Invivyd Shares Surge 22.41% on FDA Green Light for Key Monoclonal Antibody Candidate

Shares of Invivyd (NASDAQ: IVVD) surged 22.41% on Monday, reaching their highest level since October 2025, with an intraday gain of 32.76%. The rally followed regulatory progress for the company’s lead candidate, VYD2311, a monoclonal antibody designed for COVID-19 prevention.

The U.S. Food and Drug Administration (FDA) cleared Invivyd’s Investigational New Drug (IND) application for VYD2311, enabling the initiation of its REVOLUTION clinical program. This regulatory milestone allows the company to launch two pivotal trials—DECLARATION and LIBERTY—to evaluate the safety, efficacy, and comparative performance of VYD2311 against existing mRNA-based vaccines. The trials are slated to begin by year-end 2025, with preliminary results expected by mid-2026.

DECLARATION will assess the antibody’s ability to prevent symptomatic COVID-19 over three months, testing both a single-dose and monthly-dosing regimen. LIBERTY, an active-controlled study, will directly compare VYD2311 to mRNA vaccines, focusing on safety, tolerability, and co-administration strategies. The FDA’s alignment with Invivyd’s proposed accelerated approval pathway signals confidence in the drug’s potential to address limitations of current vaccines, such as repeated dosing requirements and inflammatory side effects.

Invivyd has secured $57.5 million in capital through a public offering in August 2025, funding trials through pivotal data readouts. The company has also produced commercial quantities of VYD2311, ensuring readiness for potential market entry. These financial and operational preparations bolster investor sentiment, mitigating risks related to trial execution and scalability. A planned investor event in October 2025 will further detail the REVOLUTION program and commercialization strategies.

Analysts highlight the broader implications of VYD2311’s development, which could redefine post-pandemic public health strategies by offering a non-vaccine alternative tailored to individualized healthcare preferences. The drug’s design, inspired by natural immunity mechanisms and supported by prior safety data from similar antibodies, strengthens its scientific foundation. However, risks remain, including regulatory delays, clinical outcomes, and competitive pressures in the $50 billion monoclonal antibody market.