Dyne Therapeutics Completes Enrollment for ACHIEVE Trial Phase 1/2 Expansion Cohort

By Hao Liu • Wednesday, June 03 13:02 • Permanent Link

Dyne Therapeutics said it has finished enrolling the registrational expansion cohort in its Phase 1/2 ACHIEVE trial of z-basivarsen for myotonic dystrophy type 1, with 71 participants now in that cohort.

The company said topline data from the cohort are planned for the first quarter of 2027. That timing would feed a potential biologics license application in the third quarter of 2027 for U.S. accelerated approval.

Dyne also said it expects a possible U.S. launch in the first half of 2028, assuming priority review and approval on its anticipated timeline.

The registrational expansion cohort is designed to support a primary readout at six months, measured by change from baseline in middle finger myotonia using video hand opening time. Dyne said the dose selected from the multiple ascending dose portion of the study was 6.8 mg/kg administered every eight weeks.

The company also said it continues enrollment efforts in the confirmatory Phase 3 HARMONIA trial. Today the company's shares have moved 1.71% to a price of $17.535. If you want to know more, read the company's complete 8-K report here.

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