Pharming Group NL0010391025

Ruconest overbodig dankzij Dyax...???

1. DeZwarteRidder 8 juli 2015 13:15

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   Dyax gets an FDA 'breakthrough' tag for its rare disease drug
   July 7, 2015 | By Damian Garde
   
   The FDA has conferred its coveted breakthrough-therapy designation to Dyax's ($DYAX) lead pipeline asset, an antibody designed to treat flare-ups of the rare hereditary angioedema (HAE).
   
   Breakthrough status guarantees Dyax access to senior staff as it develops DX-2930, giving the biotech an inside track at the agency and making the treatment eligible for a shortened review process once the biotech submits it to regulators. HAE, which affects about 1 in every 50,000 people, is an inflammatory ailment that results in bouts of severe swelling.
   
   Dyax's subcutaneous treatment, which blocks the enzyme plasma kallikrein, significantly lowered patients' average number of weekly HAE attacks compared with placebo in Phase Ib results disclosed in March. The antibody also met all of its safety, tolerability and pharmacokinetic goals, the company said, and Dyax is planning to launch a Phase II study later this year.
   
   The injection's initial success sent Dyax's shares up more than 50% in March, and the biotech quickly capitalized with a $230 million public offering, filling its coffers to fund the next stage of DX-2930's development.
   
   Headquartered in Burlington, MA, Dyax is working to usurp its own Kalbitor, a subcutaneous treatment for HAE attacks approved in 2009. Since that treatment's debut, rivals Shire ($SHPG) and Salix, now part of Valeant Pharmaceuticals ($VRX), have launched HAE treatments of their own, and Dyax pulls in about $65 million a year from its sole marketed therapy.
   
   Beyond its top prospect, Dyax is looking into plasma kallikrein-related diseases beyond HAE, investigating whether its proprietary technology has a future in diabetic macular edema, inflammatory bowel disease, rheumatoid arthritis and other disorders.
   
   "Receipt of Breakthrough Therapy designation is a key milestone for the DX-2930 development program," said Burt Adelman, the chief medical officer at Dyax. "We look forward to taking full advantage of the opportunities that Breakthrough Therapy designation allows in order to maximize the possibility of a rapid path to approval."
   
2. mamaloe 8 juli 2015 13:32

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   • mamaloe

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   Inwisselen voor AEX of AMX fondsen, is een hele goede optie. Dan weet je zeker dat je je verlies kan terugpakken.
3. DeZwarteRidder 27 juli 2015 16:43

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   Dyax Hereditary Angioedema Drug Gets Breakthrough Status
   
   by Zacks Equity Research Published on July 08, 2015 | 0
   
   Dyax Corp. (DYAX - Snapshot Report) announced that the FDA has granted Breakthrough Therapy designation to its fully human monoclonal antibody inhibitor of plasma kallikrein, DX-2930, being developed as a subcutaneous injection for the prevention of hereditary angioedema (HAE) attacks.
   
   We note that Breakthrough Therapy designation is granted by the FDA to expedite the development and review of a candidate that is believed to have the potential to treat a serious or life-threatening disease or condition and which may show substantial improvement over existing therapies on the basis of preliminary clinical evidence. Additionally, Breakthrough Therapy status makes the candidate eligible for certain benefits including access to the FDA's senior managers and more intensive guidance from the agency. However, this designation does not alter the standards for marketing approval of the candidate.
   
   Earlier this year, the company had announced positive results from a phase Ib study on DX-2930. The candidate met all its primary objectives including safety, tolerability and pharmacokinetics. Given the data, the company intends to move the candidate into the next stage of development pending discussions with the FDA.
   
   We are encouraged by the FDA granting Breakthrough Therapy designation to DX-2930, which will expedite its development process. According to the press release issued by the company, HAE is estimated to affect about 1 in 50,000 people. The candidate also enjoys Fast Track and orphan drug status in the U.S.
   
   We note that Dyax’s only approved product, Kalbitor is approved in the U.S. for the treatment of acute attacks of HAE in patients aged 12 years and above. Apart from this, other prescribed treatments for HAE include Shire’s (SHPG - Analyst Report) Firazyr and Valeant Pharmaceuticals International, Inc.’s (VRX - Analyst Report) Ruconest.
   
   Dyax currently holds a Zacks Rank #4 (Sell). AMAG Pharmaceuticals, Inc. (AMAG - Snapshot Report) is a better-ranked stock in the health care sector carrying a Zacks Rank #1 (Strong Buy).
4. [verwijderd] 27 juli 2015 16:49

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   Steeds oud nieuws herhalen..............(!!)