DYN

Latest SEC Filings & News for DYN

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RegulatoryJul 29, 2026Neutral

Dyne Therapeutics BLA accepted for review, IND cleared for DYNE-302

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.

View filing at SEC.gov →

RegulatoryJun 3, 2026Positive

Dyne completes enrollment of 71 participants in Z-basivarsen DM1 trial expansion

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 gr

View filing at SEC.gov →

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