DYAX - Sector: Healthcare --- Industry: Biotechnology & Drugs

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Be back shortly with charts........

Profile Get Profile for:  

Dyax Corp.
300 Technology Square
Cambridge, MA 02139
Phone: 617-225-2500
Fax: 617-225-2501
Web Site: http://www.dyax.com

DETAILS  
Index Membership: N/A
Sector: Healthcare
Industry: Biotechnology
Full Time Employees: 131


BUSINESS SUMMARY  
Dyax Corp. engages in the discovery, development, and commercialization of antibodies, small proteins, and peptides as therapeutic products, particularly in the areas of inflammation and oncology. As of December 31, 2004, the company had two product candidates in, or entering into, Phase II clinical trials for three indications. DX-88 is being studied for the treatment of both hereditary angioedema and for the prevention of blood loss, and other systemic inflammatory responses in on-pump open-heart surgery and other surgical indications, and DX-890 is being studied for the treatment of cystic fibrosis. In collaboration with Genzyme Corporation, Dyax is conducting an open-label, repeat dose Phase II clinical trial of DX-88. It has completed a Phase I/II study of DX-88 in the United States in patients undergoing coronary artery bypass grafting surgery. The company in collaboration with Debiopharm S.A. for DX-890 has completed two Phase IIa clinical trials, one in adults and one in pediatric cystic fibrosis patients. It uses its proprietary, patented technology, known as phage display, to identify a range of compounds consisting of monoclonal antibodies, small proteins, and peptides with the potential for the treatment of various diseases. The company has 12 discovery programs underway: 7 in oncology, which are focused on the discovery and development of therapies that fight cancer; 4 focused on targets that are believed to be mediators of inflammation; and 1 program focused on an infectious disease target. The company has collaboration agreements with AstraZeneca AB; Dendreon Corporation; Baxter Healthcare S.A.; Biogen Idec, Inc.; Inhibitex, Inc.; and Syntonix Pharmaceuticals, Inc. Dyax was incorporated in 1989 and is headquartered in Cambridge, Massachusetts.

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AP
Dyax Stock Up on Beginning of Drug Study
Thursday December 8, 12:51 pm ET 
Dyax Shares Rise After Late-Stage Study Commencement, Optimistic Analyst Outlook


NEW YORK (AP) -- Shares of Dyax Corp. soared Thursday after the biotech drug developer announced it began a late-stage study of its lead drug candidate, and an investment bank called worries about potential competitors "overblown."

The DX-88 drug aims to treat a rare inflammatory condition called hereditary angioedema, a potentially fatal disease that causes swelling of the limbs and internal organs. The Food and Drug Administration has given DX-88 "orphan drug" status, a label which gives the company seven years of exclusive selling rights on approval.

The start of the Phase III trial triggers a $3 million milestone payment to Dyax from its partner Genzyme Corp. Dyax will receive an additional $10 million if the drug is approved, along with 50 percent of profits.

Earlier in the morning, JPMorgan Chase & Co. predicted the trial would start by the end of the month. The firm added that while four potential competitors in development are a real threat, the stock has been discounted more than enough to account for this possibility. Analyst Eric Hoffman started Cambridge, Mass.-based Dyax at "Overweight."

Dyax shares recently rose 54 cents, or 12.5 percent, to $4.85 in afternoon trading on the Nasdaq. Shares of Genzyme, also based in Cambridge, rose 65 cents to $74.45 on the Nasdaq.

The drug has been plagued by safety concerns, and Dyax suffered a disappointment when its data from a Phase II study were insufficient to apply for FDA approval. But Hoffman said Dyax has addressed these issues with a different delivery method and the larger Phase III study.

Hoffman also noted that Dyax has the "partner of choice" for rare genetic disorders in Genzyme, which gets a large chunk of its revenue from orphan drugs. He predicted that the two companies will launch DX-88 in 2007.

Dyax is also testing DX-88 as a treatment for blood loss during heart-bypass surgery.
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Other News Articles Link:......http://finance.yahoo.com/q/h?s=DYAX

• InPlay: Dyax and Genzyme initiate pivotal phase III trial of subcutaneously administered DX-88 for the treatment of hereditary angioedema
Briefing.com (Thu 10:17am)

• Dyax and Genzyme Initiate Pivotal Phase III Trial of Subcutaneously Administered DX-88 for the Treatment of Hereditary Angioedema
Business Wire (Thu 10:17am)

• Coverage initiated on Dyax by JP Morgan
Briefing.com (Thu 6:50am) 

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With the news. Looks like picked up some good support @ the $4 area.
Broke through the 50 and 200-dma.
Volume up nicely.
Volume: 1,185,922
Avg Volume (3m): 159,572

