DYN news

Dyne Therapeutics reported Q3 financials and announced its z-rostudirsen BLA received FDA priority review with a PDUFA date of Jan 2027, marking a critical regulatory step for the treatment of Duchenne muscular dystrophy.

Dyne Therapeutics reports BLA for z-rostudirsen accepted by FDA with Priority Review. The company also cleared an IND for DYNE-302 in FSHD, extending its pipeline via the FORCE platform.

Dyne Therapeutics announced full enrollment in the registrational expansion cohort of its ACHIEVE trial for Z-basivarsen, with topline data expected in Q1 2027 to support potential U.S. Accelerated Approval by Q3 2027. The company targets a potential H1 2028 U.S. launch if FDA grants Priority Review…