Können die alten Kurse wieder erreicht werden? Dyax - 500 Beiträge pro Seite

[geldspender]

Hier Neue Infos des Investoralerts:
Das erste Unternehmen, welches wir Ihnen vorstellen möchten, ist die Dyax Corp. (NASDAQ: DYAX) aus Cambridge im US-Bundesstaat Massachusetts. Auf Sicht von einem Jahr ist die Performance des Aktienkurses deutlich negativ. Demnach brach der Kurs der Aktie von über 4 US$ auf zeitweise unter 1,50 US$ ein. In den letzten Handelstagen stabilisierte sich der Aktienkurs dann jedoch wieder ein wenig. Ein Grund dafür waren zahlreiche Insider-Käufe vom CEO und vom CFO des Unternehmens, die den jüngsten Kurssturz wohl für deutlich übertrieben hielten. Aus wirtschaftlicher Sicht scheint das Unternehmen auf einem sehr guten Weg zu sein. Demnach erwarten die Analysten, dass der Umsatz im laufenden Jahr bei 43,22 Mio. US$ liegen wird. Für das kommende Geschäftsjahr erwarten diese dann aber schon einen Umsatz in Höhe von 71,28 Mio. US$. Zwar schreibt das Unternehmen derzeit noch keine schwarzen Zahlen, der Fehlbetrag weist jedoch eine stark fallende Tendenz auf. So erwarten die Analysten im laufenden Geschäftsjahr noch einen Verlust je Aktie von 0,36 US$, sie trauen dem Unternehmen aber gleichzeitig zu, diesen Betrag im Jahr 2012 auf 0,14 US$ signifikant zu senken.
Wer hat eigene Infos zu dieser Aktie?

[kmastra]

Antwort auf Beitrag Nr.: 41.243.309 von geldspender am 21.03.11 18:42:04

Habe mir vor kurzem eine kleine position gekauft, da ich die aktie für total unterbewertet halte:
Alleine 17 verpartnerte programme in der klinik- meist antikörper. Partner sind z.B. Amgen, Biogen, Eli Lily, Genentech. Ich denke die firma ist durchaus vergleichbar mit der deutschen morphosys. Alleine 4 in P III. Und ? ja auch noch in der präklinik. Und als schmankerl noch eine kleine eigene pipeline mit einem zugelassenen medikament.
Leider kennen ich die konditionen der partnerdeals nicht. Trotzdem überwiegen hier für mich langfristig die chancen.

[kmastra]

Schon komisch. Da bekommt Shire gestern die Zulassung eines Konkurenzproduktes für das einzig auf dem Markt befindliche Medikament von Dyax und als Reaktion steigt Dyax gestern und heute jeweils um 10%.
Das verstehe wer will...

[kmastra]

Heute gute News:

http://www.bloomberg.com/news/2012-10-15/eli-lilly-s-stomach…

Definitiv eine Aktie mit solider Basis, alleine 17 Programme durch Partner in der Klinik, wie gesagt vergleichbar mit Morphosys.



Dazu noch ein zugelassenes eigenes Medikament mit Wachstumsphantasie.

[kmastra]

Gestern sehr gute Zahlen:

http://finance.yahoo.com/news/dyax-corp-announces-third-quar…

Hab mir den CC angehört. Mir gefällt die Entscheidung, sich auf eine Nischenindikation (HAE) zu fokussieren und sich dort als Spezialist zu positionieren. Ein Nachfolgemedikament und ein Diagnostikantikörper sind in der Mache. Auf jeden Fall haben sie es geschafft, ihre Kosten in den Griff zu bekommen und wollen im nächsten Jahr eventuell sogar einen kleinen Gewinn einfahren.
Dazu dann noch die Programme von Partnern: 17 in der Klinik und 18 präklinisch.

[kmastra]

[kmastra]

Soviel dann zum Thema Charttechnik...runter geht es grad wegen akzeptabler aber eben nicht berauschender Studiendaten:

http://www.asco.org/ASCOv2/Meetings/Abstracts?&vmview=abst_d…

[kmastra]

Heute ein schönes Plus. Grund war wohl eine Analyse:

http://www.bizjournals.com/boston/blog/bioflash/2013/03/dyax…

[kmastra]

Die Zahlen gestern sorgen für einen verständlichen Ausverkauf.
1. Der Umsatz von Kalbitor fällt im Vergleich zum Vorquartal.
2. Jahresprognose wird kassiert.

