• Dyne Therapeutics, Inc. recently reported that the U.S. FDA accepted for review its biologics license application for zeleciment rostudirsen (z-rostudirsen, DYNE-251) to treat Duchenne muscular dystrophy patients amenable to exon 51 skipping, granting Priority Review with a target action date of January 21, 2027.
• The BLA filing is backed by DELIVER trial data showing statistically significant dystrophin increases, functional gains and a favorable safety profile, making z-rostudirsen a key potential entrant in the exon 51 DMD treatment landscape.
• Next, we’ll examine how the FDA’s Priority Review of z-rostudirsen shapes Dyne Therapeutics’ investment narrative and long-term risk profile.

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