.dailyfinance.com/company/dynavax-technologies-cor…
Antwort auf Beitrag Nr.: 40.985.784 von Lucky72 am 04.02.11 18:28:49Hallo Lucky72,
99,x Prozent von Instis gehalten wäre schon eine beeindruckende Quote. Woher beziehst du diese Info und was steht da konkret geschrieben?
Ich habe da zugegebenermaßen Zweifel ob das mit den 99,x Prozent wirklich richtig ist - lasse mich da jedoch gerne vom Gegenteil überzeugen.
Schon mal Danke im Voraus,
Freizeitspekulant
99,x Prozent von Instis gehalten wäre schon eine beeindruckende Quote. Woher beziehst du diese Info und was steht da konkret geschrieben?
Ich habe da zugegebenermaßen Zweifel ob das mit den 99,x Prozent wirklich richtig ist - lasse mich da jedoch gerne vom Gegenteil überzeugen.
Schon mal Danke im Voraus,
Freizeitspekulant
Antwort auf Beitrag Nr.: 40.987.144 von Freizeitspekulant am 04.02.11 22:18:05Ich hab doch einen Link beigefügt!
Antwort auf Beitrag Nr.: 40.987.144 von Freizeitspekulant am 04.02.11 22:18:05Die Seite von CNBC zeigt die gleichen Daten!
Institutions 60,6% Owned of O/S
Mutual Funds 38,8% Owned of O/S
http://data.cnbc.com/quotes/DVAX/tab/8
Institutions 60,6% Owned of O/S
Mutual Funds 38,8% Owned of O/S
http://data.cnbc.com/quotes/DVAX/tab/8
Es tut sich wieder was!
Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease
http://clinicaltrials.gov/ct2/show/NCT01282762?term=Dynavax&…
Long-Term Study on Safety and Immunogenicity of HEPLISAV™ and Engerix-B® in Adults With Chronic Kidney Disease
http://clinicaltrials.gov/ct2/show/NCT01282762?term=Dynavax&…
Guten Morgen
Ich wünsche allen einen grünen Tag!
Ich wünsche allen einen grünen Tag!
Mal sehn wohin die Reise geht!
Seit 10.Januar keine News!!!
Short Update!
Short Interest (Shares Short) 6,445,800
Days To Cover (Short Interest Ratio) 9.0
Short Interest - Prior 6,298,400
http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…
Short Interest (Shares Short) 6,445,800
Days To Cover (Short Interest Ratio) 9.0
Short Interest - Prior 6,298,400
http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…
Ohne News wird das heute wieder Nix!
Heut könnte was gehn!
@ alle Shorty
Immer schön aus dem ASK kaufen!
Immer schön aus dem ASK kaufen!
Biotechnology Value Fund, L.P. ist raus!
Die haben ihre 4,x mio Aktien verkauft!
http://investors.dynavax.com/secfiling.cfm?filingID=921895-1…
Die haben ihre 4,x mio Aktien verkauft!
http://investors.dynavax.com/secfiling.cfm?filingID=921895-1…
Da war doch was im Februar!?
Based on preliminary safety data, Dynavax initiated a Phase 1b study in September 2010 to evaluate the safety of the combination of N8295, the novel component of Dynavax's Universal Flu vaccine candidate, and an investigational H5N1 avian influenza vaccine. Detailed results of the Phase 1a and 1b studies will be reported at the World Health Organization 7th Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials in Geneva, Switzerland in February 2011.
Ich hab mal den Termin gegoogelt!
7th WHO Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials. The meeting is being held February 17-18, 2011 at the WHO headquarters in Geneva, Switzerland
Based on preliminary safety data, Dynavax initiated a Phase 1b study in September 2010 to evaluate the safety of the combination of N8295, the novel component of Dynavax's Universal Flu vaccine candidate, and an investigational H5N1 avian influenza vaccine. Detailed results of the Phase 1a and 1b studies will be reported at the World Health Organization 7th Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials in Geneva, Switzerland in February 2011.
Ich hab mal den Termin gegoogelt!
