Sarepta To Request FDA For Traditional Approvals For Duchenne Drugs

Sarepta Seeks Regular FDA ApprovalsThe stock’s decline comes as the company plans to submit supplemental new drug applications to the U.S. Food and Drug Administration (FDA) by the end of April, as detailed in the regulatory update.Sarepta requested a meeting with the FDA to discuss submitting supplemental new drug applications (sNDA) seeking conversion of the accelerated approvals of AMONDYS 45 (casimersen) and VYONDYS 53 (golodirsen) to traditional approvals.Sarepta received FDA confirmation that it can s ...