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Invivyd | 8-K: Current report

SEC announcement ·  Mar 25 14:21
Summary by Moomoo AI
On March 22, 2024, Invivyd, Inc., a biopharmaceutical company, announced the FDA's emergency use authorization (EUA) for PEMGARDA™, a monoclonal antibody for pre-exposure prophylaxis (PrEP) of COVID-19, aimed at adults and adolescents with moderate-to-severe immune compromise. The EUA was based on positive immunobridging data from the ongoing CANOPY clinical trial and the antibody's in vitro neutralizing activity against major SARS-CoV-2 variants, including the dominant JN.1 variant. Invivyd also reported estimated cash and cash equivalents of $200.6 million as of December 31, 2023, and additional gross proceeds of $40.5 million from a February 2024 share sale. The company expects the existing cash balance to fund operations into the fourth quarter of 2024. The CANOPY trial's interim data showed that PEMGARDA maintained neutralizing...Show More
On March 22, 2024, Invivyd, Inc., a biopharmaceutical company, announced the FDA's emergency use authorization (EUA) for PEMGARDA™, a monoclonal antibody for pre-exposure prophylaxis (PrEP) of COVID-19, aimed at adults and adolescents with moderate-to-severe immune compromise. The EUA was based on positive immunobridging data from the ongoing CANOPY clinical trial and the antibody's in vitro neutralizing activity against major SARS-CoV-2 variants, including the dominant JN.1 variant. Invivyd also reported estimated cash and cash equivalents of $200.6 million as of December 31, 2023, and additional gross proceeds of $40.5 million from a February 2024 share sale. The company expects the existing cash balance to fund operations into the fourth quarter of 2024. The CANOPY trial's interim data showed that PEMGARDA maintained neutralizing titers consistent with efficacy levels of other monoclonal antibodies for approximately 77 days post-administration. Safety data indicated anaphylaxis in 0.6% of trial participants, leading to a boxed warning for the product. Invivyd plans to make PEMGARDA available for order imminently in the U.S., with initial supply ready at a third-party logistics provider. A conference call was held on the same day to discuss the EUA and commercial launch details.

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