On August 27, 2024, Invivyd, Inc., a biopharmaceutical company, announced positive results from its CANOPY Phase 3 clinical trial for PEMGARDA (pemivibart), a monoclonal antibody for pre-exposure prophylaxis (PrEP) of COVID-19. The trial demonstrated an 84% relative risk reduction in symptomatic COVID-19 compared to placebo in immunocompetent individuals. The data also indicated a 3% rate of confirmed symptomatic COVID-19 in immunocompromised participants, suggesting a potential signal of protection. The safety profile of pemivibart remained consistent with previous trial data, and the most common treatment-emergent adverse events were mild to moderate in severity. The U.S. FDA updated the PEMGARDA Fact Sheet for Healthcare Providers to include the 180-day exploratory clinical efficacy data. Invivyd also held a conference call to discuss the data analyses...Show More

On August 27, 2024, Invivyd, Inc., a biopharmaceutical company, announced positive results from its CANOPY Phase 3 clinical trial for PEMGARDA (pemivibart), a monoclonal antibody for pre-exposure prophylaxis (PrEP) of COVID-19. The trial demonstrated an 84% relative risk reduction in symptomatic COVID-19 compared to placebo in immunocompetent individuals. The data also indicated a 3% rate of confirmed symptomatic COVID-19 in immunocompromised participants, suggesting a potential signal of protection. The safety profile of pemivibart remained consistent with previous trial data, and the most common treatment-emergent adverse events were mild to moderate in severity. The U.S. FDA updated the PEMGARDA Fact Sheet for Healthcare Providers to include the 180-day exploratory clinical efficacy data. Invivyd also held a conference call to discuss the data analyses. The company highlighted the importance of monoclonal antibodies in providing protection against COVID-19, especially for immunocompromised individuals. Invivyd's INVYMAB platform is designed to rapidly generate new monoclonal antibodies to address evolving viral threats, and the company has received emergency use authorization (EUA) from the U.S. FDA for PEMGARDA. Full data from the CANOPY trial is expected to be published in a scientific journal.