- FDA (CDER) Type C meeting held in May 2025 for DYNE-101 in DM1 and Dyne plans to provide a regulatory update following receipt of meeting minutes -
- Registrational Expansion Cohort of ACHIEVE Trial of DYNE-101 in DM1 initiated to support potential submission for U.S. Accelerated Approval in H1 2026 -
- Registrational Expansion Cohort of DELIVER Trial of DYNE-251 in DMD fully enrolled to support potential submission for U.S. Accelerated Approval in early 2026 -
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