Invivyd, Inc. (Nasdaq: IVVD) has appointed Marc W. Elia, its current Chairman of the Board of Directors, as Chief Executive Officer, according to a press release issued by the company. Elia will hold both the Chairman and CEO roles going forward.

Elia has served as Chairman of Invivyd's board since June 2022. Ajay Royan, founder of Mithril Capital and a long-term investor in Invivyd, has been appointed Lead Independent Director. Ian Sheffield, founder and Managing Partner of North Country Holdings, a private investment firm, has joined the board as an independent director. Sheffield has more than 20 years of experience as a healthcare investor and medical technology executive, with prior roles at Ashler Capital (Citadel), Bridger Capital, Great Point Partners, and Versant Ventures.

The leadership changes come as Invivyd expects top-line data from its VYD2311 program around the end of Q3 2026. The company stated it plans to either fully unblind its Phase 3 DECLARATION study and submit a Biologics License Application (BLA) for traditional approval, or partially unblind the study and submit a BLA for Accelerated Approval based on antiviral activity and safety data, with confirmatory data to follow post-approval.

Invivyd said it has been in discussions with the U.S. Food and Drug Administration regarding potential regulatory pathways and believes either route could provide a near-term pathway to make VYD2311 available, subject to FDA review and approval.

DECLARATION is a Phase 3, randomized, triple-blind, placebo-controlled trial evaluating VYD2311 for prevention of symptomatic COVID-19, with approximately 2,400 participants. LIBERTY is a Phase 3, randomized, double-blind trial evaluating VYD2311's safety and pharmacokinetics alongside an mRNA COVID vaccine, with approximately 210 participants.

VYD2311 is a monoclonal antibody candidate being developed for COVID-19 prophylaxis and treatment, administered via intramuscular injection. Invivyd said the company plans to provide further updates in the coming weeks.