Diskussion zu Dynavax Technologies - 500 Beiträge pro Seite (Seite 5)

[Lucky72]

Wird wohl wieder ein "NO NEWS" Tag!

Und der Kurs kennt nur eine Richtung!

[Lucky72]

Wedbush Assumes Coverage on Dynavax Technologies (DVAX) at Outperform; Optimistic on HEPLISAV

March 24, 2011 1:29 PM EDT

Wedbush assumes coverage on Dynavax Technologies (NASDAQ: DVAX) with a Outperform. PT lowered from $9 to $6.

Wedbush analyst says, "Our thesis centers on the conviction that HEPLISAV, Dynavax’ lead product candidate for Hepatitis B, will report positive Phase III data in May and obtain approval in the US and EU by YE:2012. HEPLISAV benefits from remarkable efficacy in promoting seroconversion among treated patients. Not only does HEPLISAV appear to provide a significant benefit over standard-of-care in stimulating an antibody response to the Hepatitis B virus, but it also does so quicker and with fewer injections. Initially, we expect HEPLISAV to target patients whose antibody responses to current vaccines are often suboptimal (such as patients with chronic kidney disease, HIV/HCV, and also possibly diabetes mellitus). In these indications, we project revenues of $280 million by 2016 and full-year profitability by 2014. Further out, we believe it likely that HEPLISAV will also make inroads into the young and healthy population."

For more ratings news on Dynavax Technologies click here and for the rating history of Dynavax Technologies click here.

Shares of Dynavax Technologies closed at $2.63 yesterday, with a 52 week range of $1.28-$3.59.

http://www.streetinsider.com/New+Coverage/Wedbush+Assumes+Co…

[Lucky72]

Ist das heut wieder langweilig!!

[Lucky72]

Jetzt aber los!

[Lucky72]

Zitat von Lucky72: Wird wohl wieder ein "NO NEWS" Tag!

Woche und Monat!!!!

[Lucky72]

Guten Morgen!

Ich hoffe das diese Woche endlich positive News kommen!

[Lucky72]

WOW! Die Aktie fällt ja wie ein Stein!

Kaufkurse!

[Lucky72]

Was geht jetzt ab?

[Lucky72]

Aber der Kurs bewegt sich kein Stück!

18:38:47 2,585 100.000
18:37:25 2,585 56.100

[Lucky72]

Heute das gleiche Spiel!

Wer kauft die ganzen Aktien?

21:25:38 2,635 332.400
21:24:36 2,635 150.000

[Lucky72]

Vielleicht kauft ja Dino?!

http://investors.dynavax.com/secfiling.cfm?filingID=1181431-…

[Lucky72]

Dynavax Initiates First Human Trial in Lupus Program

$6 Million Milestone Payment From GSK Due to Dynavax

BERKELEY, CA -- (MARKET WIRE) -- 04/20/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today the start of dosing in the first human clinical trial in its lupus program. Initiation of this trial entitles Dynavax to receive a $6 million milestone payment from GlaxoSmithKline (GSK), its partner in a worldwide strategic alliance. GSK has an exclusive option to obtain a license to the program.

Dynavax's Phase 1 study will assess the safety of DV1179, an inhibitor of TLR7 and TLR9, in multiple ascending doses. A total of 24 healthy subjects, divided into three dose groups, will each receive four weekly injections of DV1179. Data from this study is expected later this year. Following successful completion of the trial, Dynavax expects to initiate a proof-of-mechanism study in lupus patients.

Peer-Reviewed Publications Document Program's Potential

In December, 2010, Dynavax reported in the JOURNAL OF EXPERIMENTAL MEDICINE (JEM, Volume 207, Number 13) data that suggested an important role of the key innate immune receptors TLR7 and TLR9 in a novel mouse model of skin conditions similar to cutaneous lupus. The company's inhibitor of TLR7 and TLR9 prevented and reversed disease suggesting therapeutic application of the inhibitor for the treatment of cutaneous lupus and related skin conditions.

In the June 16, 2010 issue of NATURE, data demonstrated in both human blood cells and animal models of lupus that glucocorticoid resistance characteristic of lupus could be mediated through TLR7 and TLR9 and could be reversed by Dynavax's TLR7/TLR9 inhibitor. Glucocorticoids are commonly 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 and restrict the utility of these drugs.

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. The National Institutes of Health in Bethesda, MD and the Alliance for Lupus Research contributed funding for Dynavax's preclinical work.

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," including statements related to the anticipated timing for the availability of data from the initial clinical trial in our lupus program and for the next clinical study and the potential features of the Company's inhibitors. 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 GSK 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.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=570…

[Lucky72]

Guten Morgen!

Ich wünsche allen einen dunkelgrünen Tag!

[VaJo]

Ja das dürfte heute ein schöner Tag werden

[Lucky72]

Antwort auf Beitrag Nr.: 41.436.923 von VaJo am 02.05.11 09:01:56

Das war wohl nix!

[Lucky72]

Antwort auf Beitrag Nr.: 41.436.923 von VaJo am 02.05.11 09:01:56

Ich bin trotzdem bereit!

[Lucky72]

[Lucky72]

Dynavax Reports First Quarter 2011 Financial Results

BERKELEY, CA -- (MARKET WIRE) -- 05/05/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the first quarter ended March 31, 2011, including $53.2 million in cash, cash equivalents and marketable securities at March 31, 2011. A $6 million milestone payment from GlaxoSmithKline earned after the close of the quarter from the initiation of a Phase 1 trial in the partnered lupus program was not included in the reported cash balance of $53.2 million. At December 31, 2010, Dynavax reported $72.2 million in total cash.

Total operating expenses for the quarter were in line with earlier expense guidance that full year 2011 expenses will be consistent with 2010. Net cash usage for the first quarter 2011 was higher than the average quarterly net cash usage during 2010, due to significant payments for the large-scale Phase 3 study of HEPLISAV™ which completes this month. The Company anticipates a reduction in ongoing quarterly spend through the remainder of 2011 such that its average quarterly net cash usage should approximate $13 million for 2011.

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 net cash usage and 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=574…

[Lucky72]

Antwort auf Beitrag Nr.: 41.461.824 von Lucky72 am 05.05.11 22:47:46

Total operating expenses for the quarter were in line with earlier expense guidance that full year 2011 expenses will be consistent with 2010. Net cash usage for the first quarter 2011 was higher than the average quarterly net cash usage during 2010, due to significant payments for the large-scale Phase 3 study of HEPLISAV™ which completes this month[/b]. The Company anticipates a reduction in ongoing quarterly spend through the remainder of 2011 such that its average quarterly net cash usage should approximate $13 million for 2011.

[Lucky72]

http://clinicaltrials.gov/ct2/results?term=Dynavax

[dottore]

jetzt bin ich seit ein paar Tagen zu 2,60 $ mit an Bord.

[Lucky72]

Antwort auf Beitrag Nr.: 41.486.495 von dottore am 11.05.11 16:54:50

Dann kanns jetzt UP gehn!

Ich bin schon seit 1,40$ dabei!

[Lucky72]

Was für ein langweiliger Handel!

[Lucky72]

Wird langsam Zeit für News!

[Lucky72]

Dynavax Completes Phase 3 Study of HEPLISAV(TM)

Data Expected Within Eight Weeks

BERKELEY, CA -- (MARKET WIRE) -- 05/25/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported completing the 12-month follow-up on all of the 2,449 subjects enrolled in its large-scale Phase 3 study of HEPLISAV™ evaluating immunogenicity in comparison to Engerix, lot-to-lot consistency and safety. With the study's completion, Dynavax said it expected to be in a position to report results within eight weeks.

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. In an earlier 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 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 the timing of reporting of study data. 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 and our process for its manufacture 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=581…

[Lucky72]

[Lucky72]

[Lucky72]

Jun 1, 2011
Dynavax Technologies Corp 2011 Annual Meeting of Stockholders - 12:00PM EDT -

[Lucky72]

Ein paar Cent fehlen noch um das Gap zu schließen!

Open Gaps
Direction Date range
up May-26-2011 2.51 to 2.55

[Lucky72]

[Lucky72]

Heute Gap close und dann "BOOOOM"!

[Lucky72]

Upcoming Event
Jun 8, 2011
9:30 AM ET Jefferies 2011 Global Healthcare Conference

[Lucky72]

Zitat von Lucky72: Heute Gap close und dann "BOOOOM"!

Sag ich doch!

[Lucky72]

Brenne, Shorty!

[Lucky72]

Dynavax to Present at the Jefferies 2011 Global Healthcare Conference

BERKELEY, CA -- (MARKET WIRE) -- 06/06/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the Jefferies 2011 Global Healthcare Conference in New York on Wednesday, June 8, 2011 at 9:30 am EDT (6:30 am PDT).

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 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.

Contact:

Shari Annes

Investor Relations

510-665-7211

Email Contact




Source: Dynavax Technologies

News Provided by Acquire Media
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=583…

[Lucky72]

Guten Morgen!

Ich wünsche allen einen dunkelgrünen Tag!

[Lucky72]

Die Shorty können es nicht lassen!

Short Interest (Shares Short) 6,919,400

Days To Cover (Short Interest Ratio) 7.6

Short Interest - Prior 6,866,800

http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…

[Bonderman]

Antwort auf Beitrag Nr.: 41.642.006 von Lucky72 am 14.06.11 08:22:16

Ich wünsche allen einen dunkelgrünen Tag!

[Lucky72]

Antwort auf Beitrag Nr.: 41.646.662 von Bonderman am 14.06.11 21:42:29

Na, ein paar Leser werden schon da sein!

[Bonderman]

Antwort auf Beitrag Nr.: 41.646.870 von Lucky72 am 14.06.11 22:18:13

War da wohl etwas zu voreilig. Hab mal ein paar Seiten zurückgeblättert. Mittlerweile scheinst du ja nicht mehr alleine investiert zu sein, was aber eigentlich auch nicht unbedingt verkehrt wäre. Viel Glück dir (euch) hier...

[Lucky72]

Antwort auf Beitrag Nr.: 41.646.907 von Bonderman am 14.06.11 22:25:07

Alleine bin ich nicht!

Guggst du hier!

http://www.dailyfinance.com/company/dynavax-technologies-cor…

[Lucky72]

NEW YORK, June 15 | Wed Jun 15, 2011 2:43pm EDT

(Reuters) - Small cap stocks still have room for further declines but analysts suggest this might be a good opportunity to buy the risky assets.

The Russell 2000 .TOY has fallen nearly 10 percent since early May, similar to many small-cap pullbacks since March 2009. The decline has pulled the Russell 2000's forward price-earnings ratio close to its long-term average.

"Small cap investors have been hungry for valuation opportunities, and experience has also taught us it's better to move in early to small caps than to try to peg the bottom," said Credit Suisse in a research note.

"Small is still overvalued versus the large, but a well chosen small- or mid-cap name can still help non-small-cap investors gain an edge given lower coverage and better long-term performance."

The S&P MidCap 400 index .MID fell 1.3 percent on Wednesday while the S&P SmallCap 600 index .SML lost 1.1 percent. In comparison, the benchmark S&P 500 .SPX dipped 1.5 percent. The S&P is down about 7.2 percent since early May.

Dennis Askew, analyst at Small Cap Network, said Dynavax Technologies (DVAX.O) was a stock to watch.

Dynavax shares were down 3.1 percent at $2.50 on Wednesday afternoon, slowly drifting down from $3.50 in early January.

The stock has been rolling along at the current level for the past three weeks with only one significant spike upward and subsequent dip back to $2.50.

"It looks poised to break out upward. The short/float percentage is low at 5.94 percent," Askew wrote on Small Cap Network website.

"As a drug maker play, the company really has a lot of new and developing information which doesn't appear to have reached the broader markets yet, but if and when it does, that could be the catalyst for a valuation increase." (Reporting by Angela Moon, Editing by Leslie Adler)

http://www.reuters.com/article/2011/06/15/markets-stocks-sma…

[Lucky72]

Nur zur Info!

http://www.stockta.com/cgi-bin/analysis.pl?symb=DVAX&num1=3&…

[Lucky72]

WOOOW!!!!

After Hours
Time (ET) After Hours
Price After Hours
Share Volume
16:21 $ 2.73 1,333
16:21 $ 2.7286 14,246
16:20 $ 2.73 123
16:19 $ 2.7292 144,528
16:19 $ 2.71 12,900
16:19 $ 2.7286 247,506
16:19 $ 2.73 16,989
16:19 $ 2.7286 67,200
16:18 $ 2.7289 201
16:17 $ 2.73 46,386
16:14 $ 2.7292 1,135
16:13 $ 2.73 4,883
16:12 $ 2.7295 915
16:11 $ 2.74 100
16:09 $ 2.74 5,000
16:06 $ 2.6754 100
16:01 $ 2.67 900
16:00 $ 2.74 1,300
16:00 $ 2.74 29,444




http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…

[Lucky72]

Antwort auf Beitrag Nr.: 41.698.360 von Lucky72 am 24.06.11 22:22:59

After Hours
Time (ET) After Hours
Price After Hours
Share Volume
17:00 $ 2.7286 9,792
16:58 $ 2.7292 27,271
16:58 $ 2.7308 320
16:58 $ 2.7286 932,284
16:54 $ 2.7292 1,576
16:53 $ 2.7296 124,274
16:53 $ 2.7304 1,402
16:48 $ 2.7289 5,568
16:48 $ 2.7286 1,913
16:45 $ 2.7297 9,806
16:45 $ 2.65 500
16:35 $ 2.7297 9,328
16:34 $ 2.73 6,199
16:25 $ 2.73 24,120
16:23 $ 2.7291 9,270

[Lucky72]

Nur zur Info!

http://www.stockta.com/cgi-bin/analysis.pl?symb=DVAX&num1=3&…

[Lucky72]

Nächste Woche .....?

[Lucky72]

Jefferies Reports Favorable ACIP Stance For Dynavax Tech

According to Jefferies, Dynavax Technologies (NASDAQ: DVAX) is seeing a favorable ACIP stance for diabetes vaccination mandate.

Jefferies said that, at the CDC's ACIP meeting, the hepatitis working group recommended a broad mandate to vaccinate all diabetics up to the age of 60 for hepatitis B (HBV). “We view this as a positive as it opens up a large market opportunity for DVAX's Heplisav HBV vaccine, and we see upside potential for even broader use in all diabetics. We expect Heplisav approval in early 2013.”


http://www.benzinga.com/analyst-ratings/analyst-color/11/06/…

[Lucky72]

Ohne News wirds hier bald wieder runter gehn!

[Lucky72]

Wo bleibt die News?

[Lucky72]

[Lucky72]

[Lucky72]

Zitat von dottore: jetzt bin ich seit ein paar Tagen zu 2,60 $ mit an Bord.

Ich hoffe du hast deine Teile noch!

[Lucky72]

Zitat von Lucky72: Die Shorty können es nicht lassen!

Short Interest (Shares Short) 6,919,400

Days To Cover (Short Interest Ratio) 7.6

Short Interest - Prior 6,866,800

http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…

Dynavax Technologies Corporation

$ 3.05
DVAX

Short Interest (Shares Short) 10,633,700

Days To Cover (Short Interest Ratio) 6.3

Short Interest - Prior 7,338,500

Record Date 2011-JulyA

[Lucky72]

Der Kurs nimmt jetzt Anlauf!

[Lucky72]

Nur zur Info!

News & Events
Upcoming Event
Aug 17, 2011 Wedbush 2011 Life Sciences Conference

[Lucky72]

Da bin ich mal eine Woche im Urlaub und schon kackt der Kurs ab!

[Lucky72]

Antwort auf Beitrag Nr.: 41.835.274 von Lucky72 am 23.07.11 20:46:45

Liegt vielleicht an Q-Zahlen?

Dynavax Reports Second Quarter 2011 Financial Results

BERKELEY, CA -- (MARKET WIRE) -- 07/20/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the second quarter ended June 30, 2011. Cash, cash equivalents and marketable securities were $61.7 million at June 30, 2011, compared to $53.2 million at March 31, 2011 and $72.2 million at December 31, 2010. During the second quarter, the Company raised approximately $18.7 million through its At-the-Market common stock purchase agreement with Aspire Capital and received a $6 million milestone payment from GlaxoSmithKline from the initiation of a Phase 1 trial in the partnered lupus program.

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.

- tables to follow -

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=592…

[Lucky72]

Antwort auf Beitrag Nr.: 41.835.295 von Lucky72 am 23.07.11 20:58:47

Oder wegen dem Filing?

http://investors.dynavax.com/secfiling.cfm?filingID=1193125-…

[Lucky72]

Dynavax Phase 3 Demonstrates Superiority and Safety of HEPLISAV™ vs. Engerix-B®



BERKELEY, CA -- (MARKET WIRE) -- 07/20/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today said that top-line data from its Phase 3 trial comparing HEPLISAV, an investigational hepatitis B virus (HBV) vaccine, to a currently marketed HBV vaccine, Engerix-B, demonstrated non-inferiority, superiority and the safety of HEPLISAV. The study evaluated a two-dose regimen of HEPLISAV administered at 0 and 1 month compared to a three-dose regimen of Engerix-B administered at 0, 1 and 6 months. The trial studied 2,449 healthy adults 40 to 70 years of age, randomized to HEPLISAV or Engerix-B in a 4:1 ratio. Data supporting the consistency of three consecutively manufactured lots of HEPLISAV have been submitted to the Food and Drug Administration (FDA), and Dynavax expects confirmation of its analysis shortly.

Immunogenicity data demonstrated:

At the primary endpoint, 8 weeks post the last dose of vaccine, 12 weeks for HEPLISAV and 32 weeks for Engerix-B, the seroprotection rate (SPR) was 90% for HEPLISAV and 70% for Engerix-B, demonstrating the non-inferiority and superiority of HEPLISAV to Engerix-B.
The peak SPR for HEPLISAV occurred at 24 weeks and was 95%. The peak SPR for Engerix-B occurred at 28 weeks and was 73%.
At the final visit, week 52, 48 weeks after the last dose of HEPLISAV and 28 weeks after the last dose of Engerix-B, the SPRs were 92% for HEPLISAV and 59% for Engerix-B.

Dynavax also reported that the trial's safety data showed HEPLISAV to be safe and well tolerated, and similar to Engerix-B. Careful safety evaluation over the 12 month duration of trial demonstrated:

50% of HEPLISAV subjects and 53% of Engerix-B subjects experienced an adverse event.
7% of HEPLISAV subjects and 6% of Engerix-B subjects experienced possibly related adverse events.
4% of HEPLISAV subjects and 5% of Engerix-B subjects experienced a serious adverse event.
3 new onset autoimmune adverse events were confirmed by the Safety Evaluation and Adjudication Committee (SEAC), none of which were serious adverse events. All three occurred in the HEPLISAV group, consistent with the 4:1 randomization.
There were no cases of ANCA-associated vasculitis or Wegener's Granulomatosis.

With respect to the consistency analysis of three consecutively manufactured lots of HEPLISAV, Dynavax concluded that the study had demonstrated consistency based on the complete immunogenicity data demonstrated by the three vaccine lots over the six months following second immunization.

By Geometric Mean Antibody Concentration (GMC), the results met the pre-specified consistency criteria at 12, 18, 24 and 28 weeks, but not at 8 weeks, the pre-specified primary endpoint. The GMC of one HEPLISAV lot was slightly higher than the other two lots, which resulted in not meeting the consistency criteria at week 8.
By SPR, the results met the pre-specified consistency criteria at 12, 18, 24 and 28 weeks, but not at 8 weeks.
At all of these timepoints, each lot of HEPLISAV was superior to Engerix-B.

Dynavax said it had submitted these data and its analysis supporting lot-to-lot consistency to the FDA and expects confirmation from the agency in the near future.

"These results confirm and expand the superiority of HEPLISAV vs. Engerix-B in this hyporesponsive population of persons age 40 and above. HEPLISAV again demonstrated the rapid onset of seroprotection and superior peak protection compared to Engerix-B. A new finding in this trial is the superior duration of HEPLISAV to Engerix-B. Based on the results of intensive safety monitoring over 12 months, we have again demonstrated that HEPLISAV has a similar safety profile to Engerix-B, generally considered to be a very safe vaccine. Finally, we believe the consistency of the peak immune response of three lots of HEPLISAV was clearly demonstrated in this trial," commented Tyler Martin, M.D., President and Chief Medical Officer.

Dynavax said it will present complete results from the Phase 3 trial in an oral presentation at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) on Sunday, September 18, 2011 in Chicago, IL.

Webcast and Conference Call Today

Dynavax will host a conference call and webcast a discussion of the HEPLISAV Phase 3 top-line data along with the company's second quarter 2011 financial results on Wednesday, July 20, 2011 at 9:00 a.m. Eastern Daylight Time / 6:00 a.m. Pacific Daylight Time. To join the Conference Call, please dial 1-877-280-7280. International callers can dial 1-707-287-9365. A telephonic replay of the discussion will be available 90 minutes after its conclusion and through August 3, 2011 by dialing 1-855-859-2056, access code: 85190076. International callers can dial 1-404-537-3406, access code: 85190076. The webcast can be accessed on Dynavax's website at http://investors.dynavax.com/events.cfm. A webcast replay of the discussion will be available on Dynavax's website, 90 minutes after its conclusion and through August 3, 2011.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier 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 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 expectation of confirmation in the near future by the FDA of our assessment of lot-to-lot consistency. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including the FDA's assessment of the data from this study and any requests it may make to conduct additional studies, whether successful clinical and regulatory development and approval of HEPLISAV and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether our 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.

Engerix-B® is a registered trademark of GlaxoSmithKline



http://investors.dynavax.com/releasedetail.cfm?ReleaseID=592…

[Lucky72]

Kleiner Ausschnitt von "Conference Call Transcript dated July 20, 2011" !

Dino Dina:Thank you. So I’d like to sort of close by reminding you that we’ve set for ourselves this year for key objectives.
One was to maintain a strong cash position, that’s critical, both in terms of supporting our programs, and also continuing our negotiations with potential partners for the commercialization of the vaccine, especially outside of the U.S.

The completion of the Phase III studies and the submission of our BLA and MAA for HEPLISAV, identifying partners for the commercial launch of HEPLISAV and then continuing our earlier program and in particular the clinical of development of universal flu and the TLR nine and seven inhibitors that is part of our collaboration with GSK.

I think we’ve shown both diligence and success on all of these points. So we are moving forward in a very meaningful consistent and I think timely way.

With the Phase III results we reported today, I think we are definitely one step closer to completing the program and a lot closer to filing. And I think this is a very strong foundation of data that shows not only superiority, but most importantly, and let’s not forget that, the impeccable safety of the vaccine.

This really provides us, then, a much stronger basis for continuing our discussions on commercial partnering. I’ve commented before on the fact that we have a number of initiatives ongoing. Those discussions have been quite active for many months and some new ones have gained momentum recently. The intention in these discussions to anticipate the questions that you’re not going to be able to ask is, of course, between our desire to retain profitability and our potential partners’ desire to increase theirs. And these are never particular easy discussions but I think that we’re on solid grounds and that we will find a very strong partner to commercialize outside of the U.S.

We remain committed to selling the vaccine in the U.S. ourselves, keeping, of course, the option open of a potential alliance with GSK or Merck and those discussions are also underway, although that’s all I can say about them at this point in time.

In addition, we’ve been successful in maintaining a very strong cash position that addresses both the issue of finishing the programs and maintaining a competitive attitude we respect of the negotiations that I just mentioned.

Before closing, I’d like to remind you that we have two partner programs. One is with Astra-Zeneca and the other one is with GSK. We continue to make progress on both of them in the case of GSK autoimmune disease program. We did the Phase I study that has been completed now and we have received the expected $6 million milestone from them and we’re making progress with AZ on the potential start of a clinical program, although we are not yet 100 percent there.
Finally, we did two studies with flu. Those have provided results are completely in line with the preclinical data we have obtained and have shown that the biology and the (pharamaco) dynamic immune response generated by the vaccine are appropriate for continuing the program and moving to a proof of concept study.

Thank you for your attention and your time and we will update you soon again on our progress.

http://investors.dynavax.com/secfiling.cfm?filingID=1193125-…

[Lucky72]

Ich denke das wir nächste Woche wieder auf die 3$ laufen!

[Lucky72]

http://clinicaltrials.gov/ct2/results?term=Dynavax

[Lucky72]

Guten Morgen @ all

Ich wünsche eine dunkelgrüne Woche!

[Lucky72]

Antwort auf Beitrag Nr.: 41.835.300 von Lucky72 am 23.07.11 21:01:48

Das Filing liegt den Amis auch schwer im Magen!

Aber wenn Dynavax "Heplisav" ohne Partner herstellen will, benötigen sie doch ausreichend Cash!?

[Lucky72]

Antwort auf Beitrag Nr.: 41.835.306 von Lucky72 am 23.07.11 21:05:34

Data supporting the consistency of three consecutively manufactured lots of HEPLISAV have been submitted to the Food and Drug Administration (FDA), and Dynavax expects confirmation of its analysis shortly.

Jetzt liegt es an der FDA ob sie "Grünes Licht" geben!

[Lucky72]

Bei Rhein Biotech stehen alle Zeichen auf Herstellung!

Die Jobs sind schon fast alle vergeben. Es gibt nur noch zwei offene Stellen (vor zwei Wochen waren es noch sieben!)

Leiter der Qualitätskontrolle (m/w); Department Head Quality Control

BTA oder Pharmakant(in) als technischen Mitarbeiter (w/m) Herstellung USP

http://www.rheinbiotech.de/index.php?id=44

[Lucky72]

Let's get ready to Rumble!!!

[Lucky72]

Guten Morgen @ all

[Lucky72]

Die 2,50$ hat ja gestern super gehalten!

Ich hoffe das es eine Bodenbildung ist!

[Lucky72]

Zitat von Lucky72: Data supporting the consistency of three consecutively manufactured lots of HEPLISAV have been submitted to the Food and Drug Administration (FDA), and Dynavax expects confirmation of its analysis shortly.

Jetzt liegt es an der FDA ob sie "Grünes Licht" geben!

Die Frage ist wann die Daten an die FDA übermittelt worden sind!?

Sind die Daten letzte Woche, oder schon vor zwei bzw. drei Wochen an die FDA übermittelt worden?
Bevor die Daten für uns veröffentlich worden sind!

In diesem Fall könnte das Ergebniss der FDA täglich bzw. stündlich kommen!

[Lucky72]

Meine Postings sind nur meine Meinung und keine Empfehlung zum Kauf oder Verkauf von Dynavax Aktien!

[Lucky72]

[Lucky72]

Heute sind wieder die "Taschengeldzocker" am Werk!

[Lucky72]

Auf gehts!!!!

[Lucky72]

Guten Morgen

[Lucky72]

Haben die Shorty nicht gecovert?!

