Invivyd Inc. (NASDAQ:IVVD) shares are up during Thursday’s premarket session as the company announced progress in its REVOLUTION clinical program for VYD2311, a novel monoclonal antibody aimed at preventing symptomatic COVID-19.
The company said its Phase 3 DECLARATION trial evaluating VYD2311 for COVID-19 prevention has reached a key interim milestone.
A blinded sample size re-estimation conducted after 1,500 participants reached Day 45 showed sufficient clinical events to support statistical power at the higher end of expected efficacy.
To further strengthen the dataset, Invivyd increased the study size by about 500 participants, bringing the total to more than the original 1,818 subjects.
The adjustment aims to ensure robust results across varying COVID-19 infection rates.
As a result, the company now expects topline data in the third quarter of 2026, compared with earlier expectations for mid-year 2026. Management indicated that the expanded dataset should support a broader range of potential efficacy outcomes.
Invivyd Pediatric Study Plan Aligned With FDA
Invivyd also confirmed alignment with the U.S. Food and Drug Administration on a pediatric development strategy for VYD2311.
The planned DRUMMER study will evaluate safety and immunobridging in children aged 0–11 years, contingent on a successful outcome from the DECLARATION trial.
Further details on the pediatric study are expected once the pivotal trial progresses.
Measles Antibody Candidate Moves Toward Clinical Development
Separately, Invivyd announced progress on VMS063, a novel monoclonal antibody targeting the measles virus.
The candidate is designed to block viral entry by stabilizing the fusion protein, a mechanism similar to certain RSV therapies.
Preclinical data showed strong neutralization across multiple measles strains, including currently circulating variants.
The company has initiated IND-enabling activities and manufacturing preparation, positioning VMS063 for near-term clinical testing.
The company expects to provide additional pipeline updates, including other antibody programs, later in 2026.
IVVD Stock Price Activity: Invivyd shares were up 5.91% at $1.43 during premarket trading on Thursday, according to Benzinga Pro data.
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