Vaxcyte to Present Topline Phase 3 Data for VAX-31 Vaccine

On Oct. 5 Vaxcyte presented topline OPUS-1 Phase 3 results for VAX-31, its 31-valent pneumococcal conjugate vaccine for adults. It met noninferiority on all 28 serotypes shared with Prevnar 20 (PCV20) and/or Capvaxive (PCV21), superiority on its three unique serotypes, the primary immunobridging endpoint across age groups studied, and a safety profile similar to those vaccines. Grant Pickering said that sets a new benchmark for the class and gives confidence in its potential for approval. OPUS-2 and OPUS-3 results are expected in the first half of 2027, with a Biologics License Application planned for the first half of 2028. VAX-31 is also in a Phase 2 infant program. Shares closed Friday at $56.48, up 0.77% and 22% year to date. Pre-market Monday levels were reported differently: $92.67 (MarketWatch), $94.50 (MarketScreener), or $71.00 (RTTNews). Rated coverage was center-only.