Vaxcyte announced that it has finished enrolling 905 infants in its Phase 2 dose‑finding study of the 31‑valent pneumococcal conjugate vaccine VAX‑31. The study, which began in early 2025, is now positioned to deliver safety, tolerability and immunogenicity data in the first half of 2027, a key milestone that brings the company closer to a potential Biologics License Application for the infant indication.
The company also reported that the first participants in its Phase 3 adult program, OPUS‑2, have been dosed. OPUS‑2 is a randomized, double‑blind, placebo‑controlled trial that evaluates VAX‑31 when co‑administered with a licensed seasonal influenza vaccine in adults aged 50 years and older. Dosing the first cohort marks the transition from planning to active clinical testing in the adult population.
These two milestones are pivotal for Vaxcyte’s development schedule. Completing infant enrollment removes a major regulatory hurdle, while initiating adult dosing accelerates the path to pivotal data that will support a BLA for the adult indication. Together, they move the company closer to market launch of what it claims will be the broadest‑spectrum pneumococcal vaccine available.
VAX‑31 leverages a novel carrier‑sparing, site‑specific conjugation technology that is designed to broaden strain coverage and enhance immune responses compared with traditional conjugate vaccines. The product is expected to cover roughly 95 % of invasive pneumococcal disease in adults and a high percentage of disease and acute otitis media in infants, positioning it to fill a significant unmet need in both age groups.
Vaxcyte’s financial foundation remains robust. As of September 30, 2025, the company held approximately $2.7 billion in cash, cash equivalents and investments, sufficient to fund its current operating plan through mid‑2028. The company has secured a manufacturing partnership with Thermo Fisher Scientific that could involve up to $1 billion in services and is building a custom fill‑finish line in North Carolina to support future commercial production.
CEO Grant Pickering emphasized the strategic importance of these developments, noting that the adult dosing milestone “marks a major step forward” and that the infant study progress “underscores VAX‑31’s potential to set a new standard for pneumococcal prevention.” He also highlighted the company’s Breakthrough Therapy designation for VAX‑31 in adults, which underscores regulatory confidence in the product’s clinical benefit.
Analysts continue to view Vaxcyte favorably, with a consensus “Strong Buy” rating and a median price target of $110. The positive market reaction reflects confidence in VAX‑31’s broad coverage, the company’s strong cash position, and the momentum generated by these clinical milestones.
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