7th WHO Meeting on Evaluation of Pandemic Influenza Vaccines in Clinical Trials. The meeting is being held February 17-18, 2011 at the WHO headquarters in Geneva, Switzerland
WedBush: Handful of biotechs to watch this quater
A handful of biotechnology companies could see shares moved early this year
On Monday February 14, 2011, 11:28 am EST
NEW YORK (AP) -- There are a handful of events that could send a handful of select biotechnology stocks moving sharply early this year, according to a WedBush analyst.
Analyst Y. Katherine Xu reaffirmed an "Outperform" rating and $57 price target on Pharmasset Inc. as that company or its partner Roche is expected to release study data on its potential hepatitis C drug.
"If data is satisfactory, especially on the safety side, we would increase our probabilities of success for the candidates," Xu said.
Meanwhile, she reaffirmed a "Neutral" rating and $42 price target on Vertex Pharmaceuticals Inc., saying late-stage study data is due on the company's potential cystic fibrosis drug. Positive results could push the stock value higher, she said.
She reaffirmed a "Outperform" rating and $5 price target on Achillion Pharmaceuticals Inc., saying positive results from a study on a potential hepatitis C drug could boost the stock.
She reaffirmed a "Outperform" rating and $8 price target on Dynavax Technologies Corp. citing the potential for positive data from a late-stage study on the company's potential hepatitis B drug.
She reaffirmed a "Outperform" rating and $25 price target on Medivation Inc., citing expectations for data from a Huntington's disease study on the drug candidate Dimebon.
She also reaffirmed a "Outperform" rating and $55 price target on InterMune Inc., citing expected European Union approval of the lung condition drug Esbriet.
http://finance.yahoo.com/news/WedBush-Handful-of-biotechs-ap…
A handful of biotechnology companies could see shares moved early this year
On Monday February 14, 2011, 11:28 am EST
NEW YORK (AP) -- There are a handful of events that could send a handful of select biotechnology stocks moving sharply early this year, according to a WedBush analyst.
Analyst Y. Katherine Xu reaffirmed an "Outperform" rating and $57 price target on Pharmasset Inc. as that company or its partner Roche is expected to release study data on its potential hepatitis C drug.
"If data is satisfactory, especially on the safety side, we would increase our probabilities of success for the candidates," Xu said.
Meanwhile, she reaffirmed a "Neutral" rating and $42 price target on Vertex Pharmaceuticals Inc., saying late-stage study data is due on the company's potential cystic fibrosis drug. Positive results could push the stock value higher, she said.
She reaffirmed a "Outperform" rating and $5 price target on Achillion Pharmaceuticals Inc., saying positive results from a study on a potential hepatitis C drug could boost the stock.
She reaffirmed a "Outperform" rating and $8 price target on Dynavax Technologies Corp. citing the potential for positive data from a late-stage study on the company's potential hepatitis B drug.
She reaffirmed a "Outperform" rating and $25 price target on Medivation Inc., citing expectations for data from a Huntington's disease study on the drug candidate Dimebon.
She also reaffirmed a "Outperform" rating and $55 price target on InterMune Inc., citing expected European Union approval of the lung condition drug Esbriet.
http://finance.yahoo.com/news/WedBush-Handful-of-biotechs-ap…
Der Kurs springt ja wie ein Ziegenbock!
Die Ruhe vor dem Sturm???!!
Antwort auf Beitrag Nr.: 41.039.780 von Lucky72 am 15.02.11 08:11:20MIR GEFÄLLT DIE AKTIE!
Antwort auf Beitrag Nr.: 41.053.572 von Blitzkrieger am 16.02.11 21:03:47Mir auch!
Es gibt NEWS!
Dynavax Reports New Phase 1a and Phase 1b Data for Universal Flu Vaccine Candidate
BERKELEY, CA -- (MARKET WIRE) -- 02/22/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) reported last Friday, February 18 in Geneva, Switzerland at the World Health Organization 7th Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials new Phase 1a and Phase 1b safety and immunogenicity data for its universal flu candidate vaccine. In an oral presentation, Dynavax's Robert Janssen, M.D., Senior Director, Clinical Research, described new findings for N8295, a fusion protein comprised of NP and M2e, two highly conserved influenza antigens covalently linked to Dynavax's proprietary second-generation TLR9 agonist, in combination with an investigational H5N1 avian influenza vaccine. The study evaluated 54 subjects, including 39 from the Phase 1a dose escalation study of N8295 and 15 from the Phase 1b dose escalation study of H5N1/N8295.
