other material
confidence high
sentiment positive
materiality 0.75
Invivyd announces Phase 3 DECLARATION upsizing; new measles antibody VMS063
Invivyd, Inc.
- DECLARATION Phase 3 COVID-19 prophylaxis study upsized by ~500 subjects; top-line results now expected in Q3 2026, shifted from mid-2026.
- Pooled, blinded COVID-19 events at 1,500 subjects (Day 45) already support statistical power for high end of anticipated VYD2311 efficacy.
- FDA alignment on initial Pediatric Study Plan for VYD2311 (DRUMMER study) for children aged 0-11 years, contingent on DECLARATION success.
- New measles mAb candidate VMS063 targets F protein, shows potent in vitro neutralization (picogram/mL IC50s) across B3, D8, Edmonston lineages; IND-enablement started.
- VMS063 is half-life extended, planned for treatment and prophylaxis in measles; U.S. measles incidence in 2026 on track to exceed 2025.