Invivyd Provides Another Positive SARS-CoV-2 Variant Data Analysis to Satisfy U.S. FDA’s Gating Request for Completing Its Review of EUA Request for PEMGARDA™ (pemivibart) for the Treatment of Mild-to-Moderate COVID-19 in Certain Immunocompromised Patients

Treatment immunobridging analysis, routinely updated for contemporary SARS-CoV-2 variants, compares pemivibart antiviral titers to adintrevimab antiviral titers from the company’s previous Phase 2/3 clinical trial of adintrevimab for the treatment of COVID-19 (STAMP), in which adintrevimab conferred a 66% to 74% reduction in risk of hospitalization or death from COVID-19 compared to placebo depending on time of therapy startMost recent updated analysis provided to FDA, incorporating current dominant SARS-Co ...