Erfreulich nur die Nachricht im CC. Lilly plant noch in diesem Jahr den Zulassungsantrag für Ramucirumab. Dem Medikament ist einiges zuzutrauen. Es stehen auch noch einige PIII Ergebnisse aus. Dyax bekäme die ersten 10 Jahre 2-3% Royalties.
Insgesamt aber enttäuschend. Vor allem weil nur noch ca. 20 Millionen an Cash da sind. Das macht eine Kapitalerhöhung wahrscheinlich.

http://finance.yahoo.com/news/dyax-corp-announces-first-quar…

[kmastra]

Antwort auf Beitrag Nr.: 44.520.901 von kmastra am 26.04.13 17:02:26

Ergänzen möchte ich, dass Dyax 80 Millionen Schulden hat. Die Royalties fließen (ggf.) deshalb erstmal in die Tilgung der Schulden. Von daher würde ich eine Kapitalmaßnahme hier nicht ausschließen.

[kmastra]

Schon wieder schlechte news bei einem von Dyax Partnern:

http://www.reuters.com/article/2013/04/04/merrimack-study-ca…

Viel wird jetzt von ramucirumab abhängen. Analysten trauen dem Mendikament zunächst in der ersten Indikation 600 Mio zu. Dyax bekäme 10 Jahre lang ca. 3 % Royalties.
http://www.kantarhealth.com/blog/neesha-suvarna/neesha-suvar…

Bezüglich der Rückzahlung der Schulden steht im 10k:

"Under the terms of the agreement, the Company is required to repay the Loan based on the annual net LFRP receipts. Until September 30, 2016, required payments are equal to the sum of 75% of the
first $15.0 million in specified annual LFRP receipts and 25% of specified annual LFRP receipts over $15.0 million. After September 30, 2016, and until the maturity date or the complete repayment of
the Loan, HC Royalty will receive 90% of all included LFRP receipts. If the HC Royalty portion of LFRP receipts for any quarter exceeds the interest for that quarter, then the principal balance will be
reduced. Any unpaid principal will be due upon the maturity of the Loan. If the HC Royalty portion of LFRP revenues for any quarterly period is insufficient to cover the cash interest due for that
period, the deficiency may be added to the outstanding principal or paid in cash by the Company. After five years from the dates of the Tranche A Loan and the Tranche B Loan, respectively, the
Company must repay to HC Royalty all additional accumulated principal above the original loan amounts of $21.7 million and $58.8 million, respectively."

[kmastra]

Positive news:

http://www.fiercebiotech.com/story/eli-lillys-troubled-erbit…

Dyax bekäme 2-3 % Royalties von den beiden erwähnten Programmen. Die Daten von Ramucirumab sollen auch noch dieses Jahr kommen. Sieht so aus, als hätte Dyax nächstes Jahr zwie Zulassungsanträge am Start...

[kmastra]

Die Aktie kennt zur zeit ja kein Halten mehr. Gestern kamen Ergebnisse zu ramucirumab, die schlecht für Lilly sein sollen aber gut für Dyax? Finde das Ganze wenig nachvollziehbar, zumal selbst bei Zulassung ja nur wenig Royalties fließen und selbst die werden erst mal zum Schuldenabbau benötigt.


In another stinging setback, Eli Lilly's ramucirumab fails PhIII breast cancer study
September 26, 2013 | By John Carroll

Eli Lilly announced this morning that its Phase III study for ramucirumab failed to hit its primary endpoint on progression-free survival among women with metastatic breast cancer, another stinging setback for a pharma giant that has been gambling heavily on a slate of late-stage studies to salvage its bottom line from the punishing onslaught of generic competition. A separate Phase III study for ramucirumab in gastric cancer hit its primary and secondary endpoints, but analysts were primarily focused on the outcome for the breast cancer indication.

The crucial late-stage failure--ramucirumab has been considered one of the pharma giant's top Phase III prospects--scuttles one of Eli Lilly's chief near-term hopes for a major new drug approval application. The failure also follows several years of poor trial outcomes for Lilly, which has a reputation for taking expensive and very risky chances when it comes to late-stage development. Its shares ($LLY) immediately dropped more than 5% on the news.

ISI's Mark Schoenebaum led the parade of analysts' comments this morning, noting that the Street had baked in expectations for $500 million to $600 million in annual revenue from the breast cancer indication. A number of analysts had expected the drug to clear the progression-free survival hurdle and face greater uncertainty on overall survival. Failing at PFS left several analysts shaking their heads.

"The longer term stock impact could be greater if the Street begins to lose confidence more generally in LLY's pipeline--the Street currently carries $9 billion in probability adjusted sales for the pipeline at the end of the decade, which is 40% of sales. This is significant," added Schoenebaum. The analyst also said he was more optimistic about the outcome for lung cancer, which is expected in 2014.

