Invivyd, Inc. (NASDAQ:IVVD), a biopharmaceutical company devoted to delivering protection from serious viral infectious diseases, announced today that the U.S. Food and Drug Administration (FDA) has re-issued an updated Emergency Use Authorization (EUA) Fact Sheet for Healthcare Providers (Fact Sheet) for PEMGARDA (pemivibart) to provide accurate in vitro neutralization activity of PEMGARDA against dominant circulating variants including KP.3.1.1 and LB.1.

The FDA's newly updated Fact Sheet, dated September 26, 2024, removes a contested statement that "preliminary, non-peer-reviewed data in the public domain indicate that KP.3.1.1 may have substantially reduced susceptibility to pemivibart." The FDA has now included viral neutralization data for pemivibart that is in line with prior variants represented in the CANOPY Phase 3 clinical trial based on data generated by LabCorp's Monogram Biosciences lab and provided to the FDA on September 3, 2024, and determined that PEMGARDA is likely to retain adequate neutralization activity against SARS-CoV-2 variants currently circulating in the U.S., including KP.3.1.1 (FDA updates PEMGARDA's SARS-CoV-2 variant susceptibility data).

Various laboratories, which may have competing or conflicting interests with Invivyd's core COVID-19 antibody business, may produce their own reagents meant to resemble pemivibart, and may put neutralization findings of unknown quality into the public domain. Invivyd, as a matter of policy and in partnership with the FDA, relies on the high standard of assessing authentic pemivibart under industrial-quality conditions to assess pemivibart neutralization potency and likely variant susceptibility. Such procedural rigor is critical given the difficulty of cellular bioassay development and validation and intrinsic quantitative variability of these assays even when conducted under highly controlled conditions. Invivyd encourages all stakeholders to rely on validated, scientific studies conducted with authentic pemivibart and to exercise caution when assessing the potential relevance of virology work performed under conditions of questionable quality and control.