Dyne Therapeutics said it has completed enrollment in the registrational expansion cohort of its Phase 1/2 ACHIEVE trial for z-basivarsen in myotonic dystrophy type 1, with 71 participants enrolled.
The company said topline data from that cohort are expected in the first quarter of 2027. Dyne plans to use those results, along with data from the multiple ascending dose portion and the long-term extension of ACHIEVE, to support a potential U.S. accelerated approval filing in the third quarter of 2027.
Dyne outlined a potential U.S. launch in the first half of 2028, assuming priority review and approval on the expected timeline.
The registrational expansion cohort is now fully enrolled, following the earlier selection of a registrational dose and regimen of 6.8 mg/kg every eight weeks from the multiple ascending dose portion of the study. The cohort’s primary endpoint is the change from baseline in middle finger myotonia, measured by video hand opening time at six months versus placebo.
Dyne also said it continues to pursue approval pathways outside the U.S. for z-basivarsen. Today the company's shares have moved 4.06% to a price of $17.94. If you want to know more, read the company's complete 8-K report here.