Lilly's has frequently reported setbacks for its pipeline. Just a few months ago Lilly was forced to scrap a mid-stage study on a BACE inhibitor for Alzheimer's after safety fears forced investigators to shut it down. That came on top of a particularly embarrassing failure for Lilly's late-stage program for solanezumab last year and an earlier defeat for semagacestat. Outside of Alzheimer's, Lilly has had a profoundly difficult time developing new therapies. In the summer of 2012 Lilly wrote off pomaglumetad for schizophrenia after the Phase III flunked out. Its setbacks also include the failure of the Phase III tabalumab program for rheumatoid arthritis. Last fall, when a combination of Lilly's Alimta and Avastin failed for lung cancer, the company had racked up 5 straight clinical setbacks.

On a brighter note, Lilly has had a largely successful partnership with Boehringer Ingelheim, so far, on promising diabetes drugs and recently scored an unexpected success with positive results for the cancer drug necitumumab--though there are serious questions about the safety of this therapy.

Success often comes with an asterisk at Lilly these days. The giant trumpeted late-stage results for ramucirumab in stomach cancer, even though it provided only a weak 1.4 months of added survival in the study, falling shy of analysts' expectations.

"Cancer is complex and patients with different tumor types may have varied responses due to distinct tumor biologies and individual patient characteristics. Unfortunately, anti-angiogenic agents have not yet been able to demonstrate an overall survival benefit for patients with metastatic breast cancer," said Dr. John Mackey, principal investigator of the ROSE/TRIO-012 study and professor of oncology, University of Alberta.

Lilly posted its second set of positive results for ramucirumab on gastric cancer, noting successes in hitting both overall survival and progression-free survival goals.

"We are disappointed that this breast cancer trial did not meet its primary endpoint. However, now with two positive gastric cancer trials, Lilly remains confident in the overall ramucirumab development program. We are looking forward to additional Phase III results for ramucirumab in colorectal, hepatocellular and lung cancer, expected in 2014," said Dr. Richard Gaynor, vice president, product development and medical affairs for Lilly Oncology.

http://www.fiercebiotech.com/story/another-stinging-setback-…

[Oberlaendler]

Dyax Corp. Announces Fourth Quarter and Full Year 2014 Financial ResultsTue February 24, 2015 7:01 AM|Business Wire | About: DYAX BURLINGTON, Mass.--(BUSINESS WIRE)-- Dyax Corp. (DYAX) (NASDAQ: DYAX) today announced financial results for the fourth quarter and year ended December 31, 2014. Dyax will host a webcast and conference call at 8:30 a.m. (ET) today to review financial results and provide updates regarding its key value drivers including the KALBITOR® (ecallantide) business, DX-2930 and the Licensing and Funded Research Portfolio (LFRP).

Recent highlights include:

•Completion of dosing in the expanded Phase 1b study of DX-2930 in hereditary angioedema (HAE) patients;
•KALBITOR net sales were $18.9 million for the fourth quarter of 2014 and $68.3 million for the full year;
•Commencement in 2014 of royalty revenue based on sales of Eli Lilly and Companys CYRAMZA® (ramucirumab), the first approved therapeutic product from the LFRP; and
•Cash, cash equivalents and investments at December 31, 2014 totaled $184.7 million.
In 2014, Dyax made significant progress across all our business areas, said Gustav Christensen, President and Chief Executive Officer of Dyax. We completed dosing in the Phase 1b study of DX-2930 in HAE patients and expect to report results in April. We saw growth in KALBITOR sales in 2014 along with continued profitability in the KALBITOR business. We also began receiving royalty revenues from the first marketed LFRP product, Lillys CYRAMZA®. As we look ahead, we are planning to initiate the Phase 2 trial of DX-2930 in the second half of 2015, and we are expecting a number of other milestone events from the LFRP.

2014 Fourth Quarter and Full Year Financial Results

Total revenues for the fourth quarter ended December 31, 2014 were $26.0 million, as compared to $16.9 million for the comparable quarter in 2013. These include KALBITOR net sales of $18.9 million and $12.6 million for the fourth quarter of 2014 and 2013, respectively. Fourth quarter 2014 KALBITOR net sales represent primarily patient demand units (units sold by distributors to hospitals or patients), as well as approximately $1.1 million of sales into the distributor channel. The 2014 fourth quarter revenues also included royalties of approximately $3.1 million based on sales of CYRAMZA, the first approved therapeutic product from the LFRP.

Total revenues for the twelve months ended December 31, 2014 were $81.7 million, including $68.3 million of KALBITOR net sales, as compared to $53.9 million for the comparable period in 2013, which included $40.5 million of KALBITOR net sales. The 2014 revenues also included royalties of approximately $3.8 million based on the initial sales of CYRAMZA.

