Dyne says FDA accepts z-rostudirsen BLA for exon 51 Duchenne muscular dystrophy under priority review - DYN News | RalliesDyne says FDA accepts z-rostudirsen BLA for exon 51 Duchenne muscular dystrophy under priority review
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DYN• FDA accepts BLA for priority review
- Dyne Therapeutics’ BLA for z-rostudirsen in exon 51 Duchenne muscular dystrophy was accepted by the FDA for Priority Review.
- PDUFA target action date set for Jan. 21, 2027; application seeks accelerated approval based on dystrophin as a surrogate endpoint.
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