Invivyd Inc. has announced its alignment with the U.S. Food and Drug Administration (FDA) regarding a streamlined pathway towards potential Biologics License Application $(BLA.AU)$ approval for its novel monoclonal antibody candidate, VYD2311, intended for the prevention of COVID-19. This alignment follows a Type C meeting with the FDA, which advised that a single Phase 2/3 randomized, double-blind, placebo-controlled trial could support a BLA submission. The trial will evaluate the efficacy of VYD2311 based on a modest number of RT-PCR-confirmed symptomatic COVID-19 cases. The candidate is targeted for use in individuals aged 12 and older, including those who are immunocompromised. Invivyd plans for a comprehensive trial with a 12-week primary endpoint analysis, assessing the prevention of COVID-19 among a broad population. Pending regulatory alignment, there will also be a planned head-to-head safety evaluation with existing COVID-19 vaccines. Results of the study have not yet been presented.