NasdaqGS:DYNBiotechs
Dyne Therapeutics DM1 Trial Reaches Pivotal Stage With ACHIEVE Enrollment
Dyne Therapeutics has finished enrolling patients in the registrational expansion cohort of its Phase 1/2 ACHIEVE trial for zeleciment basivarsen in myotonic dystrophy type 1 (DM1).
This moves the DM1 program into a pivotal stage that sets the timeline for Dyne’s next major regulatory filing and potential launch plans.
Topline data from the ACHIEVE trial are expected in early 2027, supporting a planned U.S. Accelerated Approval submission.
For investors watching NasdaqGS:DYN, the ACHIEVE...