Dyne submits z-rostudirsen BLA for Duchenne exon 51

Dyne Therapeutics/Z-rostudirsen (DYNE-251)

Dyne submitted z-rostudirsen BLA to FDA for Duchenne exon 51-amenable patients. Phase 1/2 DELIVER data showed record dystrophin levels. Dyne seeks Accelerated Approval and Priority Review.