Support @ $4.20...4.45...4.70
Resistance @ $4.98...5.15...5.41

Technicals
MACD is Bullish
Stochastic is Neutral......Coming out of oversold.
Close Above the 50-day EMA
Gap Up
Percentage Gainer

Last Price Quote is:
12.08%above 13-day EMA
6.44%above 50-day EMA
RS Rating: 13 

Fundamentals
Coverage Initiated: Overweight

Key Data:
Market Cap (M): $157.42 
P/E Ratio: NA 
PEG Ratio: -1.6 
Next Earnings: 02/21/2006
Last Analyst Rating: Overweight

[sebfr]

Great find...

I find DYAX as Stock of the day....Applaud...Buy this stock

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Dyax soars on rival's drug setback...

BOSTON (MarketWatch) -- Shares of biotech group Dyax Corp. rocketed Friday on word that a late-stage clinical trial for a potential competitor to its lead drug DX-88 had come up empty-handed.
Shares of Dyax (DYAX : dyax corp com
Last: 3.40+0.53+18.47%

Dyax's DX-88, also for the treatment of HAE, is currently in Phase III clinical trials. The drug's application hit a significant hurdle in August, however, when regulators requested an additional clinical trial.
Dyax and partner Genzyme Corp. (GENZ : Genzyme Corporation
Last: 65.60-0.22-0.33%

in August that DX-88 should receive regulatory approval during the second half of 2008.
HAE is a potentially life-threatening genetic disease that causes swelling attacks throughout the body. About 10,000 people have been diagnosed with the condition in Europe and the U.S.,
Shares of Genzyme closed marginally lower at $65.60.

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Triple Bottom ( Reversal )

52wk Range: 2.63 - 6.38

Volume: 599,141
Avg Vol (3m): 112,182

Technicals
Gap Up
Percentage Gainer

Last Price Quote is:
14.63%above 13-day EMA
11.73%above 50-day EMA
RS Rating: 86 

Fundamentals
Key Data:
Market Cap (M): $132.79 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 10/25/2006
Last Analyst Rating: Outperform

Triple Bottom (Reversal)
The triple bottom is a reversal pattern made up of three equal lows followed by a breakout above resistance. While this pattern can form over just a few months, it is usually a long-term pattern that covers many months. Because of its long-term nature, weekly charts can be best suited for analysis.

As the triple bottom develops, it can start to resemble a number of patterns. Before the third low forms, the pattern may look like a double bottom. Three equal lows can also be found in a descending triangle or rectangle. Of these patterns mentioned, only the descending triangle has bearish overtones; the others are neutral until a breakout occurs. Similarly, the triple bottom should also be treated as a neutral pattern until a breakout occurs. The ability to hold support is bullish, but demand has not won the battle until resistance is broken. Volume on the last advance can sometimes yield a clue. If there is a sharp increase in volume and momentum, then the chances of a breakout increase.

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Aftermarket Movers...    

DYAX CORP (NasdaqGM:DYAX) Delayed quote data 

After Hours: $5.78  +$1.78 or (44.50%) as of 5:45pm ET on 04/12/07




Aftermarket Movers:
Thursday April 12, 5:45 pm ET 
Dyax Soars on Positive Drug News

NEW YORK (AP) --

On the winning side, shares of biopharmaceutical company Dyax Corp. soared after a leading drug met a goal in a late phase trial without serious side effects.

The Cambridge, Mass.-based company said it has an ongoing study to confirm the findings and said it will be well-positioned to apply for regulatory approval.

The DX-88 drug aims to treat a rare inflammatory condition called hereditary angioedema, a potentially fatal disease that causes swelling of the limbs and internal organs.

Shares jumped $1.68, or 42 percent, to $5.68 in late trading after closing at $4 on the Nasdaq Stock Market.



52wk Range: 2.63 - 5.09
Volume: 1,483,054
Avg Vol (3m): 241,765

Technicals
Close Below the 13-day MA

Last Price Quote is:
-2.55%below 13-day MA
4.73%above 50-day MA
RS Rating: 92 

Fundamentals
Earnings Expected on Apr 25

Key Data:
Market Cap (M): $148.51 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 04/25/2007
Last Analyst Rating: Buy

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Ahead of the Bell: DYAX Soars.......
Premarket Movers: DYAX Leaps.......
DYAX DX-88 for Hereditary Angioedema Meets Primary and Secondary...

