FDA grants EUA to Invivyd’s Pemgarda for PrEP of COVID-19

Invivyd (Nasdaq: IVVD) closed 41% higher after Friday’s trading in New York.

The US biopharma’s half-life extended monoclonal antibody (MAb) has received emergency use authorization (EUA) from the US Food and Drug Administration (FDA) for the pre-exposure prophylaxis (PrEP) 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.

"The Pemgarda EUA marks a transformational moment for Invivyd and for the many moderately to severely immunocompromised people who are vulnerable to COVID-19 disease in the USA"Recipients should not be currently infected with or have had a known recent exposure to anyone infected with SARS-CoV-2, according to the approved indication.