Invivyd Announces Receipt of Twelve Months’ Advanced Notice of Emergency Use Authorization (EUA) Termination for PEMGARDA® and Provides an Update on Next Steps with the U.S. FDA

NEW HAVEN, Conn., July 06, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq:IVVD) today announced that the U.S. Food and Drug Administration (FDA) has sent Invivyd a Notice of Termination for the PEMGARDA® (pemivibart) Emergency Use Authorization (EUA), following the U.S. Department of Health and Human Services’ (HHS) announcement of advanced Notice of Termination of the COVID-19 EUA declaration on June 30, 2026 (link), with an effective date of June 29, 2027.  Consequently, the EUA for PEMGARDA is set to terminate on June 29, 2027.  PEMGARDA (pemivibart) is Invivyd’s investigational monoclonal antibody authorized by the FDA under an EUA since March 2024 for the pre-exposure prophylaxis (prevention) of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.