$PCVX · Vaxcyte, Inc.
Vaxcyte reported Q3 2026 results and announced positive topline data from the OPUS-1 pivotal Phase 3 trial of VAX-31, its 31-valent pneumococcal conjugate vaccine candidate. VAX-31 met all prespecified co-primary immunogenicity endpoints in adults 50+, with all 28 shared serotypes meeting non-inferiority criteria. Net loss was $297.1M for Q3 2026 versus $212.8M a year earlier, with R&D expenses of $270.3M. The company raised $1.1B net in October 2026 via concurrent equity and convertible note offerings, bringing pro forma cash to approximately $3.4B.
- VAX-31 met all prespecified co-primary endpoints in OPUS-1 (4,047 adults), including all 28 shared serotypes.
- Net loss widened to $297.1M in Q3 2026 from $212.8M in Q3 2025.
- R&D expenses rose to $270.3M from $209.9M year-over-year.
- October 2026 offerings raised $1.1B net; pro forma cash approximately $3.4B.
- BLA submission for VAX-31 planned for H1 2028.
Shares rose 8.01% in regular trading to $65.68, with extended-hours last trade at $65.75 (+0.11% vs close), reflecting a positive reception to the OPUS-1 pivotal data and financing.
Positive pivotal Phase 3 data for a best-in-class 31-valent pneumococcal vaccine candidate, combined with a $1.1B financing, materially de-risks Vaxcyte's path to a 2028 BLA.
Vaxcyte's 31-valent VAX-31 positions against Pfizer's PCV20 and Merck's PCV21 (Capvaxive), with the broadest-spectrum PCV candidate in the clinic.
VAX-31 missed the prespecified individual non-inferiority criterion (LBCI >0.667) versus PCV21 for serotypes 3 and 12F, though it met the historical LBCI >0.5 threshold; the company expects this comparison to be a particular focus of FDA review.