Dyne Therapeutics Advances in Myotonic Dystrophy and Duchenne Muscular Dystrophy Trials, Aiming for Commercial Launches by 2027

Dyne Therapeutics is advancing its programs in Myotonic Dystrophy and Duchenne Muscular Dystrophy, aiming for commercial launches by 2027. The Myotonic Dystrophy type 1 program, DYNE-101, is in a phase I/II global clinical trial, ACHIEVE, and a Registrational Expansion Cohort is enrolling patients. The Duchenne Muscular Dystrophy program, DYNE-251, is in a phase I/II global trial, DELIVER, and a Registrational Expansion Cohort is fully enrolled. Dyne expects to report data from both trials in 2026 and submit BLAs for U.S. Accelerated Approval.

Dyne Therapeutics Inc. (DYN) is making significant strides in its clinical programs for Myotonic Dystrophy type 1 (DM1) and Duchenne Muscular Dystrophy (DMD), aiming for potential commercial launches by 2027. The company's DM1 program, DYNE-101, is in a phase I/II global clinical trial, ACHIEVE, and a Registrational Expansion Cohort is enrolling patients. Meanwhile, the DMD program, DYNE-251, is in a phase I/II global trial, DELIVER, with a fully enrolled Registrational Expansion Cohort. Dyne expects to report data from both trials in 2026 and submit Biologics License Applications (BLAs) for U.S. Accelerated Approval.

Myotonic Dystrophy type 1 (DM1) Program

The Myotonic Dystrophy type 1 program, DYNE-101, is an investigational therapeutic being evaluated in a phase I/II global clinical trial, ACHIEVE. The trial demonstrated consistent, dose-dependent splicing correction and improvements in muscle strength, function, and patient-reported outcomes. A Registrational Expansion Cohort of the ACHIEVE trial is enrolling 60 participants, with data expected by mid-2026 to support a potential U.S. Accelerated Approval submission in late 2026 [1].

Duchenne Muscular Dystrophy (DMD) Program

The Duchenne Muscular Dystrophy program, DYNE-251, is being tested in a phase I/II global trial for people living with DMD who are amenable to exon 51 skipping, dubbed DELIVER. The trial achieved the highest level of dystrophin expression reported for an exon 51 skipping therapy and improvements in multiple functional endpoints across multiple cohorts. A Registrational Expansion Cohort of the DELIVER trial is fully enrolled with 32 patients, and data from this cohort are planned for late 2025. Dyne anticipates a potential BLA submission for U.S. Accelerated Approval in early 2026 [1].

Financial Highlights

Dyne ended June 30, 2025, with cash, cash equivalents, and marketable securities of $683.9 million. The company's common stock began trading on the Nasdaq Global Select Market on September 17, 2020, under the ticker symbol "DYN," priced at $19 per share. In the last year, DYN has traded in a range of $6.36 to $47.45, closing at $9.31 on July 28, 2025 [1].

References

[1] https://www.nasdaq.com/articles/can-dyne-deliver-and-achieve-milestones-dmd-and-myotonic-dystrophy-trials