Invivyd Gets FDA Clearance To Start Clinical Trials For COVID-19 Antibody VYD2311

(RTTNews) - Invivyd, Inc. (IVVD) Monday announced that the U.S. Food and Drug Administration (FDA) has cleared the company's Investigational New Drug (IND) application for VYD2311, a vaccine alternative antibody candidate for the prevention of COVID-19.

The FDA provided feedback to advance Invivyd's development program for VYD2311, known as REVOLUTION, under which the company plans to initiate two studies—DECLARATION and LIBERTY—by the end of the year, with top-line data expected in mid-2026.

The LIBERTY study will evaluate the safety and tolerability of VYD2311 in a head-to-head comparison with an mRNA-based COVID vaccine and assess the co-administration of VYD2311 with vaccination, subject to final alignment with the FDA.

The DECLARATION study is a Biologics License Application (BLA)-enabling Phase 3 trial designed to evaluate the safety and efficacy of VYD2311 for the prevention of COVID-19 compared with placebo.

Invivyd expects the broader REVOLUTION program to include pediatric and post-approval Phase 4 studies to support VYD2311 and potential future Invivyd antibodies as preferred options for COVID-19 protection over mRNA vaccines.

Invivyd shares were more than 13% up in pre-market. It had closed at $1.16, down 4.92% on Friday. The stock has traded in the range of $0.3550 - $2.7400 in the last 1 year.