Vaxcyte's VAX-31 Meets Phase 3 Endpoints, Stock Hits 52-Week High

Benzinga··US·Read original
4▲1 ▼2Impact / 5
Summary · why it matters

Vaxcyte Inc. reported positive topline results from its pivotal Phase 3 OPUS-1 trial of VAX-31, an investigational 31-valent pneumococcal conjugate vaccine, sending its shares up 56.91% to $88.62 in premarket trading on Monday to a new 52-week high. In the trial, VAX-31 met all prespecified co-primary immunogenicity endpoints in participants aged 50 and older, achieving noninferiority across all 28 serotypes shared with Pfizer Inc.'s Prevnar 20 and/or Merck & Co Inc.'s Capvaxive. Specifically, the candidate matched noninferiority standards for 11 serotypes common to both PCV20 and PCV21, nine serotypes shared exclusively with PCV20, and eight serotypes shared solely with PCV21, while demonstrating superiority for three unique serotypes plus the cross-reactive serotype 20B. The trial also met noninferiority criteria across all 321 serotype comparisons in immunobridging between adults aged 18 to 49 and those aged 50 to 64, and safety evaluations showed a tolerability profile comparable to PCV20 and PCV21 with no vaccine-related serious adverse events or discontinuations. The findings will form the foundation for an upcoming Biologics License Application submission to the U.S. Food and Drug Administration, and the company plans to report data from the OPUS-2 and OPUS-3 adult Phase 3 trials in the first half of 2027, with Phase 2 infant results expected by the end of that same period.

Impact on assets 3

Biotech & Genomic Medicine± Mixed · 3 stocks
Vaxcyte Inc
PCVX
▲ PositiveTechnologyrelevance

VAX-31 met all Phase 3 OPUS-1 co-primary immunogenicity endpoints with a comparable safety profile, paving the way for a BLA submission.

Merck & Company Inc
MRK
▼ NegativeCompetitionrelevance

Vaxcyte's VAX-31 met noninferiority vs Merck's Capvaxive (PCV21) across shared serotypes, a competitive threat to Capvaxive.

Pfizer Inc
PFE
▼ NegativeCompetitionrelevance

VAX-31 achieved noninferiority vs Pfizer's Prevnar 20 across shared serotypes, challenging Prevnar 20's franchise.

Theme Impact 1

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