Invivyd (NASDAQ:IVVD) received U.S. Food and Drug Administration Fast Track designation for VYD2311, an investigational monoclonal antibody designed as a long-acting, intramuscular alternative to traditional vaccines for individuals at high risk of severe COVID-19.
The regulatory milestone allows for an expedited development timeline, including the possibility of priority review and a rolling Biologics License Application (BLA) submission, providing a significant boost to the company’s effort to establish a new standard in preventative care.
The designation is underpinned by the ongoing Phase 3 DECLARATION trial, a pivotal, triple-blind study currently enrolling 1,770 participants.
Unlike previous generations of antibody treatments that often required complex intravenous infusions, VYD2311 is administered via a single or monthly intramuscular injection.
This shift is intended to provide a more accessible and patient-friendly option for the millions of Americans who remain vulnerable to severe outcomes despite widespread vaccination efforts.
Invivyd’s strategy relies on its "REVOLUTION" clinical program, which utilizes a proprietary technology platform to engineer antibodies optimized for contemporary viral variants.
VYD2311 leverages the same molecular backbone as pemivibart, the company’s earlier antibody that received emergency use authorization for immunocompromised patients.
By pursuing a full BLA for VYD2311, Invivyd is expanding its target market to include any adult or adolescent with underlying risk factors for severe disease, such as obesity, diabetes, or chronic lung conditions.
The company expects to report top-line data from the DECLARATION trial in mid-2026.
If the results demonstrate a significant reduction in symptomatic COVID-19 compared to placebo, the data will serve as the primary basis for a formal licensing application.