Invivyd, Inc. (IVVD) has advanced its COVID-19 prevention portfolio with the launch of its pivotal Phase 3 DECLARATION trial of VYD2311, an investigational monoclonal antibody, alongside securing Fast Track designation from the U.S. FDA.
The DECLARATION trial is part of Invivyd's broader REVOLUTION clinical program, which aims to establish monoclonal antibody prophylaxis as a flexible, vaccine-alternative approach for COVID-19.
The study is designed to evaluate whether a single intramuscular (IM) dose of VYD2311 can reduce PCR-confirmed symptomatic COVID-19 at three months compared with placebo, the trial's primary endpoint.
Invivyd expects that one IM dose will provide strong protection across the measured interval and potentially beyond, while a second arm assessing monthly dosing is intended to generate data that could support more flexible, individualized protection strategies for people seeking periodic extra coverage during high-risk periods.
The randomized, triple-blind, placebo-controlled Phase 3 trial will enroll approximately 1,770 adults and adolescents, including individuals with and without risk factors for severe disease.
Participants will receive either a single IM dose, monthly IM doses, or placebo. Invivyd noted that the inclusion of a monthly dosing arm could support a future administration paradigm that allows at-risk individuals to opt for additional protection rather than rely on a single, centrally defined regimen.
The company highlighted that VYD2311 was well tolerated in its Phase 1/2 study, even at four times the dose planned for Phase 3, with all adverse events mild to moderate and none considered related to the study drug.
VYD2311 is engineered using Invivyd's proprietary integrated technology platform and is designed to neutralize contemporary SARS-CoV-2 lineages. It leverages the same antibody backbone as Pemivibart, which previously received emergency use authorization for pre-exposure prophylaxis in certain immunocompromised patients.
The company believes the candidate's pharmacokinetic profile and antiviral potency may enable clinically meaningful protection through a patient-friendly intramuscular route of administration.
Invivyd has already produced commercial-launch quantities of VYD2311 and secured significant capital to support both the DECLARATION trial and potential commercialization efforts.
Enrolment is expected to occur during the typical respiratory virus season, when COVID-19 circulation historically increases, and top-line data from the study are anticipated in mid-2026.
IVVD has traded between $0.35 and $3.07 over the past year. The stock is currently trading in the pre-market at $2.94, up 2.08%.
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