Wave Life Sciences, Inc. (Nasdaq: WVE), a clinical-stage biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health, today announced alignment with the U.S. Food and Drug Administration (FDA) on key aspects of its planned registrational pathway for WVE-006, an investigational GalNAc-RNA editing oligonucleotide for the treatment of alpha-1 antitrypsin deficiency (AATD). Following the company’s FDA meeting, planning is underway for a two-year registrational trial to support potential full approval, with a one-year interim analysis to support potential accelerated approval based on AATD biomarkers. Additionally, the FDA supports the use of Wave’s current LC-MS assay to measure M-AAT (wild-type) and Z-AAT (mutant) protein for the WVE-006 registrational program.