Morgan Joseph reiterates Buy. Target $6 to $8. Morgan Joseph raises their tgt to $8 from $6 noting yesterday, after market close, Dyax reported Ph III EDEMA3 results hitting both primary and secondary endpoints for DX-88 in HAE. The firm says Dyax's main competitor, Jerini AG is developing Icatibant to treat H.A.E attacks. They believe the risk/reward profile now favors Dyax, as Jerini did not reach statistical significance in one of its two pivotal phase III trials, and although the co plans to utilize a combined analysis of the two trials, the firm does not believe this approach is appropriate since the two trials had different designs and each had its own S.P.A.

52wk Range: 2.63 - 5.09
Volume: 15,626,327
Avg Vol (3m): 262,932

Technicals
Record Price High.......
Most Actives
Record Price Break Out.....
Gap Up
Percentage Gainer
Price Gainer

Last Price Quote is:
59.18%above 13-day MA
70.14%above 50-day MA
RS Rating: 92 

Fundamentals
Earnings Expected on Apr 25

Key Data:
Market Cap (M): $148.51 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 04/25/2007
Last Analyst Rating: Buy

[setravis]

Good chart.......
Should go to at least $8.00 JMHO of course... 
The 1 Year chart below has a great looking BreakOut from
that Ascending Triangle (continuation) Pattern.

Dyax (DYAX) reported its hereditary angioedema drug DX-88 produced positive data in a Phase III trial. DX-88, a recombinant, plasma kallikrein inhibitor, treats acute attacks of HAE, a genetic disease characterized by episodes of swelling and inflammation.
The drug produced a statistically significant reduction in symptom scores in a shorter period of time than placebo.


Technicals
Close Above the 50-day MA
Close Above the 13-day MA
Percentage Gainer

Last Price Quote is:
3.59%above 13-day MA
5.57%above 50-day MA
RS Rating: 89 

Fundamentals
Key Data:
Market Cap (M): $208.93 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 07/25/2007
Last Analyst Rating: Buy

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updated chart scene.......

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Dyax's response accepted by FDA for DX-88
Dyax's response for more information on DX-88 gets FDA acceptance, decision expected by Dec.
On Monday June 8, 2009, 9:36 am EDT

CAMBRIDGE, Mass. (AP) -- Dyax Corp. said the Food and Drug Administration accepted the company's response to a request for more information on the drug candidate DX-88.

In March, the agency asked for more information, specifically on a plan to evaluate and mitigate risks of the drug. The agency also requested more data on chemistry, manufacturing and controls. DX-88 is intended to treat acute attacks of hereditary angioedema, a protein deficiency disease that can cause dangerous swelling under the skin.

In February, an FDA panel recommended that the drug be approved in a vote of six to five, with two panelists abstaining.

Dyax said the FDA is expected to make a decision on the drug candidate by Dec. 1.

Shares of Dyax rose 23 cents, or 12 percent, to $2.10 in morning trading.
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About to take off...closed above the 50-day MA
This is about to go, and when it does it could very likely double.

52wk Range: 1.55 - 5.35
Volume: 2,204,546
Avg Vol (3m): 302,046

Technicals
Percentage Gainer

RS Rating: 7 

Fundamentals
Key Data:
Market Cap (M): $119.38 
P/E Ratio: NA 
PEG Ratio: N/A 
Next Earnings: 07/15/2009
Last Analyst Rating: Sell

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CAMBRIDGE, Mass., Jun 08, 2009 (BUSINESS WIRE) -- Dyax Corp. (DYAX, Trade) announced today that the U.S. Food and Drug Administration (FDA) has accepted for review the Company's submission in response to the FDA's March 2009 Complete Response letter which outlined requirements for approval of DX-88 for the treatment of acute attacks of hereditary angioedema (HAE). In connection with the acceptance, the FDA assigned Dyax's BLA a new Prescription Drug User Fee Act (PDUFA) action date of December 1, 2009.

In the Complete Response letter, received March 25, 2009, the FDA requested submission of a Risk Evaluation and Mitigation Strategy (REMS) and additional information with respect to the chemistry, manufacturing and controls (CMC) section of the BLA. Dyax believes these issues are fully addressed in its reply, submitted June 1, 2009.

"We are confident that our proposed REMS for assuring the safe use of DX-88 and our response to other FDA requests thoroughly address the matters raised in the agency's letter," said Gustav A. Christensen, President and Chief Executive Officer of Dyax. "We will continue to work with the FDA during this final stage of review for DX-88 so this important therapy can be brought as expeditiously as possible to patients suffering from this devastating disease."