Dyax expects quarterly and annual revenues to fluctuate. For KALBITOR, revenue fluctuations are primarily due to variability in the rate at which individual patients utilize KALBITOR to treat attacks (particularly among patients who experience and treat frequent attacks), as well as the timing and amount of distributor demand. For the LFRP, revenue fluctuations may be caused by the timing of any future milestone payments, the clinical activities of our licensees, and the timing and completion of contractual commitments.

Cost of product sales for KALBITOR for the fourth quarter of 2014 were $1.6 million, as compared to $700,000 for the same quarter in 2013. For the twelve months ended December 31, 2014, cost of product sales were $4.7 million, as compared to $2.7 million for the same period in 2013. Cost of royalties for the three and twelve months ended December 31, 2014 were $1.5 million and $1.9 million, respectively, consisting of pass-through fees under an LFRP cross-licensing arrangement.

Research and development expenses at Dyax are primarily related to the following research and development initiatives: 1) development costs associated with DX-2930, a fully human monoclonal antibody inhibitor of plasma kallikrein, together with other research programs; 2) KALBITOR medical support and post-marketing requirements; and 3) pass-through license fees paid by Dyax licensees under the LFRP. Research and development expenses for the fourth quarter of 2014 were $12.3 million, as compared to $6.5 million for the comparable quarter in 2013. The 2014 increase is primarily related to costs associated with DX-2930 development, as well as pass-through license fees paid by Dyax licensees under the LFRP. For the twelve months ended December 31, 2014, research and development expenses were $35.9 million, as compared to $29.7 million for the same period in 2013.

Selling, general and administrative expenses were $10.2 million for the fourth quarter of 2014, as compared to $8.9 million for the comparable quarter in 2013. For the twelve months ended December 31, 2014, selling, general and administrative costs were $40.4 million, as compared to $38.7 million for the same period in 2013.

For the quarter ended December 31, 2014, Dyax reported a net loss of $2.3 million, or $0.02 per share attributable to common stockholders, as compared to a net loss of $2.0 million, or $0.02 per share, for the comparable quarter in 2013. For the twelve months ended December 31, 2014, Dyax reported a net loss of $11.9 million, or $0.09 per share attributable to common stockholders, as compared to a net loss of $27.8 million, or $0.26 per share, for the comparable period in 2013.

As of December 31, 2014, Dyax had cash, cash equivalents, and investments totaling $184.7 million, exclusive of restricted cash.

Financial Guidance for 2015

•Revenue guidance includes two components:
•KALBITOR net sales in the range of $60-70 million, reflecting the Companys expectation that quarterly and annual KALBITOR net sales will fluctuate due to continued volatility in the level of KALBITOR utilization for individual patients. This volatility in utilization rates is due to fluctuations in the number of HAE attacks experienced by patients and the consistency with which patients treat their HAE attacks with KALBITOR.
•Development and license fees in the range of $7-9 million. These fees exclude all potential royalties which would be earned from licensees sales of LFRP product.
•Operating costs and expenses (cost of product sales, research and development expenses, and selling, general and administrative costs) to be in the range of $105-110 million.

http://seekingalpha.com/pr/12607976-dyax-corp-announces-four…

Gruß Oberländler

[Oberlaendler]

Nachtrag:

Dyax Announces Positive Results from Phase 1b Clinical Trial of DX-2930

Nachrichtenquelle: Business Wire (engl.)
31.03.2015, 22:01

Dyax Corp. (NASDAQ: DYAX) today announced positive safety, pharmacokinetic, biomarker, and efficacy results from the Phase 1b clinical study of their investigational product, DX-2930. Discovered by Dyax, DX-2930 is a fully human monoclonal antibody inhibitor of plasma kallikrein being developed for the prevention of hereditary angioedema (HAE) attacks.

The ongoing Phase 1b study is a multi-center, randomized, double-blind, placebo-controlled, multiple-ascending dose study designed to assess the safety, tolerability and pharmacokinetics of DX-2930 in HAE patients. An analysis of HAE attack rate was also conducted following a pre-specified statistical analysis plan. A total of 37 subjects were randomized to active drug or placebo in a 2:1 ratio across 4 dosing groups of 30, 100, 300, or 400 mg. Each subject received two doses of DX-2930 or placebo, separated by 14 days, and was followed for 15 weeks after the second dose.

DX-2930 was well tolerated at all dose levels. There were no deaths or subject discontinuations due to an adverse event. There were no serious adverse events in subjects treated with DX-2930 and no evidence of dose-limiting toxicity. There was no safety signal in treatment-emergent adverse events, clinical laboratory results, vital signs, or electrocardiograms. Subcutaneous injection was well tolerated.

