Shares of Dyne Therapeutics (DYN) are moving lower after the company revised the ongoing registrational expansion cohort in the ACHIEVE trial for DYNE-101 for the treatment of myotonic dystrophy type 1. The primary endpoint is change from baseline in middle finger myotonia as measured by video hand opening time at six months, compared to placebo. Dyne and the FDA agreed that the next step toward accelerated approval was to submit for review the revised protocol for the Registrational Expansion Cohort of the ACHIEVE trial with video hand opening time as the primary endpoint, to serve as an intermediate clinical endpoint. In June, Dyne submitted the revised protocol to the FDA. The company plans to complete enrollment in the registrational expansion cohort in Q4. Shares of Dyne are down 23%, or $3.12, to $10.70 in premarket trading.
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