Wave Life Sciences WVE-006 phase 1b/2a data shows MZ-like phenotype with monthly dosing, FDA feedback expected mid-2026

Wave Life Sciences Ltd.

WVE-006 achieved 64.4% wild-type M-AAT (matching protective MZ phenotype) and 70.5% reduction in toxic Z-AAT in 200 mg biweekly cohort.
Monthly 400 mg dosing yielded similar results: 58.7% M-AAT, 67.7% Z-AAT reduction, and 13.6 µM total AAT.
Dynamic AAT production restored during acute phase responses (common cold); CRP and AAT strongly correlated (r=0.73, p<0.001).
WVE-006 well tolerated with no serious AEs or liver toxicities; monthly subcutaneous dosing confirmed feasible.
Wave expects FDA feedback on accelerated approval pathway mid-2026; 600 mg monthly cohort data due H2 2026.

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