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

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 this development, Invivyd has left its 2024 net product revenue and year-end cash guidance unchanged, as the potential EUA and commercial dynamics for COVID-19 treatment were not previously accounted for. Further details are expected to be discussed in the upcoming 1Q 2024 results call on May 9, 2024. PEMGARDA, which is currently authorized for pre-exposure prophylaxis (PrEP) of COVID-19 in certain immunocompromised individuals, has shown in vitro neutralizing activity against major SARS-CoV-2 variants. Invivyd's INVYMAB platform has been instrumental in the rapid development of new monoclonal antibodies to address evolving viral threats.