Keryx Biopharmaceuticals (KERX) on Thursday indicated that the FDA has extended the approval decision date for Zerenex (ferric citrate) by three months, to September 7, 2014, following revisions to the Chemistry, Manufacturing and Controls (CMC) section of Keryx’s new drug application. The FDA considered the revisions substantial enough to warrant an extension to provide time for a full review.
Recall that Keryx’s first quarter earnings call on May 8 opened with news that the company still had some outstanding CMC issues. KERX sold off, but the stock has trickled higher in the two weeks since. KERX is down 1.5% on Friday, suggesting that the delay was largely priced into the stock after the conference call.
Keryx has already responded to the FDA’s initial CMC-related questions, and with 3 more months in which to satisfy any additional concerns, the CMC issues seem addressable. We continue to believe that Zerenex is an approvable drug based on its clinical profile and a Special Protocol Assessment from the FDA prior to the phase 3 program. Owning KERX ahead of the September PDUFA decision later this year remains an attractive bet, particularly as the stock gets cheaper, though KERX’s biggest issue now is having enough meaningful news in the next four months to keep investors engaged, particularly if biotech remains out of favor.
You can read more on Keryx here.
