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.
