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Keryx Biopharma Shares Rally On Orphan-Drug Designation

DOW JONES NEWSWIRES Keryx Biopharmaceuticals Inc. (KERX) said the U.S. Food and Drug Administration has given orphan-drug designation to perifosine, a treatment for cancer including neuroblastoma, or cancer of the nervous system in infants. Shares of the biopharmaceutical company jumped 13% to $4.04 in recent trading, while U.S.-traded shares of Keryx's Canadian partner Aeterna Zentaris Inc. (AEZ.T, AEZS) were recently up 10% to $1.20. The designation was announced three months after the drug received fast-track status, which authorizes an expedited review for drugs that treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. "The Orphan Drug designation is an important component of our development plan for perifosine in neuroblastoma, an indication where no FDA-approved therapies currently exist," said Chief Executive Ron Bentsur. The Orphan Drug Act provides incentives to create therapies for so-called orphan diseases--those that affect fewer than 200,000 Americans. There are about 7,000 such maladies, most of them serious, that have few or no drugs to treat them. Getting an orphan-drug designation opens the door to incentives once the FDA approves a medicine for sale in the U.S., including seven years' marketing exclusivity and tax breaks. Bentsur said the company is exploring the next steps for the development, which "we hope, ultimately, could provide a new treatment option for children and infants" suffering with the illnesses. Perifosine also is in Phase 3 clinical trial for treating refractory advanced colon cancer and multiple myeloma, as well as in Phase 1 and Phase 2 trials for several other tumor types. -By Jodi Xu, Dow Jones Newswires; 212-416-3037; jodi.xu@dowjones.com

Stock News for Aeterna Zentaris (AEZS)
DateTimeHeadline
04/23/201516:30:00Aeterna Zentaris fera une présentation à la 2015 Bloom Burton...
04/23/201516:30:00Aeterna Zentaris to Present at 2015 Bloom Burton & Co. Healthcare...
04/23/201507:30:00Crystal Research Associates, LLC Issues Executive Informational...
04/23/201507:30:00Crystal Research Associates, LLC Issues Executive Informational...
04/16/201507:30:00Aeterna Zentaris dépose une demande de brevet additionnel pour...
04/16/201507:30:00Aeterna Zentaris Files Additional Patent Application to Strengthen...
04/16/201507:30:00Aeterna Zentaris Files Additional Patent Application to Strengthen...
04/13/201508:28:15Aeterna Zentaris to conduct new Phase 3 study to demonstrate...
04/13/201507:30:00Aeterna Zentaris annonce son plan pour lancer une étude de phase...
04/13/201507:30:00Aeterna Zentaris Announces Plans to Initiate Phase 3 Study of...
04/13/201507:30:00Aeterna Zentaris Announces Plans to Initiate Phase 3 Study of...
04/06/201509:58:37Biotech Weekly: Why Financials Matter
03/31/201507:30:00Aeterna Zentaris Signs Transfer Agreement of its Discovery Library...
03/31/201507:30:00Aeterna Zentaris signe une entente de transfert de sa librairie...
03/31/201507:30:00Aeterna Zentaris Signs Transfer Agreement of its Discovery Library...
03/25/201516:11:11Report of Foreign Issuer (6-k)
03/18/201506:56:55Aeterna Zentaris Q4 and FY14 results
03/17/201516:39:06Annual and Transition Report (foreign Private Issuer) (20-f)
03/17/201516:36:26Report of Foreign Issuer (6-k)
03/17/201516:15:00Aeterna Zentaris annonce ses résultats financiers et d'exploitation...

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