other material
confidence high
sentiment positive
materiality 0.85
Dyne Therapeutics completes enrollment of ACHIEVE registrational cohort with 71 DM1 patients
Dyne Therapeutics, Inc.
- Registrational expansion cohort (REC) enrolled 71 participants; topline data expected Q1 2027.
- Potential BLA submission for U.S. Accelerated Approval in Q3 2027 using REC and MAD/LTE data.
- Potential U.S. launch of z-basivarsen in H1 2028 if FDA grants Priority Review.
- Also pursuing approval pathways outside U.S. for DM1 therapy.
- ACHIEVE primary endpoint: change in middle finger myotonia via vHOT at 6 months vs placebo.