Dyne Therapeutics, Inc. - 8-K Filing
Dyne Therapeutics announced full enrollment in the registrational expansion cohort (71 participants) of its Phase 1/2 ACHIEVE trial for zeleciment basivarsen (DYNE-101), a treatment for myotonic dystrophy type 1. Topline data are expected Q1 2027 to support a potential Biologics License Application submission in Q3 2027, with an anticipated U.S. launch by H1 2028 if FDA approval is granted. (Items: 7.01 Regulation FD Disclosure, 8.01 Other Events, 9.01 Financial Statements and Exhibits)
Tickers: $DYN