Invivyd Earns FDA Fast Track Designation for VYD2311

Invivyd, Inc. announced on December 23, 2025, that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for VYD2311, an investigational vaccine-alternative monoclonal antibody candidate for the prevention of COVID-19. This designation aims to expedite the development and review of VYD2311, potentially allowing for priority review and rolling Biologics License Application (BLA) submission. The FDA granted this designation for the prevention of COVID-19 in individuals with underlying risk factors for severe COVID-19. Invivyd is currently conducting the Phase 3, randomized, triple-blind, placebo-controlled clinical trial called DECLARATION to evaluate the safety and efficacy of VYD2311, with top-line data expected in mid-2026. VYD2311 is a novel monoclonal antibody engineered using Invivyd’s proprietary technology platform, designed to neutralize contemporary virus lineages and potentially offer a more patient-friendly intramuscular route of administration. The company is also developing other antibody candidates and has previously received emergency use authorization for one such candidate.