Vaxcyte, Inc. dosed the first participants in its OPUS‑3 Phase 3 trial, a key milestone in the company’s 31‑valent pneumococcal conjugate vaccine program.
The OPUS‑3 study enrolls approximately 720 healthy U.S. adults aged 50 years and older, randomizing them 3:1 to receive the investigational VAX‑31 or the comparator PCV20. Safety and immunogenicity will be evaluated for six months after vaccination, providing critical data for the planned Biologics License Application.
This dosing marks the first step in a three‑study Phase 3 program that also includes OPUS‑1, a pivotal non‑inferiority trial, and OPUS‑2, a concomitant influenza vaccination study. Together, the trials aim to demonstrate that VAX‑31 covers roughly 95 % of invasive pneumococcal disease and 88 % of pneumococcal pneumonia in adults 50 years and older, potentially offering broader protection than current vaccines.
Vaxcyte recently completed a public offering that raised about $550 million, giving the company additional runway to support the Phase 3 program. The company will report its fourth‑quarter and full‑year 2025 financial results on February 24, 2026, providing further insight into its financial position as it advances the vaccine program.
Executive Vice President and Chief Operating Officer Jim Wassil noted that the company expects to announce topline data from OPUS‑1 in the fourth quarter of 2026 and from OPUS‑2 and OPUS‑3 in the first half of 2027, keeping the BLA submission on track. CEO Grant Pickering has described VAX‑31 as a best‑in‑class candidate that could set a new standard for pneumococcal protection.
The announcement was met with a positive market reaction, with analysts highlighting the milestone as a significant step toward de‑risking the product and the recent equity raise as a strong financial foundation for continued development.
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