Invivyd Advances COVID-19 Prevention with VYD2311 Phase 3 Trial and Fast Track Designation

Invivyd has launched its Phase 3 DECLARATION trial of VYD2311, a COVID-19 prevention monoclonal antibody, and secured Fast Track designation from the US FDA. The trial aims to evaluate whether a single dose of VYD2311 can reduce symptomatic COVID-19 at three months compared to placebo. The study will enroll approximately 1,770 adults and adolescents, with top-line data expected in mid-2026. The company has produced commercial quantities of VYD2311 and secured significant capital to support the trial and potential commercialization efforts.