Data from the Phase 1a and the Phase 1b study, initiated in September 2010, showed:
* N8295 alone or combined with H5N1 vaccine was very safe and generally well tolerated;
* The most common adverse events were mild, self-limited injection site reactions;
* There were no SAEs;
* All N8295 dose groups had an antibody response to M2e, and the placebo group did not;
* All N8295 dose groups had an antibody response to NP, and the placebo group did not;
* All N8295 dose groups had a cellular immune response to NP, and the placebo group did not;
* The addition of N8295 to a non-immunogenic dose of H5N1 vaccine resulted in H1 responses in all N8295 dose groups.(1)
Dr. J. Tyler Martin, M.D., Dynavax President and Chief Medical Officer, said, "The results of these trials demonstrate that N8295 has the attributes we intended: safety, M2e and NP immunogenicity, and the ability to adjuvant the H1 response to a HA based vaccine. These data will allow us to move forward with planning for a Phase 2 proof-of-concept trial."
Dynavax's Universal Flu Vaccine is designed to offer protection against divergent influenza strains as well as to increase the efficacy of a conventional influenza vaccine. Preclinical data have confirmed the expected immunogenicity and mechanistic effects of the vaccine candidate's novel components. The production of cytotoxic T-cells by NP and cytotoxic antibodies by M2e have been demonstrated in preclinical studies, as has an increase in neutralizing antibodies provided by a co-administered conventional influenza vaccine. A GLP toxicity study demonstrated that this Universal Flu vaccine candidate is well-tolerated.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly with fewer doses than current licensed vaccines. For more information, visit www.dynavax.com.
(1) The Journal of Infectious Diseases 2008; 198:1309-16 and Vaccine 28 (2010) 840-848
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=551…
Dynavax Reports New Phase 1a and Phase 1b Data for Universal Flu Vaccine Candidate
BERKELEY, CA -- (MARKET WIRE) -- 02/22/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) reported last Friday, February 18 in Geneva, Switzerland at the World Health Organization 7th Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials new Phase 1a and Phase 1b safety and immunogenicity data for its universal flu candidate vaccine. In an oral presentation, Dynavax's Robert Janssen, M.D., Senior Director, Clinical Research, described new findings for N8295, a fusion protein comprised of NP and M2e, two highly conserved influenza antigens covalently linked to Dynavax's proprietary second-generation TLR9 agonist, in combination with an investigational H5N1 avian influenza vaccine. The study evaluated 54 subjects, including 39 from the Phase 1a dose escalation study of N8295 and 15 from the Phase 1b dose escalation study of H5N1/N8295.
Data from the Phase 1a and the Phase 1b study, initiated in September 2010, showed:
* N8295 alone or combined with H5N1 vaccine was very safe and generally well tolerated;
* The most common adverse events were mild, self-limited injection site reactions;
* There were no SAEs;
* All N8295 dose groups had an antibody response to M2e, and the placebo group did not;
* All N8295 dose groups had an antibody response to NP, and the placebo group did not;
* All N8295 dose groups had a cellular immune response to NP, and the placebo group did not;
* The addition of N8295 to a non-immunogenic dose of H5N1 vaccine resulted in H1 responses in all N8295 dose groups.(1)
Dr. J. Tyler Martin, M.D., Dynavax President and Chief Medical Officer, said, "The results of these trials demonstrate that N8295 has the attributes we intended: safety, M2e and NP immunogenicity, and the ability to adjuvant the H1 response to a HA based vaccine. These data will allow us to move forward with planning for a Phase 2 proof-of-concept trial."
