Invivyd announces FDA IND clearance for VYD2311; Phase 3 and Phase 2 trials to start year-end 2025

Invivyd, Inc.

FDA cleared IND and aligned on pivotal clinical program for VYD2311, a vaccine-alternative monoclonal antibody to prevent COVID.
DECLARATION Phase 3 trial (N=~2,000) will evaluate single and monthly IM doses vs placebo for 3-month prevention of symptomatic COVID.
LIBERTY Phase 2 trial (N=~300) will compare safety/tolerability of VYD2311 vs mRNA vaccine and explore co-administration.
Trials to begin year-end 2025 with top-line data anticipated mid-2026; funded by recent capital raise and commercial launch quantities ready.
Details to be shared in public investor event later this month.

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