Invivyd Inc. Announces Rapid Pathway to Approval for COVID-19 Monoclonal Antibody VYD2311 Following FDA Alignment
Reuters
Aug 15
Invivyd Inc. Announces Rapid Pathway to Approval for COVID-19 Monoclonal Antibody VYD2311 Following FDA Alignment
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.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Invivyd Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9512989-en) on August 14, 2025, and is solely responsible for the information contained therein.
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