Dyne Therapeutics submits FDA BLA for Duchenne drug z-rostudirsen under priority review request

Dyne

Dyne

DYN

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  • Dyne Therapeutics submitted a BLA to the FDA for z-rostudirsen to treat Duchenne muscular dystrophy amenable to exon 51 skipping.
  • Application seeks accelerated approval using dystrophin as a surrogate endpoint.
  • Priority Review requested, which could cut review time to 6 months from 10 months after the FDA’s 60-day filing review.
  • Dyne targets a potential U.S. launch in Q1 2027 if Priority Review is granted and the drug wins approval.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Dyne Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202605260730PRIMZONEFULLFEED9726152) on May 26, 2026, and is solely responsible for the information contained therein.

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