Sarepta Therapeutics Receives Complete Response Letter from the US FDA for Golodirsen New Drug Application to treat patients with Duchenne Muscular Dystrophy (DMD)

CAMBRIDGE, Mass., Aug. 19, 2019 (GLOBE NEWSWIRE) — Sarepta Therapeutics, Inc. (NASDAQ:SRPT), the leader in precision genetic medicine for rare diseases, today announced it had received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) seeking accelerated approval of golodirsen injection for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation amenable to exon 53 skipping.

Clinical Trial
NCT02500381