Dyne Therapeutics' BLA for Duchenne Muscular Dystrophy Treatment Accepted by FDA with Priority Review

Dyne Therapeutics, Inc. (DYN) announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for zeleciment rostudirsen (DYNE-251) for the treatment of Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The FDA granted Priority Review, setting a Prescription Drug User Fee Act target action date of January 21, 2027.