Dynavax Technologies Corporation

$ 2.60

Short Interest (Shares Short) 10,387,900

Days To Cover (Short Interest Ratio) 6.6

Short Interest - Prior 10,633,700


Record Date 2011-JulyB

http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…

[Lucky72]

Die "BIG BOYS" halten such ihre Teile!

http://data.cnbc.com/quotes/DVAX/tab/8

[Lucky72]

Antwort auf Beitrag Nr.: 41.850.041 von Lucky72 am 27.07.11 09:18:31

Sollte natürlich "halten auch" heißen!

[Lucky72]

Sauber abgekackt!

Ich dachte immer MM bedeutet Market-Maker!

Ich glaube Market-Manipulator ist die bessere Berufsbezeichnung!

[Lucky72]

Alles anschnallen wir starten!!!


FDA Agrees With Dynavax on Consistency of HEPLISAV(TM) Lots

BERKELEY, CA -- (MARKET WIRE) -- 07/28/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) advised the company that "CBER agrees that clinical consistency of three consecutively manufactured lots of HEPLISAV has been demonstrated." In a written communication to Dynavax, FDA noted that "Although lot consistency criteria were not met at the pre-specified time point of 4 weeks PLD (post last dose), lot consistency criteria were met 8 weeks PLD, the time point corresponding to the primary immunogenicity endpoint, as well as at several other time points."

According to Dr. Tyler Martin, President and Chief Medical Officer, "As expected, the FDA has confirmed our assessment of lot consistency in the Phase 3 trial we just announced. With their concurrence, we can now move forward towards our goal of preparing a BLA for submission by the end of the year for hyporesponsive populations aged 40 and older."

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier 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 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 the timing of 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 and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether our 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=594…

[Lucky72]

[Lucky72]

PRE MARKET!

http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…

[pokemon]

Antwort auf Beitrag Nr.: 41.859.310 von Lucky72 am 28.07.11 15:05:01

super! dynavax ist eine spannende firma

[VaJo]

Antwort auf Beitrag Nr.: 41.859.316 von Lucky72 am 28.07.11 15:06:01

Du must SHORT sein, anders passen deine Postings nicht zu Kursverlauf.

[Lucky72]

WOW! Nur noch 17% im Plus!

Ich hätte eigentlich die 4$ erwartet!

Na dann eben morgen!

[Lucky72]

Antwort auf Beitrag Nr.: 41.860.780 von pokemon am 28.07.11 18:31:30

Für was ist der ?

[Lucky72]

Antwort auf Beitrag Nr.: 41.861.306 von VaJo am 28.07.11 20:12:27

Ich bin mit Sicherheit nicht short!

Halte die Teile schon seit 1,40$!

[Lucky72]

After-Hours trading

http://www.nasdaq.com/aspxcontent/ExtendedTradingTrades.aspx…

[Lucky72]

Langsam müßte GSK merken wie ihnen die Felle weg schwimmen!

[Lucky72]

Zitat von Lucky72: Langsam müßte GSK merken wie ihnen die Felle weg schwimmen!

Wird Zeit für eine Übernahme oder Partnerschaft!

[Lucky72]

Zitat von Lucky72:

Kleiner Ausschnitt von "Conference Call Transcript dated July 20, 2011" !

Dino Dina:Thank you. So I’d like to sort of close by reminding you that we’ve set for ourselves this year for key objectives.
One was to maintain a strong cash position, that’s critical, both in terms of supporting our programs, and also continuing our negotiations with potential partners for the commercialization of the vaccine, especially outside of the U.S.

The completion of the Phase III studies and the submission of our BLA and MAA for HEPLISAV, identifying partners for the commercial launch of HEPLISAV and then continuing our earlier program and in particular the clinical of development of universal flu and the TLR nine and seven inhibitors that is part of our collaboration with GSK.

I think we’ve shown both diligence and success on all of these points. So we are moving forward in a very meaningful consistent and I think timely way.

With the Phase III results we reported today, I think we are definitely one step closer to completing the program and a lot closer to filing. And I think this is a very strong foundation of data that shows not only superiority, but most importantly, and let’s not forget that, the impeccable safety of the vaccine.

This really provides us, then, a much stronger basis for continuing our discussions on commercial partnering. I’ve commented before on the fact that we have a number of initiatives ongoing. Those discussions have been quite active for many months and some new ones have gained momentum recently. The intention in these discussions to anticipate the questions that you’re not going to be able to ask is, of course, between our desire to retain profitability and our potential partners’ desire to increase theirs. And these are never particular easy discussions but I think that we’re on solid grounds and that we will find a very strong partner to commercialize outside of the U.S.

We remain committed to selling the vaccine in the U.S. ourselves, keeping, of course, the option open of a potential alliance with GSK or Merck and those discussions are also underway, although that’s all I can say about them at this point in time.

In addition, we’ve been successful in maintaining a very strong cash position that addresses both the issue of finishing the programs and maintaining a competitive attitude we respect of the negotiations that I just mentioned.

Before closing, I’d like to remind you that we have two partner programs. One is with Astra-Zeneca and the other one is with GSK. We continue to make progress on both of them in the case of GSK autoimmune disease program. We did the Phase I study that has been completed now and we have received the expected $6 million milestone from them and we’re making progress with AZ on the potential start of a clinical program, although we are not yet 100 percent there.
Finally, we did two studies with flu. Those have provided results are completely in line with the preclinical data we have obtained and have shown that the biology and the (pharamaco) dynamic immune response generated by the vaccine are appropriate for continuing the program and moving to a proof of concept study.

Thank you for your attention and your time and we will update you soon again on our progress.

http://investors.dynavax.com/secfiling.cfm?filingID=1193125-…

[Lucky72]

Zitat von Lucky72: Ich denke das wir nächste Woche wieder auf die 3$ laufen!

Da hatte ich wohl Recht!

[Lucky72]

Guten Morgen

[Lucky72]

After Hours war aber nicht viel Volumen!

Aber die Richtung stimmt!


After Hours
Time (ET) After Hours
Price After Hours
Share Volume
17:55 $ 2.93 1,500
17:09 $ 2.93 100
16:27 $ 2.84 470
16:15 $ 2.84 26,748
16:03 $ 2.9508 4,400

[VaJo]

Zitat von Lucky72: Ich bin mit Sicherheit nicht short!

Halte die Teile schon seit 1,40$!

Weis ich doch

Viel Erfolg!

[Lucky72]

MarketWire

FDA Agrees With Dynavax on Consistency of HEPLISAV(TM) Lots


BERKELEY, CA -- (Marketwire) -- 07/28/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) advised the company that "CBER agrees that clinical consistency of three consecutively manufactured lots of HEPLISAV has been demonstrated." In a written communication to Dynavax, FDA noted that "Although lot consistency criteria were not met at the pre-specified time point of 4 weeks PLD (post last dose), lot consistency criteria were met 8 weeks PLD, the time point corresponding to the primary immunogenicity endpoint, as well as at several other time points."

According to Dr. Tyler Martin, President and Chief Medical Officer, "As expected, the FDA has confirmed our assessment of lot consistency in the Phase 3 trial we just announced. With their concurrence, we can now move forward towards our goal of preparing a BLA for submission by the end of the year for hyporesponsive populations aged 40 and older."

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier 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 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.

http://www.finanznachrichten.de/nachrichten-2011-07/20919752…

[Lucky72]

Antwort auf Beitrag Nr.: 41.862.943 von VaJo am 29.07.11 09:07:56

Danke! Mal sehn wohin die Reise geht!

[Lucky72]

News & Events
Upcoming Events
Aug 2, 2011 Goldman Sachs Small Cap 1x1 Series
Show Additional Information
Reminder Remind me

[Lucky72]

Bin schon gespannt was wir von Goldman Sachs für eine Analysten Bewertung bekommen!

[Lucky72]

Dann wird es langsam teuer für GSK und Merck!

[Lucky72]

Kein Handel in Deutschland, warten wohl alle auf Amiland!

[Lucky72]

Nur zur Info!

http://clinicaltrials.gov/ct2/results?term=Dynavax

[Lucky72]

[Lucky72]

Ich hoffe wir sehn heute noch die 3$!

[Lucky72]

Hätte mir für Freitag mehr erwartet!

[Lucky72]

Totenstille bei den Amis!

[Lucky72]

Recent Analyst Activity

Dynavax (DVAX)
7/28 – Jefferies maintains buy, price target raised to $5.00 from $4.00 (7/20)
7/28 – William Blair & Co. maintains outperform, price target $8.00
7/28 – Cowen and Company maintains outperform

http://biotechinvestmentparadigm.com/2011/07/recent-analyst-…

[Lucky72]

[Lucky72]

Sieht so aus als würden die Amis die Kriese in den Griff bekommen!

http://www.wallstreet-online.de/nachricht/3204896-roundup-ho…

[Lucky72]

Zitat von Lucky72: Sieht so aus als würden die Amis die Kriese in den Griff bekommen!

http://www.wallstreet-online.de/nachricht/3204896-roundup-ho…

Dann werden morgen die Shorty gegrillt!

[Lucky72]

Short Interest (Shares Short) 10,387,900

Viel spaß beim covern!

[Lucky72]

Aus dem Yahoo!

Re: HEPLISAV's INEVITABLE MKT Domination @ $330M market cap 30-Jul-11 02:21 pm

$330M for the next generation Hep B vaccine leader??

MM are helping manipulate the PPS until institutions load up.

Mal sehn wie lange sie den Deckel noch drauf halten können!?

[Lucky72]

Sieht aus als würden wir heute wieder die 3$ sehn!

[derGluecksritter]

3,00$ 21:33

[Lucky72]

Antwort auf Beitrag Nr.: 41.876.012 von derGluecksritter am 01.08.11 21:33:43

Jetzt geht sie richtig UUUUPPPP!!!!

[Lucky72]

Was für eine geile Aktie!

[Lucky72]

Von twitter!

$Traders buying $DVAX ahead of the Goldman Sachs one on one mtgs tomorrow in Boston

[Lucky72]

Guten Morgen

[Lucky72]

Big News are in the pipe!

[Lucky72]

Wird Zeit für FLU-News und ein evtl. Deal mit Novartis!

[Lucky72]

[Lucky72]

Pipeline :: Flu Vaccine

Our novel Universal Flu vaccine entered clinical development in June 2010. In late September, we initiated a Phase 1b study to 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 was initiated six months ahead of schedule based on preliminary Phase 1a safety data on N8295 alone.

In mid-February, 2011, in Geneva, Switzerland at the World Health Organization 7th Meeting on Evaluation of Pandemic Influenza Prototype Vaccines in Clinical Trials, we reported new Phase 1a and Phase 1b safety and immunogenicity data for our universal flu candidate vaccine. In an oral presentation, Dynavax's Robert Janssen, M.D., Senior Director, Clinical Research, described new findings for N8295 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 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.

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 positive data from the completed 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.

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.

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.
Commercial Opportunity

Human viral influenza is an acute respiratory disease with high morbidity and mortality that occurs in annual epidemics worldwide. There are an estimated 30,000 to 40,000 viral influenza-associated deaths per year in the United States, primarily in those over 65 years of age. Influenza pandemics occur infrequently, on average every 30 to 40 years, but the next pandemic could result in millions of deaths worldwide. Analysts estimate the current worldwide market opportunity for seasonal influenza vaccines to be approximately $3 billion annually.

Standard flu vaccines can provide protection against the influenza strains predicted to be prevalent during a season. The efficacy of these vaccines is often decreased by unpredictable changes in the actual strains causing influenza. Current vaccines are also least effective in those who need prevention the most, the elderly and others with weaker immune systems. Pandemic vaccination is further complicated by the need to produce large quantities of vaccine in a short time period.

Our Universal Flu vaccine is designed to offer protection against divergent influenza strains, increase the efficacy of standard vaccines, and potentially reduce the dose of vaccine to extend the quantity available during a pandemic.

[Lucky72]

Mal sehn ob wir heute die 3,18$ knacken!

[Lucky72]

Nur zur Info!

http://www.stockta.com/cgi-bin/analysis.pl?symb=DVAX&num1=3&…

[Lucky72]

Das wird heute wohl nix!

Der ganze Markt kackt total ab!

[Lucky72]

[Lucky72]

Warum kackt der Kurs so ab?

Ist wohl wieder das Spiel der MM (Market Manipulator)?

[Lucky72]

@ Dino

Jetzt aber raus mit der News!

[Lucky72]

Guten Morgen !

Es gibt immer wieder Mißverständnisse bei den Amis über die CBER!

Hier zur Info!

About CBER

The Center for Biologics Evaluation and Research (CBER) is one Center within the Food and Drug Administration, an Agency within the United States Government's Department of Health and Human Services (HHS).



CBER's mission is to protect and enhance the public health through the regulation of biological and related products including blood, vaccines, allergenics, tissues, and cellular and gene therapies. Biologics, in contrast to drugs that are chemically synthesized, are derived from living sources (such as humans, animals, and microorganisms), are not easily identified or characterized, and many are manufactured using biotechnology. These products often represent cutting-edge biomedical research and, in time, may offer the most effective means to treat a variety of medical illnesses and conditions that presently have few or no other treatment options.



CBER's review of new biological products, and for new indications for already approved products, requires evaluating scientific and clinical data submitted by manufacturers to determine whether the product meets CBER's standards for approval. After a thorough assessment of the data, CBER makes a decision based on the risk-benefit for the intended population and the product's intended use. CBER's authority resides in the Public Health Service Act and in specific sections of the Food Drug and Cosmetic Act.



Although medical products are required to be safe, safety does not mean zero risk, since all medical products are associated with some level of risk. A safe biological product is one that has reasonable risks, given the patient's condition, the magnitude of the benefit expected, and the alternatives available. The choice to use a biological product involves balancing the benefits to be gained with the potential risks. CBER is committed to a product approval process that maximizes the benefits and minimizes the risks to patients of the biological product.



CBER is committed to providing up-to-date information to the public, healthcare professionals, the media and product manufacturers about the products CBER regulates through the Biologics Web pages. Site content is developed and reviewed by CBER staff prior to publication.

http://www.fda.gov/AboutFDA/CentersOffices/CBER/default.htm

[Lucky72]

Zitat von Lucky72: MarketWire

FDA Agrees With Dynavax on Consistency of HEPLISAV(TM) Lots


BERKELEY, CA -- (Marketwire) -- 07/28/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration (FDA) advised the company that "CBER agrees that clinical consistency of three consecutively manufactured lots of HEPLISAV has been demonstrated." In a written communication to Dynavax, FDA noted that "Although lot consistency criteria were not met at the pre-specified time point of 4 weeks PLD (post last dose), lot consistency criteria were met 8 weeks PLD, the time point corresponding to the primary immunogenicity endpoint, as well as at several other time points."

According to Dr. Tyler Martin, President and Chief Medical Officer, "As expected, the FDA has confirmed our assessment of lot consistency in the Phase 3 trial we just announced. With their concurrence, we can now move forward towards our goal of preparing a BLA for submission by the end of the year for hyporesponsive populations aged 40 and older."

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier 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 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.

http://www.finanznachrichten.de/nachrichten-2011-07/20919752…

[Lucky72]

Gap close!

[Lucky72]

[Lucky72]

Ich glaub ich schalt die Kiste gleich wieder aus!

[Lucky72]

Insider Kauf!

CANO FRANCIS kauft 66519 Aktien!

http://investors.dynavax.com/secfiling.cfm?filingID=1181431-…

[Lucky72]

Eine positive News könnte jetzt nicht schaden!

[Lucky72]

Guten Morgen!

Ich wünsche allen einen dunkelgrünen Tag!

[Lucky72]

Trade Detail
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
17:05 $ 2.49 20,067
16:42 $ 2.49 21,350
16:17 $ 2.49 2,000
16:17 $ 2.2381 31,000
16:11 $ 2.2492 13,900

[Lucky72]

[Lucky72]

WOW! Der ganze Markt ist wieder voll abgekack!

[Lucky72]

Test!!!!!!

[Lucky72]

Dynavax to Present at the Wedbush 2011 Life Sciences Conference

BERKELEY, CA -- (MARKET WIRE) -- 08/11/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the Wedbush 2011 Life Sciences Conference in New York on Wednesday, August 17, 2011 at 10:00 am EDT (1:00 pm PDT).

Brant Biehn, Chief Commercial Officer of Dynavax, and Shari Annes, Investor Relations 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 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.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=598…

[Lucky72]

Die Shorty können es nicht lassen!

Dynavax Technologies Corporation

$ 2.40

Short Interest (Shares Short) 11,201,500

Days To Cover (Short Interest Ratio) 2.4

Short Interest - Prior 10,387,900

[Lucky72]

Mr. Biehn ist wohl der Chefverkäufer!

Erfahrung hat er wohl genug bei Merck gemacht!

Brant Biehn – Vice President and Chief Commercial Development Officer

Mr. Biehn joined Dynavax in January 2010 as our Vice President and Chief Commercial Development Officer. Prior to joining Dynavax, Mr. Biehn held increasingly senior sales and marketing positions during his 21 year tenure at Merck. Since 2005, he has had responsibility for many adult vaccine products, including Merck's hepatitis A, hepatitis B and pneumococcal vaccines. Most recently, he served as International Market Lead for ZOSTAVAX®, a vaccine launched in the US in 2005 for the prevention of herpes zoster, or shingles as well as Merck's other adult vaccines. Prior to 2009, in his role as a global brand leader, he designed and managed marketing and sales programs, including distribution channels; targeted marketing to customer groups, payers, healthcare professionals, and consumers; and led country-specific marketing for ex-US markets. Over the past two years he worked with countries worldwide to supply pneumococcal polysaccharide vaccine to help prevent secondary bacterial infections that may result from pandemic flu infection. This program extended to both large public health programs as well as private health groups, with an emphasis on prevention of pandemic flu impacts. Earlier in his career Mr. Biehn created and led national sales organizations and directed multiple marketing efforts aimed at commercialization planning for new vaccine and human health products. Mr. Biehn earned a Bachelor of Science in Computer Science from the Memorial University of Newfoundland.
ZOSTAVAX is a registered trademark of Merck & Co., Inc.

http://www.dynavax.com/management.html

[Lucky72]

Ich hoffe das wir heute noch die MA200 von oben sehn!

[Lucky72]

Die Ruhe vor dem Sturm????

[Lucky72]

Guten morgen!

[Lucky72]

Wird Zeit das was kommt!

Immunogenicity and Safety of HEPLISAV™ Hepatitis B Virus Vaccine in Chronic Kidney Disease (CKD) Patients



Enrollment: 600
Study Start Date: September 2009
Estimated Study Completion Date: August 2011
Estimated Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)


http://clinicaltrials.gov/ct2/show/NCT00985426?term=Dynavax&…

[Lucky72]

Von "Kurspflege" hat das Management wohl noch nix gehört!?

[Lucky72]

Noch keine News?!

[Lucky72]

Zitat von Lucky72: Die Shorty können es nicht lassen!

Dynavax Technologies Corporation

$ 2.40

Short Interest (Shares Short) 11,201,500

Days To Cover (Short Interest Ratio) 2.4

Short Interest - Prior 10,387,900

Neuer Treibstoff für eine Shortsqeeze!

Short Interest (Shares Short) 12,478,300

Days To Cover (Short Interest Ratio) 6.0

Short Interest - Prior 11,201,500

[Lucky72]

Guten Morgen!

Ich wünsche allen einen dunkelgrünen Tag!

[Lucky72]

Heute ist "News Tag"!

Mal sehn ob wir wieder die 3$ testen!

IMO

[Lucky72]

Keine News!

Es stehen doch noch viele Ergebnisse aus!

http://clinicaltrials.gov/ct2/results?term=Dynavax

[Lucky72]

WOW!!!!

[Lucky72]

@alle Shorty

Zum Covern immer schön aus dem ASK kaufen!

[Lucky72]

Sinnlose News!

Wir brauchen Ergebnisse, sonst nix!


Dynavax to Present at William Blair & Company's 2011 Life Sciences Conference

BERKELEY, CA -- (MARKET WIRE) -- 09/01/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at William Blair & Company's 2011 Life Sciences Conference in New York on Wednesday, September 7, 2011 at 2:40 pm EDT (11:40 am PDT).

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 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.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=602…

[Lucky72]

Heute ist kein Handel in Amiland!

http://www.nasdaqtrader.com/Trader.aspx?id=Calendar

[Lucky72]

Dynavax Receives $600,000 SBIR Grant for TLR Research

BERKELEY, CA -- (MARKET WIRE) -- 09/07/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the receipt of a two-year Small Business Innovation Research grant (SBIR) for $600,000. The Award is provided by the National Institute of Allergy and Infectious Diseases and will be used to fund research to characterize the role of the phosphoinositide 3-kinase (PI3K) in preclinical models of skin autoimmune inflammation.

Scientists at Dynavax have shown that PI3K is required for the production of type I interferon (IFN) by plasmacytoid dendritic cells (PDC) in response to TLR7 or TLR9 stimulation (Journal of Experimental Medicine 2008). In subsequent studies, the chronic activation of PDC and the IFN that they produced was shown to play a role in skin autoimmune inflammation (Journal of Experimental Medicine 2010), which makes PI3k an attractive target for skin diseases such as psoriasis, cutaneous lupus, and dermatomyositis.

"This new grant supports preclinical studies focused on this key component of the TLR signaling pathway as a target for the treatment of inflammatory skin disorders. This work could well be complementary to our GSK development partnership focused on TLR inhibitors," commented Robert L. Coffman, Ph.D., Vice President and Chief Scientific Officer of Dynavax.

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," including statements related to biological mechanisms and potential usefulness of the Company's inhibitors. 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 GSK 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

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=603…

[Lucky72]

Neue Short Zahlen!

Short Interest (Shares Short) 12,838,500

Days To Cover (Short Interest Ratio) 11.0

Short Interest - Prior 12,478,300

http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…

[Lucky72]

Bei dem lausigen Volumen könnten sie den Handel eigentlich gleich einstellen!

[Lucky72]

Ich hoffe es kommen noch News vorm Wochenende!

Sept. 17-20
51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC). Presentations include Dynavax's(DVAX) Heplisav phase III results in hepatitis B prevention on Sept. 18 and updated phase I data on Sangamo BioSciences'(SGMO) experimental HIV drug SB-728.

http://www.thestreet.com/_yahoo/story/11234443/1/biotech-cal…

[Lucky72]

Dynavax to Report Additional Immunogenicity Data for HEPLISAV(TM) Phase 3 Trial

BERKELEY, CA -- (MARKET WIRE) -- 09/16/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that on Sunday, September 18, at 11:30 am CDT at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), the company will present additional immunogenicity data from its Phase 3 trial (HBV-16) evaluating the immunogenicity and safety of HEPLISAV versus Engerix-B®. Tyler Martin, M.D., President and Chief Medical Officer of Dynavax, will make an oral presentation in Session No. 80 "New Trends in Vaccines." The location of the presentation (#G1-534) is Meeting Room W194a of the McCormick Place convention center in Chicago, IL where the ICAAC annual meeting is taking place.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier 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 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.

Engerix-B® is a registered trademark of GlaxoSmithKline

Contact:

Michael Ostrach

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=606…

[Lucky72]

Das Wort zum Sonntag!


Dynavax Reports Complete Results From the HEPLISAV(TM) Phase 3 Trial in Healthy Adults Over Age 40

BERKELEY, CA -- (MARKET WIRE) -- 09/18/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today at the 51st Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago, IL presented complete results for the entire study population of its Phase 3 trial (HBV-16). The Phase 3 study, HBV-16, was a multi-center, observer-blinded study to determine if the immunogenicity of two doses of HEPLISAV was non-inferior/superior to three doses of Engerix-B® by comparing seroprotection rates (SPRs) at eight weeks post last dose.

The data reported at ICAAC demonstrate HEPLISAV's ability to generate a faster, higher, and longer-lasting response as compared to Engerix-B, as follows:

HEPLISAV induced a superior immune response to Engerix-B throughout the study. The SPRs and Geometric Mean Concentrations (GMCs) in the HEPLISAV group were significantly higher than the SPRs and GMCs in the Engerix-B group at every visit from Week 4 through Week 52.

HEPLISAV provided earlier seroprotection than Engerix-B. At the primary endpoint visit, Week 12 for HEPLISAV and Week 32 for Engerix-B, the SPR in the HEPLISAV group was 90% compared to 71% in the Engerix-B group. In fact, at Week 8, the SPR in the HEPLISAV group was higher (77%) than the peak SPR in the Engerix-B group. The GMC results also showed an earlier response from HEPLISAV; at Week 12, for HEPLISAV, GMCs were 93 mIU/mL compared to Engerix-B at Week 32 when GMCs were 61 mIU/mL.

HEPLISAV provided higher rates of seroprotection than Engerix-B. The peak SPR for the HEPLISAV group was 95% at Week 24. The peak SPR for Engerix-B was 73% at Week 28. The peak GMC for HEPLISAV was 233 mIU/mL at Week 24, and was 89 mIU/mL for Engerix-B at Week 28.

HEPLISAV provided longer-lasting antibody than Engerix-B. The immune response to HEPLISAV was longer-lasting than the immune response to Engerix-B. The SPR in the HEPLISAV group decreased from a peak of 95% at Week 24 to 92% at Week 52 while the SPR in the Engerix-B group decreased from a peak of 73% at Week 28 to 59% at Week 52. The GMC in the HEPLISAV group decreased from a peak of 233 mIU/mL at Week 24 to 151 mIU/mL at Week 52. In contrast, the GMC in the Engerix-B group decreased from a peak of 89 mIU/mL at Week 28 to 20 mIU/mL at Week 52.

The safety of HEPLISAV was similar to Engerix-B. The rates of local and systemic post-immunization reactions, adverse events, serious adverse events, and autoimmune adverse events were similar in both groups.

According to Tyler Martin, M.D., President and Chief Medical Officer who made the oral presentation in a session entitled "New Trends in Vaccines" (#80), "The data clearly indicate that HEPLISAV induces an immune response that is faster, higher, and more durable than that produced by Engerix-B, with similar safety. These results, demonstrating the superiority of HEPLISAV to Engerix-B in a hyporesponsive population, will be the basis of our BLA filing that we intend to submit by the end of this year."

Dynavax will present subgroup analyses of the study's findings at upcoming annual medical meetings, including diabetics at the Infectious Diseases Society of America (IDSA), and other hyporesponsive groups at the American Association for the Study of Liver Diseases (AASLD) later this year.

Engerix-B® is a registered trademark of GlaxoSmithKline

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier 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 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 the timing of 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 and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether our 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, including the outcome of pre-filing discussions with regulatory authorities; 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

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=606…

[Lucky72]

[Lucky72]

Gute Morgen!

Ich wünsche allen einen dunkelgrünen Tag!

[Lucky72]

Warum kackt der Kurs so ab?????

[Lucky72]

WOW!!

2Cent im Plus!

Heute lassen es die Amis aber krachen!

[Lucky72]

Na endlich! Eine News ohne Filing ist keine News!

http://investors.dynavax.com/secfiling.cfm?filingID=1193125-…

[Lucky72]

Super! Es gibt wieder Kaufkurse!

[Freizeitspekulant]

...der Chart schaut schrecklich aus - und der Kurs ist so richtig runtergewürgt worden...

