Invivyd gets EUA from FDA for Pemgarda in COVID-19 in adults and adolescents

On March 22, PEMGARDA pemivibart injection, for intravenous use, received emergency use authorization EUA from the U.S. Food and Drug Administration FDA for the pre-exposure prophylaxis of COVID-19 in adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination. Recipients should not be currently infected with or have had a known recent exposure to an individual infected with SARS-CoV-2. “I am very pleased to announce that, in less than two weeks from receiving EUA, PEMGARDA is now commercially available for order across the U.S.,” said Dave Hering, Chief Executive Officer. “This is a remarkable achievement for our organization and for the immunocompromised individuals we serve. With product now available, today we are providing initial PEMGARDA net product revenue guidance in the range of $150Mto $200M for the full year 2024. Based on this anticipated net product revenue and our continued optimization of operating expenses, we expect to end 2024 with at least $55M in cash and cash equivalents.”