Dyne Therapeutics: DELIVER trial meets primary endpoint; dystrophin 5.46% of normal; BLA submission Q2 2026

Dyne Therapeutics, Inc.

Primary endpoint met: muscle content-adjusted dystrophin expression 5.46% of normal (p<0.0001), replicating 7-fold increase from MAD portion.
Functional improvement across all six prespecified endpoints; two (TTR Velocity, 10MWR) nominal p<0.05; lung function preserved vs placebo decline.
Long-term data up to 24 months show sustained functional improvement across all assessed endpoints (TTR Velocity, 10MWR, NSAA, SV95C, PUL2.0, FVC%p).
Safety favorable: 1,441 doses administered; 113 patient-years; no related serious TEAEs in REC; two related serious TEAEs in OLE/LTE resolved.
BLA for U.S. Accelerated Approval planned Q2 2026; global Phase 3 initiation Q2 2026; potential U.S. launch Q1 2027 assuming Priority Review.

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