Dyne Therapeutics Announces Completion of Enrollment in Registrational Expansion Cohort of ACHIEVE Trial of Z-Basivarsen for Myotonic Dystrophy Type 1 (DM1)
Dyne Therapeutics completed enrollment of 71 participants in the registrational expansion cohort of its Phase 1/2 ACHIEVE trial for z-basivarsen in myotonic dystrophy type 1. Topline data from this cohort are planned for Q1 2027, supporting a potential Biologics License Application submission for U.S. Accelerated Approval in Q3 2027. The company expects a potential U.S.
Key figures
- Drug Name
- zeleciment basivarsen (z-basivarsen, DYNE-101)
- Phase Of Trial
- Phase 1/2
- Topline data date
- Q1 2027
- Potential us launch
- H1 2028
- Registrational dose
- 6.8 mg/kg every eight weeks
- Rec enrollment count
- 71
- Potential bla submission
- Q3 2027
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