FDA Backs Registrational Path for Wave's RNA Editing Drug in AATD
WVE is trading near its 52-week low of $3.555 (4.4% above the low).
Summary
Wave Life Sciences announced FDA alignment on a registrational pathway for WVE-006, its RNA editing therapy for AATD. The agency supports a single two-year trial with a one-year interim analysis for potential accelerated approval based on biomarkers. This de-risks the program and could shorten time to market. The company also confirmed FDA acceptance of its current LC-MS assay. Data from the ongoing Phase 1b/2a RestorAATion-2 trial's 600 mg cohort is expected in Q4 2026.
At the time of this announcement, WVE was trading at $3.71 on NASDAQ in the Life Sciences sector, with a market capitalization of approximately $729.1M. The 52-week trading range was $3.56 to $21.73. This news item was assessed with positive market sentiment and an importance score of 8 out of 10. Source: GlobeNewswire.