Sarepta sees clear path to DMD gene therapy Elevidys review

FDA has accepted an efficacy supplement for Sarepta’s Elevidys gene therapy for Duchenne muscular dystrophy, set a June 21 PDUFA review goal, and will not convene an advisory committee meeting to discuss the application, the company announced Friday.

The announcement comes after Peter Marks, director of FDA’s Center for Biologics Evaluation and Research (CBER), has signaled in public forums that he is likely to approve the application from Sarepta Therapeutics Inc. (NASDAQ:SRPT) to convert accelerated approval of Elevidys delandistrogene moxeparvovec to full approval. ...