Invivyd topline Phase 3 LIBERTY results for VYD2311 show safety, tolerability vs mRNA COVID vaccine
Invivyd reported positive topline Phase 3 LIBERTY results for VYD2311, including co-administration findings and plans to support a U.S. FDA accelerated approval BLA; DECLARATION topline results are expected in October, with efficacy data planned to be unblinded post-approval if granted.
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11:31:05 AM UTC
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Invivyd set plans to file a U.S. FDA Biologics License Application for COVID-19 antibody VYD2311 via the Accelerated Approval Program. Submission expected to be supported by Phase 3 DECLARATION and LIBERTY studies; DECLARATION safety and immunogenicity topline data due in October. Company expects clinical efficacy data from DECLARATION to be unblinded post-Accelerated Approval, subject to event accrual. 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 EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001193125-26-406007), on September 29, 2026, and is solely responsible for the information contained therein. (C)