Invivyd announced positive 180-day exploratory clinical efficacy data from its CANOPY Phase 3 trial of PEMGARDA (pemivibart) for COVID-19 prevention. In immunocompetent participants, pemivibart demonstrated an 84% relative risk reduction in symptomatic COVID-19 compared to placebo, with infection rates of 1.9% versus 11.9% respectively. The trial covered periods of XBB and JN.1 variant circulation.In immunocompromised participants, pemivibart showed a 3% rate of confirmed symptomatic COVID-19 over the 180-day period. The safety profile remained consistent with previous data, with the most common adverse events being viral infection, upper respiratory tract infection, and influenza-like illness. Anaphylaxis was observed in 4 participants (0.6%) in the immunocompromised cohort.The FDA has updated PEMGARDA's Fact Sheet for Healthcare Providers to include the 180-day exploratory clinical efficacy data. The study results provide important evidence that monoclonal antibodies can offer meaningful protection against COVID-19 in real-world settings, even in populations with prior immune exposure through vaccination or infection.

Invivyd announced positive 180-day exploratory clinical efficacy data from its CANOPY Phase 3 trial of PEMGARDA (pemivibart) for COVID-19 prevention. In immunocompetent participants, pemivibart demonstrated an 84% relative risk reduction in symptomatic COVID-19 compared to placebo, with infection rates of 1.9% versus 11.9% respectively. The trial covered periods of XBB and JN.1 variant circulation.In immunocompromised participants, pemivibart showed a 3% rate of confirmed symptomatic COVID-19 over the 180-day period. The safety profile remained consistent with previous data, with the most common adverse events being viral infection, upper respiratory tract infection, and influenza-like illness. Anaphylaxis was observed in 4 participants (0.6%) in the immunocompromised cohort.The FDA has updated PEMGARDA's Fact Sheet for Healthcare Providers to include the 180-day exploratory clinical efficacy data. The study results provide important evidence that monoclonal antibodies can offer meaningful protection against COVID-19 in real-world settings, even in populations with prior immune exposure through vaccination or infection.