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Invivyd Announces REVOLUTION Program Progress and Advancement of Novel, Potential First- and Best-in-Class Measles Monoclonal Antibody Candidate VMS063 for Treatment and Prevention of Measles
Confirmed, pooled, blinded COVID-19 events in the ongoing Phase 3 DECLARATION study of VYD2311 accumulated to date (~ 50% of study progress) can already
About this update from Invivyd, Inc.
[{"type":"text","content":"Confirmed, pooled, blinded COVID-19 events in the ongoing Phase 3 DECLARATION study of VYD2311 accumulated to date (~ 50% of study progress) can already provide sufficient statistical power to support the high end of anticipated VYD2311 efficacy Invivyd conducted a pre-specified sample size re-estimation analysis when 1,500 of 1,818 enrolled patients reached Day 45 of 90 total days (April 6th), designed to add robustness given future event rate variability; that upsizing was triggered and increases confidence in overall study statistical powerDECLARATION upsizing provides ~500 additional subjects and will likely shift study result timing modestly, by approximately two months, from original “mid-year” guidance to Q3 2026 Invivyd and the U.S. FDA have aligned on an initial Pediatric Study Plan for the BLA-directed pivotal pediatric immunobridging and safety “DRUMMER” clinical trial for VYD2311Invivyd today announced the discovery and advancement of VMS063, a novel, highly potent, broadly in vitro neutralizing, high resistance barrier, half-life-extended, potentially first- and best-in-class monoclonal antibody candidate for the treatment and prevention of measles Invivyd has begun IND-enablement and regulatory outreach to support rapid VMS063 development; goal is expedited development with target IND readiness in late 2026Management to host conference call this morning, April 9th, at 8:30AM ET NEW HAVEN, Conn., April 09, 2026 (GLOBE NEWSWIRE) -- Invivyd, Inc. (Nasdaq: IVVD) today announced progress in its REVOLUTION clinical program for VYD2311, a novel monoclonal antibody investigational candidate for the prevention of symptomatic COVID-19. Invivyd also announced today the discovery and advancement of a novel, potentially first- and best-in-class measles monoclonal antibody candidate for treatment and prevention of measles discovered using Invivyd’s proprietary technology. DECLARATION Study Update and New “DRUMMER” StudyThe DECLARATION Phase 3 pivotal study is Invivyd’s Biologics License Application (BLA)-directed clinical trial assessing the safety and efficacy of single and multi-dose VYD2311 for the pre-exposure prophylaxis of COVID-19 compared to placebo over 90 days. The study includes a prospectively designed, conservative, algorithmic sample size re-estimation pooled, blinded analysis aimed at ensuring adequate COVID-19 cl...