Invivyd Stock Soars 25% on FDA Fast Track for COVID Antibody
Key clinical and regulatory milestones achieved for VYD2311, an antibody alternative to vaccines, as company initiates pivotal Phase 3 trial.
Shares of Invivyd (NASDAQ: IVVD), a Massachusetts-based biotechnology firm, surged over 25% on Tuesday after the company announced a pair of significant advancements for its lead COVID-19 antibody candidate, VYD2311. The stock climbed to $2.88, touching a new 52-week high, as investors reacted to the news that the U.S. Food and Drug Administration (FDA) granted the therapy Fast Track designation while a pivotal Phase 3 clinical trial simultaneously gets underway.
The dual announcements provide substantial momentum for VYD2311, an investigational monoclonal antibody designed for the pre-exposure prophylaxis (PrEP) of COVID-19. Unlike vaccines, which stimulate the body's own immune system, VYD2311 is a lab-created antibody that provides immediate passive immunity. This approach is aimed primarily at immunocompromised and other at-risk populations who may not derive sufficient protection from traditional vaccination.
In a statement, Invivyd confirmed the FDA granted Fast Track designation to VYD2311. This regulatory pathway is designed to facilitate the development and expedite the review of drugs that treat serious conditions and fill an unmet medical need, potentially shortening the timeline to approval.
Concurrent with the FDA news, the company launched its pivotal Phase 3 study, known as DECLARATION. The placebo-controlled trial will enroll approximately 1,770 participants to evaluate the safety and efficacy of VYD2311. Invivyd anticipates reporting top-line data from the study in mid-2026. Success in this trial is the final clinical hurdle required for a potential Biologics License Application (BLA) to the FDA.
The market's bullish reaction reflects the de-risking nature of these milestones. Today's gains pushed Invivyd’s market capitalization to over $536 million. The positive sentiment echoes recent analyst commentary. Just yesterday, analysts at BTIG reiterated a "Buy" rating on the stock, setting a price target of $10.00, suggesting significant potential upside from its current trading level.
In a clear signal of confidence in the antibody's prospects, Invivyd also disclosed that it has already manufactured commercial launch quantities of VYD2311 at risk. This strategic decision could allow for a rapid rollout to the market if the Phase 3 trial is successful and regulatory approval is granted, positioning the company to quickly address the ongoing need for COVID-19 protection among the vulnerable.
With major clinical and regulatory hurdles now cleared, all eyes will be on the execution of the DECLARATION trial. The mid-2026 data readout will serve as the next major catalyst for the company as it seeks to deliver a new option for immunocompromised individuals and redefine the long-term management of COVID-19.