Dyne Therapeutics posts one-year Phase 1/2 ACHIEVE data showing functional gains for DYNE-101 in DM1
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DYN•Dyne Therapeutics reported one-year Phase 1/2 ACHIEVE data showing sustained improvements across functional, strength and patient-reported outcomes for participants treated with z-basivarsen. Topline data from the registrational expansion cohort remain on track for Q1 2027, with a planned U.S. Accelerated Approval filing in Q3 2027.
Dyne Therapeutics disclosed additional one-year Phase 1/2 ACHIEVE data for z-basivarsen in myotonic dystrophy type 1, presented at the World Muscle Society congress. Treated participants showed sustained improvements versus baseline, placebo and a matched natural history cohort across function, strength and patient-reported outcomes; no related serious treatment-emergent adverse events were reported.
Topline data from the registrational expansion cohort remain on track for Q1 2027, supporting a planned U.S. Accelerated Approval filing in Q3 2027. Related data are slated for the AANEM meeting.