Pharmacokinetic results demonstrated that DX-2930 has linear, dose-dependent exposure and a mean elimination half-life of approximately 14 days across all dose groups studied. Pharmacodynamic results from two different exploratory biomarker assays confirmed ex vivo plasma kallikrein inhibition in a dose- and time-dependent manner.

Primary proof-of-concept efficacy analyses were based on subjects in the 300 mg, 400 mg, and placebo dose groups who reported having at least 2 attacks in the 3 months prior to study entry. During the pre-specified, primary efficacy interval of 6 weeks (from days 8 to 50; corresponding to peak drug level), the HAE attack rate (adjusted for baseline attacks) was 0 in the 300 mg group and 0.045 attacks per week in the 400 mg group, compared to 0.37 attacks per week in the placebo group. This resulted in a 100% reduction for the 300 mg dose group as compared to placebo (P<0.0001), and an 88% reduction for the 400 mg dose group as compared to placebo (P=0.005). During this primary efficacy interval, 100% of subjects in the 300 mg group (P=0.026) and 82% of subjects in the 400 mg group (P=0.030) were attack-free compared with 27% of subjects in the placebo group. The study will be complete when all subjects in the 400 mg dose group finish the final safety assessments on study day 120.

Today Dyax also announced receipt of Fast Track designation from the U.S. Food and Drug Administration (FDA) for the investigation of DX-2930 for HAE.

“These data provide important clinical proof-of-concept, dose response and safety information in the target patient population,” said Burt Adelman, M.D., Executive Vice President of Research and Development and Chief Medical Officer at Dyax. “The study met all of its primary objectives, and notably, DX-2930 also demonstrated statistically significant reductions in attack rate compared to placebo, an important characteristic for a prophylactic treatment. We look forward to communicating these results to the FDA to ensure that our product development plan is supportive of drug approval. We plan to take full advantage of the opportunities that Fast Track designation allows in order to maximize the possibility of a more rapid path to approval.”

“The positive results from this trial are a significant milestone for Dyax and will be integral in guiding the future clinical development of DX-2930,” said Gustav Christensen, President and Chief Executive Officer of Dyax. “If approved, we believe that DX-2930, with its unique profile, is well positioned as a potential preventive treatment option for patients suffering from HAE.”

About DX-2930
DX-2930 is a novel, fully human monoclonal antibody inhibitor of plasma kallikrein (pKal) which is currently being developed as a subcutaneous injection for the prevention of HAE attacks. Uncontrolled pKal activity leads to excessive generation of bradykinin, a vasodilator thought to be responsible for the localized swelling, inflammation and pain characteristically associated with HAE.

http://www.wallstreet-online.de/nachricht/7505816-dyax-annou…

Schöne Entwicklung auf diese Meldung.

Gruß Oberländler

[Oberlaendler]

Naja, zu dem Kurs durchaus sinnvoll:

Dyax Announces Proposed Public Offering of 7,000,000 Shares of Common Stock
Business Wire

BURLINGTON, Mass.--(BUSINESS WIRE)--

Dyax Corp. (DYAX) today announced that it is offering, subject to market and other conditions, to sell 7,000,000 shares of its common stock in a proposed underwritten public offering. Dyax intends to grant the underwriters a 30-day option to purchase up to an additional 1,050,000 shares of its common stock. All shares to be sold in the offering are being sold by Dyax.

BofA Merrill Lynch and Cowen and Company are acting as lead book-running managers and RBC Capital Markets, LLC is acting as joint book-running manager for the offering. Needham & Company and Wedbush PacGrow are acting as co-managers.
http://finance.yahoo.com/news/dyax-announces-proposed-public…

zudem noch gefunden:
The analysts also pointed out that Dyax's partner Biogen Inc (NASDAQ: BIIB) was also expected to release top-line Phase 2 data of anti-LINGO trial for acute optic neuritis in early 2015 -- Dyax's partnership includes a 2.5 percent royalty rate.
http://finance.yahoo.com/news/rbc-capital-called-50-gain-113…

Hatte ich nicht auf dem Radar.

Gruß Oberländler

[Oberlaendler]

Also das habe ich selten erlebt, ziehen eine Kapitalerhöhung nach starkem Kursanstieg durch und der Kurs steigt weiter.

Dyax Shares Defy Gravity on Secondary Offering News
By Chris Lange April 7, 2015 10:45 am EDT

The newest hot stock in biotechnology is now giving everyone the chance to get a piece of it. Dyax Corp. (NASDAQ: DYAX) announced that it will have an offering of 7 million shares of its common stock, with an overallotment option for an additional 1.05 million shares. Considering the most recent closing price for Dyax at $28.61, the total offering — including the option — would be valued at $230.3 million.
http://247wallst.com/healthcare-business/2015/04/07/dyax-sha…

1:34 am Dyax prices 7,400,000 shares of common stock at $27.00 per share (DYAX)
http://finance.yahoo.com/news/inplay-briefing-com-055139997.…


Dyax Corp. Real Time Stock Quotes
$28.8445* 0.7895 2.81%
*Real-Time - data as of 4/8/2015 9:37:41 AM

Ob an den Übernahmegerüchten doch was dran ist?

