Sarepta shares rocket as FDA again delays decision on Duchenne drug

25 May 2016

US RNA-based drug developer Sarepta Therapeutics (Nasdaq: SRPT) today announced that the US Food and Drug Administration has notified the company that it is continuing its review and internal discussions related to the pending New Drug Application 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 it will continue to work past the PDUFA goal date and strive to complete their work in as timely a manner as possible.

The news of the deferral sent Sarepta’s shares soaring 16.2% to $21.43 in mid-morning trading on Wednesday, with the delay fueling hopes that the treatment could ultimately be cleared for sale.

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