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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
05/11/201515:03:56Report of Foreign Issuer (6-k)
05/11/201513:36:00Aeterna Zentaris annonce l'élection des administrateurs à son a...
05/11/201513:35:00Aeterna Zentaris Announces Election of Directors at 2015 Shareholders...
05/11/201513:35:00Aeterna Zentaris Announces Election of Directors at 2015 Shareholders...
05/07/201517:13:15Report of Foreign Issuer (6-k)
05/07/201517:12:22Report of Foreign Issuer (6-k)
05/07/201517:03:00Aeterna Zentaris annonce ses résultats financiers et d'exploitation...
05/07/201517:02:00Aeterna Zentaris Reports 1st Quarter 2015 Financial and Operating...
05/07/201517:02:00Aeterna Zentaris Reports 1st Quarter 2015 Financial and Operating...
05/07/201507:30:00Aeterna Zentaris et EMD Serono concluent une entente de services...
05/07/201507:30:00Aeterna Zentaris and EMD Serono Finalize Promotional Services...
05/07/201507:30:00Aeterna Zentaris and EMD Serono Finalize Promotional Services...
05/06/201508:30:00Are These in Your Portfolio? 4 Trending Companies (GALE, AEZS...
05/06/201507:51:51Zacks Reiterates "Strong-Buy" Rating for AEterna Zentaris (AEZS)
05/04/201514:52:37Confidential Treatment Order (ct Order)
05/01/201510:00:00Aeterna Zentaris dévoilera ses résultats financiers et d'exploitation d...
05/01/201510:00:00Aeterna Zentaris to Announce First Quarter 2015 Financial and...
04/30/201515:24:46AEterna Zentaris Rating Reiterated by Zacks (AEZS)
04/27/201516:15:00Aeterna Zentaris : un comité indépendant recommande la poursuite d...
04/27/201516:15:00Aeterna Zentaris: Data Safety Monitoring Board Recommends Continuation...

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