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Sarepta Falls On FDA's Surprise Decision To Convene Advisory Committee Meeting For SRP - 9001

Sarepta Therapeutics, Inc. (SRPT) shares are sliding more than 19 percent on Friday morning trade after FDA decided for a surprise advisory committee meeting to be held for SRP-9001 in advance of the May 29, 2023, regulatory action date. SRP-9001 is an investigational gene therapy for the treatment of ambulant individuals with Duchenne muscular dystrophy. Sarepta's Biologics License Application for accelerated approval of SRP-9001 has been under priority review, with a decision due on May 29.

Doug Ingram CEO of Sarepta, "we are disappointed that we must communicate a change in decision..." However, he said the company had been preparing for an advisory committee meeting in the fall of 2022.

Currently, shares are at $120.81, down 19.28 percent from the previous close of $149.67 on a volume of 2,181,618.

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