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Invivyd | 8-K: Current report

SEC ·  Sep 3 19:11

Summary by Futu AI

On September 3, 2024, Invivyd, Inc., a biopharmaceutical company, announced the continued neutralizing activity of its investigational monoclonal antibody, PEMGARDA™ (pemivibart), against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1, as well as other variants of interest. The announcement was made through a press release and filed with the SEC as part of a Form 8-K report. The Center for Disease Control (CDC) reported that KP.3.1.1 is currently the only major variant increasing in proportionality across the U.S. Invivyd's industrial virology effort, which includes independent third-party pseudoviral testing, confirmed that these variants are susceptible to pemivibart. The company has submitted the data to the FDA for updates to the PEMGARDA Healthcare Providers Fact Sheet. Invivyd also highlighted the potential of...Show More
On September 3, 2024, Invivyd, Inc., a biopharmaceutical company, announced the continued neutralizing activity of its investigational monoclonal antibody, PEMGARDA™ (pemivibart), against dominant SARS-CoV-2 variants KP.3.1.1 and LB.1, as well as other variants of interest. The announcement was made through a press release and filed with the SEC as part of a Form 8-K report. The Center for Disease Control (CDC) reported that KP.3.1.1 is currently the only major variant increasing in proportionality across the U.S. Invivyd's industrial virology effort, which includes independent third-party pseudoviral testing, confirmed that these variants are susceptible to pemivibart. The company has submitted the data to the FDA for updates to the PEMGARDA Healthcare Providers Fact Sheet. Invivyd also highlighted the potential of another pipeline candidate, VYD2311, which shows promising neutralization potency against the same viruses. PEMGARDA, which targets the SARS-CoV-2 spike protein, has been authorized for emergency use by the FDA for pre-exposure prophylaxis in certain immunocompromised individuals. Invivyd's Chief Scientific Officer and Chairman of the Board emphasized the robustness of the data and the importance of reliable antibody neutralization assessments. The company's INVYMAB™ platform is designed to rapidly generate new monoclonal antibodies to address evolving viral threats.

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