Aber: fundamental hat sich weder was verschlechtert - eher im Gegenteil...endlich sind firmenseitig mal Fakten auf den Tisch gekommen und auch offiziell verlautbart worden.
Zudem sind die Anteile aktuell nach zwei Tagen ordentlicher Tracht Prügel grade richtig verbilligt zu bekommen...

Fazit: heute Nachmittag werde ich mir mal welche ins Depot legen - rein aus der Betrachtung heraus daß wie schon erwähnt die veröffentlichten Daten durchaus reizvoll erscheinen, 63% der Firmenanteile lt. Nasdaq in Händen von Instis liegen......

....und Stand Ende August ca. 12 Millionen Shares geshortet waren - diese Zahl dürft eher in den letzten Tagen zugenommen haben....

Mein Riecher hat mich bei TSPT vor ein paar Tagen schon zum Kauf bewogen - vor Jahren bei MYOGEN und Inhibitex - die sich vermehrfacht haben :-))

Ich halte derzeit noch eine Position TZYM - kleiner Laden, extrem geringer Float - mit ziemlichen Preisschwankungen in beide Richtungen - aber das mal nur nebenbei...

Allen hier bei DVAX schon Investierten viel Erfolg und irgendwann den Urknall :-))

[Freizeitspekulant]

...na also - gleich noch welche zum Auftakt erwischt... aktuell 1,91$ :-))

[Lucky72]

Antwort auf Beitrag Nr.: 42.128.100 von Freizeitspekulant am 23.09.11 15:51:00

Willkommen an Bord!

[Lucky72]

[Lucky72]

Ich glaub es geht bald los!

About Us :: Careers :: USA :: Sr. Manager, Quality Assurance Commercial Product
Back to Careers

PRIMARY PURPOSE OF POSITION:

Act as the QA designated subject matter expert for commercial product(s). Coordinate and/or perform QA activities related to commercial product(s) compliance and operations. Duties will include but are not limited to assurance of commercial product quality, oversight of exceptions, and assuring timely and meaningful resolution of potential quality issues that affect the commercial product(s). This position is located at the Berkeley Dynavax site, and will involve up to 20% travel.



This position may propose operational objectives and assignments which are approved by senior management. The job holder may participate in developing, improving, and executing company policies that affect immediate operations(s) and may also have companywide effect. This level position works on complex problems in which analysis of situations or data requires an in-depth evaluation of various factors. At the senior manager level, the incumbent will exercise judgment within broadly defined practices and policies in proposing methods, techniques and evaluation criteria for obtaining results.



Decisions made at this level may impact project timelines and/or affect compliance risk.



MAJOR DUTIES OF POSITION:

Manage the quality activities related to the Company’s commercial product(s) including preparing the annual product quality report.

Maintain knowledge of commercial product – from product history to current.

Review batch records and recommend batch disposition as required.

Convenes the Materials Review Board as needed for commercial product quality issues. Identifies, review quality issues, develop proposals and decides with input from QA management. Implement decisions and/or corrective actions, etc., that concern the commercial product(s).

Establish and maintain effective working relationship with key stakeholders both internal and external.

Review all exceptions or concerns involving commercial product(s), including but not limited to regulatory inspections, complaints, adverse events, non-conforming products, etc. Make appropriate notification to senior management, and propose remedies.

Work closely with Regulatory Affairs to assess changes and exceptions for regulatory impact, and to assure appropriate notification to regulators occurs.

Stay abreast of current regulatory trends and changes.

Work with the key stakeholders to assure resolution of compliance issues;

Notify management when significant potential exists for serious compliance issue to impact the supply chain.

Support the Quality team during regulatory inspections related to commercial product(s). Provide guidance to the Dynavax team, act as QA product representative during regulatory inspections.

Represent Quality Assurance at meetings and ensure compliance of approved quality agreements with CMOs. May propose changes to quality agreements as needed.

Oversee outsourced commercial product complaints.

Coordinate with production, Quality Control, and other departments to ensure quality compliance and operations at all times.

Provides quality expertise, advice, and/or assistance across the organization as required.

Maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.

Other duties as assigned.

KNOWLEDGE AND SKILL REQUIREMENTS:

BS degree in life sciences, bioengineering, or related field and 8 years of experience in biopharmaceutical or vaccine industry, with 2 years experience in QA/QC supporting commercial product(s).

Knowledge of FDA regulatory requirements for biologics, especially vaccines or pharmaceuticals.

Experience with late stage products including licensure and commercial stage.

Experience with regulatory inspections and licensure as well as national and international requirements.

Must be an effective communicator with proven abilities to communicate complex information and concepts with clarity.

Should possess a flexible approach to problem-solving, be an adept negotiator, and be able to trouble-shoot.

Proven ability to establish collaborative working relationships with internal and external stakeholders; strong team-orientation and the ability to work independently.

Ability to effectively prioritize and manage multiple projects and tasks.



The ideal candidate is highly ethical, flexible, action- and goal- oriented; works well under pressure, and is effective in meeting tight deadlines.

http://www.dynavax.com/careers/usa/Sr.ManagerQACommercialPro…

[Lucky72]

US Commerce Official To Lead Biotech Trade Mission To China, Hong Kong


WASHINGTON -(Dow Jones)- A senior U.S. Commerce official will lead top biotech companies on a trade mission to Beijing and Hong Kong next month to explore increasing access to China's fast-growing market.

Amgen Inc. (AMGN), Thermo Fisher Scientific Inc. (TMO), and Sanofi (SNY, SAN.FR) unit Genzyme Corp. are among 19 firms that will join the mission scheduled for Oct. 13 to 18.

Francisco Sanchez, Commerce undersecretary for international trade, said he is leading the group to tap into an industry that's growing at a rate of 20% to 25% a year.

"China is considered the most important future market in terms of sales, clinical trial opportunities, and potential investment for U.S. biotech and life science firms," Sanchez said in a statement Wednesday.

Despite China's market potential, U.S. businesses doing business there have cited increasing concerns about lax protection for intellectual property and government pressure for foreign firms to transfer their technologies.

Companies participating in the trip will include not just biotech drug and equipment makers, but architecture firms specializing in biotech facilities. Other companies selected for the mission include Abaxis Inc. (ABAX), Dynavax Technologies Corp. (DVAX) and Fujifilm Diosynth Biotechnologies (4901.TO).

url]http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…[/url]

[Lucky72]

Wird Zeit das GSK, Novartis usw. ein Übernahmeangebot abgeben!

Sonst schlagen die Chinesen zu!

IMO

[Lucky72]

Mal sehn wohin die Reise geht!

[Lucky72]

Schon wieder CT Order!!!

http://investors.dynavax.com/sec.cfm

[Lucky72]

Dynavax Reports Modified Intent to Treat Analysis From the HEPLISAV(TM) Phase 3 Trial in Healthy Adults Over Age 40

BERKELEY, CA -- (MARKET WIRE) -- 10/03/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) presented yesterday at the 5th Global Vaccine Congress in Seattle, WA an analysis of the modified intent to treat population from its Phase 3 trial (HBV-16), showing the superiority of HEPLISAV vs. Engerix-B®. The previously reported per protocol analysis compared the three consistency lots of HEPLISAV to Engerix-B and included 1123 HEPLISAV and 359 Engerix-B subjects who completed the vaccination regimens according to the protocol. The modified intent to treat (MITT) populations of 1947 HEPLISAV subjects and 476 Engerix-B subjects included all subjects that had received at least one dose of any of the four HEPLISAV lots or Engerix-B and had at least one post vaccination immunogenicity result. The Phase 3 study, HBV-16, was a multi-center, observer-blinded study to determine if the immunogenicity of two doses of HEPLISAV was non-inferior/superior to three doses of Engerix-B by comparing seroprotection rates (SPRs) at eight weeks post last dose.

The data demonstrate HEPLISAV's ability to generate a faster, higher, and longer-lasting response as compared to Engerix-B in both the per protocol and the modified intent to treat populations, as follows:

For the MITT population, HEPLISAV provided earlier seroprotection than Engerix-B. At the primary endpoint visit, Week 12 for HEPLISAV and Week 32 for Engerix-B, the SPR in the HEPLISAV group was 89% compared to 69 % in the Engerix-B group.

In the previously reported per protocol analysis, at the primary endpoint visit, Week 12 for HEPLISAV and Week 32 for Engerix-B, the SPR in the HEPLISAV group was 90% compared to 71% in the Engerix-B group.

For the MITT population, HEPLISAV also provided higher rates of seroprotection than Engerix-B. The peak SPR for the HEPLISAV group was 95% at Week 24. The peak SPR for the Engerix-B group was 71% at Week 28.

As previously reported for the per protocol analysis, the peak SPR for the HEPLISAV group was 95% at Week 24. The peak SPR for the Engerix-B group was 73% at Week 28.

For the MITT population, HEPLISAV provided longer-lasting antibody than Engerix-B, and the immune response to HEPLISAV was longer-lasting than the immune response to Engerix-B. The SPR in the HEPLISAV group was 92% at Week 52 while the SPR in the Engerix-B group was 59% at Week 52.

As previously reported for the per protocol analysis, the SPR in the HEPLISAV group was 92% at Week 52 while the SPR in the Engerix-B group was 59% at Week 52.

The safety of HEPLISAV was similar to Engerix-B. The rates of local and systemic post-immunization reactions, adverse events, serious adverse events, and autoimmune adverse events were similar in both groups.

According to Tyler Martin, M.D., President and Chief Medical Officer, "The results of the modified intent to treat analysis corroborate the previously reported per protocol analysis and support the robustness of our conclusion that HEPLISAV is superior to Engerix-B in this hyporesponsive population."

Dynavax will present subgroup analyses of the study's findings at upcoming annual medical meetings, including diabetics at the Infectious Diseases Society of America (IDSA), and other hyporesponsive groups at the American Association for the Study of Liver Diseases (AASLD) later this year.

Engerix-B® is a registered trademark of GlaxoSmithKline

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In an earlier 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 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. 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 and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays in development or clinical trial enrollment, whether our 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, including the outcome of pre-filing discussions with regulatory authorities; 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=610…

[Lucky72]

Der Kurs kennt nur eine Richtung!!!!

[Lucky72]

Dynavax and AstraZeneca to Advance TLR-9 Agonist Into Clinic for Asthma

BERKELEY, CA -- (MARKET WIRE) -- 10/05/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) and AstraZeneca have amended their existing Collaboration Agreement to accelerate the initiation of clinical development of AZD 1419, a proprietary second-generation TLR-9 agonist for asthma. Dynavax will manage the early clinical development on behalf of the collaboration, and development expenses will be fully funded by AstraZeneca. Dynavax will receive an initial payment of $3 million to begin the clinical program.

Under the terms of the 2006 research collaboration and license agreement and as now amended, AstraZeneca will provide to Dynavax approximately $20 million in payments to cover the cost of clinical development activities through Phase 2a. If AstraZeneca chooses to advance the program following completion of Phase 2a, Dynavax will receive a $20 million milestone payment, and AstraZeneca will retain its rights to develop the candidate therapy and to commercialize the resulting asthma product. Additional remaining milestone payments to Dynavax amount to nearly $100 million. Dynavax will receive royalties on worldwide sales of approved products and will have the opportunity to co-promote the product in the United States.

AZD 1419 has been selected as the lead clinical candidate to enter formal clinical development based on extensive preclinical studies conducted by Dynavax and AstraZeneca. These include demonstration that AZD 1419 is capable of producing long lasting disease-modifying effects in a mouse model of atopic asthma. Initiation of a Phase 1 study is planned after regulatory requirements are met and clinical materials are released.

According to Maarten Kraan, Vice President, Head of Respiratory & Inflammation, AstraZeneca Research and Development, "New approaches to asthma that have the potential to modify the course of severe respiratory disease represent a significant clinical need. We believe that Dynavax's TLR-9 agonist has potential as an innovative, next-generation therapy that could expand and strengthen our respiratory franchise."

Dino Dina, M.D., Dynavax's Chief Executive Officer, commented, "The success of this collaborative effort confirms once more the potential of our TLR-9 based therapies. The candidate molecule represents a therapy that has been shown preclinically to modify the course of asthmatic disease and produce long term remissions. With AstraZeneca's financial support and commitments to success milestones, we can now extend our clinical portfolio with a highly innovative and differentiated drug."

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," including statements related to the anticipated timing for the first clinical study in our asthma program, expected payments under our AstraZeneca agreement and the potential features of the Company's TLR-9 agonists. 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 AstraZeneca 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.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=611…

[Lucky72]

Das Volumen heute ist ein Witz!

[Lucky72]

Dynavax Reports Diabetic Subset Data From Modified Intent to Treat Analysis of the HEPLISAV(TM) Phase 3 Trial in Healthy Adults Over Age 40


BERKELEY, CA -- (MARKET WIRE) -- 10/06/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today the results of a prospective analysis of the diabetic subset population from its Phase 3 trial (HBV-16), showing the superiority of HEPLISAV vs. Engerix-B®, at all measured time points. The modified intent to treat (MITT) analysis of adults with type II diabetes showed that HEPLISAV given as 2 doses over 4 weeks protected a significantly greater proportion of subjects in a shorter time and with longer-lasting protection than Engerix-B given as 3 doses over 24 weeks. The modified intent to treat (MITT) subpopulations included all diabetic subjects that had received at least one dose of any of the four HEPLISAV lots or Engerix-B and had at least one post vaccination immunogenicity result.

Of the 218 diabetics in the MITT population (179 HEPLISAV; 39 Engerix-B), the SPRs for HEPLISAV were superior to Engerix-B at weeks 8 through 52.



At the prespecified comparison time points of week 12 for HEPLISAV and week 32 for Engerix-B, the SPR was 79% in the HEPLISAV group and 61% in the Engerix-B group.



At week 12, the SPR was 79% in the HEPLISAV group and 11% in the Engerix-B



At week 52, the SPR in the HEPLISAV group was 82% whereas the SPR in the Engerix-B group was 54% by week 52.



According to Tyler Martin, M.D., President and Chief Medical Officer, "The Phase 3 results we are reporting today for HEPLISAV vs. Engerix-B are the first to be obtained in a prospectively defined diabetic population. The data clearly demonstrate the superiority of HEPLISAV in diabetics and confirm our retrospective analysis reported last year. In light of the current public health discussions regarding HBV protection of this susceptible population, these results have important medical significance."

Dynavax will present additional data for the diabetic subset population at the Infectious Diseases Society of America (IDSA) on October 21, 2011.

Engerix-B® is a registered trademark of GlaxoSmithKline


http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=2…

[Lucky72]

Sind die ganzen positiven News schon eingepreist???!!

[Lucky72]

Dynavax Reports Positive Immunogenicity Data From an Analysis of Hypo-Responsive Populations in HEPLISAV(TM) Phase 3 Trial

BERKELEY, CA -- (MARKET WIRE) -- 10/10/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced immunogenicity data for subpopulations known to be hypo-responsive (males, obese, and smokers) to currently licensed hepatitis B vaccines from its Phase 3 trial (HBV-16). The Phase 3 study was a multi-center, observer-blinded study to determine if the immunogenicity of two doses of HEPLISAV was non-inferior/superior to three doses of Engerix-B® by comparing seroprotection rates (SPR) at eight weeks post last dose in healthy adults over age 40.

The data demonstrate HEPLISAV's enhanced immune response and superiority as measured by peak SPRs for the subpopulations as follows:



HEPLISAV SPR% Engerix-B SPR%

------------- --------------

Adults ≥ 40 yrs. 95.1 70.5

Males 94.6 67.8

Females 95.6 77.8

Obese (BMI ≥ 30 kg/m2) 94.7 65.4

Non-obese 95.4 78.4

Smokers 95.6 65.3

Non-smokers 95.0 74.8




As reported previously, for all safety parameters, HEPLISAV was similar to the Engerix-B control arm.

Dynavax President and Chief Medical Officer, Tyler Martin, MD, said, "These subset analyses from HBV-16 further underline the superiority of HEPLISAV compared to the current market leading HBV vaccine, Engerix-B. It has long been known that males, the obese, and smokers have an impaired response to current licensed HBV vaccines. Not only was HEPLISAV superior to Engerix-B in each of these subpopulations, the seroprotection rates in the HEPLISAV group did not decline for any hypo-responsive subset, in comparison to the responsive subset. These results substantially strengthen the observation that HEPLISAV is superior to Engerix-B."

Dynavax will present additional detail on the hypo-responsive groups at the American Association for the Study of Liver Diseases (AASLD) later this year.

Engerix-B® is a registered trademark of GlaxoSmithKline


http://investors.dynavax.com/releasedetail.cfm?ReleaseID=613…

[Lucky72]

2.00$ +0.17 (9.29%)

WOW! Die Woche fängt ja gut an!

[Lucky72]

Dynavax to Host Analyst & Investor Day Webcast October 27, 2011

BERKELEY, CA -- (MARKET WIRE) -- 10/12/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it will webcast its 2011 Analyst & Investor Day on Thursday, October 27, 2011, from 8:00 - 11:00 a.m. Eastern Time.

Presentations and discussions by outside experts and the management team will focus on how Dynavax plans to translate the superior clinical results provided by HEPLISAV™, its investigational hepatitis B vaccine, to a commercial success. Dynavax will discuss its action plan, market opportunity, the regulatory landscape, the potential upside of a diabetic vaccination recommendation, and its TLR9-based approach that leverages the mechanism of action of natural immunity.

To access the live webcast and the subsequent archived audio recording of the presentation, please log on to 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 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.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=614…

[Lucky72]

Neue "Short" Zahlen!!!

Short Interest (Shares Short) 12,810,100

Days To Cover (Short Interest Ratio) 10.8

Short Interest - Prior 12,761,100

http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…

[Lucky72]

[Lucky72]

About Us :: Careers :: USA :: Vice President Sales


PRIMARY PURPOSE OF POSITION:

Responsible for oversight and leadership of the Company’s commercial products for the Americas or all of the US. Develop sales strategies and forecasts including partnership arrangements, channel management and product forecasts for sales volumes across the portfolio of on-market products. Participates in setting strategies for new product launch and brand management to optimize revenue generation and product placement for market share advantage. Oversee the structuring and design of the field sales activities to meet revenue and territory requirements for advancing the company’s products. Oversee the sales operations and support function, and may lead the managed care operations.


Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, and teamwork to maintain and expand the organization’s capabilities.



MAJOR DUTIES OF POSITION:

As a member of the leadership team, the Vice President of Sales will ensure that their area of corporate responsibility is aligned with the Company’s commercial strategy and vision.

Establish and maintain a world-class sales organization with the appropriate management depth to ensure successful launch and growth of the Company’s product(s).

Develop and implement the appropriate strategic and tactical sales direction at the regional and national level to achieve profitability.

Partner with marketing to target and leverage market research, product development, and other marketing initiatives to increase.

Contribute to the planning and execution of the Company’s product development strategies.

Lead and motivates staff and ensures that training and development of employees are focused towards building competencies to support both current and future needs of the business.

This position requires travel up to 75%.

Other duties as assigned.

KNOWLEDGE AND SKILL REQUIREMENTS:

BS in life science with 10+ years relevant work experience including 5 years management and leadership experience in sales and marketing at the VP level.

Proven experience in building in building and motivating a world-in-class sales organization.

Proven success in leading multidisciplinary teams.

Proven successful leader in building positive relationships across functional lines; able to influence positive decisions and build consensus in project meetings, external associates, and with senior management.

Understand the Company’s business direction and make significant contributions to new technologies, applications or business opportunities.

Vaccine, Oncology, and/or medical device sales experience beneficial.

Personal attributes include
Flexibility and integrity,
Goal oriented and self-starter,
Practical approach to science and business,
Demonstrated good judgment and decision-making experience,
Collaborative and team oriented.


http://www.dynavax.com/careers/usa/VPSales.html

[Lucky72]

[Lucky72]

Eigentlich wollte ich heute die 2,50$ sehn!

[Lucky72]

Guten Morgen!

Ich wünsche allen einen dunkelgrünen Tag!

[Lucky72]

Zitat von Lucky72: Guten Morgen!

Ich wünsche allen einen dunkelgrünen Tag!

Ich versuche es heute mal anders und hoffe (wünsche) das der Kurs heute so richtig abkackt!

Vielleicht gehts jetzt hoch!

[Lucky72]

Cool, es hilft!

Also runter mit dem Dreck!

[Lucky72]

Mal sehn wohin die Reise heute geht!

Dynavax to Present at Newsmakers in the Biotech Industry Conference

BERKELEY, CA -- (MARKET WIRE) -- 10/14/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the NewsMakers in the Biotech Industry Conference in New York on Friday, October 21, 2011 at 10:00 a.m. EDT (7:00 a.m. PDT).

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 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.

Contact:

[Lucky72]

Dynavax and GlaxoSmithKline Expand Their Worldwide Strategic Alliance

BERKELEY, CA -- (MARKET WIRE) -- 10/21/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today the expansion of its worldwide strategic alliance with GlaxoSmithKline (GSK) focused on toll-like receptor (TLR) inhibitors. The addition of a new target, TLR8, entitles Dynavax to receive a $3 million milestone payment from GSK. Subject to reaching sales and development milestones, Dynavax has the potential to receive approximately $200 million in milestone payments over the term of the alliance. Based on preclinical data, Dynavax and GSK will work to develop a TLR8 inhibitor for the treatment of multiple autoimmune and inflammatory diseases.

The activation of TLR8 in myeloid cells yields the production of multiple pro-inflammatory cytokines including tumor necrosis factors (TNF), IL-1, IL-6 and IL-12. Therapeutic approaches that target these inflammatory cytokines include a number of autoimmune diseases, such as rheumatoid arthritis. Dynavax and GSK will evaluate the hypothesis that inhibition of TLR8 could prevent the inflammatory cascade these cytokines initiate in many autoimmune conditions.

Dino Dina, M.D., Chief Executive Officer, commented, "The expansion of our alliance with GSK underscores the successes achieved in the ongoing TLR7 and TLR9 program. Importantly, this strategic alliance has had the effect of both expanding Dynavax's pipeline as well as providing additional financial resources over the short- and mid-terms."

About Dynavax's TLR Inhibitors

Dynavax has an ongoing Phase 1 study that is assessing the safety of DV1179, an inhibitor of TLR7 and TLR9, in multiple ascending doses. Data are expected later this year. GSK has an exclusive option to license this program on a worldwide basis upon achievement of certain agreed milestones. 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 several animal models of autoimmune diseases, such as lupus, inflammatory skin disorders, and rheumatoid arthritis.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=616…

[Lucky72]

Data From Two Phase 3 Studies Demonstrate HEPLISAV's Superiority in Immunizing Persons With Diabetes From Hepatitis B

New National Recommendations Announced Today Urge Vaccinations for Unvaccinated Adults With Diabetes Under 60 Years of Age

BERKELEY, CA -- (MARKET WIRE) -- 10/25/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today highlighted data from two phase 3 studies of its investigational vaccine HEPLISAV™, one of which was the first clinical trial to prospectively evaluate the effectiveness of vaccinations with recombinant hepatitis B vaccines in patients diagnosed with diabetes. The data for both studies demonstrated that HEPLISAV provides faster, more robust and convenient, and longer-lasting immunity in persons with diabetes than a currently available vaccine, Engerix-B®. An analysis of pooled data from these studies will be presented at Dynavax's analyst and investor day this Thursday, October 27, 2011 in New York City.

Also today, the Centers for Disease Control and Prevention's (CDC) Advisory Committee on Immunization Practices (ACIP) voted to recommend that hepatitis B vaccine should be administered to unvaccinated adults with diabetes who are less than 60 years of age. This change significantly expands the number of persons for whom vaccination is recommended. Since 1991, infants in the U.S. have been recommended to be routinely vaccinated for hepatitis B.

At the annual meeting of the Infectious Disease Society of America (IDSA) in Boston last Friday, October 21, 2011, Dynavax reported the diabetic subset data from a modified intent to treat (MITT) analysis of the HEPLISAV Phase 3 trial in adults over age 40. These results represent an evaluation of the first prospectively defined diabetic population and demonstrate the superiority of HEPLISAV vs. Engerix-B.

Of the 218 subjects with diabetes in the MITT population (179 HEPLISAV; 39 Engerix-B), the seroprotection rates (SPRs) for HEPLISAV were superior to Engerix-B at Weeks 8 through 52.

At the pre-specified primary comparison time points of Week 12 for HEPLISAV and Week 32 for Engerix-B, the SPR was 79% in the HEPLISAV group and 61% in the Engerix-B group.

At Week 12, the SPR was 79% in the HEPLISAV group and 11% in the Engerix-B group.

At Week 52, the SPR was 82% in the HEPLISAV group and 54% in the Engerix-B group.

Last year, in a late-breaker oral presentation on October 23, 2010 at the IDSA annual meeting in Vancouver, British Columbia, Dynavax also reported data showing superior seroprotection of HEPLISAV in persons with diabetes compared to Engerix-B. These data reflected a post hoc subset analysis of 62 adults with diabetes in Dynavax's previously reported Phase 3 multicenter PHAST study, as follows:

At 12 weeks, 84 percent of adult with diabetes who received HEPLISAV achieved seroprotection as compared to 0 percent of adult diabetics who received Engerix-B.

At Week 28, 93% of subjects in the HEPLISAV group versus 35% in the Engerix-B group achieved seroprotection.

Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said, "There is a significant unmet medical need in hepatitis B vaccination. Given today's ACIP recommendation, we believe HEPLISAV will, if approved, play an important role in meeting the needs of these patients. In addition, Dynavax has demonstrated similar advantages in other hard-to-immunize populations, including males, smokers and obese subjects."

Today's vote to recommend hepatitis B vaccine should be administered to unvaccinated adults with diabetes who are less than 60 years of age reflects the ACIP conclusion after a multi-year analysis on the need for preventing hepatitis B infection in diabetics. According to the CDC, there are at least 18 million people diagnosed with diabetes in the United States with an incidence of 2 million new diagnoses annually. New diagnosis of diabetes in adults is made at a mean age of 53 years with two-thirds of new diagnoses being in persons 40-64 years of age.

The ACIP is an advisory body to the CDC that provides advice and guidance regarding control of vaccine-preventable diseases in the United States civilian population. This recommendation to vaccinate adults with diabetes against hepatitis B infection amends the previous categories of adults recommended to receive hepatitis B vaccination published in December 2006 (MMWR, Vol. 55, RR-16).

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=617…

[Lucky72]

[Freizeitspekulant]

Abgefischt - kaum ein besseres Beispiel dafür wie hier intraday ca. 4,8 Mio Shares eingesackt wurden...

...aber klar - nach diesen News dürfte DVAX irgendwo auf dem Einkaufszettel einer großen Adresse stehen :-)

Inhale (INHL) ist vor einigen Jahren auch mit solchen Kursspielchen und dem einfachen Auslösen reihenweiser Stopp-Loss-Marken in beachtlichem Ausmaß eingetütet worden bevor man sie geschluckt hat.

