2023-04-10 12:20:08 ET
- Sarepta Therapeutics ( NASDAQ: SRPT ) announced Monday that the FDA would hold an advisory committee meeting on May 12, 2023, to evaluate its marketing application for gene therapy SRP-9001, targeted at Duchenne muscular dystrophy.
- Sarepta ( SRPT ) shares sank early this month after disclosing that the FDA's Office of Therapeutics has decided to convene an advisory committee meeting to discuss its biologics license application for SRP-9001, also known as delandistrogene moxeparvovec.
- The company said that the FDA's Cellular, Tissue, and Gene Therapies Advisory Committee would meet virtually to discuss the BLA ahead of the regulatory action date of May 29, 2023.
- The FDA's advisory committees issue non-binding recommendations. However, the regulator usually follows them before making a final decision on authorizations.
- Read: Seeking Alpha contributor Clinically Sound Investor upgraded Sarepta ( SRPT ) to Strong Buy from Buy, noting that the upcoming AdCom meeting can lead to a positive catalyst for the biotech.
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Sarepta announces May AdCom for muscular dystrophy therapy