FDA Expands Sarepta's (SRPT) DMD Gene Therapy Label

Shares of Sarepta (SRPT) rose nearly 34% in after-market trading on Thursday after it announced that the FDA approved the expanded use of its Duchenne muscular dystrophy (DMD) gene therapy Elevidys. Elevidys is now approved to treat all DMD patients aged four years and older. While the FDA granted traditional approval for the therapy to treat ambulatory DMD patients (those who can still walk), it has granted accelerated approval for non-ambulatory patients. The label expansion is mainly supported by data fr ...