09:11 AM EDT, 05/26/2026 (MT Newswires) -- Dyne Therapeutics Inc. ( DYN ) said Tuesday it submitted a Biologics License Application to the US Food and Drug Administration for its experimental Duchenne muscular dystrophy treatment zeleciment rostudirsen, also known as DYNE-251, seeking accelerated approval for patients amenable to exon 51 skipping.

The company said it has requested Priority Review from the FDA, which could shorten the review timeline to six months from the standard 10 months after the agency completes its filing review.

Dyne said it continues to expect a potential US launch in Q1 of 2027 if the therapy receives priority review and approval.

The filing is based on data from the registrational expansion cohort of the Phase 1/2 DELIVER trial, where the company said the treatment met its primary endpoint.