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Wave Life Sciences Announces FDA Feedback Supports Registrational Pathway for WVE-006 (RNA Editing) in AATD

Source: GlobeNewswire

Healthcare & BiotechRegulation & LegislationCorporate Guidance & Outlook

Wave plans to pursue a single two-year registrational trial for its alpha-1 antitrypsin deficiency (AATD) program following an FDA meeting. A one-year interim analysis could support potential accelerated approval using AATD biomarkers, providing a clearer and potentially faster development and regulatory pathway.

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