Invivyd宣布其LIBETY 3期研究中具有临床意义和统计学意义的总体数据，该研究评估了VYD 2311、COVID-19疫苗COIRNATY以及VYD 2311与基于mRNA的COVID-19疫苗联合给药的安全性和耐受性

2026-09-29 19:05

VYD2311 met all primary and secondary endpoints comparing VYD2311 to an mRNA-based COVID-19 vaccine, demonstrating VYD2311 safety and tolerability that is clinically and statistically superior to the safety and tolerability of an mRNA-based COVID-19 vaccine
VYD2311 combined with an mRNA-based COVID-19 vaccine demonstrated no interference with vaccine-induced neutralizing titers, and instead added substantially to vaccine-induced neutralizing titers
VYD2311 observed profile in LIBERTY indicates high measured neutralizing antiviral titers supporting the target profile for VYD2311 under study in the DECLARATION pivotal clinical study
Invivyd plans for DECLARATION and LIBERTY clinical studies to be the basis of a planned Biologics License Application (BLA) submission for VYD2311 to the U.S. Food and Drug Administration via Accelerated Approval Program following a recent Type C meeting; DECLARATION topline data on safety and immunogenicity to support the submission are now expected in October; DECLARATION clinical efficacy data will be planned to be unblinded post-Accelerated Approval, if granted, subject to clinical event accrual
Investor call to be held at 8:30 am ET on September 29, 2026