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Enrollment Now Completed for OPUS-1, OPUS-2 and OPUS-3 Phase 3 Trials Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults

Vaxcyte is evolving from a single-product biotech into a commercial vaccine platform with advanced manufacturing and regulatory alignment. VAX-31, a 31-valent pneumococcal conjugate vaccine, targets broader serotype coverage than competitors and is in pivotal Phase 3 adult and Phase 2 infant trials. PCVX boasts strong financials, with over $2.4B in cash and a completed manufacturing facility, enabling concurrent late-stage development and commercial preparation.

SAN CARLOS, Calif., April 07, 2026 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced that Company management will participate in a fireside chat at the 25th Annual Needham Virtual Healthcare Conference on Tuesday, April 14, 2026 at 2:15 p.m. ET / 11:15 a.m. PT.

OPUS-1 Phase 3 Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines (PCVs) Through Head-to-Head Safety, Tolerability and Immunogenicity Comparisons of VAX-31 with Capvaxive® (PCV21) and Prevnar 20® (PCV20), the Current Standard-of-Care PCVs

Based on the Strength of Unprecedented Results from the Positive Phase 1/2 Study in Adults Aged 50 and Older, Vaxcyte Advanced VAX-31 High Dose into Comprehensive Phase 3 Adult Program; Topline Data from the OPUS-1 Pivotal Noninferiority Trial Expected in the Fourth Quarter of 2026

Vaxcyte, Inc. (PCVX) Q4 2025 Earnings Call Transcript

Comprehensive VAX-31 Adult Phase 3 Clinical Program, Finalized in Consultation and Alignment with FDA, Advances with Three Phase 3 Studies Underway to Support Planned BLA Submission Topline Safety, Tolerability and Immunogenicity Data from OPUS-1 Expected in Fourth Quarter of 2026; OPUS-2 and OPUS-3 Results Expected in First Half of 2027 Enrollment Completed in VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Immunization Series and Booster Dose Expected Either Sequentially or Together by End of First Half of 2027 Company Advancing Early-Stage Pipeline, Expects to Initiate Phase 1 Adult Clinical Study for VAX-A1, a Vaccine Candidate to Prevent Group A Strep, in 2026 Company Advances Global and U.S. Manufacturing Capabilities to Support Commercialization of Pneumococcal Conjugate Vaccines with Completion of Dedicated Lonza Facility and Initiation of North Carolina Fill-Finish Line Buildout Approximately $2.4 Billion in Cash, Cash Equivalents and Investments as of December 31, 2025 ; Excludes Approximately $600.2 Million in Net Proceeds from February 2026 Equity Offering Company to Host Webcast/Conference Call Today at 4:30 p.m. ET / 1:30 p.m.