Invivyd (NASDAQ:IVVD), a biopharmaceutical company specializing in infectious diseases, announced on April 9, 2026, a strategic expansion of its ongoing Phase 3 clinical trial alongside significant progress in its respiratory and viral pipeline.
The company has upsized its DECLARATION trial following a sample-size re-estimation and is advancing a new monoclonal antibody candidate targeting measles.
The DECLARATION Phase 3 trial will increase its enrollment by approximately 500 subjects.
This expansion follows a planned re-estimation designed to ensure the study maintains sufficient statistical power to meet its primary endpoints.
As a result of the increased enrollment period, Invivyd now expects to report top-line data from the trial in the third quarter of 2026, representing a modest shift from previous estimates.
In tandem with the trial update, Invivyd confirmed it has reached an agreement with the U.S. Food and Drug Administration (FDA) regarding an initial pediatric study plan.
This alignment is a critical regulatory step as the company seeks to broaden the potential patient population for its viral treatments.
The company also provided technical details on VMS063, its potent monoclonal antibody candidate for measles.
VMS063 is designed to target a highly conserved epitope on the measles F protein, a mechanism intended to maintain efficacy across various circulating lineages.
Preliminary data indicates high potency, with neutralization levels in the low ng/mL to high pg/mL range.
The candidate has been engineered for a long half-life to provide durable protection.
Invivyd is currently moving VMS063 through IND-enabling studies, with a goal of achieving Investigational New Drug (IND) readiness by late 2026.
This timeline positions the company to potentially enter the clinic with a first-in-class therapeutic option for a disease that continues to see outbreaks in undervaccinated populations.