Invivyd receives FDA notice of PEMGARDA EUA termination effective June 29, 2027; plans to pursue BLA approval

Invivyd, Inc.

• FDA sent Invivyd Notice of Termination for PEMGARDA EUA, effective June 29, 2027, following HHS termination of COVID-19 EUA declaration.
• PEMGARDA (pemivibart) authorized since March 2024 for COVID-19 pre-exposure prophylaxis in immunocompromised individuals.
• Invivyd intends to pursue Biologics License Application (BLA) for full FDA approval, citing clinical and post-authorization data.
• Company is in active dialogue with FDA on next steps; HHS has not provided specific written advice on approval pathway.
• Chairman Marc Elia states PEMGARDA has sufficient data for BLA submission and approval.