Gruß Oberländler

[Oberlaendler]

Dyax Corp. Announces First Quarter 2015 Financial Results
Wed April 29, 2015 4:01 PM|Business Wire | About: DYAX

BURLINGTON, Mass.--(BUSINESS WIRE)-- Dyax Corp. (DYAX) (NASDAQ: DYAX) today announced financial results for the first quarter ended March 31, 2015. Dyax will host a webcast and conference call at 5:00 p.m. (ET) today to review financial results and provide updates regarding its key value drivers including DX-2930, KALBITOR® (ecallantide), and the Licensing and Funded Research Portfolio (LFRP).

Recent highlights include:
• Reported positive safety, pharmacokinetic, biomarker and proof-of-concept efficacy results from the Phase 1b study of DX-2930 in hereditary angioedema (HAE) patients;
• Receipt of Fast Track designation from the U.S. Food and Drug Administration (FDA) for the investigation of DX-2930 for HAE;
• KALBITOR net sales were $16.0 million for the first quarter of 2015;
• Dyaxs licensee Eli Lilly and Company received FDA approval for CYRAMZA® (ramucirumab), in a fourth indication, for use with FOLFIRI (irinotecan, folinic acid and 5-fluorouracil) in the second-line treatment of metastatic colorectal cancer; and
• Cash, cash equivalents and investments at March 31, 2015 totaled $181.9 million, excluding net proceeds of $215.8 million from the April 2015 public offering of common stock.

Dyax achieved several milestones in the early months of 2015, said Gustav Christensen, President and Chief Executive Officer of Dyax. DX-2930, our lead development candidate being investigated for the prevention of HAE attacks, demonstrated impressive Phase 1b results. This study provided important clinical proof-of-concept, dose response and safety information in HAE patients. We also strengthened our balance sheet with our recent equity offering, the net proceeds of which totaled approximately $216 million. The KALBITOR business and the LFRP continue to generate cash flow which supports our development programs. We have made tremendous progress at Dyax and are well positioned for long-term growth.

2015 First Quarter Financial Results

Total revenues for the first quarter ended March 31, 2015 were $20.4 million, as compared to $14.1 million for the comparable quarter in 2014. These include KALBITOR net sales of $16.0 million and $12.5 million for the first quarter of 2015 and 2014, respectively. The 2015 first quarter revenues also included royalties of approximately $3.4 million based on sales of Eli Lilly and Companys CYRAMZA® (ramucirumab), the first approved therapeutic product from the LFRP.

Dyax expects quarterly and annual revenues to fluctuate. For KALBITOR, revenue fluctuations are primarily due to variability in the rate at which individual patients utilize KALBITOR to treat attacks (particularly among patients who experience and treat frequent attacks), as well as the timing and amount of distributor demand. For the LFRP, revenue fluctuations may be caused by the timing of any future milestone payments, the clinical activities of our licensees, and the timing and completion of contractual commitments.

Cost of product sales for KALBITOR for the first quarter of 2015 were $2.1 million, as compared to $785,000 for the same quarter in 2014. Cost of royalties for the three months ended March 31, 2015 were $1.7 million, consisting of pass-through fees under an LFRP cross-licensing arrangement.

Research and development expenses at Dyax are primarily related to the following: 1) the DX-2930 development program, together with other research programs; 2) KALBITOR medical support and post-marketing requirements; and 3) pass-through license fees paid by Dyax under the LFRP. Research and development expenses for the first quarter of 2015 were $10.2 million, as compared to $6.9 million for the comparable quarter in 2014. The 2015 increase is primarily related to costs associated with DX-2930 development.

Selling, general and administrative expenses were $11.0 million for the first quarter of 2015, as compared to $9.5 million for the comparable quarter in 2014.

For the quarter ended March 31, 2015, Dyax reported a net loss of $7.3 million, or $0.05 per share attributable to common stockholders, as compared to a net loss of $5.7 million, or $0.05 per share, for the comparable quarter in 2014.

As of March 31, 2015, Dyax had cash, cash equivalents, and investments totaling $181.9 million, exclusive of restricted cash and $215.8 million of net proceeds from the April 2015 public offering of common stock.

Financial Guidance

Dyax has re-iterated its financial guidance for 2015.

