Invivyd Announces FDA Authorization For Emergency Use Of PEMGARDA For Pre-Exposure Prophylaxis Of COVID-19
Portfolio Pulse from Benzinga Newsdesk
Invivyd, Inc. (NASDAQ:IVVD) announced FDA emergency use authorization (EUA) for PEMGARDA (pemivibart) for pre-exposure prophylaxis of COVID-19 in certain adults and adolescents with moderate-to-severe immune compromise. This marks the first EUA for a monoclonal antibody (mAb) based on Invivyd's novel technology platform, aimed at addressing rapid viral evolution. The authorization is supported by positive data from the CANOPY clinical trial and ongoing in vitro activity against major SARS-CoV-2 variants. Product availability in the U.S. is expected imminently. Invivyd also reported having $200.6 million in cash and cash equivalents as of December 31, 2023, and raised an additional $40.5 million in February 2024 to strengthen its balance sheet ahead of the PEMGARDA launch.
March 22, 2024 | 7:07 pm
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Invivyd, Inc. received FDA EUA for PEMGARDA, marking a significant milestone for the company and its novel mAb technology platform. The company also reported strong financials with $200.6 million in cash as of December 31, 2023, and an additional $40.5 million raised in February 2024.
The FDA's emergency use authorization for PEMGARDA represents a significant achievement for Invivyd, potentially leading to increased investor confidence and positive stock price movement in the short term. The strong financial position and successful capital raise further support the company's stability and growth prospects, likely contributing to positive investor sentiment.
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