Wave Life Sciences plans single two-year WVE-006 trial after FDA feedback
WVE•Wave Life Sciences plans a single two-year registrational trial of WVE-006 for alpha-1 antitrypsin deficiency. A one-year interim analysis could support an accelerated approval filing based on biomarker evidence.
1. Trial plan
Wave Life Sciences said its FDA-aligned plan for WVE-006 includes a single two-year registrational trial, with a one-year interim analysis that could support an accelerated approval filing based on biomarker evidence. The company said FDA feedback removes the need for a separate confirmatory trial. Results from the ongoing Phase 1b/2a RestorAATion-2 trial have not been presented; 600 mg monthly multidose data are due in Q4 2026. Management described WVE-006 as generally safe and well tolerated to date, with no liver toxicities reported.
