FDA Fast Tracks Keryx Colorectal Cancer Drug, Shares Soar

Date : 04/05/2010 @ 11:06AM
Source : Dow Jones News
Stock : Aeterna Zentaris Inc. (AEZS)
Quote : 2.4  0.12 (5.26%) @ 8:00PM

FDA Fast Tracks Keryx Colorectal Cancer Drug, Shares Soar

Keryx Biopharmaceuticals, Inc. (NASDAQ:KERX)
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Keryx Biopharmaceuticals Inc. (KERX) said the U.S. Food and Drug Administration has given fast-track designation to perifosine, its drug for treating colorectal cancer.

Shares of the biopharmaceutical company jumped 25% to $3.43 in recent trading, while U.S.-traded shares of Keryx's Canadian partner Aeterna Zentaris Inc. (AEZ.T, AEZS) were recently up 23% to 99 cents.

Drugs given fast-track designation are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs, Keryx said. They usually qualify for expedited review from the FDA.

"We believe that commercialization of perifosine in this indication could potentially commence by mid-2012," said Chief Executive Ron Bentsur.

Keryx said it expects to begin Phase III testing of the drug in the second quarter of this year, and it expects to complete the study in the second half of 2011.

Keryx in December received fast-track status from the FDA for perifosine for the treatment of multiple myeloma. The treatment is licensed by Keryx from Aeterna for the U.S., Canada and Mexico.

-By Nathan Becker, Dow Jones Newswires; 212-416-2855; nathan.becker@dowjones.com;


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