Sarepta sheds 11% as report hints at early FDA opposition to gene therapy
Apr. 13, 2023 7:54 AM ETSarepta Therapeutics, Inc. (SRPT), CTLTBy: Dulan Lokuwithana, SA News Editor
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- Sarepta Therapeutics (NASDAQ:SRPT) lost ~11% pre-market Thursday after a Stat News report indicated that certain FDA staff members had initially opposed the company's gene therapy candidate SRP-9001 before the agency eventually agreed to hold an AdCom meeting on May 12 on its approval.
- Contract manufacturer Catalent (NYSE:CTLT), with which Sarepta (SRPT) has partnered for SRP-9001, is also trading ~6% lower in the pre-market.
- SRP-9001 is currently under the FDA review for Duchenne muscular dystrophy, with a PDUFA regulatory action date on May 29, 2023.
- According to three people with direct knowledge of the matter, some officials at the FDA unit that oversees gene therapies had reportedly come to a non-binding conclusion to reject the treatment initially.
- However, Dr. Peter Marks, the head of the FDA's biologics unit who champions accelerated approvals for gene therapies, intervened, directing staff to conduct an AdCom meeting on May 12 to discuss the treatment's approvability.
- Read: Seeking Alpha contributor Clinically Sound Investor upgraded Sarepta (SRPT) to Strong Buy from Buy in March, arguing that the upcoming AdCom meeting can lead to a positive catalyst for the biotech.