Sarepta Therapeutics (SRPT) Says FDA Will Not Complete Review of Eteplirsen by PDUFA Date

Sarepta Therapeutics, Inc. (Nasdaq: SRPT) announced that the U.S. Food and Drug Administration (FDA) has notified the Company that they are continuing their review and internal discussions related to our pending NDA for eteplirsen and will not be able to complete their work by the Prescription Drug User Fee Act (PDUFA) goal date of May 26, 2016. The FDA has communicated that they will continue to work past the PDUFA goal date and strive to complete their work in as timely a manner as possible.

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