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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;

Stock News for Aeterna Zentaris (AEZS)
02/01/201617:33:00Aeterna Zentaris to Participate in 18th Annual BIO CEO & Investor...
01/29/201608:30:00Aeterna Zentaris Announces Appointments to Board of Directors
01/26/201608:30:00Aeterna Zentaris Files International Patent Application for Novel...
01/25/201608:30:00Aeterna Zentaris Announces Additional Market Purchases of Common...
01/19/201608:30:00Aeterna Zentaris Concludes Successful Meeting of Clinical Investigators...
01/14/201615:24:03Amended Statement of Ownership (sc 13g/a)
01/13/201615:00:00Aeterna Zentaris Affirms Focus on Targeted Oncology During 2016...
01/12/201617:08:33Amended Registration Statement for Securities of Certain Canadian...
12/30/201516:06:00Aeterna Zentaris Announces Filing of Preliminary Base Shelf Prospectus
12/30/201512:07:36Appointment of Agent for Service of Process and Undertaking (f-x)
12/30/201511:36:19Registration Statement for Securities of Certain Canadian Issuers...
12/15/201514:09:24Report of Foreign Issuer (6-k)
12/14/201514:17:49Report of Foreign Issuer (6-k)
12/14/201512:30:00Aeterna Zentaris Announces Closing of US$16.65 Million Public...
12/09/201517:26:15Voluntary Supplemental Material Filed Pursuant to Section 11(a...
12/09/201512:39:55Report of Foreign Issuer (6-k)
12/09/201508:25:00Aeterna Zentaris Announces Pricing of US$16.65 Million Public...
12/09/201506:08:30Report of Foreign Issuer (6-k)
12/09/201506:05:49Voluntary Supplemental Material Filed Pursuant to Section 11(a...
12/08/201516:15:00Aeterna Zentaris Announces Proposed Public Offering of Common...

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