FDA clears Sarepta's Duchenne muscular dystrophy gene therapy after death ruled unrelated.

The FDA has allowed Sarepta Therapeutics to resume shipping its gene therapy, Elevidys, for Duchenne muscular dystrophy patients who can still walk. This follows an investigation into the recent death of an 8-year-old patient, which was found to be unrelated to the therapy. Shares of Sarepta Therapeutics rose over 16% after the announcement. Elevidys is the first gene therapy approved in the US for Duchenne muscular dystrophy. The FDA still requires more safety data for older, non-ambulatory patients.