Invivyd receives FDA clearance for COVID antibody prevention trials

NEW HAVEN, Conn. - Invivyd, Inc. (NASDAQ:IVVD), a clinical-stage biotech company with a strong balance sheet showing more cash than debt and impressive gross profit margins of 93.4%, announced Monday that the U.S. Food and Drug Administration has cleared its Investigational New Drug application for VYD2311, a monoclonal antibody candidate designed as a vaccine alternative for COVID prevention. According to InvestingPro analysis, the company’s market capitalization stands at $226 million, with significant investor interest reflected in its stock performance.

The company plans to launch two clinical trials around year-end 2025, with top-line data expected by mid-2026. While InvestingPro data indicates the company is currently unprofitable and burning through cash, investors have shown strong confidence in its potential, driving the stock up 123% over the past six months. The DECLARATION trial, a Phase 3 study involving approximately 2,000 participants, will evaluate COVID prevention efficacy of VYD2311 versus placebo. The study will assess both single-dose and monthly administration options.

The LIBERTY trial will compare VYD2311’s safety profile against mRNA-based COVID vaccines in about 300 participants, and will include a co-administration arm exploring the combination of VYD2311 with vaccination, pending final FDA alignment.

"We are moving as fast as possible to bring Americans a new choice in protection from COVID," said Marc Elia, Chairman of Invivyd’s Board of Directors, in the press release statement.

VYD2311 is administered via intramuscular injection and leverages the same antibody backbone as pemivibart, Invivyd’s monoclonal antibody that received emergency use authorization in the U.S. earlier this year for pre-exposure prophylaxis in certain immunocompromised patients.

The company has already produced commercial launch quantities of VYD2311 and secured capital to fund the clinical trials through data readouts. Invivyd plans to share additional details about the clinical program in an investor event later this month.

If approved, VYD2311 could provide an alternative protection option for individuals seeking COVID prevention without the use of vaccines. Analyst price targets collected by InvestingPro range from $1 to $5 per share, reflecting varied expectations about the company’s potential success in this endeavor. For deeper insights into Invivyd’s financial health and growth prospects, investors can access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.

In other recent news, Invivyd, Inc. has successfully closed a public offering, raising approximately $57.5 million in gross proceeds. This financing round included the sale of over 89 million shares of common stock and pre-funded warrants, following the full exercise of the underwriter’s option to purchase additional shares. Additionally, Invivyd announced the pricing of this offering at $0.52 per share, aiming to raise about $50 million to support its clinical programs. In a strategic move, Invivyd appointed Dr. Paul B. Bolno, CEO of Wave Life Sciences, to its Board of Directors, enhancing its leadership team. H.C. Wainwright reaffirmed its Buy rating on Invivyd, citing the potential of its next-generation monoclonal antibody, VYD2311, which is undergoing a pivotal Phase 2/3 trial. The trial’s design aligns with FDA guidelines and aims to support a full biologics license application. Furthermore, Invivyd has gained attention as a potential alternative to traditional COVID-19 vaccines, following a commentary highlighting its monoclonal antibody’s promise in the current political climate.

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