About DX-88 for HAE

The recombinant, small protein, DX-88 (ecallantide), was discovered utilizing Dyax's proprietary phage display technology and is being evaluated as a subcutaneous therapy for treating acute HAE attacks. DX-88 is a potent and selective plasma kallikrein inhibitor, a key mediator of inflammation in angioedema, and has demonstrated effectiveness for treating all attack locations, included life-threatening laryngeal attacks. DX-88 has been evaluated in five clinical trials for HAE, including two Phase 3 placebo-controlled trials, which represent the largest placebo-controlled evaluation of any therapeutic for this indication. A continuation trial is ongoing.

About HAE

Hereditary angioedema (HAE) is an acute inflammatory condition characterized by episodes of severe, often painful swelling affecting the extremities, the gastrointestinal tract, the genitalia, and in potentially life-threatening cases, the 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.

About Dyax

Dyax is focused on advancing novel biotherapeutics for unmet medical needs, with an emphasis on inflammatory and oncology indications. Dyax utilizes its proprietary drug discovery technology to identify antibody, small protein and peptide compounds for clinical development. Dyax's lead product candidate is DX-88 (ecallantide), a recombinant small protein that is currently being evaluated for its therapeutic potential in two separate indications. On June 1, 2009, Dyax submitted a response to the FDA's Complete Response letter regarding the review of Dyax's Biologics License Application (BLA) of DX-88 for the treatment of hereditary angioedema (HAE). The FDA accepted the submission and assigned Dyax's BLA a new Prescription Drug User Fee Act (PDUFA) action date of December 1, 2009. DX-88 has orphan drug designation in the U.S. and E.U., as well as Fast Track designation in the U.S., for this indication. Additionally, DX-88 is being evaluated in Phase 2 trials for the prevention of blood loss during on-pump cardiothoracic surgery (CTS), which are being conducted by Dyax's partner, Cubist Pharmaceuticals. Dyax licensed to Cubist the intravenous formulation of DX-88 for surgical indications in North America and Europe. DX-88 and other compounds in Dyax's pipeline were identified using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly with over 70 revenue generating licenses and collaborations for therapeutic discovery, as well as in non-core areas such as affinity separations, diagnostic imaging, and research reagents. Dyax is headquartered in Cambridge, Massachusetts. For online information about Dyax Corp., please visit www.dyax.com.

Dyax Disclaimer

This press release contains forward-looking statements, including statements regarding the timing and prospects for review and FDA approval of the BLA for DX-88 for HAE, including the sufficiency of Dyax's response to the FDA's Complete Response letter. Statements that are not historical facts are based on Dyax's current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax competes. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements. Important factors which may affect the prospects for review and FDA approval of the BLA for DX-88 for HAE include the risks that: DX-88 could take a significantly longer time to gain regulatory approval than Dyax expects or may never gain approval; others may develop technologies or products superior to DX-88 or that receive regulatory approval and are on the market before DX-88; DX-88 may not gain market acceptance; Dyax is dependent on the expertise, effort, priorities and contractual obligations of third parties in the manufacture, marketing, sales and distribution of DX-88; and other risk factors described or referred to Item 1A, "Risk Factors" in Dyax's most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.

Dyax and the Dyax logo are registered trademarks of Dyax Corp.

SOURCE: Dyax Corp.


 
Dyax   
Ivana Magovcevic-Liebisch, 617-250-5759   
Executive Vice President of Administration   
and General Counsel   
[email protected]   
or   
Nicole Jones, 617-250-5744   
Director, Investor Relations and   
Corporate Communications   
[email protected] 

Copyright Business Wire 2009

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long time no post...

In Play
12:46PM Dyax and Five Prime Therapeutics announces that they have entered into an antibody funded research agreement for the discovery of therapeutic antibodies (DYAX) 1.93 +0.11 : Under the terms of this agreement, Dyax will utilize its proprietary "gold-standard" phage display technology to identify therapeutic antibodies for multiple targets from FivePrime, with an option to expand the scope of the collaboration to include additional targets. Dyax will receive technology license fees and full-time employee payments from FivePrime for the funded research as well as clinical and sales milestone payments and royalties on net sales that may result from FivePrime's development and commercialization of antibodies from Dyax's libraries.

Day's Range: 1.74 - 1.95
52wk Range: 1.44 - 3.67
Volume: 3,328,177
Avg Vol (3m): 450,825
Market Cap: 189.52M
P/E (ttm): N/A
EPS (ttm): -0.26
Div & Yield: N/A (N/A)

Technicals
Record Volume
RS Rating: 25 

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InPlay:
DYAX: U.S. Patent Office Grants Co's request for an interference with U.S. Patent No. 7,700,302 issued to AdimabBriefing.com(Wed, May 11)

Closed above the 200-day MA by a penny...

