Sarepta Therapeutics Inc. stock SRPT slid 11% in premarket trade Thursday, after a report said the U.S. Food and Drug Administration was leaning toward rejecting the company’s experimental gene therapy for Duchenne muscular dystrophy, before a top official intervened and directed staff to schedule an advisory committee meeting. In early March, Sarepta cheered investors by saying the FDA would not require an advisory meeting, suggesting the treatment had a path toward approval. That uptrend reversed in mid-March, when the FDA contradicted the biotech company and said it would require one. On Thursday, STAT News reported that the reversal came at the direction of Peter Marks, a top FDA official, who is an advocate for faster gene therapy approvals. The specialized healthcare website cited three people familiar with the FDA’s deliberations. Duchenne muscular dystrophy is an inherited disorder of progressive muscular weakness that typically affects boys. The company already markets three drugs for the condition. The advisory committee meeting has been scheduled for May 12. The stock has gained 65% in the last 12 months, while the S&P 500 SPX has fallen 8%.
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