Invivyd announced progress in its Phase 3 DECLARATION study for COVID-19 candidate VYD2311, including a triggered sample size increase and updated timeline, and introduced a new measles antibody candidate VMS063.
Key takeaways
The DECLARATION Phase 3 study for VYD2311 triggered a pre-specified sample size increase, adding ~500 subjects to the initial 1,818, shifting top-line result expectations from mid-year 2026 to Q3 2026.
Pooled, blinded COVID-19 events accumulated to date (~50% study progress) are stated to already provide sufficient statistical power to support the high end of anticipated VYD2311 efficacy.
Invivyd announced the discovery and advancement of VMS063, a novel monoclonal antibody candidate for the treatment and prevention of measles, targeting a highly conserved epitope.
The company has begun IND-enablement and regulatory outreach for VMS063, with a target IND readiness in late 2026.
Invivyd and the U.S. FDA have aligned on an Initial Pediatric Study Plan for a BLA-directed pediatric trial for VYD2311, named 'DRUMMER', to be actioned only if DECLARATION is successful.