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CAMBRIDGE, Mass., May 11, 2011 (BUSINESS WIRE) -- Dyax Corp. (DYAX), a developer of novel biotherapeutics for unmet medical needs, announced today that the United States Patent and Trademark Office (USPTO) Board of Patent Appeals and Interferences has granted the Company's suggestion to declare an interference between Dyax's U.S. Patent Application No. 12/625,337 and Adimab LLC's U.S. Patent No. 7,700,302 (the '302 patent), both of which cover methods of displaying a library of antibodies on the surface of yeast cells.

A patent interference is a proceeding conducted by the USPTO to determine priority when two or more parties claim patent rights to the same technology. The U.S. patent system awards patents to the first party to invent a particular technology. The USPTO presumes that the parties made their inventions in the order of the filing dates for their patent applications. The party with the earliest filing date is referred to as the senior party, while the party with the later filing date is referred to as the junior party.

In this matter, the USPTO has determined that Dyax is the senior party and Adimab is the junior party, as the subject matter claimed in the '302 patent was disclosed in a Dyax patent application filed 16 months before the corresponding Adimab application. As the junior party, Adimab bears the burden of proof and will have to clearly demonstrate that it invented the technology at issue before Dyax.

"We believe that Adimab's '302 patent should not have issued and that the technology central to Adimab's antibody display technology is, in fact, a Dyax invention," stated Ivana Magovcevic-Liebisch, PhD, JD, Executive Vice President Corporate Development and General Counsel. "Dyax technology has long been the industry "gold standard" for the discovery and optimization of therapeutic antibodies. Our investment in innovation is what sustains this leadership position. It is central to Dyax and to the life science industry that innovation, and the investment that sustains it, are protected."

In preparation for the interference, the USPTO has already determined that the claims of Dyax's patent application are allowable and that Adimab's '302 patent is not entitled to the priority date of the three earliest applications Adimab listed on the face of the '302 patent (all of which were filed after Dyax's earliest application).

About Dyax

Dyax is a fully integrated biopharmaceutical company focused on discovering, developing and commercializing novel biotherapeutics for unmet medical needs. The Company's lead product, ecallantide, has been approved under the brand name KALBITOR(R) in the United States for the treatment of acute attacks of hereditary angioedema (HAE) in patients 16 years of age and older.

Dyax is commercializing KALBITOR in the United States independently, and establishing strategic partnerships to develop and commercialize ecallantide for the treatment of HAE in key regions worldwide. Currently, Dyax has partnership agreements for regions including Europe, Japan, Russia, the Middle East, Israel, North Africa, Australia and New Zealand. The company is also exploring other potential indications for ecallantide, either alone or through partnerships, including drug-induced angioedema and retinal vein occlusion-induced macular edema.

Ecallantide and other compounds in Dyax's pipeline were identified using its patented phage display technology, which rapidly selects compounds that bind with high affinity and specificity to therapeutic targets. Dyax leverages this technology broadly through the LFRP, which has approximately 75 revenue generating licenses and collaborations for therapeutic discovery, as well as for affinity separations, diagnostic imaging, and research reagents. The success of the Company's LFRP royalty portfolio is illustrated by the program's advanced licensee pipeline that includes 17 candidates in clinical development. Of those candidates, four are in Phase 3 clinical trials, four are in Phase 2 and nine are in Phase 1.

Disclaimer

This press release contains forward-looking statements, including statements regarding Dyax's position in its interference proceedings with Adimab and the potential outcome of such proceedings. Statements that are not historical facts are based on Dyax's current expectations, beliefs, assumptions, estimates, forecasts and projections about the industry and markets in which Dyax and its licensees compete. The statements contained in this release are not guarantees of future performance and involve certain risks, uncertainties and assumptions, which are difficult to predict. Therefore, actual outcomes and results may differ materially from what is expressed in such forward-looking statements because of uncertainties involved in any future projections, as well as uncertainties associated with various activities and aspects of Dyax's business, including risks and uncertainties associated with proceedings to obtain, enforce and defend our intellectual property rights and other risk factors described or referred to Item 1A, "Risk Factors" in Dyax's most recent Annual Report on Form 10-K and other periodic reports filed with the Securities and Exchange Commission. Dyax cautions investors not to place undue reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this release, and Dyax undertakes no obligations to update or revise these statements, except as may be required by law.

Dyax, the Dyax logo and KALBITOR are registered trademarks of Dyax Corp.

SOURCE: Dyax Corp.


Dyax Corp.
Ivana Magovcevic-Liebisch, 617-250-5759
Executive Vice President Corporate
Development and General Counsel
[email protected]
or
Nicole Jones, 617-250-5744
Director, Investor Relations and
Corporate Communications
[email protected]