Dynavax's Universal Flu Vaccine is designed to offer protection against divergent influenza strains as well as to increase the efficacy of a conventional influenza vaccine. Preclinical data have confirmed the expected immunogenicity and mechanistic effects of the vaccine candidate's novel components. The production of cytotoxic T-cells by NP and cytotoxic antibodies by M2e have been demonstrated in preclinical studies, as has an increase in neutralizing antibodies provided by a co-administered conventional influenza vaccine. A GLP toxicity study demonstrated that this Universal Flu vaccine candidate is well-tolerated.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly with fewer doses than current licensed vaccines. For more information, visit www.dynavax.com.
(1) The Journal of Infectious Diseases 2008; 198:1309-16 and Vaccine 28 (2010) 840-848
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=551…
Warum kackt der Kurs so ab?
WOW! Dynavax setzt noch eine News drauf!
Dynavax Reports Additional Positive Phase 1B Immunogenicity Data for Hepatitis B Therapy Candidate
BERKELEY, CA -- (MARKET WIRE) -- 02/22/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) reported in a poster session Saturday, February 19 at the 21st Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) in Bangkok, Thailand new Phase 1b immunogenicity data for DV-601, its proprietary hepatitis B therapeutic vaccine. The study evaluated three doses of the candidate therapeutic vaccine escalation in 14 patients with chronic hepatitis B infection, including six patients that were HBeAg negative and eight patients who were HBeAg positive, and found:
* The therapeutic regimen was safe and generally well tolerated at all dose levels;
* Most common systemic reactions were fatigue and malaise. No SAEs were recorded;
* DV601 was found to elicit immune responses at all dose levels, and anti-HBe antibodies were elicited in two of eight (2/8) patients;
* Anti-HBs antibodies were elicited in four of 14 (4/14) patients;
* Amongst the eight HBeAg positive patients, two had HBeAg clearance, and one of those individuals also had HBsAg clearance;
* Three patients are still in the follow-up observation period.
According to Tyler Martin, M.D., President and Chief Medical Officer, "This trial was primarily designed to assess the safety of our vaccine. The positive immunogenicity results, in particular, the two HBeAg seroconversions, including one HBsAg serocoversion, provide a strong rationale for an expanded evaluation of our approach in collaboration with a potential partner."
Dynavax in December 2010 reported that all doses were generally safe and well tolerated and that individual immunologic and virologic responses had been observed across cohorts at all dose levels.
Dynavax's treatment approach combines both the surface and core hepatitis B virus (HBV) antigens with ISCOMATRIX® adjuvant originally entered into development by Rhein Biotech prior to its acquisition by Dynavax in 2006. The candidate vaccine, DV-601, is designed to induce an immune response against HBV-infected cells and if proven to be safe and effective, may offer an alternative therapeutic option for patients chronically infected with HBV.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly with fewer doses than current licensed vaccines. For more information, visit www.dynavax.com.
ISCOMATRIX® is a registered trademark of ISCOTEC AB, a CSL Limited Company
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=551…
Dynavax Reports Additional Positive Phase 1B Immunogenicity Data for Hepatitis B Therapy Candidate
BERKELEY, CA -- (MARKET WIRE) -- 02/22/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) reported in a poster session Saturday, February 19 at the 21st Conference of the Asian Pacific Association for the Study of the Liver (APASL 2011) in Bangkok, Thailand new Phase 1b immunogenicity data for DV-601, its proprietary hepatitis B therapeutic vaccine. The study evaluated three doses of the candidate therapeutic vaccine escalation in 14 patients with chronic hepatitis B infection, including six patients that were HBeAg negative and eight patients who were HBeAg positive, and found:
* The therapeutic regimen was safe and generally well tolerated at all dose levels;
* Most common systemic reactions were fatigue and malaise. No SAEs were recorded;
* DV601 was found to elicit immune responses at all dose levels, and anti-HBe antibodies were elicited in two of eight (2/8) patients;
* Anti-HBs antibodies were elicited in four of 14 (4/14) patients;
* Amongst the eight HBeAg positive patients, two had HBeAg clearance, and one of those individuals also had HBsAg clearance;
* Three patients are still in the follow-up observation period.
According to Tyler Martin, M.D., President and Chief Medical Officer, "This trial was primarily designed to assess the safety of our vaccine. The positive immunogenicity results, in particular, the two HBeAg seroconversions, including one HBsAg serocoversion, provide a strong rationale for an expanded evaluation of our approach in collaboration with a potential partner."
