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Invivyd Earns Fast Track Designation for VYD2311, a Vaccine-Alternative Antibody to Prevent COVID
NEW HAVEN, Conn., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced 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. Fast Track is a process that enables the FDA to expedite the development and review of new drugs that address a serious or life-threatening condition and fill an unmet medical need. If relevant criteria are m
About this update from Invivyd, Inc.
[{"type":"image","alt":"Invivyd","displaySize":"","headline":null,"caption":"Invivyd","className":"","disableSlideshowImg":false,"size":{"original":{"width":300,"height":44,"url":"https://media.zenfs.com/en/globenewswire.com/4a4d9d450de79e16fc0a485fff104ca6"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/MyR5b2vdhRgALtKrzLKLAQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTQyMDtoPTYyO2NmPXdlYnA-/https://media.zenfs.com/en/globenewswire.com/4a4d9d450de79e16fc0a485fff104ca6","width":300,"height":44}},"lazy":false},{"type":"text","content":"NEW HAVEN, Conn., Dec. 23, 2025 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced 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.","length":291,"tagName":"p"},{"type":"text","content":"Fast Track is a process that enables the FDA to expedite the development and review of new drugs that address a serious or life-threatening condition and fill an unmet medical need. If relevant criteria are met, programs with Fast Track designation can become eligible for priority review and rolling Biologics License Application (BLA) submission, which can reduce the timelines associated with regulatory action. VYD2311 was granted Fast Track designation by the FDA for the prevention of COVID in individuals with underlying risk factors for severe COVID.","length":558,"tagName":"p"},{"type":"text","content":"“COVID is a critical ongoing endemic and chronic health challenge, and Americans need more options to prevent themselves from getting sick,” said Marc Elia, Chairman of Invivyd’s Board of Directors. “We are thrilled that the FDA recognizes the need to move quickly to prevent COVID as we move forward with our placebo-controlled, pivotal clinical trial DECLARATION.”","length":366,"tagName":"p"},{"type":"text","content":"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.","length":161,"tagName":"p"},{"type":"text","content":"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 facto...