: Sarepta Therapeutics plummets 20% after FDA contradicts company and requires advisory meeting


Sarepta Therapeutics Inc. SRPT, +2.89% shares plummeted in the extended session Thursday after the Food and Drug Administration contradicted the biotech company and said it required an advisory committee meeting for its experimental Duchenne muscular dystrophy drug. Shares of Sarepta dropped as much as 20% after hours, following a 2.9% gain in the regular session to close at $149.67. At the beginning of the month, Sarepta said the FDA did not plan on requiring a meeting, and shares soared 23.5% that day. FDA Advisory Committees make recommendations to the FDA on whether to approve or not approve a drug, but the agency is not bound to the committee’s decision. “While we are disappointed that we must communicate a change in decision after our prior statement on the topic, we are not disappointed with the decision to hold an advisory committee,” said Doug Ingram, Sarepta chief executive, in a statement. “We had been preparing for an advisory committee meeting from the filing of the [biologics licensing agreement] in the fall of 2022.”  

This article was originally published by Marketwatch.com. Read the original article here.

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