FDA Breakthrough Therapy Designation for DYNE-101 in DM1; revised Accelerated Approval path

Dyne Therapeutics, Inc.

FDA granted Breakthrough Therapy Designation to DYNE-101 for myotonic dystrophy type 1 (DM1).
Revised ACHIEVE trial protocol submitted with vHOT as primary endpoint (60 patients, 3:1 randomization).
Enrollment in Registrational Expansion Cohort expected to complete Q4 2025; data mid-2026, submission late 2026.
New 12-month data: sustained vHOT improvement of 3.3 sec at 6 months; QMT strength improved 10% at 6 mo, 20% at 12 mo.
Cash $677.5M as of March 31, 2025; runway extended into Q4 2026.

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