Invivyd’s COVID Antibody VYD2311 Receives FDA Fast Track

Claim 50% Off TipRanks Premium and Invest with Confidence Unlock hedge-fund level data and powerful investing tools designed to help you make smarter, sharper decisions Stay ahead of the market with the latest news and analysis so your portfolio is always positioned for maximum potentialThe latest announcement is out from Invivyd ( (IVVD) ). On December 23, 2025, Invivyd announced that the U.S. Food and Drug Administration granted Fast Track designation to VYD2311, its investigational vaccine-alternative monoclonal antibody designed to prevent COVID in individuals with underlying risk factors for severe disease. The designation could accelerate regulatory review for VYD2311, which is being evaluated in DECLARATION, a pivotal Phase 3 randomized, triple-blind, placebo-controlled trial enrolling about 1,770 adults and adolescents—with and without risk factors—to test single and monthly intramuscular dosing over three months, with top-line data expected in mid-2026; the program underscores Invivyd’s push to secure a stronger position in the COVID prevention market as an antibody-based alternative to vaccines, potentially broadening options for high-risk and general populations if efficacy and safety are confirmed. The most recent analyst rating on (IVVD) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on Invivyd stock, see the IVVD Stock Forecast page. Spark’s Take on IVVD Stock According to Spark, TipRanks’ AI Analyst, IVVD is a Neutral. Invivyd’s overall stock score reflects significant financial and technical weaknesses, marked by ongoing losses and bearish trends. While recent corporate developments offer a glimpse of potential strategic improvement, these are overshadowed by the current financial instability and weak market sentiment. To see Spark’s full report on IVVD stock, click here. More about Invivyd Invivyd, Inc. (Nasdaq: IVVD) is a biopharmaceutical company focused on delivering protection from serious viral infectious diseases, beginning with SARS-CoV-2. Using a proprietary integrated technology platform to assess, monitor and develop antibodies, the company is building a pipeline of monoclonal antibody candidates, including one that received U.S. emergency use authorization in March 2024 for pre-exposure prophylaxis of symptomatic COVID-19 in certain immunocompromised patients. Average Trading Volume: 7,658,086 Technical Sentiment Signal: Buy Current Market Cap: $637.4M For a thorough assessment of IVVD stock, go to TipRanks’ Stock Analysis page.