Da ich so einige K´s davon habe bin ich in dieser Hinsicht froh hier keinen SL gesetzt zu haben - so einige dürften heute ihre Shares unfreiwillig losgeworden sein....um dann abends festzustellen daß der Kurs sich wieder nahezu unverändert eingependelt hatte....

Etwas erstaunt bin ich allerdings daß hier außer dem User Lucky kaum mehr jemand etwas von sich gibt...zudem es sich hier ja auch nicht gerade um einen Nischenmarkt handelt in dem DVAX offensichtlich die Oberhand gewinnen wird.

Egal ob man hier auf eine nicht ausgeschlossene Übernahme durch GSK oder einen anderen Big-Player spekuliert - oder das in weiten Teilen dem bisherigen Standardvaccine überlegene "Eigenprodukt" vermarktet werden wird - es wird den Preis treiben...und nicht nur um ein oder zwei Dollarchen... :-)

...also fest die Shares vor den Räubern festhalten - dabei nicht vergessen daß die nicht nächtens, sondern um 15:30 MEZ kommen und nur drauf warten sie ihren Besitzern mit Bauerntricks billig abzujagen.

Allen bereits Investierten viel Erfolg

[Lucky72]

Antwort auf Beitrag Nr.: 42.263.382 von Freizeitspekulant am 27.10.11 00:53:08

Heute hagelt es News!

Dynavax Phase 3 Data in Chronic Kidney Disease Demonstrates Superiority of HEPLISAV(TM) vs Engerix-B(R)
Detailed Phase 3 Data to Be Presented at Kidney Week

BERKELEY, CA -- (MARKET WIRE) -- 10/27/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the company has unblinded its Phase 3 primary endpoint immunogenicity data in subjects with chronic kidney disease and that the data achieved statistical significance demonstrating both the superiority and non-inferiority of HEPLISAV as compared to Engerix-B. A partial safety analysis also showed a similar safety profile for the two vaccines, with the incidence of post-injection reactions and adverse events similar in both groups. This Phase 3 multi-center trial evaluated 507 subjects with chronic kidney disease, as defined by a modified intent-to-treat analysis, and compared three doses of HEPLISAV given at months 0, 1 and 6 with eight doses of Engerix-B given as double-doses at months 0, 1, 2 and 6. Detailed results of the trial will be presented in November at the American Society of Nephrology Kidney Week meeting in Philadelphia.

Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said, "The demonstrated superiority of HEPLISAV in chronic kidney disease patients who are at high risk of HBV infection and hypo-responsive to hepatitis B vaccine adds to the growing body of evidence of HEPLISAV's advantages in a well known hypo-responsive patient population already being vaccinated against hepatitis B infection. These results, with three doses of HEPLISAV compared to eight doses of Engerix-B, provide the data necessary to support an indication and specific treatment regimen for HEPLISAV in persons with chronic kidney disease."

The observer-blinded trial was conducted among 507 patients 18-75 years of age with chronic kidney disease (GFR ≤ 45 mL/min/1.73 m2). Subjects were recruited at 69 sites in the U.S., Canada, and Germany and were randomized 1:1 to receive HEPLISAV or Engerix-B. The primary objective was to determine if HEPLISAV is non-inferior to Engerix-B by comparing seroprotection rates (anti-HBs ≥ 10mIU/mL) one month after the last dose of vaccine (Month 7) and if non-inferior, to determine if HEPLISAV was superior to Engerix-B.

The Advisory Committee on Immunization Practices (ACIP) and other public health authorities recommend vaccination for all persons with end-stage renal disease, including predialysis, hemodialysis, peritoneal dialysis, and home dialysis patients. Specific regimens or formulations are recommended for both of the currently available hepatitis B vaccines due to the hypo-responsiveness of chronic kidney disease patients. For immunocompromised persons, including dialysis patients, it is also recommended that additional vaccine be administered as needed to retain seroprotective levels of antibody against hepatitis B.

There are 750,000 persons with end-stage kidney disease in the United States and the five major European markets and an annual incidence of 150,000 new diagnoses and entry onto dialysis. Dialysis patients typically receive dialysis treatments, vaccination and monitoring of antibody levels through a network of dialysis centers that include approximately 5,000 sites in the United States.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=618…

[Lucky72]

Dynavax Reports Third Quarter 2011 Financial Results

BERKELEY, CA -- (MARKET WIRE) -- 10/27/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the third quarter ended September 30, 2011, including $53.2 million in cash, cash equivalents and marketable securities at September 30, 2011. This amount does not include a total of $8.6 million, consisting of $6 million in previously announced payments from Dynavax's collaborations with AstraZeneca and GlaxoSmithKline to be made after the close of the quarter and proceeds of $2.6 million from the sale of common stock to Aspire Capital received after the close of the third quarter.

Dynavax said that, based on developments to date and additional potential payments anticipated to be received or earned by year end under existing arrangements, it expects to end 2011 with approximately $50 million in cash, cash equivalents and marketable securities.

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 net cash usage and cash position. 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=618…

[Lucky72]

Noch eine News!

Oct. 27, 2011, 4:00 p.m. EDT
Dynavax Confirms HEPLISAV(TM) Submission Strategies With U.S. FDA and EMA

BERKELEY, CA, Oct 27, 2011 (MARKETWIRE via COMTEX) -- Dynavax Technologies Corporation DVAX +5.46% today said that the U.S. Food and Drug Administration (FDA) had concurred with the company's plan to submit a Biologics License Application (BLA) for HEPLISAV for persons over 40 years of age, followed by a supplemental BLA for licensure of a specific regimen for vaccinating chronic kidney disease (CKD) patients against hepatitis B infection at the time the initial application is approved. Dynavax also updated its timeline for the company's first BLA submission saying it expected to submit in the first quarter of 2012.

Dynavax also said that the European Medicines Agency (EMA) has advised the company it could submit the primary endpoint immunogenicity data and associated safety data for the over-40 population as well as the CKD indication as part of the initial Marketing Authorization Application (MAA) and that the outstanding CKD data can be submitted in the course of the application's review. Dynavax confirmed its plan to submit the MAA for European approval after the submission of its BLA in the U.S.

http://www.marketwatch.com/story/dynavax-confirms-heplisavtm…

[Freizeitspekulant]

...mittlerweile dürfte jedem DVAX-Interessiertem klar sein warum Mitte der Woche - wie ja angesprochen - erst richtig mit dem herbeigeführtem "Kurseinbruch" Shares nochmal zu kurzfristig extrem günstigen Preisen abgefischt wurden.... :-))

Die Nachrichten letzter Woche (wie von Lucky72 eingestellt) - mit dem ebenfalls tollen Quartalsbericht waren natürlich einigen im Vorfeld bekannt...daher wurden auch die ebenfalls angesprochenen 4,8 Mio (!!!) Shares eingesammelt.

Ich denke wir werden hier noch richtig schöne - auch zweistellige Kurszuwächse an einigen Tagen sehen.... :-))

Bin weiterhin dabei - und bleib es auch.

Schönes Restwochenende

[Lucky72]

Guten Morgen!

Handelsbeginn in USA ist heute schon um 14:30Uhr!

[Lucky72]

Runter mit dem Dreck!

Ich warte weiter unten!

[Lucky72]

Dynavax Phase 3 Data in Chronic Kidney Disease Demonstrates Superiority of HEPLISAV(TM) vs Engerix-B(R)
Detailed Phase 3 Data to Be Presented at Kidney Week

BERKELEY, CA -- (MARKET WIRE) -- 10/27/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the company has unblinded its Phase 3 primary endpoint immunogenicity data in subjects with chronic kidney disease and that the data achieved statistical significance demonstrating both the superiority and non-inferiority of HEPLISAV as compared to Engerix-B. A partial safety analysis also showed a similar safety profile for the two vaccines, with the incidence of post-injection reactions and adverse events similar in both groups. This Phase 3 multi-center trial evaluated 507 subjects with chronic kidney disease, as defined by a modified intent-to-treat analysis, and compared three doses of HEPLISAV given at months 0, 1 and 6 with eight doses of Engerix-B given as double-doses at months 0, 1, 2 and 6. Detailed results of the trial will be presented in November at the American Society of Nephrology Kidney Week meeting in Philadelphia.

Nur zur Info!

Das Meeting ist vom 8.11-13.11.11 also sollten spätestens nächste Woche genaue Daten kommen!

[Lucky72]

Die Shorty lachen sich heute bestimmt einen Ast!

[Lucky72]

[Lucky72]

Nur zur Info!

http://clinicaltrials.gov/ct2/results?term=Dynavax

[Lucky72]

Der Todesstoß für den Kurs????

Dynavax Announces Proposed Public Offering of Common Stock

BERKELEY, CA -- (MARKET WIRE) -- 11/02/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it intends to offer and sell shares of its common stock, subject to market and other conditions, in an underwritten public offering. Dynavax also expects to grant the underwriters a 30-day option to purchase additional shares of common stock to cover overallotments, if any. Dynavax anticipates using the net proceeds from the offering primarily to fund activities in connection with the anticipated approval and commercial launch of HEPLISAV™, and for other general corporate purposes, including working capital.

Cowen and Company, LLC is acting as sole book-running manager for the offering and William Blair & Company, L.L.C. is acting as co-manager.

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 July 22, 2011. 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, when available, may be obtained from Cowen and Company, LLC (c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, Phone: [phone], Fax: [phone]).

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 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.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=620…

[Lucky72]

War schon bekannt und sollte eigentlich schon eingepreist sein!

Hier das Filing vom 22.7.2011

PROSPECTUS

$150,000,000

Common Stock

Preferred Stock

Debt Securities

Warrants

Units





From time to time, we may offer, issue and sell up to $150,000,000 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 any applicable antidilution 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 July 21, 2011 was $2.63 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 July 22, 2011.

[Lucky72]

Mal sehn was heute geht!

An der "Jobfront" tut sich was. Drei Stellen sind schon vergeben!

Darunter auch die Stelle des Vice President Sales!

http://www.dynavax.com/careers/careers_usa.html

[Lucky72]

Dynavax Prices Public Offering of Common Stock

BERKELEY, CA -- (MARKET WIRE) -- 11/03/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the pricing of a previously announced underwritten public offering of 24,000,000 shares of its common stock, offered at a price to the public of $2.50 per share. The gross proceeds to Dynavax from this offering are expected to be $60 million, before deducting the underwriting discount and other estimated offering expenses payable by Dynavax. Dynavax has granted the underwriters a 30-day option to purchase at the public offering price up to an aggregate of 3,600,000 additional shares of its common stock to cover overallotments, if any. The offering is expected to close on or about November 8, 2011, subject to customary closing conditions. Dynavax anticipates using the net proceeds from the offering primarily to fund activities in connection with the anticipated approval and commercial launch of HEPLISAV™, and for other general corporate purposes, including working capital.

Cowen and Company, LLC is acting as sole book-running manager for the offering and William Blair & Company, L.L.C. is acting as co-manager.

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 July 22, 2011. A final 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 final prospectus supplement and the accompanying prospectus relating to this offering, when available, may be obtained from Cowen and Company, LLC (c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, Phone: [phone], Fax: [phone]).

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=620…

[Lucky72]

Guten Morgen!

Heute beginnt das American Society of Nephrology Kidney Week meeting in Philadelphia.

Hier ist der Link!

http://www.asn-online.org/education_and_meetings/kidneyweek/

[Lucky72]

Dynavax Announces Exercise in Full of Overallotment Option and Completion of Public Offering of Common Stock
$64.5 Million in Net Proceeds

BERKELEY, CA -- (MARKET WIRE) -- 11/08/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the completion of a public offering of 27,600,000 shares of its common stock, including 3,600,000 shares sold pursuant to the full exercise of an overallotment option previously granted to the underwriters. All of the shares were offered by Dynavax at a price to the public of $2.50 per share. 160,000 shares were purchased by the Chairman of Dynavax's board of directors. The net proceeds to Dynavax from this offering were approximately $64.5 million, after deducting the underwriting discount and other estimated offering expenses payable by Dynavax. Dynavax anticipates using the net proceeds from the offering primarily to fund activities in connection with the anticipated approval and commercial launch of HEPLISAV™, and for other general corporate purposes, including working capital.

Cowen and Company, LLC acted as sole book-running manager for the offering and William Blair & Company, L.L.C. acted as co-manager.

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 July 22, 2011. A final prospectus supplement related to the offering was filed with the SEC and is available on the SEC's website located at http://www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may be obtained from Cowen and Company, LLC (c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, Phone: [phone], Fax: [phone]).

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 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.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=621…

[Lucky72]

Ich hoffe nur das heute keine News kommt!

Die würde bei dem Marktumfeld verpuffen!

[Lucky72]

WOW!!!!

http://files.shareholder.com/downloads/DVAX/1293540983x0x516…

[Lucky72]

Zitat von Lucky72: Guten Morgen!

Heute beginnt das American Society of Nephrology Kidney Week meeting in Philadelphia.

Hier ist der Link!

http://www.asn-online.org/education_and_meetings/kidneyweek/

Am Samstag gibts die Ergebnisse!

Mal schaun wer heut oder morgen noch rein will!

Hier ist der Link
http://www.asn-online.org/education_and_meetings/kidneyweek/…

[Lucky72]

Ohne News wird das heut nix!

[Lucky72]

WOW, es sind immer noch 12,7mio. short!!!!

Short Interest (Shares Short) 12,774,000

Days To Cover (Short Interest Ratio) 6.0

Short Interest - Prior 12,724,500

Record Date 2011-NovA

http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…

[Lucky72]

Ist was im Busch???

[Lucky72]

Wo bleiben die Ergebnisse von Phase 3 in Chronic Kidney Disease????!!!!

[Lucky72]

Antwort auf Beitrag Nr.: 42.370.784 von Lucky72 am 18.11.11 17:54:10

Schwups! Schon sind sie da!

http://files.shareholder.com/downloads/DVAX/1293540983x0x519…

[Lucky72]

Es werden immer mehr!

Ich freu mich drauf wenn die Shorty covern müssen!

Short Interest (Shares Short) 13,969,900

Short Interest - Prior 12,774,000

Record Date 2011-NovB

[Lucky72]

Heute knallt es!

IMO

[Lucky72]

Na also, es geht doch!

[Lucky72]

[Lucky72]

Uhrzeit Kurs letztes Volumen kumuliert
22:00:22 3,11 11.291 4.668.480
22:00:22 3,11 9.329 4.657.189
22:00:22 3,11 3.979 4.647.860
22:00:12 3,11 3.158.471 4.643.881
22:00:00 3,09 100 1.485.410
22:00:00 3,09 200 1.485.310
22:00:00 3,09 100 1.485.110

[Lucky72]

Eine positive News könnte nicht schaden!

Dann machts BOOOOOM!

[Lucky72]

MA50 durchbricht MA200!

http://stockcharts.com/h-sc/ui?s=DVAX&p=D&yr=0&mn=3&dy=0&id=…

[Lucky72]

Warum kackt der Kurs heute so ab?

Ich kann nix finden!

[pokemon]

Antwort auf Beitrag Nr.: 42.451.940 von Lucky72 am 07.12.11 20:10:00

ich finde dvax gut!

[pokemon]

Antwort auf Beitrag Nr.: 42.475.399 von pokemon am 13.12.11 19:44:12

über 50% plus in drei monaten!

[Lucky72]

Was sind schon 50%?

Mein persönliches Kursziel liegt bei 20$!

[Lucky72]

Geheimsache!

CT ORDER Confidential Treatment Order

http://investors.dynavax.com/sec.cfm

[Lucky72]

Antwort auf Beitrag Nr.: 42.404.381 von Lucky72 am 27.11.11 10:10:50

Short Interest (Shares Short) 14,219,100

Days To Cover (Short Interest Ratio) 8.4

Short Interest - Prior 13,969,900

Record Date 2011-DecA

[Lucky72]

Super Rebound!

Nicht schlecht für einen Freitag!

[Lucky72]

AH gehts weiter!

http://www.nasdaq.com/symbol/dvax/after-hours

[pokemon]

Antwort auf Beitrag Nr.: 42.493.780 von Lucky72 am 16.12.11 22:50:22

und verwenden auch TLR 9 ansatz bei der adjuvanz....

[Lucky72]

Jetzt zieh schon!!!!

[Lucky72]

[Freizeitspekulant]

Hallo Lucky,

im Vergleich zu vielen anderen Biotechs hat sich DVAX in den letzten Wochen nicht nur gut gehalten, sondern sogar schön zugelegt - und das bei dem "Sch...markt".

Momentan kann mich da gar nichts aus der Ruhe bringen, weil die kurstreibenden Kräfte in den nächsten Wochen sicher noch in Fahrt kommen werden.
Ich hab mir im Zeitraum Sept/Okt. eine schöne Portion zusammengekauft und lege an Tagen wo am Kurs gesägt wird gelegentlich nochmal ein paar Stücke nach - von daher bin ich auch nicht beleidigt wenn mal kleinere Kaufgelegenheiten entstehen... :-)

Die Fundamentals passen meiner Ansicht nach. Habe mich auf "long" eingestellt und im Hinblick auf ein doch als recht wahrscheinliches "Ja" der FDA denke ich sollten da ganz andere Kurse zu sehen sein.

Mach dir also nichts draus wenn DVAX im Moment nur trabt und nicht galoppiert....andere Biotechs finden momentan auf der Bahn nicht mal den richtigen Weg.... :-)

LG

[Lucky72]

Antwort auf Beitrag Nr.: 42.500.820 von Freizeitspekulant am 19.12.11 21:31:26

Ich dachte nur an der Börse wird die Zukunft gehandelt und deshalb bin ich mit dem Kursverlauf nicht ganz zufrieden!

Das Unternehmen hilft auch nicht gerade!!!

Seit Oktober gab es keine Infos mehr, weder über Heplisav oder den Grippeimpfstoff!

[Freizeitspekulant]

Antwort auf Beitrag Nr.: 42.501.055 von Lucky72 am 19.12.11 22:19:28

...es betrachtet ja jeder etwas anders...

Ich sehe es mal so: eine gute PR-Abteilung ist für ein Unternehmen auch wichtig - nicht nur bei den Biotechs.
Gemessen an dem wie in den letzten Wochen auch wirklich gute News von Unternehmen verpuffen tut eine clevere PR auch sicher gut daran sich ergebende Neuigkeiten auch mal etwas einzuteilen - sofern sie nicht gerade mit Terminbekanntgaben oder ähnlichem versehen sind. ...alles andere dann als "Zuckerl"
Die Eckdaten z.B. bezüglich des "public-offerings" kamen ja noch Anfang Nov. und bei vielen Firmen kannst du ja beobachten daß im Zuge der Bekanntgabe guter Firmennews derzeit in den steigenden Kurs hinein abverkauft wird...teils um Gewinne einzutüten - andererseits wird den Shorties ja durch die nahezu tägliche Bekanntgabe von irgendwelchen "Größen" der Wirtschaft und des Finanzwesens in Form schlechter wirtschaftlicher Prognosen, Ratings und wie die warnenden Hinweise mit erhobenem Zeigefinger sonst noch alle heißen mögen auch eine prima Steilvorlage zum shorten gegeben...

Für meinen Teil tut DVAX gut daran sich eventuelle - noch nicht bekannte News für einen Zeitpunkt aufzuheben wo eben auch kurstechnisch mehr zu machen ist. Mag sein daß das für eine eher etwas kurzfristigere Spekulation nicht gerade herzerfrischend erscheint - tröste dich aber vielleicht am besten damit daß du mit DVAX in den letzten Wochen keine Kohle versemmelt hast - wie viele bei eben anderen Investments schon...

Verluste für 2011 zum Jahresende zu realisieren kann bei DVAX kaum möglich sein weil aufs Jahr gesehen jeder Käufer auf zumindest kleinem Gewinn "sitzen" muß - es sei denn er hat genau im Bereich von 3,15 - 3,40$ eingekauft - und sogar da bin ich mir sicher wird in den letztn Tagen des Jahres noch das Kaufniveau mindestens erreicht...

...wenn der Kurs nach oben läuft werden also "noch aufgesparte" News noch kommen...also kein Grund mit den Hufen zu scharren...

[Freizeitspekulant]

Antwort auf Beitrag Nr.: 42.501.191 von Freizeitspekulant am 19.12.11 22:59:16

...na siehste...kaum ist die Nasdaq grün kommen auch schon die guten News...

...wie gesagt - das zum Thema gute PR-Abteilung..




Dynavax Initiates Proof of Mechanism Trial in Lupus Patients

Milestone Payment From GSK Earned


BERKELEY, CA--(Marketwire -12/20/11)- Dynavax Technologies Corporation (NASDAQ: DVAX - News) announced today the initiation of a proof-of-mechanism clinical trial of the TLR7 and TLR9 inhibitor, DV1179, in systemic lupus erythematosus (SLE) patients. Initiation of this trial entitles Dynavax to receive a $6 million milestone payment from GlaxoSmithKline (GSK) under their worldwide strategic alliance. GSK has an exclusive option to obtain a license to the program following completion of this trial.

The first of two stages of the trial will evaluate ascending doses of DV1179 for safety and tolerability in SLE patients, each of whom will receive eight weekly injections of DV1179. The second stage of the trial will evaluate DV1179's mechanism of action via inhibition of type 1 interferon by enrolling additional SLE patients in selected dose groups. DV1179 was previously shown to be well-tolerated in a Phase 1 trial in healthy subjects.

"To begin the evaluation of DV1179 in lupus patients is an important achievement for Dynavax," said Tyler Martin, M.D., President and Chief Medical Officer at Dynavax. "Excessive production of type 1 interferons is thought to be a critical factor in the pathogenesis of lupus. At the completion of this trial, we will be able to determine if DV1179 can reduce interferon levels in lupus patients."

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. The National Institutes of Health in Bethesda, MD and the Alliance for Lupus Research contributed funding for Dynavax's preclinical work.

Peer-Reviewed Publications Document Program's Potential

In December, 2010, Dynavax reported in the JOURNAL OF EXPERIMENTAL MEDICINE (JEM, Volume 207, page 2931) data that suggested an important role of the key innate immune receptors TLR7 and TLR9 in a novel mouse model of skin conditions similar to cutaneous lupus. The company's inhibitor of TLR7 and TLR9 prevented and reversed disease suggesting therapeutic application of the inhibitor for the treatment of cutaneous lupus and related skin conditions.

In the June 16, 2010 issue of NATURE, data demonstrated in both human blood cells and animal models of lupus that glucocorticoid resistance characteristic of lupus could be mediated through TLR7 and TLR9 and could be reversed by Dynavax's TLR7/TLR9 inhibitor. Glucocorticoids are commonly 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 and restrict the utility of these drugs.

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," including statements related to the objectives of our clinical trial in lupus patients and the potential features of the Company's inhibitors. 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 GSK agreement objectives and exercise of the license option by GSK; 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

[Lucky72]

Antwort auf Beitrag Nr.: 42.503.729 von Freizeitspekulant am 20.12.11 15:41:39

Das ist auch langsam Zeit geworden das was kommt!

Nur leider ist das nicht die News die ich mir erhofft habe!

[Freizeitspekulant]

...auf was genau hast denn gewartet...?

[Lucky72]

Antwort auf Beitrag Nr.: 42.505.964 von Freizeitspekulant am 20.12.11 23:11:13

BLA oder Partnerschaftsnews!

Am Besten würde mir gefallen wenn GSK den ganzen Laden übernimmt und zahlt mir min.20$ je Aktie!

[Lucky72]

Antwort auf Beitrag Nr.: 42.505.964 von Freizeitspekulant am 20.12.11 23:11:13

Dynavax and AstraZeneca Agree to Conduct Toxicology Studies for TLR-9 Agonist for Asthma
$2.6 Million Payment From AstraZeneca Due to Dynavax

BERKELEY, CA -- (MARKET WIRE) -- 12/21/11 -- Dynavax Technologies Corporation (NASDAQ: DVAX) and AstraZeneca announced today their decision to advance AZD1419, a proprietary second-generation TLR-9 agonist for asthma, into IND-enabling preclinical toxicology studies. These toxicology studies are scheduled to be the first module of work performed by Dynavax under the recently amended collaboration agreement for the clinical development of AZD1419. Development expenses will be fully funded by AstraZeneca, and Dynavax will receive payment of $2.6 million to begin the studies.

About AZD1419

AZD1419 has been selected as the lead clinical candidate to enter formal clinical development based on extensive preclinical studies conducted by Dynavax and AstraZeneca. These include demonstration that AZD1419 is capable of producing long lasting disease-modifying effects in a mouse model of atopic asthma. Under the terms of the amended 2006 research collaboration and license agreement, AstraZeneca will provide to Dynavax approximately $20 million in payments to cover the cost of clinical development activities through Phase 2a. If AstraZeneca chooses to advance the program following completion of Phase 2a, Dynavax will receive a $20 million milestone payment, and AstraZeneca will retain its rights to develop the candidate therapy and to commercialize the resulting asthma product. Additional remaining milestone payments to Dynavax amount to nearly $100 million. Dynavax will receive royalties on worldwide sales of approved products and will have the opportunity to co-promote the product in the United States.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=634…

[Lucky72]

[Lucky72]

Langweilig!!

[Lucky72]

Na wenigstens gibt es neue Short Zahlen!

Short Interest (Shares Short) 14,326,700

Days To Cover (Short Interest Ratio) 8.5

Short Interest - Prior 14,219,100

Record Date 2011-DecB

[Lucky72]

MLV Capital Markets - Dynavax Technologies "buy"

16:45 04.01.12

New York (aktiencheck.de AG) - Die Analysten von MLV Capital Markets stufen die Aktie von Dynavax Technologies (DYNAVAX TECHNOLOGIES CORP Aktie) in einer Ersteinschätzung mit "buy" ein. Das Kursziel werde bei 8 USD gesehen. (Analyse vom 04.01.2011) (04.01.2012/ac/a/a)

[Lucky72]

Upcoming Event
Jan 12, 2012
12:30 PM PT 30th Annual J.P. Morgan Healthcare Conference
Speaker: Dino Dina, M.D., CEO

[Lucky72]

Pre-Market
Time (ET) Pre-Market
Price Pre-Market
Share Volume
08:00 $ 3.43 100
08:00 $ 3.50 1,000
08:00 $ 3.50 100
08:00 $ 3.78 800

[Lucky72]

Hier ist der Link!
http://www.nasdaq.com/symbol/dvax/premarket

[Lucky72]

Jetzt ziehhhh schon!!!!!

[Lucky72]

[Lucky72]

@ Shortys

Ich schmeiß schon mal den Grill an!!

[pokemon]

schöne bewegung!

[Lucky72]

Antwort auf Beitrag Nr.: 42.580.957 von pokemon am 11.01.12 20:16:48

Ich hoffe das geht so weiter!

[Lucky72]

Die neuen Shortzahlen sind da!

Settlement Date..Short Interest..Avg Daily Share Volume..Days To Cover

12/30/2011... 15,145,186... 1,748,413... 8.662247

12/15/2011... 14,326,661... 1,679,894... 8.528313


http://www.nasdaq.com/symbol/dvax/short-interest

[Lucky72]

@ Shortys

Immer schön aus dem ASK kaufen!!!!

