Sarepta Therapeutics (SRPT) announced AdCom to be held for SRP-9001

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Sarepta (SRPT) sinks 20% as surprise FDA AdComm for SRP-9001 adds risk

March 17, 2023 6:52 AM EDT

Shares of Sarepta Therapeutics (NASDAQ: SRPT) fell 20% in pre-open trading Friday after the company announced a surprise FDA AdComm for SRP-9001, its investigational gene therapy for the treatment of Duchenne muscular dystrophy. The news comes just a few weeks after management indicated that there would be no AdComm.

While the news adds a layer of risk, most analysts still expected FDA approval at the May 29th PDUFA date.

"FDAs decision to hold a public advisory committee meeting on the SRP 9001 BLA is a change from the communicated... More