Sarepta muscular dystrophy drug SRP-9001 endorsed by FDA advisors
May 12, 2023 6:31 PM ETSarepta Therapeutics, Inc. (SRPT)RHHBY, CTLTBy: Jonathan Block, SA News Editor1 Comment

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- A panel of advisors to the US FDA has voted that the benefits of Sarepta Therapeutics' (NASDAQ:SRPT) gene therapy SRP-9001 for Duchenne muscular dystrophy outweigh the risks.
- The vote from members of the Cellular, Tissue, and Gene Therapies Advisory Committee was 8-6.
- Sarepta is partnered with Catalent (CTLT) on SRP-9001, which is also known as delandistrogene moxeparvovec. Roche (OTCQX:RHHBY) also has a partnership to market the product overseas.
- The FDA is set to make a decision on SRP-9001 by the end of May.
- In briefing documents released prior to the meeting, FDA scientists expressed concerns over SRP-9001's efficacy.