[Blitzkrieger]

Antwort auf Beitrag Nr.: 42.586.705 von Lucky72 am 12.01.12 19:47:19

DANKE! ICH HABE GEKAUFT!

[Lucky72]

Antwort auf Beitrag Nr.: 42.586.731 von Blitzkrieger am 12.01.12 19:52:35

Wann hast du gekauft?

Ich bin seit 1,40$ drin!

[Blitzkrieger]

Antwort auf Beitrag Nr.: 42.586.760 von Lucky72 am 12.01.12 19:56:30

AWSOME!!!

[Freizeitspekulant]

...sei froh JETZT gekauft zu haben - später wärs nur noch kostenintensiver geworden...

[Lucky72]

Antwort auf Beitrag Nr.: 42.587.025 von Freizeitspekulant am 12.01.12 20:52:07

Eigentlich wollte ich heute die 4$ sehn!

[Freizeitspekulant]

...völlig egal ob DVAX gestern die "4" genommen hat oder nicht - es kommt jedenfalls Bewegung in den Kurs...und nordwärts ist vom Trend her sowiso angesagt, auch wenn da mal tageweise kleinere Rücksetzer mit dabei sind.

Die 15Mio geshortete Shares werden ihre "Tiefenwirkung" schon noch entfalten. Jeden Tag werden ein paar mehr von den Shorties nervös - einer jagt letztendlich den anderen.

[Lucky72]

Info von der 30th Annual J.P. Morgan Healthcare Conference!!!

http://files.shareholder.com/downloads/DVAX/1293540983x0x533…

[VaJo]

Hey Lucky,

Glückwunsch die Aktie läuft ja wirklich gut.
Ich habe meine aber schon letztes Jahr verkauft.

Viel Erfolg weiterhin!

[Lucky72]

Antwort auf Beitrag Nr.: 42.594.053 von VaJo am 14.01.12 09:50:06

Danke ,ich hoffe das läuft weiter so gut mit Dynavax!

Ich hab mir vor paar Wochen auch eine kleine Posi von Alimera ins Depot gelegt und warte jetzt auf positive News!

"Kaufen wenn sie keiner will!" Mal sehn ob das bei Alimera auch klappt!

IMO

LG Lucky

[Lucky72]

Das wird heut wohl nix!

[Lucky72]

Nur zur Info!

http://clinicaltrials.gov/ct2/results?term=Dynavax

[Lucky72]

Die "Zittrigen" sollten langsam raus sein!

Wird Zeit für eine Gegenbewegung!

[Lucky72]

Nur zur Info!

Rhein Biotech (Dynavax Europe) entscheidet sich für Yaveon Probatch und process4.biz

Entwickler und Hersteller von Impfstoffen und Biotech-Produkten setzt auf GMP-konforme Geschäftsprozesse

(PresseBox) Würzburg, 09.01.2012, Die Rhein Biotech GmbH, Partner der Pharmaindustrie in der Entwicklung, Herstellung und Vermarktung von Impfstoffen und Biotech-Produkten, hat sich für die Einführung eines neuen ERP-Systems auf der Basis von Microsoft Dynamics ERP mit der Branchenlösung Yaveon Probatch und der Geschäftsprozessmodellierung mit process4.biz entschieden.

Rhein Biotech, eine Tochter der Dynavax Technologies Corporation, ist ein Biotechnologie-Unternehmen mit Tradition: Seit über 20 Jahren forscht man an der Herstellung neuer Impfpräparate und anderer biopharmazeutischer Produkte wie z.B. Insulin oder Antigene für die Diagnostik. Rhein Biotech entwickelt innovative Herstellmethoden gemäß GMP-Anforderungen und gibt diese an die Industrie und Lohnfertiger weiter.

Im Zuge des weiteren Ausbaues der Geschäftstätigkeiten führt Rhein Biotech Yaveon Probatch als ERP-System für die Pharma- und Biotech-Industrie ein. "Die GMP-Erfahrung von YAVEON und die Möglichkeit auch in den USA das System einzusetzen, haben uns überzeugt", sagt Dr.-Ing. Jürgen Stevens, Head of Operational Services bei Rhein Biotech.

Um das System effizient und nahe an den Standardprozessen einzuführen, hat sich Rhein Biotech entschieden mit Hilfe von process4.biz die Geschäftsprozesse zu modellieren und zu schulen. Durch die Verfügbarkeit eines Standard-Referenzmodelles und die direkte Verbindung in das ERP-System ist es möglich, sehr schnell die eigenen Prozesse zu optimieren und auszurollen. Insgesamt entsteht ein Geschäftsprozessmodell, das nicht nur die ERP-Prozesse sondern alle Unternehmensbereiche abdeckt.

www.rheinbiotech.de

http://www.pressebox.de/pressemeldungen/yaveon-ag/boxid/4740…

[Freizeitspekulant]

...versöhnlicher Abschluß der Handelswoche bei DVAX :-))

Nachbörslich gehts gut 5% nach oben - hat anscheinend was mit den auf 21.01.2012 datierten Optionen zu tun. Da der 21. jedoch ein Samstag ist werden wir wohl Montag die Auswirkungen sehen...

After Hours Last:
Net / % Change $ 3.60
.18 (5.26%) After Hours High: $ 3.60
After Hours Volume: 10,000 After Hours Low: $ 3.46

Read more: http://www.nasdaq.com/symbol/dvax/after-hours#ixzz1k2tkKDeu

Trade Detail
After Hours
Time (ET) After Hours
Price After Hours
Share Volume
16:10 $ 3.60 9,000
16:04 $ 3.46 1,000

Read more: http://www.nasdaq.com/symbol/dvax/after-hours#ixzz1k2ufhSM7

[Hermana]

Würde mich interessieren, warum wir grade einen solchen Rücksetzter sehen, ohne ersichtlichen Grund. Konnte auch keine neuen Nachrichten diesbezüglich finden.

[Lucky72]

Ich kann auch nix finden, und genau das ins das Problem!

Ohne News gehts hier immer runter!

Einfach cool bleiben und sich nicht rausschütteln lassen!

IMO

[Lucky72]

[Lucky72]

Jetzt zieh schon!

[Lucky72]

[Lucky72]

Antwort auf Beitrag Nr.: 42.634.805 von Hermana am 23.01.12 19:05:28

Hast BM!

[Lucky72]

Neue "Shortzahlen" sind da!

Settlement Date...Short Interest...
1/13/2012...... 14,162,210
12/30/2011......15,145,186

http://www.nasdaq.com/symbol/dvax/short-interest#ixzz1kVYgKI…

[Lucky72]

Was zum lesen!

Top Hepatitis C Virus Biotech Picks By The World's Largest Fund Managers

Dynavax Technologies (DVAX): DVAX is a clinical-stage biotech company that is engaged in the discovery and development of novel products to prevent and treat infectious and inflammatory diseases. Its lead clinical stage product candidate is HEPLISAV™, a phase 3 investigational adult hepatitis B vaccine designed to provide protection with fewer doses than current licensed vaccines. In addition it has early stage product candidates, including a universal flu vaccine in phase 1, TLR inhibitor for lupus in phase 1, and then hepatitis B and hepatitis C therapies, also in phase 1 development.

Mega funds added a net $7 million in Q3 to their $102 million prior quarter position, and taken together they hold 25.8% of outstanding shares. The top mega fund buyers were Fidelity Investments ($3.3 million) and Bank of America Corp. ($1.6 million), and the top holder by far was also Fidelity Investments ($64 million). DVAX is currently engaged in preparing to submit its first Biologics License Application (BLA) for HEPLISAV™ Hepatitis B Vaccine to the FDA in the first quarter of 2012, followed soon by a submission of Marketing Authorization Application (MAA) for European approval.

http://seekingalpha.com/article/321858-top-hepatitis-c-virus…

[Lucky72]

Insiderkauf!!!

Dino legt sich nochmal 200k ins Depot!

http://investors.dynavax.com/secfiling.cfm?filingID=1181431-…

[VaJo]

Zitat von Lucky72: Insiderkauf!!!

Dino legt sich nochmal 200k ins Depot!

http://investors.dynavax.com/secfiling.cfm?filingID=1181431-…

Naja er kauft sie sich nicht, er bekommt sie

[Lucky72]

Antwort auf Beitrag Nr.: 42.660.902 von VaJo am 27.01.12 21:54:49

Solange er keine verkauft ist das positiv!

[Lucky72]

[Lucky72]

Dynavax Reports on Heplisav(TM) Pre-BLA Meeting With FDA

BERKELEY, CA -- (MARKET WIRE) -- 02/02/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it met with the Food and Drug Administration (FDA) in a Pre-Biologics License Application (pre-BLA) meeting, and Dynavax and the FDA have agreed that the initial HEPLISAV BLA submission will be for an indication in healthy adults 18-70 years of age. This agreement represents a significant expansion of the previously anticipated population of healthy adults age 40 and over. In addition, it was confirmed that a supplemental BLA with an indication for patients with chronic kidney disease will be filed when the initial BLA is approved.

According to Dr. Tyler Martin, President and Chief Medical Officer of Dynavax, "This meeting with the FDA marks an important milestone for Dynavax. We have clarified the indication, scope and structure of the BLA submission. Following the submission, the BLA will undergo review and the HEPLISAV manufacturing facilities must be inspected prior to regulatory approval."

Dynavax said it is now making the required modifications to the BLA to support the expanded indication and plans to submit the BLA by the middle of May.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In earlier Phase 3 trials, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. 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 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.


http://investors.dynavax.com/releasedetail.cfm?ReleaseID=645…

[Lucky72]

Jetzt geht sie ab!

[pokemon]

Antwort auf Beitrag Nr.: 42.690.297 von Lucky72 am 02.02.12 20:51:41

cool die party beginnt jetzt!

[pokemon]

Antwort auf Beitrag Nr.: 42.690.297 von Lucky72 am 02.02.12 20:51:41

und wieder geht eine TLR 9 firma bald in die hand der großen!

nur gut dass wir die deutsche TLR 9 company noch günstig zukaufen können

[Freizeitspekulant]

....schöne Kursentwicklung in den letzten Tagen - und das bei Mega-Volumen...vorgestern und gestern bei über 10 Mio/6 Mio gehandelten Shares :-))

Wie im Yahoo-Board zu lesen war ist DVAX mit diesem Handelsvolumen unter den Hotstocks im Biotechbereich angekommen - da engagieren sich verstärkt Daytrader, aber auch für Institutionelle dürfte DVAX mehr und mehr interessant werden...

Mit dem was über DVAX bislang bekannt ist sollte sich der schöne Aufwärtstrend fortsetzen. Mein persönliches Kursziel sehe ich in den nächsten Wochen zwischen 6 und 7 US$.

Bei einem Übernahmeangebot sollte jedoch weit mehr zu holen sein )

[Lucky72]

Mal schaun was diese Woche bringt!

[Lucky72]

Guten Morgen!

Ich hab da bei den Amis was gefunden!

Moving forward with Heplisav / Dr J Tyler Martin - Dynavax - World Vaccine Congress

http://www.youtube.com/watch?v=j27Zm857jKY

[Lucky72]

Ohne News wird das heute nix!

[Lucky72]

Warum kackt der Kurs heute so ab?

[Hermana]

DAX und DOW sehen Heute auch nicht grade rosig aus. Auch wenn du andere Aktien beobachtest, wirst du erkennen, dass es Heute allgemein gegen Süden geht.
Wir hatten dieses Jahr eine fast zu positive Entwicklung an den Börsen, jetzt wird die Zeit gekommen sein, wo es auch mal wieder etwas dreht.
Auch wenn es relativ ruhig um die Euro-Krise (oder wie man sie immer nennen will) geworden ist, so bleibe ich auf der misstrauischen Seite und rechne jeder Zeit mit einem Einbruch an den Aktienmärkten.
Trotzdem bleibe ich hier vorläufig investiert!

[Lucky72]

Antwort auf Beitrag Nr.: 42.734.162 von Hermana am 10.02.12 18:10:16

Na dann hoffe ich mal das Dino an einer positiven News bastelt und wir wieder einen Schub richtung Norden machen!

[Lucky72]

Raketentreibstoff!?

Short Interest (Shares Short) 15,300,800

Days To Cover (Short Interest Ratio) 13.8

Short Interest - Prior 14,162,200

Record Date 2012-FebA


http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…

[Lucky72]

Phase 3 Data on HEPLISAV(TM) in Adults Aged 18-55 Published in VACCINE

BERKELEY, CA -- (MARKET WIRE) -- 02/13/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that results of a pivotal Phase 3 trial of HEPLISAV (HBV-10) were published online in the journal VACCINE. Data from this study will be used to support the HEPLISAV Biologics License Application (BLA) submission for an indication in adults 18-70 years of age. The article concludes that a short, two-dose regimen of HEPLISAV over 1 month was well-tolerated and induced superior immunogenicity and earlier onset of protection than a three-dose regimen of a licensed hepatitis B vaccine over 6 months.

The article entitled "Comparison of Safety and Immunogenicity of Two Doses of Investigational Hepatitis B Virus Surface Antigen Co-administered with an Immunostimulatory Phosphorothioate Oligodeoxyribonucleotide and Three Doses of a Licensed Hepatitis B Vaccine in Healthy Adults 18-55 Years of Age" describes the results from one of the two pivotal Phase 3 trials of HEPLISAV. Dr. Scott Halperin of Dalhousie University was the principal investigator and lead author. The trial compared the safety and immunogenicity of HEPLISAV with Engerix-B® in 2,415 adults randomized in a ratio of 3:1, HEPLISAV to Engerix-B. The seroprotection rate at the primary endpoint after 2 doses for HEPLISAV (95%) was significantly higher than after 3 doses for Engerix-B (81%). Superiority of the seroprotection rates for HEPLISAV was demonstrated at all time points measured.

Dynavax plans to submit the BLA for HEPLISAV by the middle of May for an indication in adults 18-70 years of age.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In earlier Phase 3 trials, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as 1018 ISS to enhance the immune response.

Engerix-B® 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 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.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=648…

[Lucky72]

[Lucky72]

Upcoming Events

Feb 28, 2012... Citi 2012 Global Health Care Conference
Speaker: Dino Dina, M.D., CEO


Mar 6, 2012... Cowen 32nd Annual Health Care Conference
Speaker: Dino Dina, M.D., CEO

[Lucky72]

Wird Zeit für eine Gegenbewegung!

[Lucky72]

Sieht gut aus!

Kommt heute noch was?

[Lucky72]

[Lucky72]

Langsam kommt wieder Bewegung rein!

[Blitzkrieger]

Antwort auf Beitrag Nr.: 42.799.111 von Lucky72 am 23.02.12 21:18:10

FETTE BEUTE AUCH HIER !

[Hermana]

Ich hoffe mal, die Aktie hat genug Luft geholt um den Aufwärtstrend fortzusetzen. Hatte schon die Hälfte verkauft (leider) vor 3 Tagen.
Aber schauen wir weiter, ich denke, hier sind wir gut investiert!

[Lucky72]

Heute werden die Shorty gegrillt!

[Lucky72]

Short Interest (Shares Short) 16,340,100

Days To Cover (Short Interest Ratio) 5.7

Short Interest - Prior 15,300,800

Record Date 2012-FebB

http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…

[Blitzkrieger]

GUTER TAG HEUTE!

[Lucky72]

Dynavax Reports Fourth Quarter and Year End 2011 Financial Results

BERKELEY, CA -- (MARKET WIRE) -- 03/06/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the fourth quarter and year ended December 31, 2011.

Dynavax reported $114 million in cash, cash equivalents and marketable securities, cumulatively referred to as total cash, at December 31, 2011. This compared to $72.2 million at December 31, 2010. Total cash at the end of 2011 included $64.5 million in net proceeds from a public offering completed in November 2011. Subsequent to the year end, the Company received $8.6 million in milestone payments from its collaboration partners, GlaxoSmithKline and AstraZeneca.

Total revenues were $11.4 million for the fourth quarter 2011, compared to $1.8 million for the fourth quarter 2010. Total revenues were $21.6 million for the year ended December 31, 2011, compared to $24.0 million for the same period of 2010. The increase in total revenues for the fourth quarter resulted from milestones achieved under the Company's partnered development programs. The decline in total revenues for the year was primarily due to the recognition during 2010 of deferred revenue.

Total operating expenses were $16.2 million for the fourth quarter 2011, compared to $17.4 million for the fourth quarter 2010. Total operating expenses were $69.2 million for the year ended December 31, 2011, compared to $71.5 million for the same period of 2010. The decrease in total operating expenses for the fourth quarter and full year was primarily related to lower clinical trial expenses for HEPLISAV™ following the completion of a pivotal phase 3 study.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist 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 and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com.

- tables to follow -

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=654…

[Freizeitspekulant]

Tuesday, March 6, 2012

Steve Cohen's SAC Capital Boosts Dynavax Technologies Stake

Steve Cohen's hedge fund SAC Capital just filed a 13G with the SEC regarding shares of Dynavax Technologies (DVAX).

The hedge fund has boosted its holdings by 831,731 shares, almost a 12% increase in their position size since the end of 2011.

SAC Capital now owns 7,856,130 shares of DVAX which is a 5.1% ownership stake in the company. The SEC filing was made due to trading activity on February 22nd.

Per Google Finance, Dynavax Technologies is "a biopharmaceutical company that discovers and develops products to prevent and treat infectious diseases, asthma and inflammatory and autoimmune diseases. The Company’s principal product candidate is HEPLISAV, a Phase III investigational adult hepatitis B vaccine. Its pipeline of product candidate includes HEPLISAV; its Universal Flu vaccine; clinical-stage programs for hepatitis C and hepatitis B therapies, and preclinical programs partnered with AstraZeneca and GlaxoSmithKline (GSK)."

SAC Capital was recently named one of the top 10 hedge funds by net gains since inception.

Read more: http://www.marketfolly.com/2012/03/steve-cohens-sac-capital-…

[Lucky72]

Antwort auf Beitrag Nr.: 42.861.834 von Freizeitspekulant am 07.03.12 01:06:41

Guten morgen!

Was wollen wir mehr?

Zahlen sind besser als erwartet und es gibt starke Insiderkäufe!

Also ich halte meine Stücke!

[Blitzkrieger]

Antwort auf Beitrag Nr.: 42.862.528 von Lucky72 am 07.03.12 09:07:46

STEIGENDE KURSE !

[Lucky72]

Dynavax Technologies Corporation

Short Interest (Shares Short) 17,040,200

Days To Cover (Short Interest Ratio) 13.4

Short Interest - Prior 16,340,100

[Lucky72]

Dynavax sucht viele MA!

Current Openings

Controller

Clinical Research Associate II

Director/Senior Director, Pharmaceutical Sciences

Director / Sr. Director, Supply Chain Operations

Help Desk Technician II

Manager / Sr. Manager, CMC Documentation

Manager / Sr. Manager, GLP QA

Manager/Senior Manager, Oligonucleotide Technologies

Medical Writer / Sr. Medical Writer

Recruiter / Sr. Recruiter- 12 Month Position

Sr. Accountant

Sr. Manager, Quality Assurance Commercial Product

Sr. Scientist Syringe

[Lucky72]

Update!!!!

Current Openings

Associate Director, Project Management

Controller

Clinical Research Associate II

Director/Senior Director, Pharmaceutical Sciences

Director / Sr. Director, Supply Chain Operations

Help Desk Technician II

Help Desk Technician III

Manager, Project Management

Manager / Sr. Manager, Drug Product

Manager / Sr. Manager, CMC Documentation

Manager / Sr. Manager, GLP QA

Manager / Sr. Manager, Oligonucleotide Technologies

Manager / Sr. Manager, Quality Control

Manager, Technical Operations

Medical Writer / Sr. Medical Writer

Recruiter / Sr. Recruiter- 12 Month Position

Scientist / Sr. Scientist, Analytical Development

Sr. Accountant

Sr. Clinical Research Associate

Sr. Manager, Quality Assurance Commercial Product

Sr. Scientist Syringe

[Lucky72]

News gibt es auch!

Phase 3 Data on HEPLISAV(TM) in Adults Aged 40-70 Published in VACCINE

BERKELEY, CA -- (MARKET WIRE) -- 03/13/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that results of an early Phase 3 trial (HBV-04) of HEPLISAV™ investigational hepatitis B vaccine were published online in the journal VACCINE. The article concludes that HEPLISAV was well-tolerated and demonstrated superior and more durable seroprotection earlier than the licensed comparator hepatitis B vaccine.

The article, entitled "Demonstration of Safety and Enhanced Seroprotection Against Hepatitis B with Investigational HBsAg-1018 ISS Vaccine Compared to a Licensed Hepatitis B Vaccine" by first author Benjamin Sablan, describes the results from a Phase 3 clinical trial of HEPLISAV conducted in Asia. The trial compared the safety and immunogenicity of HEPLISAV with Engerix-B® in 412 adults 40-70 years of age. The seroprotection rate at one month after the second dose in the HEPLISAV group was 97% versus 24% in the Engerix-B group (p < 0.0001). At one month after the third dose, the seroprotection rates were 100% for HEPLISAV and 73% for Engerix-B (p < 0.0001). Seroprotection rates at one year after the first dose were 100% for HEPLISAV and 69% for Engerix-B (p < 0.0001).

Senior study author and Vice President of Clinical Development at Dynavax, Dr. William Heyward, commented, "The 97% seroprotection rate of HEPLISAV after two doses in older adults in this trial was early evidence of the potential of HEPLISAV as a highly effective two-dose vaccine for older adults. These results provided important information leading to the design of our pivotal Phase 3 trial in adults 40-70 years of age in which HEPLISAV provided a peak seroprotection of 98%".

Dynavax plans to submit the BLA for HEPLISAV by the middle of May for an indication in adults 18-70 years of age.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

Engerix-B® 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 and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com.

Forward-Looking Statements
http://investors.dynavax.com/releasedetail.cfm?ReleaseID=656…

[Lucky72]

[pokemon]

Antwort auf Beitrag Nr.: 42.895.583 von Lucky72 am 13.03.12 18:45:41

weiter so!!!!!

[Lucky72]

Hier geht ja richtig die Post ab!

Hammer Volumen und ein steigender Kurs!

[Lucky72]

WOW!!!!

After Hours
Time (ET) After Hours
Price After Hours
Share Volume
16:51 $ 4.4875 526,300
16:51 $ 4.4875 82,500
16:35 $ 4.49 16,657
16:35 $ 4.49 472
16:27 $ 4.49 100
16:17 $ 4.4445 4,100
16:16 $ 4.4855 735
16:15 $ 4.46 15,470
16:15 $ 4.4375 4,100 - Cancelled Trade
16:02 $ 4.4375 4,100

[Freizeitspekulant]

Hier mal was ganz interessantes im Hinblick auf DVAX.

http://www.fool.com/investing/general/2012/03/20/small-and-w…

Das bestätigt einmal mehr daß die DVAX-Anteile mehr und mehr von Fonds und dergl. eingesackt wurden und vermutlich auch weiterhin werden. Einige davon haben auch die Eigenschaft erst in bestimmte Papiere zu investieren wenn der Kurs die 5$-Marke erreicht bzw. durchbrochen hat.

Der Kurs von DVAX scheint geradewegs auf diese Marke zuzusteuern. Lange glaube ich die "5" vorne im Kurs allerdings nicht zu sehen, gehe davon aus daß wir schnell ins "6-Dollar-Lager" wechseln.

[Lucky72]

Dynavax Reports Final Phase 3 Data for HEPLISAV(TM) in CKD Patients and New Data From Booster Trial in Hemodialysis Patients

BERKELEY, CA -- (Marketwire) -- 03/27/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced final data from a pivotal Phase 3 trial in patients with chronic kidney disease (CKD) demonstrating early seroprotection and the durability of the immune response to HEPLISAV compared to Engerix-B®. In October 2011, Dynavax reported that the superiority endpoint had been met in this trial. The trial included 516 patients 18-75 years of age with CKD (stage 3b or higher) in the U.S., Canada and Germany who received 3 doses of HEPLISAV at 0, 1 and 6 months or 4 double doses of Engerix-B at 0, 1, 2 and 6 months (8 doses total).

Analysis of the final data demonstrated that:

HEPLISAV provided seroprotection to 90% of patients compared to 82% for Engerix-B (P=0.01) at the primary endpoint (7 months), 1 month after the 3rd dose of HEPLISAV and the 8th dose of Engerix-B. This result demonstrated the previously reported superiority of HEPLISAV seroprotection over Engerix-B.
HEPLISAV provided seroprotection to more than twice as many patients (HEPLISAV: 48%; Engerix-B: 20%) at 2 months, 1 month after the 2nd dose of HEPLISAV and the 4th dose of Engerix-B. This result confirmed the earlier seroprotection of HEPLISAV in this population.
The geometric mean concentration (GMC) of antibody, which is commonly used to predict the duration of protection in patients with CKD, was approximately four-fold higher in the HEPLISAV group compared to the Engerix-B group. At Week 28, the GMC for HEPLISAV was 448 mIU/mL compared to the Engerix-B GMC of 109 mIU/mL. At one year, six months after completing the 3-dose regimen of HEPLISAV, the GMC was 121 mIU/mL compared to a GMC of 38 mIU/mL six months after completing the 8-dose regimen of Engerix-B.

In a separate trial, in CKD non-responder patients on hemodialysis who had failed to develop seroprotection after two or more previous vaccination series with the licensed vaccines, new data showed a higher seroprotection rate for HEPLISAV compared to each of Fendrix® and Engerix-B.

HEPLISAV is a trademark of Dynavax, and Fendrix® and Engerix-B® are registered trademarks of GlaxoSmithKline.

In this study of 119 patients in Germany, the immune responses were compared 4 weeks after a single booster dose of HEPLISAV or Fendrix or two booster doses of Engerix-B. Data from this booster study showed that HEPLISAV provided seroprotection to 44% of patients (17/39) compared to 31% (13/42) for Fendrix and 21% (8/38) for Engerix-B.
Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said, "These results add to the growing body of evidence of HEPLISAV's advantages. Patients with CKD are difficult to protect with current HBV vaccines, requiring 8 doses of Engerix rather than 3 doses for healthy adults. The pivotal CKD trial demonstrated the same profile as our healthy adult trials: earlier onset of seroprotection, higher peak seroprotection and improved duration. In addition, the results from the booster trial suggest HEPLISAV should be the preferred vaccine in this very difficult to protect population, which represents a substantial proportion of patients on hemodialysis."

Dynavax plans to submit a U.S. Biologics License Application (BLA) for HEPLISAV by the middle of May for an indication in healthy adults 18-70 years of age for a 2-dose vaccination regimen at 0 and 1 month. A supplemental BLA with an indication and 3-dose primary vaccination regimen for patients with CKD will be filed when the initial BLA is approved.

The Advisory Committee on Immunization Practices (ACIP) and other public health authorities recommend vaccination for all persons with end-stage renal disease, including predialysis, hemodialysis, peritoneal dialysis and home dialysis patients. Specific regimens or formulations are recommended for both of the currently available hepatitis B vaccines due to the hypo-responsiveness of CKD patients. For immunocompromised persons, including dialysis patients, it is also recommended that additional vaccine be administered as needed to retain seroprotective levels of antibody against hepatitis B.

