Dec. 23 at 1:34 PM
Invivyd said the U.S. Food and Drug Administration has granted Fast Track designation to VYD2311, its monoclonal antibody candidate for COVID-19 prevention. The program targets individuals at higher risk of severe disease and is positioned as a vaccine alternative. Fast Track status is intended to speed development and regulatory review for therapies addressing serious conditions with unmet medical needs.
The company has launched DECLARATION, a Phase 3 clinical trial supporting a BLA submission, with preliminary data from 1,770 participants expected by mid-2026. VYD2311 will be administered via intramuscular injection, either as single-dose or monthly dosing.
Invivyd said VYD2311 was developed using its proprietary integrated technology platform, designed to generate antibodies that can potentially remain effective against evolving viral variants.
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