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FDA accepts BLA for zeleciment rostudirsen to treat Duchenne muscular dystrophy with Priority Review target date January 21, 2027
DYNDyne Therapeutics, Inc.
Dyne Therapeutics, Inc. announced that the FDA has accepted for review its biologics license application (BLA) for zeleciment rostudirsen (DYNE-251) to treat Duchenne muscular dystrophy (DMD) amenable to exon 51 skipping. The FDA has granted Priority Review with a target action date of January 21, 2027, and the company expects a potential U.S. launch in Q1 2027. Dyne Therapeutics, Inc. is a biotechnology company developing therapeutic solutions for neuromuscular diseases.