There are an estimated 750,000 persons with end-stage kidney disease in the United States and the five major European markets and an annual incidence of 150,000 new diagnoses and entry into dialysis. Dialysis patients typically receive dialysis treatments, vaccination and monitoring of antibody levels through a network of dialysis centers that include approximately 5,000 sites in the United States.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=659…

[pokemon]

Antwort auf Beitrag Nr.: 42.963.162 von Lucky72 am 27.03.12 20:10:33

schöner steigender trend! wann kommt die übernahme?

[Lucky72]

Antwort auf Beitrag Nr.: 42.997.780 von pokemon am 03.04.12 21:40:10

Bald!!

[Lucky72]

[Lucky72]

Super Gegenbewegung!

[Lucky72]

[Lucky72]

[Lucky72]

Wird Zeit das Dino eine News bringt!

[Lucky72]

Short Interest (Shares Short) 18,451,500

Short Interest - Prior 17,936,800

Record Date 2012-AprilA

http://www.shortsqueeze.com/?symbol=DVAX&submit=Short+Quote%…

[Lucky72]

Nur zur Info!

http://files.shareholder.com/downloads/DVAX/1293540983x0x561…

[Lucky72]

Kein Wunder das der Kurs abkackt!

Short Interest (Shares Short) 19,276,000

Days To Cover (Short Interest Ratio) 12.3

Short Interest - Prior 18,451,500

[Lucky72]

Dynavax Reports HEPLISAV(TM) BLA Submission

BERKELEY, CA -- (Marketwire) -- 04/26/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that it has submitted a U.S. Biologics License Application (BLA) to the Food and Drug Administration (FDA) for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age.

Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said:

This submission is a very important milestone for Dynavax. The final document consists of 305 volumes, and the expansion of the indicated age group following the pre-BLA meeting required complete rewrites of the clinical summaries. The entire HEPLISAV team did outstanding work to complete the revisions and submit the BLA ahead of schedule.

We have requested priority review for HEPLISAV, as we believe it is a significant improvement compared to marketed products. We look forward to working with the FDA on the BLA and to ultimately bringing the benefits of HEPLISAV to the public.

The Company anticipates submitting a European Marketing Authorization Application (MAA) for HEPLISAV in the third quarter of 2012. Upon approval of the initial HEPLISAV BLA, Dynavax plans to submit a supplemental BLA with an indication and 3-dose primary vaccination regimen for patients with chronic kidney disease.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist 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 and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=667…

[Lucky72]

Dynavax Reports First Quarter 2012 Financial Results

BERKELEY, CA -- (Marketwire) -- 04/27/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the first quarter ended March 31, 2012, including $106.9 million in cash, cash equivalents and marketable securities at March 31, 2012. This compared to $114 million at December 31, 2011. Total cash for the first quarter of 2012 included $8.6 million in milestone payments from Dynavax's collaborative partners.

Total revenues were $2.4 million for the first quarter 2012, an increase over the $1.7 million reported for the first quarter of 2011 due primarily to the recognition of collaboration revenue under the Company's partnership with AstraZeneca.

Total operating expenses of $18.2 million for the first quarter 2012 decreased from the $19.7 million reported for the first quarter of 2011, resulting primarily from the completion of certain clinical activities for HEPLISAV.

Net loss for the first quarter 2012 of $16.5 million improved from the loss of $18.5 million reported for the same period in 2011.

About HEPLISAV

HEPLISAV™ is an investigational adult hepatitis B vaccine. In earlier Phase 3 trials, HEPLISAV demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as 1018 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 and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com.

- tables to follow -

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=668…

[Lucky72]

Wird wohl nix mit Partnerschaft!

Die ziehn das Ding in USA selber durch!

Dynavax Embarks on Transition to Commercialization

BERKELEY, CA -- (Marketwire) -- 05/08/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today, that following the recent submission of the U.S. Biologics License Application (BLA) to the Food and Drug Administration (FDA), it intends to begin developing a commercial operation capable of independently launching HEPLISAV™ in the U.S. The Company believes that being able to bring HEPLISAV to the market successfully will ultimately help maximize long-term value for its shareholders.

With the goal of laying the foundation for long-term success, Dynavax plans to strengthen its senior team with the addition of experienced commercial leadership. Subsequent to a recommendation from Dino Dina, the Company's Chief Executive Officer, the Company's Board of Directors has agreed to initiate a process that they anticipate will include his succession. Dr. Dina plans to continue in his role as CEO through this process and will support the transition to his eventual successor. He will also continue as a member of the Company's Board thereafter.

Dr. Dina joined Dynavax in May 1997 and has led the transformation of the Company from its early days through the research and development phase. Said Dr. Dina, "I believe now is the right time to prepare Dynavax to effectively capitalize on the significant market opportunity we have ahead of us when we are able to bring the benefits of HEPLISAV to the public. I am committed to working with our Board to plan for the success of Dynavax."

"Dino's leadership and vision have been critical in making Dynavax what it is today, a diversified company with an important product candidate in HEPLISAV and a maturing pipeline. We fully endorse the strategic direction for Dynavax that Dino has set and appreciate Dino's commitment to a smooth and seamless transition process," said Arnold Oronsky, Ph.D., Chairman of the Board. "We are confident that Dino and the leadership team will remain focused on Dynavax's success and building value for shareholders in the years ahead."

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=671…

[Lucky72]

Mal sehn wo wir heute starten! Volumen AH ist wohl eher ein Witz!

#
After Hours Last:
Net / % Change $ 4.55
-.54 (-10.61%) After Hours High: $ 5.09
(16:26:01 PM)
After Hours Volume: 48,386 After Hours Low: $ 4.45
(18:17:10 PM)

[Lucky72]

Dynavax Prices Public Offering of Common Stock

BERKELEY, CA -- (Marketwire) -- 05/09/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the pricing of an underwritten public offering of 17,500,000 shares of its common stock, offered at a price to the public of $4.25 per share. The gross proceeds to Dynavax from this offering are expected to be approximately $74.4 million, before deducting underwriting discounts and commissions and other offering expenses payable by Dynavax. Dynavax has granted the underwriters a 30-day option to purchase up to an aggregate of 2,625,000 additional shares of common stock to cover over-allotments, if any. All of the shares in the offering are to be sold by Dynavax. The offering is expected to close on or about May 14, 2012, subject to customary closing conditions. Dynavax expects to use the net proceeds from the offering primarily to fund activities in preparation for the anticipated commercial launch of HEPLISAV™, subject to receipt of regulatory approval, including the manufacture of commercial supply, to fund the marketing, sales and medical affairs infrastructure and personnel, including the hiring of a field sales force, and to commercialize HEPLISAV in the United States, if approved by the U.S. Food and Drug Administration, as well as for other general corporate purposes.

J.P. Morgan Securities LLC is acting as sole book-running manager for the offering. Cowen and Company, LLC is acting as co-manager.

The securities described above are being offered by Dynavax pursuant to two shelf registration statements previously filed with and declared effective by the Securities and Exchange Commission (the "SEC"). Final prospectus supplements 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 final prospectus supplements and the accompanying prospectuses relating to this offering, when available, may be obtained from J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, or by telephone at 1-866-803-9204.

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=671…

[Lucky72]

News & Events
Upcoming Events

May 30, 2012 Annual Meeting of Dynavax Stockholders

Jun 4–7, 2012 Jefferies 2012 Global Healthcare Conference

Jul 12–13, 2012 JMP Securities Healthcare Conference

[Lucky72]

Dino tritt noch als CEO auf!

Na wenn das kein gutes Zeichen ist?!

Dynavax to Present at the Jefferies 2012 Global Healthcare Conference

BERKELEY, CA -- (Marketwire) -- 05/29/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the Jefferies 2012 Global Healthcare Conference in New York on Tuesday, June 5, at 9:30 a.m. EDT (6:30 a.m. PDT).

Dino Dina, M.D., Chief Executive Officer of Dynavax, will provide a corporate overview presentation. To access the slide presentation, live webcast, and subsequent archived recording, please visit 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 and inflammatory diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. A U.S. BLA for HEPLISAV has been submitted to the FDA. For more information visit www.dynavax.com.

Contact:

Michael Ostrach

Vice President and Chief Business Officer

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=677…

[Lucky72]

[Lucky72]

[Lucky72]

Langsam wird es ernst!

About Us :: Careers :: USA :: Director / Senior Director, External Manufacturing Operations
Back to Careers

PRIMARY PURPOSE OF POSITION:

This is a key leadership position with responsibility and accountability for oversight of global third-party manufacturing vendors. This position ensures consistency of production of drug substance to finished product as well as managing the relationship between the contract manufacturing organization (CMO) and Dynavax. CMO oversight will include start-up and on-going performance of CMOs’ ensuring implementation of strategic initiatives meets Dynavax’s requirements for quality, compliance, delivery and cost.

The incumbent in this position is expected to partner with other members of the Global Technical Operations’ (GTO) team to ensure product and/or program expectations are applied at the CMO.

A director level position may participate in the development of corporate and/or organizational policies which may include the authorization to implement such policies. This position level provides general direction to and review of manager level personnel in various functional areas and/or teams.

Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration, and teamwork.

Works on abstract problems across functional areas of the business; identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables. Erroneous decisions may have a serious impact on the overall success at the functional and/or program level.........

http://www.dynavax.com/careers/usa/Dir_External_Manuf.Ops.ht…

[Lucky72]

WOW!!!!!

[Lucky72]

Wurde auch langsam Zeit!

Dynavax Announces FDA Acceptance of HEPLISAV(TM) BLA

BERKELEY, CA -- (Marketwire) -- 06/26/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the Food and Drug Administration (FDA) has accepted for review the U.S. Biologics License Application (BLA) for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age.

Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said, "The FDA has established February 24, 2013, as the PDUFA action date. We look forward to working with the FDA in moving HEPLISAV through the regulatory review process over the next few months."

The Company anticipates submitting a European Marketing Authorization Application (MAA) for HEPLISAV in the third quarter of 2012. Upon approval of the HEPLISAV BLA, Dynavax plans to submit a supplemental BLA for an indication in patients with chronic kidney disease.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA and a European Marketing Authorization Application (MAA) is expected to be submitted in the third quarter of 2012. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist 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 and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com.

Forward-Looking Statements

This press release contains "forward-looking statements," including those relating to the HEPLISAV MAA submission and supplemental BLA filing, 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 review and approval of HEPLISAV and our process for its manufacture can occur in a timely manner or without significant additional studies or difficulties or delays; whether our 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, including whether the BLA will be approved and the timely filing of the MAA; our ability to obtain additional financing to support the development and commercialization of HEPLISAV and our other operations; our ability to successfully transition to a commercial operation and execute on our commercial strategy; possible claims against us, including enjoining sales of HEPLISAV, 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 our current periodic reports with the SEC.

Source: Dynavax Technologies

News Provided by Acquire Media

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=686…

[Lucky72]

Dynavax Reports New CPT Code for Adult Two Dose Hepatitis B Vaccination Schedule

BERKELEY, CA -- (Marketwire) -- 07/02/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the American Medical Association (AMA) Current Procedural Terminology (CPT) Panel has established a CPT code for an adult 2 dose hepatitis B vaccination schedule. HEPLISAV™ will be reported using the new code, differentiating it from a 3 dose hepatitis B vaccine schedule. The revision has been posted to the AMA website.

Dynavax also reported that the proposed proprietary name, HEPLISAV, has been tentatively accepted for use in the U.S. by the Food and Drug Administration (FDA) and also accepted as valid in the E.U. by the Committee for Medicinal Products for Human Use.

Tyler Martin, President and Chief Medical Officer, said: "These developments are key steps in ensuring a smooth commercialization process for HEPLISAV. The CPT code distinguishes our vaccine candidate from existing vaccines, which can help streamline reimbursement and may facilitate adoption by providers. Additionally, we believe that approval of our preferred name, HEPLISAV, in the E.U. and preliminary acceptance in the U.S. will allow us to capitalize on our already existing name recognition and simplify the product launch process."

CPT codes are used by medical practitioners, including physicians, hospitals, and other health care providers, to report medical, surgical, and diagnostic services and procedures to insurers for the purpose of reimbursement. This standardized nationwide system of coding provides a uniform language for reporting medical services. CPT® is a registered trademark of the American Medical Association, which develops and maintains CPT codes.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=688…

[Lucky72]

Dynavax to Present at the 7th Annual JMP Securities Healthcare Conference

BERKELEY, CA -- (Marketwire) -- 07/09/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it plans to present at the 7th Annual JMP Securities Healthcare Conference in New York on Thursday, July 12, at 10:00 a.m. EDT (7:00 a.m. PDT).

Tyler Martin, M.D., President and Chief Medical Officer of Dynavax, will provide a company overview. To access the slide presentation, live webcast, and subsequent archived recording, please visit 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 and inflammatory diseases. The Company's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. A U.S. BLA for HEPLISAV has been accepted for review by the FDA. For more information visit www.dynavax.com.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=690…

[Lucky72]

Dynavax Appoints David Happel Vice President, Global Sales and Marketing

BERKELEY, CA -- (Marketwire) -- 07/10/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the appointment of David Happel to the position of Vice President of Global Sales and Marketing. Mr. Happel has more than 25 years of experience in the biotech and pharmaceutical industry, including senior level leadership roles in global marketing, sales, product management and commercial operations. Mr. Happel will direct the execution of Dynavax's commercialization strategy, market development and sales and distribution. In addition, Mr. Happel will oversee the company's commercial organization including Vice President, Brant Biehn, a 20-year veteran in the adult vaccine industry, who will focus on developing the commercial opportunity in Europe and the rest of world as well as continuing to help prepare for the U.S. launch of HEPLISAV™.

"Now that the BLA for HEPLISAV is filed and our February 2013 PDUFA date has been assigned, we are excited to have Dave join the Dynavax team," said President and Chief Medical Officer, Tyler Martin, M.D. "His extensive experience launching new products in a biotech environment and his proven track record leading sales and marketing organizations will be critical as we work to bring HEPLISAV to the market."

Said Mr. Happel, "I look forward to leading the team to commercialize HEPLISAV, an important product candidate with a significant market opportunity. In addition, the MAA submission planned for the third quarter of 2012 demonstrates our commitment to develop the markets beyond the U.S. and explore potential strategic partnerships to launch HEPLISAV in Europe and the rest of world."

Mr. Happel joins Dynavax from Dr. Reddy's, where he focused on building a proprietary products business for North America. Prior to Dr. Reddy's, Mr. Happel served as the Executive Vice President and Chief Commercial Officer at Aerovance. Previously at Chiron Corporation, he held leadership positions as Vice President and Global Commercial Director in the pulmonary business unit of the biopharmaceuticals division overseeing the commercialization of TOBI®. Mr. Happel was also with InterMune, Inc. as Senior Director, Sales and Marketing where he built the commercial organization from the ground up and directed all aspects of a start-up biotech company for the commercial development of Actimmune®. Earlier in his career he held positions with Parke-Davis/Pfizer (Warner-Lambert). Mr. Happel received his B.A. in Chemistry from Indiana University and an M.B.A. in Marketing from Indiana State University.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=690…

[Lucky72]

Irgendwas funzt mit dem Login bei Wheute nicht!

[Lucky72]

Ich hoffe das Team von Wallstreet-Online bekommt das bald in den Griff!

[Lucky72]

Dynavax Submits HEPLISAV(TM) for EU Marketing Authorization

BERKELEY, CA -- (Marketwire) -- 07/24/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age and in patients with chronic kidney disease.

Dynavax President and Chief Medical Officer, Tyler Martin, M.D., said, "This submission is another significant step in the development of HEPLISAV. We look forward to working with the EMA to progress HEPLISAV toward approval in Europe in order to realize our goal that it be available to physicians and patients in Europe and the U.S."

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist 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 and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=694…

[Lucky72]

Ist Dynavax pleite oder warum kackt der Kurs so ab???

[Lucky72]

Es gibt Q-Zahlen!

DYNAVAX REPORTS SECOND QUARTER 2012 FINANCIAL RESULTS

BERKELEY, CA - August 1, 2012 - Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the second quarter ended June 30, 2012. The Company had $160.2 million in cash, cash equivalents and marketable securities as of June 30, 2012 as compared to $114.0 million at December 31, 2011. Total cash for the second quarter of 2012 included $69.6 million in net proceeds from the sale of 17,500,000 shares of common stock.

Total revenues were $2.7 million and $5.0 million for the three and six months ended June 30, 2012, respectively, compared to $7.3 million and $9.0 million, respectively, reported for the same periods of 2011. Revenues for the second quarter and first half of 2011 included a $6 million milestone earned under the Company's collaboration with GlaxoSmithKline.

Research and development expenses were $11.4 million and $23.8 million for the three and six months ended June 30, 2012, respectively. This compared to $13.3 million and $27.9 million, respectively, reported for the same periods of 2011. Research and development expenses decreased primarily due to the significant decline in clinical activities for HEPLISAV TM .

General and administrative expenses were $6.0 million and $11.8 million for the second quarter and first half of 2012, respectively, compared to $4.1 million and $8.8 million, respectively, in the same periods of the prior year. General and administrative expenses increased primarily due to growth in commercial development expenses.

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA and a Marketing Authorization Application (MAA) has been submitted. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known 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 and inflammatory diseases. The Company's lead product candidate is HEPLISAV, a Phase 3 investigational adult hepatitis B vaccine designed to provide rapid and earlier protection with fewer doses than currently licensed vaccines. For more information visit www.dynavax.com.



http://investors.dynavax.com/secfiling.cfm?filingID=1181431-…

[Lucky72]

Ist heute was im Busch?

[Lucky72]

[Lucky72]

Dynavax Appoints Christine Larson as Chief Financial Officer

BERKELEY, CA -- (Marketwire) -- 08/13/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the appointment of Christine Larson to the position of Vice President and Chief Financial Officer, a newly created position. Ms. Larson brings nearly 25 years of experience as a financial professional to the role, including a background in corporate finance and investment banking. Ms. Larson joins Dynavax from PDL Biopharma, Inc. (PDL), where she was responsible for leading financial and strategic planning, accounting, and treasury and investor relations for the public company, which earned annual revenues of $350 million. During her tenure at PDL, Ms. Larson designed and implemented a complex recapitalization strategy, including debt issuance and restructuring, as well as led the development of new accounting infrastructure following the company's spin-out of biotechnology assets to Facet Biotech Corporation in 2008.

"Cris' background and experience will be a valuable addition to our senior management team as we advance Dynavax toward commercial operations," said Chief Executive Officer, Dino Dina, M.D. "We look forward to her contributions in the planning and implementation of a successful strategy for the growth of the Company."

Prior to PDL, Ms. Larson served as a Director at Grant Thornton, LLP in their Transactions Advisory group from 2007 to 2008. Previously from 2003 to 2005, Ms. Larson was Chief Financial Officer for Trinity Learning Corporation, a publicly held, technology-enabled learning company. From 1985 to 1999, Ms. Larson was with Bank of America Corporation, most recently as a senior vice president and managing director and was responsible for business development in their Global Capital Markets group. In this role, she established Bank of America's equity derivatives business and structured a strategic alliance with a major New York-based investment firm involving a $1 billion plus recapitalization of the firm. Ms. Larson received a B.S. in Food and Nutritional Sciences from the University of California, Berkeley, and an M.B.A. from California State University, East Bay. Ms. Larson is a Certified Public Accountant in the State of California.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=700…

[Lucky72]

Mal schaun was die Amis daraus machen!

Dynavax Marketing Authorization Application for HEPLISAV(TM) Accepted for Review by European Medicines Agency

BERKELEY, CA -- (Marketwire) -- 08/22/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that the European Medicines Agency (EMA) has accepted the filing of the Marketing Authorization Application (MAA) for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age and in patients with chronic kidney disease. Acceptance of the MAA confirms that the submission is sufficiently complete to permit a substantive review by the EMA.

"This milestone marks the initiation of the regulatory review for HEPLISAV in Europe," said Dynavax President and Chief Medical Officer, Tyler Martin, M.D. "We look forward to working through the review process with our designated rapporteur from Sweden and co-rapporteur from Belgium."

About HEPLISAV

HEPLISAV is an investigational adult hepatitis B vaccine for which a U.S. BLA has been accepted for review by the FDA and a MAA has been accepted for review by the EMA. In Phase 3 trials, HEPLISAV demonstrated higher and earlier protection with fewer doses than currently licensed vaccines. Dynavax has worldwide commercial rights to HEPLISAV. HEPLISAV combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=701…

[Lucky72]

[Lucky72]

Dynavax Announces FDA Advisory Committee to Review HEPLISAV(TM)
Vaccines and Related Biological Products Advisory Committee Meeting Scheduled for November 14-15, 2012

BERKELEY, CA -- (Marketwire) -- 08/28/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and Drug Administration (FDA) has informed the Company that its Vaccines and Related Biological Products Advisory Committee (VRBPAC) is scheduled to discuss HEPLISAV at its meeting on November 14-15, 2012. Dynavax's Biologic License Application (BLA) for HEPLISAV, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age, is currently under review by the FDA. The Prescription Drug User Fee Act (PDUFA) date for the FDA to complete its review is February 24, 2013.

"The VRBPAC meeting is the next step toward bringing HEPLISAV to physicians and patients," said Dynavax President and Chief Medical Officer, Tyler Martin, M.D. "Our team looks forward to discussing HEPLISAV with the advisory committee and will continue to work closely with the FDA through the review process."

About Vaccines and Related Biological Products Advisory Committee

VRBPAC reviews and evaluates data concerning the safety, effectiveness, and appropriate use of vaccines and related biological products which are intended for use in the prevention, treatment, or diagnosis of human diseases

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=702…

[Lucky72]

William Blair Reiterates an 'Outperform' on Dynavax (DVAX); Heplisav VRBPAC Panel Set - What to Watch For

William Blair reiterates an 'Outperform' on Dynavax Technologies (NASDAQ: DVAX) price target of $9.00.

Analyst, Y. Katherine Xu, said, "A favorable vote could lead to potential approval and launch in the United States in first quarter 2013. We continue to assign 90% probability to eventual approval and a full adult label (18-70 years as opposed to 40-70 years). We note that Dynavax submitted Heplisav’s biological license application (BLA) in April, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults aged 18 through 70."

We summarize the key issues to watch for in the VRBPAC panel review as follows: 1) Efficacy should be unequivocal; 2) Safety will be the focus of discussion, in our opinion; and 3) Discussions might also focus on the one case of Wegener’s granulomatosis that put Heplisav on clinical hold during 2008-2009.


http://www.streetinsider.com/Analyst+Comments/William+Blair+…

[Lucky72]

Wird langsam Zeit das wir die 4$ knacken!

[Lucky72]

Guten Morgen

Ich wünsche allen einen dunkelgrünen Tag!

Die Zeichen stehn nicht schlecht!


MLV & Co Sees 146% Upside For Dynavax Technologies' Shares

My goal is to highlight biotech firms that I believe are offering compelling risk/reward opportunities at current market levels. This led me to pursue an interview this week with MLV & Co analyst Dr. Megan McCloskey Dow, to discuss Dynavax Technologies (DVAX).

Dynavax Technologies is a clinical-stage biopharmaceutical company that 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 higher and earlier protection with fewer doses than currently licensed vaccines. Heplisav combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

The U.S. Food and Drug Administration (FDA) has set November 14-15, 2012, to discuss Heplisav's approvability at the Vaccines and Related Biological Products Advisory Committee panel. A two years data set shows that when a committee recommended approval, in 80% of cases, the FDA agreed. The FDA has established February 24, 2013, as the PDUFA date for Heplisav. If approved, Heplisav would be the standard-of-care hepatitis B vaccine.

Dynavax estimates the worldwide market for adult hepatitis B vaccines at approximately $700 million annually. This market is primarily comprised of GlaxoSmithKline's (GSK) Engerix-B and Twinrix, as well as Merck's (MRK) Recombivax-HB, which are the primary players in the hepatitis B prophylactic vaccines market. Dynavax has worldwide commercial rights to Heplisav.

The company also recently announced that the European Medicines Agency has accepted the filing of the Marketing Authorization Application for Heplisav, pursuing an indication for immunization against infection caused by all known subtypes of hepatitis B virus in adults 18 through 70 years of age, and in patients with chronic kidney disease.

I would like to introduce Dr. McCloskey Dow, an Equity Analyst and member of the Life Sciences equity research team at MLV & Co. Dr. McCloskey Dow's scientific work focused on immunology and pathology, and she brings direct scientific discovery and development experience to her analysis.

Ben Yoffe: Dr. McCloskey Dow, what are the differences between Heplisav and the current standard-of-care Engerix-B of GlaxoSmithKline? Does Heplisav have any safety or efficacy advantages?

McCloskey Dow: There are several key advantages to Heplisav over Engerix-B. In four head-to-head Phase III trials and a total of 5,770 patients, Heplisav demonstrated superiority over Engerix-B. Seroprotection following two immunizations of Heplisav was achieved in 95% of adults aged 18-55 and 89% of adults aged 40-70. In contrast, seroprotection after three immunizations of Engerix-B was achieved in 81% in adults aged 18-55, and only 69% in adults 40-70. Importantly, patients were protected from HBV following the second immunization of Heplisav, given one month after the initial vaccination. In all patient age groups, Engerix-B was shown to offer limited protection without the third dose, administered six months following the initial immunization. Heplisav was also recently shown to provide protection to patients suffering chronic kidney disease (CKD) in three doses and to a greater extent and more rapidly than eight doses of Engerix-B.

Both vaccines were shown to be safe, and the FDA has seen safety data from each patient dosed with Heplisav to ensure that the new adjuvant in the vaccine does not induce autoimmune events. Heplisav is adjuvanted with an ImmunoStimulatory Sequence that activates the immune system through Toll-like receptors.

Yoffe: Can you share with us your forecast for the upcoming meeting of the Vaccines and Related Biological Products Advisory Committee, which will decide by November 14-15, 2012 whether or not to recommend approval of Heplisav?

McCloskey Dow: We are confident that the Advisory Committee will give a positive recommendation to approve Heplisav because the vaccine could increase vaccination compliance and coverage, in addition to the data demonstrating Heplisav's superiority over Engerix-B.

Yoffe: In February 2012, the FDA agreed that Heplisav's label could be expanded to include healthy adults between the age of 18 and 70. Do you think that this agreement may increase the odds of approval?

McCloskey Dow: Absolutely. The company had originally intended to file a BLA for adults aged 40-70, but the FDA had the opportunity to see all of the data, including vaccinated adults aged 18-55, and the agency acknowledged that an expanded BLA would be appropriate for Heplisav. We view this as a strong indication that the FDA will look favorably on the vaccine during its review.

Yoffe: How many sales from Heplisav, if approved, you expect to see in the U.S.?

