WALTHAM, Mass. – Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company, announced today the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for PEMGARDA™ (pemivibart), a monoclonal antibody (mAb) for pre-exposure prophylaxis (PrEP) of COVID-19.
This authorization targets certain adults and adolescents with moderate-to-severe immune compromise who are not expected to mount an adequate immune response to COVID-19 vaccination.
PEMGARDA is the first PrEP mAb to receive EUA from the FDA based on a novel immunobridging trial design. It is also the first authorized mAb from Invivyd's technology platform designed to address the rapid evolution of viruses. The company anticipates product availability in the U.S. to be imminent, with initial supply already packaged and awaiting final release.
Dave Hering, CEO of Invivyd, expressed the company's commitment to ongoing process improvement and regulatory collaboration to enhance the development efficiency of new mAb candidates. He also highlighted the strategic significance of the EUA for Invivyd and the vulnerable populations it aims to protect.
The EUA is supported by positive immunobridging data from the CANOPY clinical trial and ongoing in vitro neutralizing activity against major SARS-CoV-2 variants, including the currently dominant JN.1 variant.
Cameron R. Wolfe, M.B.B.S., M.P.H., from Duke University School of Medicine, and Jorey Berry, President and CEO of the Immune Deficiency Foundation, welcomed the additional COVID-19 preventive option for immunocompromised patients.
Financially, Invivyd reported an estimated $200.6 million in cash and cash equivalents as of December 31, 2023. In February 2024, the company strengthened its balance sheet by selling shares totaling $40.5 million in gross proceeds under its At-the-Market facility, in preparation for the PEMGARDA launch.
PEMGARDA (pemivibart) is administered intravenously and is expected to be repeatable to address ongoing viral evolution. The mAb was developed using Invivyd's INVYMAB™ platform, which combines viral surveillance and predictive modeling with advanced antibody engineering.
Invivyd will host a conference call and webcast today at 4 pm ET to discuss the EUA and commercial launch of PEMGARDA. This information is based on a press release statement.
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