On October 6, 2025, Invivyd, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for VYD2311, a vaccine‑alternative monoclonal antibody candidate for COVID‑19 prevention. The clearance is part of the company’s REVOLUTION clinical program, which includes the DECLARATION Phase 3 pivotal trial and the LIBERTY head‑to‑head trial against mRNA vaccines.
The IND approval enables Invivyd to initiate the DECLARATION trial, a BLA‑enabling Phase 3 study that will evaluate VYD2311 safety and efficacy in preventing symptomatic COVID‑19 with either a single intramuscular dose or monthly dosing over three months. The LIBERTY trial will assess safety and tolerability of VYD2311 in a head‑to‑head comparison with mRNA vaccines and evaluate co‑administration of the antibody with vaccination, pending final FDA alignment.
This regulatory milestone is significant for Invivyd because it removes a major barrier to clinical development, allowing the company to move from preclinical and early‑phase studies to definitive efficacy testing. Successful completion of these trials could lead to a BLA submission and broaden the company’s product portfolio beyond its existing PEMGARDA product, potentially capturing a larger share of the COVID‑19 prophylaxis market for immunocompromised patients and other high‑risk groups.
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