McCloskey Dow: Currently, Dynavax is intending to launch Heplisav initially in the U.S. for healthy adult vaccinations with a marketing team of 60 reps on the ground, and 10 sales managers for a proprietary launch. The company is weighing partnership options and co-promotion plans to specifically target the diabetes market. We project sales through 2015, our discount year, to be approximately $177 million in the US, but we see this number growing substantially in the years following. After launching into the healthy adult market in the U.S, we anticipate that Dynavax will formalize a partnership to specifically target diabetics, and we believe a successful launch with their own team will improve their negotiating position so as to not undervalue Heplisav early in its lifecycle.

There has been renewed interest in protecting the American public from hepatitis in recent years, and while hepatitis C virus (HCV) has garnered most of the attention, the CDC's Advisory Committee on Immunization Practices (ACIP) voted in October of last year to recommend hepatitis B virus (HBV) vaccination for diabetic adults. We believe this recommendation will change the HBV vaccination market significantly over the coming years. The CDC estimates that 4.3-5.6% of us have been infected at some point with HBV, and the risk of chronic infection, liver failure, and hospitalization increases when patients suffer co-morbidities such as concomitant infection or chronic disease (e.g., diabetes).

In our discussions with healthcare professionals, the CDC's mission to increase HBV vaccination coverage in adults (currently self-reported data indicate 45% of adults have been vaccinated) should get a big boost from Heplisav, which has a vaccination schedule that only requires two clinic visits, only one month apart, as opposed to that of Engerix-B, which requires three clinic visits over six months. Furthermore, American adults battling obesity, smoking, disease, and the elderly have low seroprotection rates when vaccinated with the currently approved vaccine Engerix-B, and the FDA is aware of that.

Dynavax knows that the recommendation from the CDC last year for diabetics to be vaccinated against HBV is a potential market changer, not only for them, but for the HBV vaccination market as a whole. Whereas the traditional adult HBV vaccination market was limited to those at risk from sexual activity or drug use, healthcare workers, or adults who were traveling to HBV endemic regions of the world, the recommendation now creates demand for the nearly 2 million adults over 20 diagnosed with diabetes each year in the U.S. As the first commercial product for the biotechnology company, they do not have the manpower to launch the vaccine immediately into the diabetes market.

Yoffe: What is the potential market for Heplisav in Europe?

McCloskey Dow: The European market is changing, given the economic struggles and healthcare burdens therein. As a smaller market to begin with, a European launch is not a top priority for Dynavax in the first year of sales. We project that the company will seek a European or several European partners, but again, like the diabetes market in the U.S., we think the potential value of those deals to Dynavax can be greater when the company gets a handle on how the current HBV market is impacted by Heplisav. We therefore project a European deal(s) after sales data for Heplisav has been generated from Dynavax's own team, which we think will strengthen its negotiation position.

Yoffe: Are there any other significant products in Dynavax's clinical-stage pipeline?

McCloskey Dow: Although they are much earlier in development, we look to the company's collaboration with GlaxoSmithKline on developing Toll-like receptor antagonists for systemic lupus erythematosus, and to a renewed collaboration with AstraZeneca (AZN) as potential milestone generators. However, the focus for Dynavax is Heplisav at this moment.

Yoffe: What is the financial picture for Dynavax? Does the company have sufficient liquidity to get through the PDUFA date?

McCloskey Dow: Dynavax finished 2Q12 with $160.2 million in cash, and we calculate an adjusted annualized burn rate of $52.2 million. Dynavax has more than enough cash to launch Heplisav and see it past the PDUFA date.

Yoffe: What is your one-year price target for DVAX?

McCloskey Dow: We use a discounted P/E model applied to our projected 2015 EPS to arrive at our one-year price target of $10.00 per share (146% upside on today's closing price). In our view, a 20% discount rate is appropriate for post-BLA filing and current uncertainties regarding the timing and outcome of the ongoing regulatory review and market penetration following launch. We believe a 25x P/E multiple is appropriate for our projection of the company's growth.

My opinion on DVAX:

A positive Advisory Committee recommendation for Heplisav will be a significant milestone for DVAX. The chances are positive, and a run-up prior to the meeting on November 14-15 is expected.
Analysts are highly bullish on DVAX based on their latest research notes, and believe that Heplisav will be approved.

The company has a solid cash position. As of June 30, 2012, the company had $160.2 million in cash and cash equivalents. This fact should reduce the fear from near dilution.
83% of the company's shares are owned by institutions and mutual funds. It is a good indicator, since institutional investors (a.k.a. the "smart money") have access to sophisticated research and have a great deal of information on the companies they trade.

http://seekingalpha.com/article/848551-mlv-co-sees-146-upsid…

[Lucky72]

SL fischen vom Feinsten!

[Lucky72]

WOW! Freitag ging es AH ja noch voll zur Sache!

Da kommen die Shorty langsam ins Schwitzen!

After Hours Last:$ 5
.45 (9.89%)
After Hours High: $ 5.66
(18:26:06 PM)
After Hours Volume:417,008
After Hours Low: $ 4.53
(17:00:00 PM)

http://www.nasdaq.com/symbol/dvax/after-hours

[Lucky72]

Der Kurs nimmt wohl erst Anlauf!

[Lucky72]

[pokemon]

Antwort auf Beitrag Nr.: 43.618.515 von Lucky72 am 18.09.12 21:18:55

eigentlich wie bei molos. erst neue hochs dann ke und wieder zu den alten hochs


denke beider werden neue höchstkurse zeitnahm machen
und ich bin dabei

[Lucky72]

Antwort auf Beitrag Nr.: 43.618.695 von pokemon am 18.09.12 21:59:37

Schade das die Shortys so (günstig!) covern können!

[Lucky72]

News könnten nicht schaden!

[Lucky72]

WOW! Der Kurs nimmt aber viel Anlauf!

Ich glaube heute knallts noch!

IMO

[Lucky72]

Die Zittrigen sind jetzt raus!

Jetzt kann es wieder UP gehn!

[me_2]

Wieso hängt denn der Kurs so durch, bin vor paar Tagen eingestiegen, kein guter Einstand ... ??

[Lucky72]

Antwort auf Beitrag Nr.: 43.725.763 von me_2 am 18.10.12 11:31:49

Kannst dich bei Mark Kessel bedanken!

http://investors.dynavax.com/secfiling.cfm?filingID=1104659-…

[me_2]

Antwort auf Beitrag Nr.: 43.728.414 von Lucky72 am 18.10.12 20:44:20

Danke, hat wohl Geld für ein neues Auto gebaucht. Soweit ich das übersehe, waren das ca. 4% der Aktien. Wie weit dürfte das den Kurs noch beeinfussen, (ohne weitere News) ?

[Lucky72]

Zitat von me_2: Danke, hat wohl Geld für ein neues Auto gebaucht. Soweit ich das übersehe, waren das ca. 4% der Aktien. Wie weit dürfte das den Kurs noch beeinfussen, (ohne weitere News) ?

Das kann man bei Dynavax nicht sagen!

Fundamental hat sich nix geändert!

[Lucky72]

Antwort auf Beitrag Nr.: 43.729.503 von me_2 am 19.10.12 09:05:09

Ich hoffe du hast dich nicht rausschütteln lassen!

Nur zur Info!

November 14-15, 2012: Vaccines and Related Biological Products Advisory Committee Meeting Announcement

Agenda

On November 14, 2012, the committee will meet in open session to discuss and make recommendations on the safety and immunogenicity of an Influenza A (H5N1) Virus Monovalent Vaccine manufactured by GlaxoSmithKline. On November 15, 2012, the committee will meet in open session to discuss and make recommendations on the safety and efficacy of a Hepatitis B Vaccine manufactured by Dynavax.
Meeting Materials

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting. Background material is available at: http://www.fda.gov/AdvisoryCommittees/Calendar/default.htm. Scroll down to the appropriate advisory committee link.
Public Participation Information

Interested persons may present data, information, or views, orally or in writing, on issues pending before the committee.

Written submissions may be made to the contact person on or before November 7, 2012.
Oral presentations from the public will be scheduled between approximately 1:30 p.m. and 2:00 p.m. on November 14, 2012, and between approximately 12:15 p.m. and 12:45 p.m. on November 15, 2012. Those individuals interested in making formal oral presentations should notify the contact person and submit a brief statement of the general nature of the evidence or arguments they wish to present, the names and addresses of proposed participants, and an indication of the approximate time requested to make their presentation on or before October 30, 2012. Time allotted for each presentation may be limited. If the number of registrants requesting to speak is greater than can be reasonably accommodated during the scheduled open public hearing session, FDA may conduct a lottery to determine the speakers for the scheduled open public hearing session. The contact person will notify interested persons regarding their request to speak by October 31, 2012 .

Webcast Information

CBER plans to provide a free of charge, live webcast of the November 14-15, 2012 meeting of the Vaccines and Related Biological Products Advisory Committee. While CBER is working to make webcasts available to the public for all advisory committee meetings held at the White Oak campus, there are instances where the webcast transmission is not successful; staff will work to re-establish the transmission as soon as possible. The link for the webcast is available at: https://collaboration.fda.gov/vrbpac.
Contact Information

Donald Jehn or Denise Royster
1401 Rockville Pike, HFM-71, Rockville, MD 20852
301-827-0314
FAX: [phone]
e-mail: [e-mail] or email: [e-mail]
FDA Advisory Committee Information Line, 1-800-741-8138 (301-443-0572 in the Washington, DC area)

FDA intends to make background material available to the public no later than 2 business days before the meeting. If FDA is unable to post the background material on its Web site prior to the meeting, the background material will be made publicly available at the location of the advisory committee meeting, and the background material will be posted on FDA’s Web site after the meeting.

A notice in the Federal Register about last minute modifications that impact a previously announced advisory committee meeting cannot always be published quickly enough to provide timely notice. Therefore, you should always check the agency’s Web site and call the appropriate advisory committee hot line/phone line to learn about possible modifications before coming to the meeting.

Persons attending FDA’s advisory committee meetings are advised that the agency is not responsible for providing access to electrical outlets. FDA welcomes the attendance of the public at its advisory committee meetings and will make every effort to accommodate persons with physical disabilities or special needs. If you require special accommodations due to a disability, please contact Donald Jehn or Denise Royster at least 7 days in advance of the meeting.

Information regarding special accommodations due to a disability, visitor parking and transportation may be accessed at: http://www.fda.gov/AboutFDA/WorkingatFDA/BuildingsandFacilit…

FDA is committed to the orderly conduct of its advisory committee meetings. Please visit our Web site at for procedures on public conduct during advisory committee meetings.

Notice of this meeting is given under the Federal Advisory Committee Act (5 U.S.C. app. 2).

http://www.fda.gov/AdvisoryCommittees/Calendar/ucm324825.htm

[me_2]

Antwort auf Beitrag Nr.: 43.733.176 von Lucky72 am 20.10.12 02:23:23

Nein, ich bin noch dabei. Solange es keine negativen Daten zum operativen Geschäft gibt und die Produkte/Pipeline stimmen.

[Lucky72]

Seit zwei Monaten keine News!

Reife Leistung!

[me_2]

"85% Probability Of FDA Approval For Dynavax's Heplisav, Says Cowen's Senior Analyst" (seekin alpha)
immerhin ein Lichtblick

[Lucky72]

Jetzt zieh schon!

[Lucky72]

Antwort auf Beitrag Nr.: 43.749.949 von me_2 am 25.10.12 10:29:44

Hier ist der Link!

http://seekingalpha.com/article/948531-85-probability-of-fda…

[Lucky72]

Dynavax to Initiate Phase 1 Studies for TLR-9 Agonist for Asthma
$6 Million Payment From AstraZeneca Due to Dynavax

BERKELEY, CA -- (Marketwire) -- 10/31/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it will advance AZD1419, a proprietary second-generation TLR-9 agonist for asthma, into Phase 1 clinical studies. Development expenses will be fully funded by AstraZeneca under the terms of a collaboration announced in 2006, and Dynavax expects to receive an advance payment of $6 million in the fourth quarter of 2012. Dynavax anticipates the Phase 1 studies will begin in the first half of 2013.

About AZD1419

AZD1419 has been selected to enter formal clinical development based on extensive preclinical studies conducted by Dynavax and AstraZeneca. Under the terms of a previously-announced research collaboration and license agreement, AstraZeneca will provide to Dynavax approximately $20 million in payments to cover the cost of clinical development activities through Phase 2a. If AstraZeneca chooses to advance the program following completion of Phase 2a, Dynavax will receive a $20 million milestone payment, and AstraZeneca will retain its rights to develop the candidate therapy and to commercialize the resulting asthma product. Additional remaining milestone payments to Dynavax amount to approximately $100 million. Dynavax will receive royalties on worldwide sales of approved products and will have the opportunity to co-promote the product in the United States.

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.

About AstraZeneca

AstraZeneca is a global, innovation-driven biopharmaceutical business with a primary focus on the discovery, development and commercialization of prescription medicines for gastrointestinal, cardiovascular, neuroscience, respiratory and inflammation, oncology and infectious disease. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com.

Forward Looking Statements

This press release contains "forward-looking statements," including statements related to expected payments under our AstraZeneca agreement, the potential features of the Company's TLR-9 agonists, and the timing of clinical studies. 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 AstraZeneca 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=717…

[me_2]

Dynavax Reports Third Quarter 2012 Financial Results


BERKELEY, CA -- (Marketwire) -- 11/01/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today reported financial results for the third quarter ended September 30, 2012. The Company had $148.3 million in cash, cash equivalents and marketable securities as of September 30, 2012.

Total revenues for the quarter ended September 30, 2012 were $2.9 million compared to $1.2 million for the quarter ended September 30, 2011, due primarily to higher collaboration and grant revenue recognized as a result of research and development reimbursable under Dynavax's partnerships with AstraZeneca and the National Institute of Allergy and Infectious Diseases.

Research and development expenses for the quarter ended September 30, 2012 were $12.9 million compared to $11.8 million for the quarter ended September 30, 2011. Increased research and development expenses in the third quarter of 2012 were primarily attributed to manufacturing and regulatory activities for HEPLISAV™.

General and administrative expenses for the quarter ended September 30, 2012 were $7.1 million compared to $4.2 million for the quarter ended September 30, 2011. General and administrative expenses increased primarily due to growth in the organization and activities to prepare for and support the commercial launch of HEPLISAV in the United States.

http://www.finanznachrichten.de/nachrichten-2012-11/25048581…

[Lucky72]

Guten Morgen!

Ich wünsche allen eine dunkelgrüne Woche!

[Lucky72]

Analysts At William Blair Maintain Outperform On Dynavax Technologies
November 5, 2012 |

In a research note issued last week, William Blair Maintained coverage with an "Outperform" rating on Dynavax Technologies (DVAX), and a one-year price target of $9 a share, representing a premium of 122% to DVAX stock closing price of $4.06.

Dynavax's lead product candidate is Heplisav, a Phase 3 investigational adult hepatitis B vaccine designed to provide higher and earlier protection with fewer doses than currently licensed vaccines. Heplisav combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response.

The FDA has set November 15, 2012, to discuss Heplisav's approvability at the VRBPAC (vaccines and related biological products advisory committee) panel. William Blair analysts assign 90% probability to eventual approval and a full adult label (18-­70 years as opposed to 40­-70 years). If approved, Heplisav will become the standard‐of‐care hepatitis B vaccine.

Customarily, the FDA sends the briefing documents of an advisory panel to the sponsor a month before the panel. The firm points out that Dynavax has received the briefing book from the FDA by now and no news so far is good news. Moreover, Dynavax had communicated that if there were material information, the company would disclose it to the public.

The firm summarized the key issues likely to be discussed at the VRBPAC as follows.

Efficacy - should be unequivocal. Since Heplisav has been shown to be superior to the current standard of care Engerix‐B of GlaxoSmithKline's (GSK) in all populations tested to date, the discussions on efficacy should be unequivocal.
Safety - the safety profile of Heplisav has been shown to be comparable to Engerix‐B. Integrated safety analysis demonstrated that serious adverse event (SAE) rates for Heplisav and Engerix‐B are 2.7% and 3.7%, respectively. Integrated autoimmune event rates are 0.23% and 0.35% for Heplisav and Engerix‐B, respectively. To the firm knowledge, there is no single category of adverse events that stands out at a higher incidence than others in Heplisav‐vaccinated subjects.
One case of Wegener's granulomatosis - In March 2008, the FDA placed a clinical hold on Heplisav after occurrence of a single SAE of Wegener's granulomatosis, a rare form of autoimmune vasculitis that stains positive for c‐ANCA, in a Heplisav‐ vaccinated subject. A few months later, a vasculitis SAE was confirmed in a subject in the Engerix‐B arm as well, stained positive for p‐ANCA, demonstrating a more‐balanced incidence of systemic vasculitis between Heplisav and Engerix‐B (3:1 randomization favoring Heplisav). During the clinical hold, Dynavax retested more than 9,000 sera from subjects vaccinated with Heplisav, and none of the sera, except for the one Wegener's case, was positive for c‐ or p‐ANCA. Further, there was no presence of ds‐DNA antibodies detected either. After removal of the clinical hold in September 2009, Dynavax launched two Phase III studies involving more than 3,000 subjects and a data safety monitoring board (DSMB) was put in place to detect and adjudicate SAEs and autoimmune‐related SAEs. Heplisav passed every review by the DSMB, and the final integrated safety data, as discussed above, shows numerically lower adverse event rates than Engerix‐B. Therefore, the VRBPC panel might come to the conclusion that Heplisav is not likely associated with Wegener's.
The mechanism of the novel adjuvant - Heplisav is the first product containing the novel adjuvant TLR9 agonist that is up for approval. GlaxoSmithKline's Cervarix was the first vaccine approved in the United States that contained a novel adjuvant (a TLR4 agonist) other than alum. The FDA in October 2009 approved Cervarix for preventing human papillomavirus (HPV) infection. The firm points out that it is highly likely that the FDA would approve Heplisav, as it did Cervarix, and that the FDA recognizes the high unmet need in the hyporesponsive populations and desires to have these subjects adequately protected against potential HBV infection.
The extent of the label - After the removal of the clinical hold, the FDA instructed that further studies should be conducted in older adults who are less responsive to the currently licensed vaccines, including adults over 40 years old, and individuals with chronic kidney disease. In February 2012, the FDA agreed in the pre‐BLA meeting that Heplisav's label could be expanded to include healthy adults between the ages of 18 and 70, which is the full adult label. The VRBPAC panel could discuss this topic as well and vote on it.

William Blair analysts project peak sales of $330 million for Heplisav in 2018 for the CKD population and the HIV/HCV/liver disease population. For the U.S. diabetic opportunity, although Dynavax could cover this market itself, they continue to model a bell‐shaped curve peaking at about $475 million in revenue, with 35% royalties (net of cost of goods sold) to Dynavax on total U.S. sales from a partner with an established diabetes franchise, to be conservative.

In parallel, all partnering and/or acquisition talks will continue. The firm believes that it is the correct strategy for Dynavax to launch Heplisav independently and not subject the launch to the unpredictability of striking any partnership or acquisition deals. The key piece to the commercialization strategy is how to address the vast diabetic population in the United States. Good clarity on the commercial strategy should be continually positive to the stock.

The firm notes that Dynavax ended the quarter with $148.3 million in cash, which could be sufficient to sustain operations through Heplisav's commercial launch in the United States in 2013. Additionally, a $6 million milestone payment is expected to be received in fourth quarter 2012, as part of the collaboration with AstraZeneca (AZN), and in advance of the initiation of the Phase I clinical studies of AZD1419, a second­ generation TLR9 agonist for asthma.

William Blair analysts think that Dynavax shares continue to represent a compelling risk/reward opportunity and with such assumptions, they derive the fair value of the stock at $9 per share.

The risks to the Outperform thesis include regulatory risks and intellectual property risks associated with Dynavax's lead candidate, Heplisav, as well as risks related to business‐development and clinical‐development activities.

My opinion on DVAX:

Currently, Dynavax represents an undervalued opportunity with a high reward potential. Given the strong Phase 3 data package, Dynavax's lead commercial candidate, Heplisav, is expected to receive FDA approval. If approved, a $9 price target which was given by William Blair is reachable.
Analysts are highly bullish on DVAX based on their latest research notes, and believe that Heplisav will be approved.


The company has a solid cash position. As of September 30, 2012, the company had $148.3 million in cash and cash equivalents. This fact should reduce the fear from near dilution.
85% of the company's shares are owned by institutions and mutual funds. It is a good indicator, since institutional investors (a.k.a. the "smart money") have access to sophisticated research and have a great deal of information on the companies they trade.

[Lucky72]

Antwort auf Beitrag Nr.: 43.786.916 von Lucky72 am 05.11.12 14:08:21

Quelle:

http://seekingalpha.com/article/977731-analysts-at-william-b…

[me_2]

Antwort auf Beitrag Nr.: 43.786.916 von Lucky72 am 05.11.12 14:08:21

Hört sich alles sehr gut an.

[Lucky72]

Schau ma mal!

[Lucky72]

[Lucky72]

Da ist noch viel Luft nach Oben!

IMO

[Lucky72]

Obama-Effekt und Dynavax-Effekt??!!!

[Lucky72]

Vielleicht sehn wir heute noch eine kleine Rally!

[Lucky72]

WOW!

SL sauber abgefischt!

Langsam wirds ernst!

[Lucky72]

Hammer Volumen!

Aber der Kurs bewegt sich kein µ!

[me_2]

Dynavax +18% nach good news


Dynavax’s Heplisav Vaccine Works on Hepatitis B, FDA Says

By Anna Edney - Nov 13, 2012 6:39 PM GMT+0100.

Dynavax Technologies Corp. (DVAX)’s Heplisav vaccine works against the contagious liver disease hepatitis B, Food and Drug Administration staff said.

Heplisav worked as well as GlaxoSmithKline Plc (GSK)’s Engerix-B vaccine to protect patients against the virus, FDA staff said today in a report released ahead of an advisory panel meeting scheduled Nov. 15 on Dynavax’s vaccine.

Heplisav would be Berkeley, California-based Dynavax’s first product on the market if the vaccine is cleared by Feb. 24 when the FDA is scheduled to decide on approval. Dynavax originally sought to market the drug to healthy adults ages 40 and older. When the company met with the FDA in February, the agency determined the vaccine should be for healthy adults 18 to 70 years old.

The vaccine may generate an estimated $775 million in peak worldwide sales in 2020, Katherine Xu, an analyst with William Blair & Co. in New York, said in an e-mail.

Hepatitis B, like HIV, is transmitted through the exchange of body fluids such as blood, saliva or semen, according to the Centers for Disease Control and Prevention. It attacks the liver, which removes toxins from the body, and can lead to scarring, cancer or organ failure.

http://www.bloomberg.com/news//2012-11-13/dynavax-s-heplisav…

[Lucky72]

Antwort auf Beitrag Nr.: 43.819.822 von me_2 am 13.11.12 19:29:40

Knacken wir heute noch die 5Dollllaar?

[Lucky72]

[Lucky72]

Nur zur Info!

http://google2.fda.gov/search?q=heplisav&x=21&y=7&filter=0&p…

[Lucky72]

Es geht schon los!!!

http://www.nasdaq.com/symbol/dvax/premarket

[Lucky72]

Wo bleibt die Gegenbewegung??!

[me_2]

Antwort auf Beitrag Nr.: 43.825.300 von Lucky72 am 14.11.12 20:44:43

Ich fürchte die Gegenbewegung sind wir, nur dass unser Volumen ein bisschen schwach ist ...
Aber heute 15.11. müßt sich ja was tun, hoffentlich in die richtige Richtung. Der Abend wird spannend

[me_2]

Antwort auf Beitrag Nr.: 43.826.711 von me_2 am 15.11.12 09:22:17

Handel in US scheint ausgesetzt zu sein ??

[dottore]

Übernahmegerüchte?

[me_2]

Antwort auf Beitrag Nr.: 43.829.219 von dottore am 15.11.12 16:51:25

FDA/VRBPAC meeting. In diesem Moment entscheidet sich die Zukunkt

[Lucky72]

Antwort auf Beitrag Nr.: 43.829.294 von me_2 am 15.11.12 17:05:29

Kein Handel!

[Lucky72]

[Lucky72]

Auf diesen Tag warte ich schon fast 2Jahre!

Ich hoffe es lohnt sich!

[Lucky72]

Verdammt! Das war wohl nix!

[Lucky72]

FDA Panel: Not Enough Safety Data for Proposed Dynavax Hepatitis B Vaccine

By Jennifer Corbett Dooren

WASHINGTON--A federal advisory panel Thursday said more safety information is needed for a proposed Hepatitis B vaccine being developed by Dynavax Technologies Corp. (DVAX), which could delay the vaccine's approval.

The company is seeking Food and Drug Administration approval for use of the vaccine, called Heplisav, in adults who are 18 to 70 years old.

Dynavax's vaccine was reviewed by FDA's vaccines advisory committee, which is made up of non-FDA medical experts. The panel voted 5-to-8 against a question that asked if the company submitted enough data to support the vaccine's safety. One person abstained from voting. However, the same panel voted 13-to-1 saying that data submitted by the company supported the vaccine's effectiveness.

Some of the panel members who voted against the vaccine's safety said larger and longer studies should be conducted before the vaccine is approved, but others suggested it might be done after approval. The FDA will make the final decision.

There are already Hepatitis B vaccines on the market from GlaxoSmithKline PLC (GSK, GSK.LN) and Merck & Co. (MRK), according to the FDA.

Write to Jennifer Corbett Dooren at [e-mail]

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

http://www.nasdaq.com/article/fda-panel-not-enough-safety-da…

[me_2]

Antwort auf Beitrag Nr.: 43.830.473 von Lucky72 am 15.11.12 20:42:50

Mist !

[VaJo]

Sorry, Lucky. Die FDA folgt eigentlich immer der Empfehlung des Panel. Beim naechsten mal klappts bestimmt.

Viel ERFOLG weiterhin.

[where-is-the-insider]

Zitat von me_2: Mist !

DAS KANN MAN WOHL SAGEN

Den ganzen Tag war der Handel ausgesetzt,
nachbörslich haben Eure Banken? vermutlich kräftig Leerverkauft,


aktuelles nachbörsliches Tief war bei 1,525- US-Dollar*

bin mal auf den Eröffnungskurs morgen gespannt...,

Freitag und vllt. 60 % Minus da können ganz schnell noch 25 % Minus zum
Start hinzu kommen?

1/15/2012 Market Closed
DVAX's NASDAQ Last Sale
1.70 2.93 -63.28%
NLS Volume
10,747,685
Previous Close
$ 4.63
Today's High
$ 2.5000
Today's Low
$ 1.5250

NmM*

Sorry für alle Longies*
LG where-

[me_2]

Antwort auf Beitrag Nr.: 43.830.986 von where-is-the-insider am 15.11.12 23:01:13

In D vorbörslich so um die 1,50 Eur. Halte das für übertrieben. Viellleicht ein dreiviertel Jahr Verzögerung und ein paar Mio. für zusätzliche Daten, aber Dy. ist deswegen ja nicht wertlos.

