On its quarterly conference call in early May, Keryx Biopharma (NASDAQ:KERX) discussed the progress of its New Drug Application for its first product, Zerenex. Additional data was submitted, raising the possibility that the FDA could extend the review time. The stock declined by about 10% to 15% that day, reflecting the uncertainties of approval and launch.
On May 22, 2014, the company announced that the FDA determined that the additional data was an amendment to the New Drug Application. The FDA then gave itself a three-month extension to the PDUFA goal date to evaluate the new data. This extension pushes the expected approval data to September 7, 2014. Importantly, the company reiterated its guidance for the product launch...
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