Invivyd receives regulatory termination notice for covid antibody
- Invivyd (NASDAQ:IVVD) received notice from the FDA that the Emergency Use Authorization for PEMGARDA will officially terminate on June 29, 2027.
- The regulatory shift follows a broader decision by the Department of Health and Human Services to conclude the national COVID-19 emergency declaration.
- Invivyd plans to utilize its accumulated clinical and post-authorization safety data to pursue a permanent Biologics License Application for the therapy.
Invivyd (NASDAQ:IVVD) announced it received formal notification from the FDA that the Emergency Use Authorization for its monoclonal antibody treatment PEMGARDA will terminate on June 29, 2027.
The regulatory transition follows an overarching directive by the Department of Health and Human Services to conclude the broader federal COVID-19 emergency declaration frameworks.
The therapeutic asset is engineered specifically to provide pre-exposure prophylaxis against viral infections in adult and adolescent patients with moderate-to-severe immune compromises.
The Waltham, Massachusetts-based biopharmaceutical firm focuses on using advanced evolutionary analytics to discover, develop, and commercialize antibody therapies for viral threats.
The regulatory timeline provides the corporation with a multi-month window to compile and file its formalized documentation for permanent commercial marketing authorization.
