Sarepta Therapeutics Says FDA Will Not Complete Eteplirsen Review By PDUFA Date; Stock Surges
Sarepta Therapeutics Inc (NASDAQ: SRPT), a developer of innovative RNA-targeted therapeutics, revealed Wednesday that the U.S. Food and Drug Administration has notified that they were continuing their review in respect of Eteplirsen.
The company indicated that the regulator was holding internal discussions related to its pending NDA for eteplirsen. Sarepta indicated that the FDA would not be in a position to complete their work by the Prescription Drug User Fee Act (PDUFA) goal date of May 26, 2016.
Sarepta said that as a result, the FDA communicated that they would continue to work past the PDUFA goal date and strive to complete their work in as timely a manner as possible.
Following the news, the stock surged 23.6 percent in the pre-market trading on Wednesday.
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