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Sarepta Drops as Report Hints at Opposition from FDA to its Gene Therapy

Sarepta Drops as Report Hints at Opposition from FDA to its Gene Therapy

Shares of the medical research and drug development company, Sarepta Therapeutics (NASDAQ: SRPT) were down in morning trading on Thursday after a Stat News report indicated that certain FDA staff members were initially opposed to the company’s gene therapy candidate SRP-9001 before the FDA eventually agreed to hold an AdCom meeting on May 12 regarding its approval.

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SRP-9001 is an investigational gene therapy treatment currently under the FDA review for Duchenne muscular dystrophy, a severe muscular dystrophy with a Prescription Drug User Fee Act (PDUFA) regulatory action date on May 29, 2023.

Analysts are bullish about SRPT stock with a Strong Buy consensus rating based on 18 Buys and three Holds.

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