Dyne Therapeutics' z-rostudirsen Wins Priority Review for Duchenne Muscular Dystrophy

Dyne Therapeutics' z-rostudirsen has received FDA Priority Review designation for Duchenne muscular dystrophy patients amenable to exon 51 skipping, compressing the standard 10-month review to six months. The approval decision could arrive before the Phase 3 FORZETTO confirmatory trial completes, placing full regulatory weight on the dystrophin biomarker data already submitted in the BLA.

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