DYNE-251

Dyne Therapeutics announced positive clinical data from its Phase 1/2 ACHIEVE trial for DYNE-101 in DM1, showing splicing correction and functional improvements. Plans for a global Registrational Expansion Cohort aim for U.S. Accelerated Approval by H1 2026. DYNE-251 for DMD is also advancing, with data expected late 2025 for potential early 2026 submission.

Dyne Therapeutics announced positive clinical data from its Phase 1/2 ACHIEVE trial for DYNE-101 in DM1, showing splicing correction and functional improvements. Plans for a global Registrational Expansion Cohort aim for U.S. Accelerated Approval by H1 2026. DYNE-251 for DMD is also advancing, with data expected late 2025 for potential early 2026 submission.

Dyne Therapeutics announced positive clinical data for DYNE-101 in DM1, showing splicing correction and functional improvements, aiming for U.S. Accelerated Approval by H1 2026. DYNE-251 for DMD targets accelerated approval with dystrophin as a surrogate endpoint, expecting data late 2025 for early 2026 submission.

Dyne Therapeutics' stock fell 25% despite positive Phase 1/2 ACHIEVE trial results for DYNE-101, targeting myotonic dystrophy type 1, due to investor concerns over 6-month splicing correction data inconsistencies. The company plans for accelerated approval submissions by 2026 and is advancing its DYNE-251 program for Duchenne muscular dystrophy.

Dyne Therapeutics reports positive Phase 1/2 ACHIEVE trial results for DYNE-101 in treating myotonic dystrophy type 1, with plans for a global Registrational Expansion Cohort aiming for U.S. Accelerated Approval by 2026. The DELIVER trial for DYNE-251 in Duchenne muscular dystrophy also shows favorable safety data, targeting accelerated approval submissions in early 2026.

Dyne Therapeutics announced positive clinical data for DYNE-101 in DM1, showing splicing correction and functional improvements, aiming for U.S. Accelerated Approval by H1 2026. DYNE-251 for DMD targets accelerated approval with dystrophin as a surrogate endpoint, expecting data by late 2025. Both programs aim for regulatory submissions in 2026.

The ACHIEVE trial for DYNE-101 in DM1 showed significant splicing correction and functional improvements, with a favorable safety profile. A 6.8 mg/kg Q8W dose was selected for further evaluation, aiming for U.S. Accelerated Approval. DYNE-251 in DMD also demonstrated safety and efficacy, with plans for a Registrational Expansion Cohort.

The ACHIEVE trial highlights DYNE-101's potential in treating DM1, showing significant splicing correction and functional improvements at 6.8 mg/kg Q8W dose. DYNE-101 demonstrated a favorable safety profile, with most adverse events being mild or moderate. Dyne plans for U.S. Accelerated Approval based on splicing as a surrogate endpoint, with a Registrational Expansion Cohort expected to complete enrollment by mid-2025.

The ACHIEVE trial highlights DYNE-101's potential in treating DM1, showing significant splicing correction and functional improvements at 6.8 mg/kg Q8W dose. DYNE-101 demonstrated a favorable safety profile, with plans for U.S. Accelerated Approval based on splicing as a surrogate endpoint. Dyne also reported positive safety and efficacy data for DYNE-251 in DMD, aiming for global expedited approval.

Dyne Therapeutics announced new clinical data for DYNE-101 showing significant improvements in myotonic dystrophy type 1 (DM1) patients, including splicing correction and functional benefits. Plans for a global Registrational Expansion Cohort aim to support U.S. Accelerated Approval submission by H1 2026. DYNE-251 for DMD also progresses towards accelerated approval.