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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; [email protected]

Stock News for Aeterna Zentaris (AEZS)
01/09/201714:22:43Amended Statement of Ownership (sc 13g/a)
01/05/201712:49:24Report of Foreign Issuer (6-k)
01/04/201717:15:00Aeterna Zentaris Announces Top-Line Results of Confirmatory Phase...
11/08/201617:29:46Report of Foreign Issuer (6-k)
11/08/201617:21:43Report of Foreign Issuer (6-k)
11/08/201616:45:00Aeterna Zentaris Reports Third Quarter 2016 Financial and Operating...
11/01/201612:07:47Report of Foreign Issuer (6-k)
11/01/201611:27:00Aeterna Zentaris Announces Closing of US$7,560,000 Registered...
10/28/201617:26:26Voluntary Supplemental Material Filed Pursuant to Section 11(a...
10/28/201608:30:00Aeterna Zentaris to Announce Third Quarter 2016 Financial and...
10/28/201606:04:43Report of Foreign Issuer (6-k)
10/27/201609:00:00Aeterna Zentaris Announces US$7,560,000 Registered Direct Offering...
10/26/201608:00:00Aeterna Zentaris Completes Patient Recruitment for Confirmatory...
10/21/201616:32:12Report of Foreign Issuer (6-k)
10/12/201608:00:00Aeterna Zentaris & Specialised Therapeutics Asia Sign Exclusive...
09/14/201608:30:00Aeterna Zentaris Announces Expiration of Remaining Series B Warrants
09/12/201608:30:00Aeterna Zentaris to Present at Upcoming Aegis Capital Corp. 2016...
09/06/201608:30:00Aeterna Zentaris to Present at Upcoming Rodman & Renshaw Annual...
08/09/201617:19:14Report of Foreign Issuer (6-k)
08/09/201616:30:00Aeterna Zentaris Reports Second Quarter 2016 Financial and Operating...

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