Dyne Therapeutics, Inc. 8K

Dyne Therapeutics completed enrollment in the registrational expansion cohort of its Phase 1/2 ACHIEVE trial of zeleciment basivarsen for DM1, planning Q1 2027 topline data to support an accelerated U.S. approval and potential 2028 launch.

On June 3, 2026, Dyne Therapeutics, Inc. announced that it has completed enrollment of 71 participants in the registrational expansion cohort of its global Phase 1/2 ACHIEVE trial evaluating zeleciment basivarsen (DYNE-101) for myotonic dystrophy type 1 (DM1), with topline data from this cohort planned for the first quarter of 2027 to support a potential Biologics License Application submission for U.S. Accelerated Approval in the third quarter of 2027 and a potential U.S. launch in the first half of 2028, while also pursuing regulatory pathways outside the United States.

Filing Facts

CIK

1818794

Ticker

DYN

Form

8K

Source Type

sec

Accession

0001193125-26-254597

Alert Tier

6