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Noticias de IVVD
Eventos de IVVD
Invivyd Appoints Marc Elia as CEO
Invivyd announced that the company has appointed Marc Elia, current chairman of the Invivyd board of directors, as CEO of the company. He will serve as chairman and CEO of Invivyd going forward.
Invivyd Expects Top-Line Data for VYD2311 by End of Q3
Invivyd continues to expect top-line data from the VYD2311 program around the end of Q3. At that time, Invivyd plans to either unblind the DECLARATION study in its entirety and submit a Biologics License Application towards traditional product approval, or partially unblind the study and submit a BLA towards Accelerated Approval on the basis of antiviral activity and safety, with greater statistical power expected to be achieved in a post-approval confirmatory clinical cohort. Preparing such options for filing pathway will substantially reduce the risk that play of chance related to the statistical powering in DECLARATION intrudes into the near-term availability of VYD2311, a highly active anti-COVID-19 monoclonal antibody that is functionally identical to prior Invivyd antibodies adintrevimab and pemivibart. The company has been in discussions with FDA about potential paths forward and believes that either route can provide a near-term pathway to make VYD2311 available for millions of Americans, subject to FDA review and approval. Invivyd will provide further updates in the coming weeks as previously guided.
Invivyd Receives FDA Termination Notice for Pemgarda EUA
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 Completes Enrollment for LIBERTY Clinical Trial
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 Completes Enrollment in DECLARATION Trial for VYD2311
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.
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