Dyne Therapeutics issued a press release on June 17, 2025, indicating a delay in filing for U.S. Food and Drug Administration (“FDA”) approval of DYNE-101, an experimental therapy for myotonic dystrophy type 1 (“DM1”). Following a Type C meeting with the FDA’s Center for Drug Evaluation and Research in May, the Company agreed to a revised protocol for its Phase 1/2 global ACHIEVE trial for DYNE-101 in DM1, then submitted the revised protocol to the FDA in June, incorporating changes to ACHIEVE’s ongoing Registrational Expansion Cohort. Dyne had previously set a goal to complete enrollments in the cohort in mid-2025 before generating data and submitting the regulatory submission in the first half of 2026. Under its revised schedule, however, Dyne intends to complete enrollment in the cohort in the fourth quarter of 2025, seeking a data readout in mid-2026 and a potential Accelerated Approval submission in late 2026.
Following this news, Dyne’s stock price fell over 21% on June 17, 2025.
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