Adagio(US:IVVD) Globenewswire·2025-12-23 12:05Core Insights - Invivyd, Inc. announced that the FDA has granted Fast Track designation for VYD2311, a monoclonal antibody candidate aimed at preventing COVID-19 [1][2] Group 1: FDA Fast Track Designation - Fast Track designation allows for expedited development and review of drugs addressing serious conditions and unmet medical needs, potentially leading to priority review and reduced regulatory timelines [2] - VYD2311 is specifically designated for individuals with underlying risk factors for severe COVID-19 [2] Group 2: Clinical Trials - The DECLARATION trial is a Phase 3, randomized, triple-blind, placebo-controlled study to evaluate the safety and efficacy of VYD2311 in preventing symptomatic COVID-19 [4][7] - The trial will enroll approximately 1,770 participants, including adults and adolescents, and will compare a single or monthly dose of VYD2311 against a placebo [4][7] - Top-line data from the DECLARATION trial is expected by mid-2026 [3] Group 3: Product Information - VYD2311 is a novel monoclonal antibody developed to address the urgent need for new prophylactic and therapeutic options against COVID-19 [5] - The antibody is engineered using Invivyd's proprietary technology platform and is designed to neutralize contemporary virus lineages [6] - VYD2311 shares the same antibody backbone as other investigational monoclonal antibodies in Invivyd's pipeline, which have shown promising results in clinical trials [6] Group 4: Company Overview - Invivyd, Inc. is focused on delivering protection from serious viral infectious diseases, starting with SARS-CoV-2 [8] - The company utilizes a unique integrated technology platform to develop and adapt antibodies for various viral threats [8]