Invivyd earns Fast Track designation for VYD2311

Invivyd (IVVD) announced that the U.S. Food and Drug Administration has granted Fast Track designation for VYD2311, an investigational vaccine-alternative monoclonal antibody candidate for the prevention of COVID. Invivyd previously announced initiation of DECLARATION, the company’s BLA-enabling clinical trial of VYD2311. Top-line data from the trial are expected mid-2026. DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial to evaluate VYD2311 safety and efficacy in prevention of symptomatic COVID in a broad population of participants including adults and adolescents both with and without underlying risk factors for progression to severe COVID-19, at three months. Participants will receive either a single dose or a monthly dose of VYD2311, each administered via intramuscular injection, compared to placebo. Total enrollment of the trial is expected to be 1770 participants.