IVVD News & Events

Invivyd announced that the FDA has sent Invivyd a notice of termination for the Pemgarda Emergency Use Authorization, or EUA, following the U.S. Department of Health and Human Services', or HHS, announcement of advanced notice of termination of the COVID-19 EUA declaration on June 30, with an effective date of June 29, 2027. Consequently, the EUA for Pemgarda is set to terminate on June 29, 2027. Pemgarda is Invivyd's investigational monoclonal antibody authorized by the FDA under an EUA since March 2024 for the pre-exposure prophylaxis of COVID-19 in certain adults and adolescents who have moderate-to-severe immune compromise due to certain medical conditions or receipt of certain immunosuppressive medications or treatments and are unlikely to mount an adequate immune response to COVID-19 vaccination.

Invivyd announced enrollment of participants in its Phase 3 LIBERTY clinical trial is complete. The trial is comparing the safety and tolerability of the company's investigational COVID-19 monoclonal antibody VYD2311 with an mRNA COVID-19 vaccine. The trial is also evaluating the safety and immune response when both are given together. VYD2311 is being developed as an alternative to vaccines for preventing COVID-19. The LIBERTY study is a randomized, double-blind trial involving healthy adults. A primary endpoint of the trial is to assess the side effects and tolerability of COVID antibody versus vaccine through Day six, for a total of seven days. Invivyd expects to report initial results from the study in the third quarter of 2026. These results may be released alongside data from the company's pivotal DECLARATION clinical trial.

Invivyd announced the completion of enrollment in the DECLARATION trial evaluating VYD2311, an investigational monoclonal antibody candidate for the prevention of symptomatic COVID-19. DECLARATION is the company's biologics license application, or BLA-enabling, Phase 3 randomized, placebo-controlled clinical trial to evaluate VYD2311 efficacy and safety in prevention of symptomatic COVID in a broad population of participants including adults and adolescents. Top-line results continue to be expected in approximately late Q3.