Invivyd Upsizes Phase 3 COVID-19 Trial and Announces New Measles Antibody Candidate VMS063

Invivyd, Inc. announced progress in its REVOLUTION clinical program, specifically regarding VYD2311, a monoclonal antibody (mAb) candidate for COVID-19 prevention. The company conducted a pre-specified sample size re-estimation analysis for its Phase 3 DECLARATION study, which triggered an "upsizing" of the trial by approximately 500 subjects to a total of roughly 2,318 participants. This move is intended to ensure robust statistical power across varying COVID-19 event rates. Consequently, topline results for the DECLARATION study are now expected in Q3 2026, a modest shift from the previous mid-year guidance. Additionally, Invivyd aligned with the FDA on an Initial Pediatric Study Plan for "DRUMMER," a pivotal immunobridging and safety trial for VYD2311 in children aged 0-11 years. Beyond COVID-19, Invivyd announced the discovery of VMS063, a novel, half-life-extended mAb candidate for the treatment and prevention of measles. The company has commenced IND-enabling studies and regulatory outreach for VMS063, targeting IND readiness by late 2026. This expansion highlights Invivyd's strategy to utilize its proprietary platform for a multi-virus portfolio including RSV, mumps, and Lyme disease.