Invivyd, Inc. has received official notification from the U.S. Food and Drug Administration (FDA) regarding the termination of the Emergency Use Authorization (EUA) for its COVID-19 monoclonal antibody, PEMGARDA (pemivibart). This termination follows an earlier announcement by the U.S. Department of Health and Human Services (HHS) of the termination of the COVID-19 EUA declaration. The EUA for PEMGARDA will officially end on June 29, 2027, providing a twelve-month transition period. PEMGARDA has been authorized under EUA since March 2024 for pre-exposure prophylaxis (prevention) of COVID-19 in certain immunocompromised individuals who may not respond adequately to vaccination. Invivyd is currently in dialogue with the FDA to discuss appropriate next steps for PEMGARDA, aiming to secure permanent medical protection for vulnerable populations. The company believes PEMGARDA has sufficient clinical and post-authorization data to support a Biologics License Application (BLA) submission and approval.