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; firstname.lastname@example.org