FDA delays Sarepta's Duchenne gene therapy decision by a month
The FDA delayed its decision whether to grant accelerated approval to Sarepta Therapeutics’ gene therapy for Duchenne muscular dystrophy, pushing it back about one month to June 22.
Sarepta announced the delay in a news release on Wednesday morning, saying the FDA needs “modest additional time to complete the review, including final label negotiations and post-marketing commitment discussions.”
The company’s stock tumbled about 9% in trading on Wednesday.
To read Endpoints News become a free subscriber
Unlock this article instantly, along with access to limited free monthly articles and our suite of newsletters