Vaxcyte, Inc. (PCVX)’s VAX-24 Achieves Phase 2 Success in Infants
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Vaxcyte, Inc. (NASDAQ:PCVX) is a clinical-stage biotech company focused on developing next-generation pneumococcal conjugate vaccines (PCVs) to prevent invasive pneumococcal disease (IPD). The company recently reported positive topline results from its Phase 2 study of VAX-24 in infants. The 24-valent vaccine candidate met all primary endpoints for safety, tolerability, and immunogenicity compared to Pfizer’s Prevnar 20, with robust immune responses and no serious vaccine-related adverse events. Full data following the fourth booster dose is expected by year-end 2025.
Building on this progress, Vaxcyte, Inc. (NASDAQ:PCVX) is advancing VAX-31, a 31-valent PCV targeting broader strain coverage, approximately 94% in U.S. children and 95% in adults. The final stage of its infant Phase 2 trial is underway, with topline results expected by mid-2026. Adult Phase 3 trials are set to begin in mid-2025. VAX-31 has received FDA Breakthrough Therapy designation for adults and investigational approvals for pediatric use, highlighting its potential to address significant unmet medical needs.
The business also unveiled VAX-XL, its third-generation PCV candidate offering the broadest coverage yet, signaling continued innovation in its pipeline. To support commercialization, Vaxcyte, Inc. (NASDAQ:PCVX) is constructing a manufacturing facility at Lonza, expected to be operational by early 2026. Its strong cash reserves of approximately $3 billion provide the necessary funding for R&D and scale-up.
A biotechnologist in a laboratory wearing a lab coat, preparing samples for a clinical trial.
Strategically, the corporation is aligning clinical, regulatory, and manufacturing efforts to become a leader in the global pneumococcal vaccine market. The recent appointment of Dr. Olivier Brandicourt, former CEO of Sanofi, to its board reinforces this vision with deep commercial expertise.
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