NEW HAVEN, Conn., July 6, 2026
Invivyd announced that the U.S. Food and Drug Administration (FDA) has issued a Notice of Termination for the Emergency Use Authorization (EUA) of PEMGARDA® (pemivibart) following the U.S. Department of Health and Human Services (HHS) decision to terminate the COVID-19 EUA declaration effective June 29, 2027. Under the transition framework established by HHS, PEMGARDA will remain authorized for emergency use during a twelve-month transition period before the EUA officially expires. Invivyd confirmed it is actively engaging with the FDA regarding the appropriate regulatory pathway and intends to pursue permanent approval to ensure continued access for immunocompromised and other vulnerable individuals who remain at elevated risk of severe COVID-19.
FDA and HHS Transition Signals Shift to Traditional Regulatory Pathways
The HHS decision marks a significant regulatory milestone as the United States transitions away from emergency pandemic authorities toward standard approval processes for COVID-19 therapeutics. Under federal law, HHS is required to notify manufacturers of potential regulatory obstacles associated with products authorized under an EUA and outline actions needed to support future approval. Invivyd stated that while discussions with the FDA are ongoing, the company has not yet received formal written guidance describing the specific regulatory pathway required for PEMGARDA’s full approval. The company emphasized that it will continue working closely with federal regulators throughout the transition period to establish an appropriate Biologics License Application (BLA) pathway before the EUA expires.
PEMGARDA Continues to Provide Protection for Immunocompromised Patients
PEMGARDA is a long-acting investigational monoclonal antibody authorized since March 2024 for the pre-exposure prevention of COVID-19 in adults and adolescents with moderate-to-severe immune compromise who are unlikely to generate adequate protection from vaccination. Developed from Invivyd’s investigational antibody adintrevimab, PEMGARDA targets the SARS-CoV-2 spike protein receptor-binding domain to block viral attachment to human cells. Clinical and laboratory data have demonstrated neutralizing activity against several contemporary SARS-CoV-2 variants, including JN.1, KP.3.1.1, XEC, LP.8.1, and XFG. According to the company, the therapy has accumulated more than two years of clinical use while maintaining a favorable safety profile supported by both clinical trials and post-authorization monitoring.
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Company Pursues Permanent Approval Based on Clinical Evidence
Invivyd believes the totality of evidence generated through the pivotal CANOPY clinical trial and real-world clinical experience supports submission of a Biologics License Application (BLA) for full FDA approval. Company leadership stated that PEMGARDA has generated extensive randomized clinical evidence supporting its efficacy and safety as a non-vaccine preventive option for vulnerable populations. As the federal government concludes the COVID-19 emergency authorization framework, Invivyd intends to continue collaborating with regulators to secure permanent approval and maintain access to monoclonal antibody protection for patients who remain at increased risk of COVID-19 despite vaccination or who are unable to mount an adequate immune response.
Source: Invivyd press release
