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Wave Life Sciences Says FDA Feedback Supports Registrational Pathway for WVE-006

Wave Life Sciences Says FDA Feedback Supports Registrational Pathway for WVE-006

MT newswireMT newswire2026/10/01 13:02
09:02 AM EDT, 10/01/2026 (MT Newswires) -- Wave Life Sciences (WVE) has aligned with the US Food and Drug Administration regarding key aspects of its planned registrational pathway for its investigational treatment for alpha-1 antitrypsin deficiency, WVE-006, the company said Thursday. Based on feedback from the agency, Wave said it plans a single, two-year registrational trial, with a one-year interim analysis for potential accelerated approval based on alpha-1 antitrypsin deficiency biomarkers. WVE-006, an investigational GalNAc-RNA editing oligonucleotide, is currently being evaluated in a Phase 1b/2a clinical trial, and Wave is on track to share data from the 600 mg monthly multidose cohort in Q4, according to a statement.
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