Dynavax in December 2010 reported that all doses were generally safe and well tolerated and that individual immunologic and virologic responses had been observed across cohorts at all dose levels.
Dynavax's treatment approach combines both the surface and core hepatitis B virus (HBV) antigens with ISCOMATRIX® adjuvant originally entered into development by Rhein Biotech prior to its acquisition by Dynavax in 2006. The candidate vaccine, DV-601, is designed to induce an immune response against HBV-infected cells and if proven to be safe and effective, may offer an alternative therapeutic option for patients chronically infected with HBV.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly with fewer doses than current licensed vaccines. For more information, visit www.dynavax.com.
ISCOMATRIX® is a registered trademark of ISCOTEC AB, a CSL Limited Company
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=551…
Noch eine News!!!!
Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue to Study Completion
Planned Safety Assessments Complete
BERKELEY, CA -- (MARKET WIRE) -- 02/23/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 trials for HEPLISAV™ has completed its planned safety assessments. The DSMB determined that the studies may continue without protocol modification, and that no other formal meetings of the DSMB are required.
Tyler Martin, M.D., President and Chief Medical Officer, commented, "This DSMB review is an important milestone for our Phase 3 program. All subjects in our large safety and lot-to-lot consistency trial randomized to HEPLISAV are now eight months past their last dose. It would be unlikely to see a serious adverse event related to HEPLISAV at this time. Based on our progress, we look forward to completing the trials as planned and filing our BLA by the end of 2011."
The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials evaluating HEPLISAV, the first a lot-to-lot consistency trial in adults 40 years and older, and the second a trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in the U.S., Canada and Europe. Enrollment has been completed for both studies. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties, including statements regarding the timing of study completion and the BLA submission. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=551…
Dynavax's Two Phase 3 HEPLISAV Trials Cleared by DSMB to Continue to Study Completion
Planned Safety Assessments Complete
BERKELEY, CA -- (MARKET WIRE) -- 02/23/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Data Safety Monitoring Board (DSMB) established for Dynavax's two ongoing Phase 3 trials for HEPLISAV™ has completed its planned safety assessments. The DSMB determined that the studies may continue without protocol modification, and that no other formal meetings of the DSMB are required.
Tyler Martin, M.D., President and Chief Medical Officer, commented, "This DSMB review is an important milestone for our Phase 3 program. All subjects in our large safety and lot-to-lot consistency trial randomized to HEPLISAV are now eight months past their last dose. It would be unlikely to see a serious adverse event related to HEPLISAV at this time. Based on our progress, we look forward to completing the trials as planned and filing our BLA by the end of 2011."
The DSMB reviewed safety data from two ongoing multi-center Phase 3 trials evaluating HEPLISAV, the first a lot-to-lot consistency trial in adults 40 years and older, and the second a trial in chronic kidney disease patients. The DSMB is comprised of an independent group of medical experts who are responsible for reviewing and evaluating subject safety data at regular intervals during the ongoing trials.
About HEPLISAV
HEPLISAV is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in the U.S., Canada and Europe. Enrollment has been completed for both studies. In a completed pivotal Phase 3 trial, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements," that are subject to a number of risks and uncertainties, including statements regarding the timing of study completion and the BLA submission. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=551…
Antwort auf Beitrag Nr.: 41.095.543 von Lucky72 am 23.02.11 21:33:49Das war wohl Nix!
Eigentlich wollte ich heute die 3$ wieder sehn!
Nur zur Info!
Short Interest (Shares Short) 6,228,200
Short Interest - Prior 6,445,800
Short Interest (Shares Short) 6,228,200
Short Interest - Prior 6,445,800
@Dino
Wo bleibt die Novartis News?
Wo bleibt die Novartis News?
Dynavax to Present at the Cowen Healthcare Conference
BERKELEY, CA -- (MARKET WIRE) -- 03/03/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the Cowen and Company 31st Annual Health Care Conference in Boston on Tuesday, March 8, 2011 at 9:30 am EST (6:30 am PST) at the Boston Marriott Copley Place.
