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FDA Fast Tracks Keryx Immune-System Cancer Drug; Shares Rise

DOW JONES NEWSWIRES Keryx Biopharmaceuticals Inc.'s (KERX) experimental drug to treat a kind of cancer in white blood cells received fast-track status from the Food and Drug Administration. Shares were up 13% premarket at $3. The stock has soared this year due to progress on its renal-disease drug, rising more than tenfold. U.S.-traded shares in Keryx's Canadian partner Aeterna Zentaris Inc. (AEZ.T, AEZS) were also up 10% at $1.10. Keryx expects to start late-stage trials on KRX-0401, a potentially first-in-class, oral anti-cancer agent, later this month under a special protocol assessment with the FDA. In September, the agency also granted the treatment orphan status, which is reserved for new therapies for diseases or conditions that affect fewer than 200,000 people in the country. It gives drug developers seven years of market exclusivity. The treatment was in-licensed by Keryx from Aeterna in the U.S., Canada and Mexico, while Aeterna holds rights elsewhere. In September, Keryx said its renal-disease drug Zerenex was well tolerated and safe for long-term use in its first long-term trial. Multiple myeloma, also known as Kahler's disease, is a cancer in white blood cells, a integral part of the body's immune system. The FDA's fast-track designation is meant to accelerate the availability of new drugs that could provide a therapy for patients with serious diseases where no other treatment exists or where the existing therapy may be inferior. -By Joan E. Solsman, Dow Jones Newswires; 212-416-2291; joan.solsman@dowjones.com

Stock News for Aeterna Zentaris (AEZS)
DateTimeHeadline
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...
03/17/201516:15:00Aeterna Zentaris Reports Fourth Quarter and Full-Year 2014 Financial...
03/17/201516:15:00Aeterna Zentaris Reports Fourth Quarter and Full-Year 2014 Financial...
03/13/201508:58:33Statement of Ownership (sc 13g)
03/12/201506:04:26Report of Foreign Issuer (6-k)

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