[Berliner_Landstreicher]

Antwort auf Beitrag Nr.: 43.831.363 von me_2 am 16.11.12 08:22:32

Ich hab das bei Adolor auch erlebt. Da wurden zusätzliche Studien über einen Zeitraum von mindestens 1 Jahr verlangt. Dies führte dazu, dass ADLR die Entwicklung einstellte. Also 12 Monate sollte man an zusätzlicher Geduld mitbringen. Die FDA hat nun die finale Entscheidung zu treffen. Wenn der Wirkstoff so sehr überzeugt in seiner Wirksamkeit, dann kann es auch eine Überraschung geben. Oder es wird mit Auflagen zugelassen.

[Lucky72]

Die Jungs von GSK lachen sich bestimmt einen Ast!

Jetzt könnten sie DVAX günstig übernehmen!

IMO

[Lucky72]

Antwort auf Beitrag Nr.: 43.833.394 von Berliner_Landstreicher am 16.11.12 16:39:17

Die FDA hat nun die finale Entscheidung zu treffen.

Das sehe ich auch so!

Ich hab im Amibord gelesen das die FDA auch festlegen kann das es eine weitere Sicherheitsstudie nach Markteinführung geben kann!

Geht das wirklich?

[Lucky72]

Ups! Die läuft ja schon!

http://clinicaltrials.gov/ct2/show/NCT01282762?term=Dynavax&…

[lunatics]

Aktie down -52%
Hepislav: FDA panel voted that there wasn't enough clinical trial data to support the idea that the vaccine is safe.

DVAX tot.

[me_2]

Antwort auf Beitrag Nr.: 43.834.947 von lunatics am 17.11.12 01:22:29

Tot würde ich so nicht sagen. Aber ganz schön angeschlagen.
Die von dir zitierte laufende Studie betrifft geplante 700 Pat. mit Niereninsuffizienz und ist sicher nicht ausreichend.

Man sollte erst mal die Reaktion des Managements abwarten.
Die werden sich dann mit der FDA zusammensetzen und besprechen, wie man weiter vorgehen könnte...

Eine Zulassung im Februar bei der aktuellen Datenlage und gegen das Panel-Voting kann ich mit nicht vorstellen.

Im schlimmsten Fall (Einstellung der Hepl-Entwicklung) reduziert sich der Wert von D. auf die Rest-pipeline (wie hoch ist der wohl?).

Aber zwischen diesen beiden Extrtemen gibt es noch alle möglichen Szenarien.

[Lucky72]

Ist schon komisch!

Dynavax’s Heplisav Vaccine Works on Hepatitis B, FDA Says
By Anna Edney on November 13, 2012


Dynavax Technologies Corp. (DVAX)’s Heplisav vaccine works against the contagious liver disease hepatitis B, Food and Drug Administration staff said. The company’s shares jumped the most in about 14 months on the report.

Heplisav worked as well after two doses as three doses of GlaxoSmithKline Plc (GSK)’s Engerix-B vaccine to protect patients against the virus, FDA staff said today in a report released ahead of an advisory panel meeting scheduled Nov. 15 on Dynavax’s vaccine. Heplisav also had a similar safety profile to Engerix-B, agency staff said.

Heplisav would be Berkeley, California-based Dynavax’s first product if the vaccine is cleared by Feb. 24 when the FDA is scheduled to decide on approval. The vaccine may generate an estimated $775 million in peak worldwide sales in 2020, Katherine Xu, an analyst with William Blair & Co. in New York, said in an e-mail.

Dynavax rose 13 percent to $4.74 at the close in New York, the largest single-day increase since Sept. 16, 2011. The company has gained 43 percent this year.

Dynavax originally sought to market the drug to healthy adults ages 40 and older. When the company met with the FDA in February, the agency determined the vaccine should be for healthy adults 18 to 70 years old.
Attacks Liver

Hepatitis B, like HIV, is transmitted through the exchange of body fluids such as blood, saliva or semen, according to the Centers for Disease Control and Prevention. It attacks the liver, which removes toxins from the body, and can lead to scarring, cancer or organ failure.

In a final-phase study of about 2,400 patients ages 18 to 55, 95 percent of those who took two doses of Heplisav were protected from hepatitis B compared with 81 percent of those who took three doses of Glaxo’s Engerix-B, FDA staff said in a report.

FDA staff recommended evaluation of Heplisav after the drug is on the market because some patients experienced autoimmune diseases. Two main trials on the vaccine weren’t set up to detect such rare adverse events, according to the report.

One woman experienced Wegener’s granulomatosis, a rare disease in which blood vessels are inflamed and another woman developed Guillain-Barré syndrome, a disorder in which the body’s immune system attacks the nerves. The woman with Guillain-Barré syndrome also received an influenza vaccine that was thought to have caused the disorder rather than Heplisav.

The FDA put a hold on two clinical trials in March 2008 after a patient given the vaccine was diagnosed with Wegener’s granulomatosis. U.S. regulators allowed testing to resume in September 2009.

Dynavax plans to submit an application to expand Heplisav’s use to patients with chronic kidney disease if the drug is approved in healthy adults, the company has said.

To contact the reporter on this story: Anna Edney in Washington at [e-mail]

http://www.businessweek.com/news/2012-11-13/dynavax-s-heplis…

[me_2]

Dynavax Announces FDA Advisory Committee Meeting Outcome for HEPLISAV(TM)

BERKELEY, CA -- (Marketwire) -- 11/15/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the U.S. Food and Drug Administration (FDA) Vaccines and Related Biological Products Advisory Committee (Committee) voted 13 to one that HEPLISAV data adequately demonstrated immunogenicity. Additionally, the Committee voted eight to five with one abstention that there was insufficient data to adequately support the safety of HEPLISAV.

Now that Dynavax has received the Committee's input and vote, the Company will continue working with the FDA as it completes its review of the HEPLISAV application. The scheduled Prescription Drug User Fee Act (PDUFA) date for HEPLISAV is February 24, 2013.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=721…

Dann warten wir mal ab was da raus kommt ...

[Lucky72]

Freitag wollten sie alle raus und heute wollen alle wieder rein!

[Lucky72]

[Lucky72]

Würde mich nicht wundern wenn wir heute noch die 3$ testen!

[fortuna924]

NB bei 2,66$. Morgen geht es über die 3$

[fortuna924]

NB geht es weiter hoch. Spätestens im Februar wissen wir mehr ...

[Lucky72]

Antwort auf Beitrag Nr.: 43.841.177 von fortuna924 am 19.11.12 22:43:32

Spätestens im Februar wissen wir mehr ...

So lange werden wir nicht warten müssen!

IMO

[fortuna924]

TH war heute die 2,80$. Da wird morgen die Eröffnung sein.

[fortuna924]

Antwort auf Beitrag Nr.: 43.841.218 von fortuna924 am 19.11.12 23:06:27

NB 2,69$

[me_2]

Eröffnung 2,5 - jetzt 2,75 . Die Erholung geht weiter.

Hoffe nicht dass wir bis Februar auf News warten müssen, sd. dass in den nächsten Tagen ein Statement von D kommen sollte welche Richtung sie generell jetzt verfolgen wollen.

[fortuna924]

bleibe dabei. Heute noch über 3$

[dottore]

und ich wollte bei 4,60 $ aussteigen, hatte dann aber noch zu tun. Am nächsten Tag konnte ich meinen Augen nicht trauen 50% minus.
Ich fand die Nachricht nicht so schlimm. Deshalb bin ich ja auch nicht vorangig ausgestiegen.
Wenn schon ausstieg verpasst, dann heute nachgelegt. Ich will die 5 $ von oben her sehen bevor ich auch nur ans Verkaufen denke

[fortuna924]

bin wieder raus. Glaube doch eher an einen Sk von 2,75$. Wird wahrscheinlich wie gestern sein. Letzte Stunde 25 Cent nach unten. Abwarten. Nur m.Meinung ....

[fortuna924]

Antwort auf Beitrag Nr.: 43.844.450 von fortuna924 am 20.11.12 19:17:46

sorry meinte 15 Cent. SK bei 2,75$ und dann morgen erst über die 3$. Werde morgen wieder dabei sein.

[me_2]

Wegweisender Artikel !!!!! (für diejenigen die fundamental interessiert sind)

Why Dynavax's HEPLISAV Is Likely To Be Approved: Impact On Future Vaccine Development

http://seekingalpha.com/article/1022981-why-dynavax-s-heplis…

[me_2]

Die 3 $ sind da

[Lucky72]

HealthCor Management, L.P. Raises Stake in Dynavax Technologies Corporation (DVAX) to 9.18%

In a 13G filing on Dynavax Technologies Corporation (NASDAQ: DVAX), hedge fund HealthCor Management, L.P. disclosed a 9.18%, or 16,400,000 share, stake in the company. This is up 105.00% from the 8,000,000 shares held at the end of the latest quarter ending September 30, 2012.

http://www.streetinsider.com/13Gs/HealthCor+Management%2C+L.…

Jetzt wissen wir wer die Aktien von Mark Kessel gekauft hat!

Nur meine Meinung!

Zur INFO!
http://investors.dynavax.com/secfiling.cfm?filingID=1104659-…

[Lucky72]

[Lucky72]

Lausiges Volumen!

Die Amis bereiten sich schon auf Thanksgiving vor!

[Lucky72]

Langweilig!

[Lucky72]

Raketentreibstoff!

Settlement Date 11/15/2012

Short Interest 22,253,627

Avg Daily Share Volume 5,599,826

Days To Cover 3.973985

http://www.nasdaq.com/symbol/dvax/short-interest

[dottore]

hey lucky

verstehe ich das richtig? 4 mal so viel Short als durchschnittlicher Tagesumsatz und fällig innerhalb 4 Tagen?

Dann haben wir diese Woche zuletzt Kurse unter 3 $ gesej´hen, oder?

[me_2]

Antwort auf Beitrag Nr.: 43.871.742 von dottore am 28.11.12 17:10:26

Ich dachte immer das heißt: 4 days to cover, das brauchen die shorties wenns eng wird, bei den angegebenen Tagesumsätzen, um sich wieder einzudecken. Nicht: in 4 days fällig. Bin aber auch nicht sicher...

[Lucky72]

Antwort auf Beitrag Nr.: 43.871.767 von me_2 am 28.11.12 17:17:06

Hast schon recht! So lange würden die Shorty brauchen um bei diesem Volumen (Durchschnitt) zu covern!

[me_2]

DVAX nochmal -17% in US. Was ist da los ????

[dottore]

Antwort auf Beitrag Nr.: 43.875.444 von me_2 am 29.11.12 15:23:52

bei mir geht der Kurs hoch. Ich sehe kein Minus 17 %. Wer gibt dir dafür den grünen Daumen?

[me_2]

Antwort auf Beitrag Nr.: 43.879.283 von dottore am 30.11.12 12:29:48

Sorry ,das war eine Premarket Quote die ich auf Nasdaq gesehen hatte und daraufhin etwas panisch wurde. Nach Eröffnung liefs dann ja auch auf dem Vortagsniveau weiter. Also no problem. Woher der Daumen kommt, keine Ahnung.

[Lucky72]

Ohne News wird das hier nix!

[Lucky72]

Dynavax to Present at the 31st Annual J.P. Morgan Healthcare Conference

BERKELEY, CA -- (Marketwire) -- 12/17/12 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it will present at the 31st Annual J.P. Morgan Healthcare Conference in San Francisco on Monday, January 7, 2013 at 6:00 p.m. Eastern Time (3:00 p.m. Pacific Time).

Dino Dina, M.D., Chief Executive Officer of Dynavax, will provide a company overview. To access the slide presentation, live webcast, and subsequent archived recording, please visit Dynavax's website at http://investors.dynavax.com/newsevents.cfm.

About Dynavax

Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. Dynavax's lead product candidate is HEPLISAV™, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=727…

[Lucky72]

Neues Jahr ,neues Glück!

Mal schaun was 2013 bringt!

Ich wünsche allen ein gutes neues Jahr 2013!

[Lucky72]

Pre Market gehts schon los!

Pre-Market Volume:
12,500 $ 2.93
(04:05:02 AM)

http://www.nasdaq.com/symbol/dvax/premarket

[dottore]

wir haben nun genug gelitten. Es sollte endlich wieder hoch gehen

Die dazugehörige Nachricht wird ja nun auch bald kommen. Die zusätzlichen Anforderungen zur Zulassung sind eigentlich nur eine Frage der Zeit wie ja bekannt ist. ALso auf i

[dottore]

http://www.fool.com/investing/general/2013/01/08/is-this-vac…

und schon ging es heute 10 % hoch

[Lucky72]

[Lucky72]

Jetzt aber hoch mit dem .....!

[Lucky72]

[Lucky72]

Kommt heute noch was?

[Lucky72]

Sieht aber nicht nach PDUFA Rally aus!

[me_2]

Antwort auf Beitrag Nr.: 44.138.386 von Lucky72 am 13.02.13 21:43:59

Kommt schon noch

[Lucky72]

Antwort auf Beitrag Nr.: 44.139.202 von me_2 am 14.02.13 09:11:52

Das wird heute wieder nix!

Aber wenigstens sammeln die "Big Boys"!

[Lucky72]

Hier ist der Link!

http://investors.dynavax.com/sec.cfm

[Lucky72]

In Düsseldorf kommt auch Bewegung rein!

http://www.rheinbiotech.de/index.php?id=44

[me_2]

Die PDUFA Ralley geht aber in die falsche Richtung!!

[dottore]

mann ist das nervig

[dottore]

da schmeißt einer, weil er schon jetzt weiß, dass die Approvation nicht gelingt oder noch eine Studie verlangt wird. Welcher Tag genau wurde fixiert? Morgen oder Übermorgen?

[Lucky72]

WOW! Der Kurs nimmt aber heute gewaltig Anlauf!

SK 3$++?

[Lucky72]

Na super, jetzt kackt der ganze Markt ab!

[me_2]

Sieht nicht gut aus, Kurs in Frankfurt 1 EUR.


25.02.2013 | 12:01

Dynavax Receives FDA Complete Response Letter on HEPLISAV(TM) Biologic License Application / Conference Call Scheduled for 9:00 a.m. ET Today

http://www.finanznachrichten.de/nachrichten-2013-02/26069084…

[dottore]

Zitat von dottore: da schmeißt einer, weil er schon jetzt weiß, dass die Approvation nicht gelingt oder noch eine Studie verlangt wird. Welcher Tag genau wurde fixiert? Morgen oder Übermorgen?

aers war wohl tatsächlich für manchen Insider vorhersehbar, dass die <Zulassung nicht erfolgen würde. Dann liegt das vielleicht daran, dass die "Zusatzstoffe" des Impfstoffes noch zu neu auf dem Markt sind um Spätschäden sicher ausschließen zu können. So weit offiziel. Aber was soll da schon passieren, wenn nicht kurz nach der Impfung? Die kleine Menge an Substanzen könnte einen "Spätschaden" doch nur dann anrichten, wenn es zur Akkumulation käme. Dafür wären sicherlich mehr Impfungen erforderlich als die Drei für die Grundimmunisierung und die 10-jährige Auffrischung.

Dieser neue Impfstoff käme auf dem Markt bereits vorhandenen Impfstoffen zur Konkurrenz. Selbst wenn es gelänge große Teile der Umsätze abzugraben, würden Riesen GSK dovon keine wesentlichen Verluste erleiden. Solche Gedanken werden es nicht sein. Aber die Tatsache, bereits einen Impfstoff zu haben erlaubt es eben, besondere Vorsicht walten zu lassen, weil der neue Impfstoff nicht zwingend erwartet wurde.
Vielleicht können die Erfahrungen mit den neuen "Zusatzstoffen" dann für folgeprodukte herangezogen werden und spätere andere Zulassungen erleichtern. Erst einmal aber sitzt der Schck tief.
Ist das jetzt die endgültige Absage der FDA? Wird Dynavax einen neuen Antrag stellen und in welchem Zeitrahmen könnte es dazu kommen?

Die Telefonkonferenz wird diese Fragen wohl beantworten, aber lewider habe ich keine Gelegenheit da mit zu hören und mein englisch ist nur in der Schriftform ausreichend.

Vielleicht findet sich jemand, der hier entsprechend posten kann.

[dottore]

Antwort auf Beitrag Nr.: 44.183.257 von dottore am 25.02.13 16:38:01

... und noch etwas

Warum die Frage nach Qualitätskriterien bei der Herstellung? Gibt es da vielleicht Mängel, auf die konkret hingwiesen wurde, oder ist das nur eine Ergänzung im ZUsammenhang mit den Adjuvanzien? Warum wurde die Frage nicht schon beim ersten Mal aufgeworfen?
Insgesamt besser dieses Mal als nächstes Mal und noch 6 Wochen verlieren.

Wenn sich die Adjuvanzien als sicher herausstellen und sie deshalb auch für andere Impfstoffe zugelassen werden, könnte das derzeitige Gezauder sogra zum Vorteil für Dynavax werden, denn auch andere Hersteller müssen in Zukunft damit rechnen. Dann wird das zum Vorsprung für Dynavax. Hoffentlich haben die dann auch ein Patent darauf.

[me_2]

Ich hab reingehört. Es blieb vieles offen weil der Conference Call ja recht knapp nach Erhalt des CRL erfolgte.

Lt. Herrn Dina bemängelte die FDA 1. daß die safety Daten (für eine Zulassung bei 18-70 jährigen) nicht ausreichend seien und 2. Mängel im (bzw. in der Dokumentation des) Herstellungsprozesses.

Punkt 2. sei "addressable" und könne innerhalb kurzer Zeit ("Months") durch entsprechende Vertiefung der Dokumentation des Herstellvorgangs behoben werden.(ob hier die Tatsache daß die Herstellung in EU stattfindet eine Rolle spielt wurde nicht weiter ausgeführt, es geht evtl. auch um eine Anerkennung der EU-Betriebs- und Herstellerlaubnis durch US/FDA).

Punkt 1 ist ja bekannt. Es wurde nochmal klargestellt, dass man 5000 Subjects eigtl. als Basis für die Safety für ausreichend hält. Eine zusätzliche Safety Studie zur Untermauerung einer Re-Submission ist nicht geplant. Man wird innerhalb von 6 Wochen mit der FDA das weitere Vorgehen absprehcen. Dabei kommen kleinere Zulassungen bei Personen im Alter 40-70 oder bei Niereninsuffizienz in Frage, hier besteht besonderer Bedarf und diese Gruppen hätten besonders in den Studien profitiert. Der Markt für 40-70 jährige ist recht beachtlich (25%, später wurden 50% genannt, ist nicht ganz klargeworden). Ob und wie die Frage der Safetydaten für 18-70 Jährige weiterverfolgt wird, war mit letztlich nicht klar.

Die Zulassung bei EMA sollen in vollem Umfang weiterverfolgt werden, mit Submission geplant in 2014.

Als Vorgriff auf die anstehende Diskussion der Zahlen: Cashbestand Ende 2012 125 Mio.

[dottore]

danke, das reicht mir, um nachzukaufen

[me_2]

Antwort auf Beitrag Nr.: 44.183.763 von dottore am 25.02.13 17:45:49

Jetzt schon oder lieber noch 2 Tge warten?

[me_2]

Hier die offizielle Version der Telefonkonferenz zum CRL:

http://seekingalpha.com/article/1221131-dynavax-technologies…

[Lucky72]

Autsch!!!

[dottore]

sowohl als auch

[Lucky72]

Stahlhelm aufsetzen und nachladen!

[dottore]

naja, scheint dass USA insgesamt noch etwas fallen werden. Also Geld noch etwas im Trockenen halten!

Übrigens ist es nach meiner Meinung durchaus noch möglich, dass berluskoni mit Beppo grillo zusammen geht - und doch an die Macht kommt.

[Lucky72]

Berluskoni? Was hat der mit DVAX zu tun?

[me_2]

Antwort auf Beitrag Nr.: 44.184.607 von Lucky72 am 25.02.13 20:10:23

Da gibts einen klaren Zusammenhang: HWG und >70 also Risikoguppe und potenzieller Heplisav-Kunde

[dottore]

Zitat von dottore: naja, scheint dass USA insgesamt noch etwas fallen werden. Also Geld noch etwas im Trockenen halten!

Übrigens ist es nach meiner Meinung durchaus noch möglich, dass berluskoni mit Beppo grillo zusammen geht - und doch an die Macht kommt.

@ lucky72
Dvax hat natürlich nichts direkt mit Berlusconi zu tun. Alberne Frage!

Viel schlimmer sind da meine Schreibfehler und inhaltlich ist es wohl eher ausgeschlossen, dass grillo mit Berlusconi. Ist der Grillo doch gerade wegen seiner Antikorruption angetreten. Aber die Patt-Situation führt zur Fortsetzung der Ungewissheit. In Italien wird erfolgreich (leider) Stimmung gemacht, gegen Europa und es erscheint jetzt nicht mehr unmöglich, dass Europa und Euro zerbrechen.
Viel wichtiger scheint mir aber, dass die Fiskalklippe und das verminderte Verbrauchervertrauen in USA mit dem Ausstieg aus dem Anleihenkaufprogramm zusammen einen trifftigen Grund aufwerfen, ob die aktuelle Aktienbewertung gerechtfertigt ist. In der Kursralley der zweiten Jahreshälfte 2012 sind die positiven Aussichten schon alle eingepreißt und zwar dermaßen, dass schon vor den aktuellen Sorgen die Kurse nicht mehr steigen konnten.

Ich befürchte, dass es zum supergau kommen wird. Wi sich das auf Dvax auswirken wird, ist nicht klar, aber am Beispiel DAX halte ich einen Einbruch bis unter 6000 für durchaus möglich.

[me_2]

01.03.2013 | 22:01

Dynavax Reports Fourth Quarter and Year End 2012 Financial Results

http://www.finanznachrichten.de/nachrichten-2013-03/26131805…

[Lucky72]

Vielleicht kommt heute was positives!


Dynavax to Present at the Cowen and Company 33rd Annual Healthcare Conference

BERKELEY, CA -- (Marketwire) -- 02/26/13 -- Dynavax Technologies Corporation (NASDAQ: DVAX) announced today that it will present at the Cowen and Company 33rd Annual Healthcare Conference in Boston on Tuesday, March 5, 2013 at 8:40 a.m. Eastern Time (5:40 a.m. Pacific Time).

Dino Dina, M.D., Chief Executive Officer of Dynavax, will provide a company overview. To access the slide presentation, live webcast, and subsequent archived recording, please visit Dynavax's website at http://investors.dynavax.com/newsevents.cfm.

About Dynavax

Dynavax, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious and inflammatory diseases. Dynavax's lead product candidate is HEPLISAV ™, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.

[me_2]

Antwort auf Beitrag Nr.: 44.214.077 von Lucky72 am 05.03.13 08:20:00

Was könnte das sein, ich rechne nicht mit wesentlichen Neuigkeiten.

[Lucky72]

Antwort auf Beitrag Nr.: 44.214.188 von me_2 am 05.03.13 08:45:19

Was auch kommt, schlechter kanns nicht werden!

[Lucky72]

Nix Neues!

http://files.shareholder.com/downloads/DVAX/1293540983x0x641…

[Lucky72]

[Lucky72]

Dynavax Appoints David Novack as Senior Vice President, Operations and Quality

BERKELEY, CA -- (Marketwire) -- 03/21/13 -- Dynavax Technologies Corporation (NASDAQ: DVAX) today announced the appointment of David Novack to the position of Senior Vice President, Operations and Quality, effective March 25, 2013. Mr. Novack brings nearly 25 years of industry experience in manufacturing and supply chain operations, implementing multi-national commercial manufacturing and supply chain strategies for both global industry leaders and emerging companies in vaccines, diagnostics, and biopharmaceuticals. Mr. Novack will be joining Dynavax from Novartis Vaccines & Diagnostics where he served most recently as the Global Head of Technical Operations and Supply Chain for Diagnostics, and previously as the Global Head of Vaccine Manufacturing Strategy. During his tenure at Novartis, Mr. Novack successfully developed and executed manufacturing capacity plans to meet commercial requirements, designed and executed remediation programs to be compliant with current quality standards, and was responsible for cost-effective supply chain solutions across multiple product lines.

"David's background and experience will be a valuable addition to our senior management team," said President and Chief Medical Officer, Tyler Martin, M.D. "We look forward to his contributions in the planning and implementation of a successful commercial manufacturing strategy for the advancement of HEPLISAV™ and long-term growth of the Company."

Prior to Novartis, Mr. Novack was the Vice President, Business Development for Vaxin, Inc., a vaccine company, from 2004 to 2006. From 1993 until 2004, Mr. Novack worked at MedImmune, formerly Aviron, serving in several capacities including business development, manufacturing, contract operations and most recently as Senior Director, Supply Chain Operations. Previously, from 1989 to 1993, Mr. Novack was with American Cyanamid Company in various roles. Mr. Novack received a B.S. in Biology from State University of New York and an M.B.A. from Columbia University.

Dynavax also reported that Stephen Tuck, Vice President, Global Technical Operations, will be departing the Company as of March 29, 2013. Said Chief Executive Officer, Dino Dina, M.D., "I want to personally express my appreciation for Stephen's many years of service and commitment to Dynavax dating back nearly to the inception of the Company."

President and Chief Medical Officer, Tyler Martin, M.D., commented, "Stephen's leadership and expertise in Technical Operations was critical to the HEPLISAV™ program over the past two years, in particular for the submission of our U.S. and European regulatory applications for HEPLISAV. We greatly appreciate his contributions to Dynavax."

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. For more information visit www.dynavax.com.

http://investors.dynavax.com/releasedetail.cfm?ReleaseID=750…

[me_2]

is aber kein gutes Zeichen in so einer kritischen Situation einen Schlüsselposition auszuwechseln ... noch dazu ohne offiziell Begründung

[Lucky72]

Keine FDA News!

[me_2]

Dynavax Names Eddie Gray as Chief Executive Officer and Member of the Board of Directors / Dynavax Meeting With FDA Scheduled First Half of June

http://www.finanznachrichten.de/nachrichten-2013-04/26686642…

""It is a privilege to be joining Dynavax at this exciting time in the Company's history," said Mr. Gray."

Hat Galgenhumor, der Neue.

"The Company also indicated that Tyler Martin, M.D., President, is departing from Dynavax on May 31, 2013"


I hope we're not getting into trouble.

[me_2]

Antwort auf Beitrag Nr.: 44.541.299 von me_2 am 30.04.13 15:39:12

Das wären dann schon 3 Führungsleute die innerhalb von wenigen Wochen gehen, da stimmt doch was nicht. Verlassen hier einige das sinkende Schiff ???

[me_2]

Antwort auf Beitrag Nr.: 44.541.397 von me_2 am 30.04.13 15:46:46

Hab mich von DVAX verabschiedet, wg. Langeweile und Aussichtslosigkeit. Wünsch euch noch viel Glück, ich denke ihr werdet es brauchen.

[Lucky72]

Antwort auf Beitrag Nr.: 44.585.271 von me_2 am 07.05.13 20:01:48

Langweilig: JA!

Aussichtslos: NEIN!