Summary by Futu AI
On May 7, 2024, Invivyd, Inc., a biopharmaceutical company, announced its plan to submit an Emergency Use Authorization (EUA) application to the U.S. FDA for its investigational monoclonal antibody, PEMGARDA (pemivibart), for the treatment of COVID-19 in moderately to severely immunocompromised individuals. This submission is based on a rapid immunobridging pathway, which leverages serum virus neutralizing antibody titers from prior successful clinical trials. Invivyd anticipates the EUA application to be submitted imminently, with the goal of addressing the critical treatment needs of immunocompromised patients in the U.S. who have limited access to or are not suitable for existing COVID-19 treatments. The company plans to initiate a compact clinical trial focused on confirmatory safety and efficacy following the EUA submission. Despite...Show More