Invivyd receives FDA Fast Track designation for COVID antibody VYD2311

Invivyd, Inc.

FDA Fast Track granted for VYD2311 to prevent COVID in individuals with risk factors for severe disease.
VYD2311 is an investigational vaccine-alternative monoclonal antibody candidate.
Phase 3 DECLARATION trial ongoing; top-line data expected mid-2026.
Fast Track enables priority review and rolling BLA submission if criteria met.
Total enrollment of 1770 participants in the placebo-controlled trial.

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