Dino Dina, M.D., Chief Executive Officer of Dynavax, will provide a corporate overview presentation. To access the live webcast and the subsequent archived recording of the presentation, please log onto Dynavax's website at http://investors.dynavax.com/newsevents.cfm.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
BERKELEY, CA -- (MARKET WIRE) -- 03/03/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the Cowen and Company 31st Annual Health Care Conference in Boston on Tuesday, March 8, 2011 at 9:30 am EST (6:30 am PST) at the Boston Marriott Copley Place.
Dino Dina, M.D., Chief Executive Officer of Dynavax, will provide a corporate overview presentation. To access the live webcast and the subsequent archived recording of the presentation, please log onto Dynavax's website at http://investors.dynavax.com/newsevents.cfm.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to enhance protection more rapidly with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
30 Small Caps Snapped By Smart Money
10. Dynavax Technologies Corporation (DVAX): Drug Manufacturers - Other Industry. Market cap of $342.12M. In the most recent quarter, institutional investors bought 28.6M shares vs. 9.7M shares purchased by mutual funds. This is a risky stock that is significantly more volatile than the overall market (beta = 2.76). The stock is a short squeeze candidate, with a short float at 5.41% (equivalent to 6.43 days of average volume). The stock has gained 45.1% over the last year.
http://community.nasdaq.com/News/2011-03/30-small-caps-snapp…
10. Dynavax Technologies Corporation (DVAX): Drug Manufacturers - Other Industry. Market cap of $342.12M. In the most recent quarter, institutional investors bought 28.6M shares vs. 9.7M shares purchased by mutual funds. This is a risky stock that is significantly more volatile than the overall market (beta = 2.76). The stock is a short squeeze candidate, with a short float at 5.41% (equivalent to 6.43 days of average volume). The stock has gained 45.1% over the last year.
http://community.nasdaq.com/News/2011-03/30-small-caps-snapp…
Dynavax Reports Fourth Quarter and Year End 2010 Financial Results
BERKELEY, CA -- (MARKET WIRE) -- 03/08/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2010.
Dynavax reported $72.2 million in cash, cash equivalents and marketable securities at December 31, 2010. This compared to $36.7 million at December 31, 2009. Total cash at the 2010 year end included approximately $83 million in net proceeds from public offerings completed during the year.
Total revenues were $1.8 million for the fourth quarter 2010, compared to $2.2 million for the fourth quarter 2009. Total revenues were $24.0 million for the year ended December 31, 2010, compared to $40.3 million for 2009. The decline in total revenues for the year was primarily due to the recognition of collaboration revenue in June 2009 from our terminated collaboration with Merck.
Total operating expenses were $17.4 million for the fourth quarter 2010, compared to $13.8 million for the fourth quarter 2009. Total operating expenses were $71.5 million for the year ended December 31, 2010, compared to $55.4 million for 2009. The increase in total operating expenses for the year was due to continued clinical and manufacturing activities to support HEPLISAV™. The Company expects total operating expenses in 2011 to be consistent with 2010.
The tables included as part of this press release provide a reconciliation of GAAP revenues and operating expenses to pro forma revenues and operating expenses.
About Dynavax
Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and superior protection with fewer doses than current licensed vaccines. For more information visit www.dynavax.com.
Forward Looking Statements
This press release contains "forward-looking statements" that are subject to a number of risks and uncertainties, including statements regarding our projected 2011 operating expenses. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and approval of HEPLISAV can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether the studies can support registration for commercialization of HEPLISAV; the results of clinical trials and the impact of those results on the initiation and completion of subsequent trials and issues arising in the regulatory process; the Company's ability to obtain additional financing to support the development and commercialization of HEPLISAV and its other operations, possible claims against the Company based on the patent rights of others; and other risks detailed in the "Risk Factors" section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax's website at www.dynavax.com is not incorporated by reference in the Company's current periodic reports with the SEC.
- tables to follow -
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=555…
Wird langsam Zeit für eine Gegenbewegung!
Form 10-K
Annual Report
Filed Mar 11, 2011
http://investors.dynavax.com/secfiling.cfm?filingID=1193125-…
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