Invivyd, Inc.

Invivyd, Inc. is a biopharmaceutical company that discovers, develops, and commercializes monoclonal antibody (mAb) therapies to prevent and treat serious viral infectious diseases. The company focuses on providing protection from these diseases, starting with SARS-CoV-2, the virus responsible for COVID-19. PEMGARDA® (pemivibart) is Invivyd's first mAb to receive regulatory authorization. On March 22, 2024, the U.S. Food and Drug Administration (FDA) granted emergency use authorization (EUA) for PEMGARDA injection, for intravenous (IV) use. This investigational mAb is authorized for the pre-exposure prophylaxis (prevention) of COVID-19 in adults and adolescents (12 years of age and older weighing at least 40 kg) who have moderate-to-severe immune compromise due to specific medical conditions or immunosuppressive medications/treatments, and are unlikely to develop an adequate immune response to COVID-19 vaccination. Recipients must not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. The emergency use of PEMGARDA is authorized for the duration of the declaration justifying emergency use of drugs and biological products during the COVID-19 pandemic under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. The company aims to expand its mAb development into other high-need indications, such as respiratory syncytial virus (RSV) and measles.