Revenue guidance includes two components:
• KALBITOR net sales in the range of $60-70 million, reflecting the Company's expectation that quarterly and annual KALBITOR net sales will fluctuate due to continued volatility in the level of KALBITOR utilization for individual patients. This volatility in utilization rates is due to fluctuations in the number of HAE attacks experienced by patients and the consistency with which patients treat their HAE attacks with KALBITOR.
• Development and license fees in the range of $7-9 million. These fees exclude all potential royalties which would be earned from licensees' sales of LFRP product.

Operating costs and expenses (cost of product sales, research and development expenses, and selling, general and administrative costs) to be in the range of $105-110 million.
http://seekingalpha.com/pr/13319106-dyax-corp-announces-firs…

Gruß Oberländler

[RTLOLDY]

Dyax Gets FDA Breakthrough Therapy Designation for DX-2930

By Marilyn Mullen
Tuesday, 07 July 2015 15:06

Dyax Corp. (NASDAQ : DYAX) has confirmed that U.S. Food and Drug Administration has given approval to Breakthrough Therapy designation for investigation of DX-2930 for hereditary angioedema.

http://www.biomedreports.com/20150707228804/dyax-gets-fda-br…

[Oberlaendler]

Dyax Corp. Receives Positive Opinion for Orphan Medicinal Product Designation in the European Union for DX-2930 for the Treatment of Hereditary Angioedema
Wed September 30, 2015 7:12 AM|Business Wire | About: DYAX

BURLINGTON, Mass.--(BUSINESS WIRE)-- Dyax Corp. (DYAX) today announced that the European Medicines Agency (EMA) Committee for Orphan Medicinal Products (COMP) has adopted a positive opinion recommending DX-2930 for designation as an orphan medicinal product for the treatment of hereditary angioedema (HAE). Dyax is developing DX-2930, an investigational fully human monoclonal antibody inhibitor of plasma kallikrein (pKal), as a subcutaneous injection for prevention of HAE attacks.

There is a significant unmet medical need for a prophylactic treatment option for HAE, a potentially life-threatening condition, said Burt Adelman, M.D., Executive Vice President of Research and Development and Chief Medical Officer at Dyax. Our regulatory strategy supports our global development plan for DX-2930 and our goal for providing an improved therapy for patients with HAE around the world. We look forward to initiating a Phase 3 clinical trial for DX-2930 for HAE prophylaxis by year-end 2015.

Under the EMA guidelines, the COMP adopts an opinion on the granting of orphan drug designation, after which the opinion is submitted to the European Commission (EC) for the endorsement of the opinion. Orphan drug designation by the EC provides regulatory and financial incentives for companies to develop and market therapies that treat a life-threatening or chronically debilitating condition affecting no more than five in 10,000 persons in the EU, and where no satisfactory treatment exists, or where a treatment exists, a new treatment may provide a significant benefit to patients affected by the condition. Additionally, this designation provides up to 10 years of market exclusivity if the product candidate is approved for marketing in the European Union and the orphan designation is maintained. Orphan status also permits EMA assistance in optimizing the candidates clinical development through participation in clinical trial design and preparation of the product marketing application. Orphan Medicinal Product designation does not change the standards for approval.

DX-2930 has previously been granted Orphan Drug, Fast Track and Breakthrough Therapy designations from the U.S. Food and Drug Administration (FDA) for the prevention of attacks of HAE.

About DX-2930

DX-2930 is a novel, fully human monoclonal antibody inhibitor of pKal which is currently being developed as a subcutaneous injection for the prevention of HAE attacks. Uncontrolled pKal activity leads to excessive generation of bradykinin, a vasodilator thought to be responsible for the localized swelling, inflammation and pain characteristically associated with HAE.

About HAE

HAE is a rare acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, gastrointestinal tract, genitalia, and larynx. HAE is caused by low or dysfunctional levels of C1 esterase inhibitor (C1-INH), a naturally occurring molecule that inhibits plasma kallikrein, a key mediator of inflammation, and other serine proteases in the blood. HAE is estimated to affect up to 1 in 50,000 individuals. Learn more at www.HAEHope.com.

About Dyax

Dyax is a biopharmaceutical company focused on the development and commercialization of novel biotherapeutics for unmet medical needs. The Company is developing DX-2930, a fully human monoclonal antibody, for the prevention of HAE attacks. In March 2015, the Company reported positive safety, pharmacokinetic, biomarker and proof-of-concept efficacy results from its Phase 1b clinical trial of DX-2930 in HAE patients. Additionally, Dyax markets KALBITOR® (ecallantide) for the treatment of acute attacks of HAE in patients 12 years of age and older.

