Vaxcyte reports positive OPUS-1 topline data for VAX-31, outlines BLA path to first half of 2028

Vaxcyte reported financial results for the third quarter ended September 30, 2026, on November 4, 2026. In October 2026, the company announced positive topline results from OPUS-1, the pivotal adult Phase 3 trial evaluating the safety, tolerability and immunogenicity of VAX-31, its next-generation 31-valent pneumococcal conjugate vaccine candidate, for the prevention of invasive pneumococcal disease and pneumococcal pneumonia.¹ The randomized, double-blind, active-controlled trial enrolled 4,047 healthy, pneumococcal-naïve U.S. adults, including 3,572 aged 50 and older and 475 aged 18-49.¹

In adults 50 and older, VAX-31 met all prespecified co-primary immunogenicity endpoints, with all 28 shared serotypes with Prevnar 20 and/or Capvaxive meeting noninferiority criteria based on opsonophagocytic activity geometric mean ratios.¹ The vaccine was well tolerated with a safety profile similar to PCV20 and PCV21 across ages studied, with no serious adverse events considered related to study vaccines and no discontinuations due to adverse events.¹ Compared to PCV21, serotypes 3 and 12F did not meet the stricter noninferiority threshold but did meet a historical secondary threshold; the company said it expects the VAX-31 to PCV21 comparison to be a particular FDA review focus given current U.S. epidemiology.¹

The fully enrolled OPUS-2 and OPUS-3 Phase 3 trials are expected to report results in the first half of 2027, supporting a planned Biologics License Application submission in the first half of 2028.¹ VAX-31 infant Phase 2 data are expected by the end of the first half of 2027.¹ The VAX-A1 Phase 1 study is advancing to Stage 2 following a DSMB review of Stage 1 data.¹

In October 2026, the company completed concurrent offerings generating $1.15 billion in gross proceeds, including $575 million in common stock and pre-funded warrants and $575 million in convertible senior notes.¹ Cash, cash equivalents and investments were $2,264.4 million as of September 30, 2026, not including the roughly $1.1 billion in net proceeds from the October offerings.¹