Invivyd Reports Preliminary Fourth Quarter 2025 Revenue and Recent Business Highlights

Core Insights - Invivyd, Inc. reported strong revenue growth for its monoclonal antibody PEMGARDA® (pemivibart), with preliminary Q4 2025 net product revenue of $17.2 million, reflecting a 25% year-over-year increase and a 31% quarter-over-quarter increase [4][8] - The company is preparing for the potential commercial launch of VYD2311, a vaccine-alternative for COVID-19, which has received Fast Track designation from the FDA [2][5] - 2026 is anticipated to be a pivotal year for Invivyd as it aims to establish a new standard of care for COVID prophylaxis and expand its pipeline of monoclonal antibodies [2][4] Business Highlights - Preliminary Q4 2025 revenue for PEMGARDA® reached $17.2 million, marking a 25% increase from Q4 2024 and a 31% increase from Q3 2025 [4] - The company ended 2025 with cash and cash equivalents of $226.7 million, bolstered by over $200 million raised in financing during the second half of 2025 [4][8] - The DECLARATION Phase 3 clinical trial for VYD2311 has been initiated, with top-line data expected in mid-2026 [5][8] Clinical & Regulatory Developments - The DECLARATION trial is a Phase 3, randomized, placebo-controlled study to evaluate VYD2311's efficacy and safety in preventing COVID-19, with a total expected enrollment of 1770 participants [5][17] - VYD2311 has been granted Fast Track designation by the FDA, which may expedite its development and review process [5][8] - The trial aims to assess both a single dose and monthly dosing of VYD2311 compared to placebo [5][17] Pipeline Expansion - Invivyd is expanding its pipeline with the nomination of VBY329, a potential best-in-class monoclonal antibody for preventing Respiratory Syncytial Virus (RSV) in infants and children [6][18] - The company is also targeting a preclinical measles mAb candidate selection in the first half of 2026 [6][8] - VBY329 is expected to advance toward IND readiness in the second half of 2026, with the pediatric RSV prophylaxis market projected to grow to $3-$4 billion by 2030 [6][8] Corporate and Financial Updates - The company has a strong balance sheet with sufficient cash to support ongoing clinical trials and commercial preparations for VYD2311 [4][8] - Total shares of common stock outstanding as of December 31, 2025, were 281,987,033, excluding pre-funded warrants [4][8] - Invivyd's financial position is expected to support continued research and development efforts across its pipeline programs [4][8]