Both DX-2930 and KALBITOR were identified using Dyax's proprietary phage display technology. Dyax has broadly licensed this technology under its Licensing and Funded Research Portfolio (LFRP). The current portfolio includes one FDA approved product, Eli Lilly and Companys CYRAMZA® (ramucirumab), for which Dyax receives royalties, and multiple product candidates in various stages of clinical development for which the Company is eligible to receive future milestones and royalties.
http://seekingalpha.com/pr/14827696-dyax-corp-receives-posit…

Bisher hat es der Markt noch nicht gemerkt, oder es wird ignoriert.

Gruß Oberländler

[Oberlaendler]

Pharmakonzern Shire will US-Biotechfirma Dyax kaufen
Nachrichtenagentur: dpa-AFX
| 02.11.2015, 12:44 | 113 | 0
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DUBLIN (dpa-AFX) - In der Pharmabranche bahnt sich die nächste Milliardenübernahme an: Der britisch-irische Pharmakonzern Shire will die US-Biotechnologiegesellschaft Dyax kaufen, teilten die Gesellschaften am Montag gemeinsam mit. Der Gesamtwert der Transaktion liege bei rund 5,9 Milliarden US-Dollar. Je Aktie betrage der gebotene Preis 37,30 Dollar in bar. Je nach Erfolg wird eine weitere Zahlung fällig.

Shire sichert sich so den Zugriff auf den vielversprechenden Produktkandidaten DX-2930. Dieser steht vor der abschließenden klinischen Prüfungsphase und könnte pro Jahr bis zu zwei Milliarden Dollar an Umsatz bringen, hieß es. Mit dem Mittel soll die seltene Erbkrankheit hereditäre Angioödem bekämpft werden. Diese führt zu Haut- und Organschwellungen. Mit einem Abschluss der Transaktion werde in der ersten Jahreshälfte 2016 gerechnet, wenn die Behörden zustimmten./jha/fbr
http://www.wallstreet-online.de/nachricht/8079117-pharmakonz…



Schönen Abend
Oberländler

[Oberlaendler]

Dyax shareholders vote tomorrow on Shire bid
Jan 20 2016, 15:46 ET | About: Dyax Corp. (DYAX) | By: Douglas W. House, SA News Editor

Tomorrow is the special meeting of (DYAX +0.1%) shareholders at which they will vote on Shire's (SHPG -1.7%) $37.30 per share bid ($5.9B). Overwhelming support is expected.

Previously: Shire buys Dyax for $5.9B in cash (Nov. 2, 2015)
http://seekingalpha.com/news/3040686-dyax-shareholders-vote-…

Gruß Oberländler

[Oberlaendler]

Es sieht gut aus für einen Nachschlag (für DX-2930 - lanadelumab - und die eingebuchten CVR):

Shire's lanadelumab successful in late-stage HAE study; shares ahead 6% premarket
May 18, 2017 7:58 AM ET|About: Shire PLC (SHPG)|By: Douglas W. House, SA News Editor

•Shire plc (NASDAQ:SHPG) is up 6% premarket on increased volume in response to its announcement of positive results from a Phase 3 clinical trial, HELP, assessing lanadelumab for the treatment of hereditary angioedema (HAE), an inherited disorder characterized by recurrent swelling in the extremities, GI tract and upper airways.

•The study met it s primary endpoint and all secondary endpoints. Patients receiving 300 mg of lanadelumab once every two weeks experienced a statistically significant reduction in average HAE attack frequency of 87% compared to placebo (p<0.001). The trial was representative of the full HAE disease spectrum.

•The company intends to file its U.S. marketing application in Q4 or Q1 2018. It has Orphan Drug and Breakthrough Therapy status in the U.S. and Orphan Drug status in the EU.

•Lanadelumab is a human monoclonal antibody that binds to (inhibits) an enzyme called plasma kallikrein that plays a key role in blood pressure regulation, thrombosis and inflammation.
https://seekingalpha.com/news/3268414-shires-lanadelumab-suc…

Gruß Oberländler

[Oberlaendler]

FDA accepts Shire's lanadelumab marketing application for HAE under accelerated review status
Feb. 23, 2018 6:43 AM ET|About: Shire PLC (SHPG)|By: Douglas W. House, SA News Editor

•The FDA accepts under Priority Review Shire plc's (NASDAQ:SHPG) marketing application seeking approval for lanadelumab for the prevention of attacks in patients at least 12 years old with hereditary angioedema (HAE).
•The agency's action date is August 26. ...
https://seekingalpha.com/news/3333718-fda-accepts-shires-lan…

Mal sehen, ob es als Abschluss auf ein ohnehin sehr gutes Invest im August zusätzliches Urlaubsgeld für die CVRs gibt, wäre eine netter Zuschlag.

Gruß Oberländler