regulatory
confidence high
sentiment positive
materiality 0.75
FDA accepts Dyne's BLA for DYNE-251 in DMD exon 51 skipping; Priority Review granted
Dyne Therapeutics, Inc.
- FDA accepted BLA for z-rostudirsen (DYNE-251) to treat Duchenne muscular dystrophy amenable to exon 51 skipping.
- Priority Review assigned; PDUFA target action date is January 21, 2027.
- Company expects potential U.S. launch in Q1 2027 if approved on anticipated timeline.
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