FDA accepts Dyne Duchenne BLA, grants Priority Review
US biotech Dyne Therapeutics (Nasdaq: DYN) has moved closer to a possible first approval after the US Food and Drug Administration (FDA) accepted its biologics license application for zeleciment rostudirsen, or z-rostudirsen, in Duchenne muscular dystrophy.
The agency granted the application Priority Review and set a Prescription Drug User Fee Act target action date of January 21, 2027. Dyne is seeking accelerated approval for the exon 51-skipping therapy in patients with Duchenne muscular dystrophy (DMD) whose mutations are amenable to that approach.
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