Wave Life Sciences Announces FDA Feedback Supports Registrational Pathway for WVE-006 (RNA Editing) in AATD
Following meeting with FDA, Wave plans for a single, two-year registrational trial, with a one-year interim analysis for potential accelerated approval based on AATD biomarkersWVE-006 (RNA editing) has potential to offer the AATD community a new standard-of-care treatment to protect the liver and l…
Story updates
11:32:35 AM UTC
SquawkNews
Wave Life Sciences said FDA feedback supports a single two-year registrational trial for WVE-006 in AATD, with a one-year interim analysis for potential accelerated approval based on biomarkers. FDA also supports use of the company’s current LC-MS assay.Material DetailsContext by AI AnalystThis is…