
Shares of therapy developer Dyne Therapeutics DYN.O fall 19.03% to $11.20
Co revises timelines for data updates and submission for its genetic disorder therapy DYNE-101 after meeting with FDA
DYNE-101 is being studied for the treatment of myotonic dystrophy type 1, a genetic disorder causing progressive muscle weakness and wasting
Co revises main goal in the registration expansion cohort to change from baseline in middle finger myotonia, a symptom which causes delayed muscle relaxation, as measured by video hand opening test at 6 months, compared to placebo
Data from the trial is now expected in mid-2026, compared to first half of 2026 expected previously
Also pushes submission seeking accelerated approval to late 2026 from H1 2026
Stock down ~47% YTD