Avidity reports positive one-year del-zota data in DMD44; plans BLA submission year-end 2025

Avidity Biosciences, Inc.

Dystrophin production increased ~25% of normal; total dystrophin restored up to 58% of normal.
CK levels reduced >80% from baseline; 50% of participants reached normal range at one year.
Functional improvements vs natural history: 4SC improved 2.1s (vs decline 2.7s), 10mWRT improved 0.7s.
PUL2 score improved 1.5 points (all participants) vs 0.7-point decline in natural history.
Safety favorable; most TEAEs mild/moderate. On track to submit BLA to FDA by year-end 2025.

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