Wave reports positive Phase 2 FORWARD-53 data for WVE-N531 in DMD; plans NDA in 2026

Wave Life Sciences Ltd.

TTR improved 3.8 seconds vs natural history (p<0.05); fibrosis reduced 28.6% (p<0.01); CK declined 50%.
Mean dystrophin 7.8% (88% >5%); muscle health reversal shown; no SAEs.
FDA confirms accelerated approval pathway; NDA filing planned in 2026 based on all FORWARD-53 data.
Monthly dosing supported by 61-day half-life; additional DMD exons (52,51,45,44) CTAs expected in 2026 addressing ~$2.4B US market.
Pipeline milestones: WVE-006 AATD data, WVE-007 obesity data H2 2025, WVE-003 HD IND H2 2025.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.