Vaxcyte Doses First Participants in the OPUS Phase 3, Noninferiority Trial Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults

Trial Design Finalized in Consultation and Alignment with U.S. Food and Drug Administration  Study Designed to Establish a New Standard for Adult Pneumococcal Conjugate Vaccines Through Head-to-Head Safety, Tolerability and Immunogenicity Comparisons of VAX-31 with Capvaxive (PCV21) and Prevnar 20 (PCV20), the Current Standards of Care Company Expects to Report Topline Safety, Tolerability and Immunogenicity Data for OPUS Phase 3, Noninferiority Trial in the Fourth Quarter of 2026 and Initiate Additional Phase 3 Studies in 2026 with Readouts in 2027, Supporting Planned BLA Submission VAX-31 is Designed to Cover ~95% of Invasive Pneumococcal Disease (IPD) and ~88% of Pneumococcal Pneumonia in U.S. Adults Aged 50+, with Potential to Provide an Incremental 14-34% Broader IPD Coverage and 19-31% Broader Pneumonia Coverage than Standard-of-Care Vaccines VAX-31 Aims to Advance Adult Pneumococcal Protection by Maintaining Critical Pressure on Both Currently Circulating and Long-Established, Historically Disease-Causing Serotypes, While Maintaining or Improving Immune Responses SAN CARLOS, Calif., Dec. 08, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, today announced that the first participants were dosed in the OPUS (OPA-based Pivotal U.S. Study) Phase 3 pivotal, noninferiority trial evaluating VAX-31 for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults.

GlobeNewsWire • Dec 8, 2025

Vaxcyte Reports Third Quarter 2025 Financial Results and Provides Business Update Including Final Data from Positive VAX-24 Infant Phase 2 Dose-Finding Study

Final Data from VAX-24 Infant Phase 2 Dose-Finding Study Consistent with Previously Reported Positive Interim Data; Provide Additional Evidence Supporting Higher VAX-31 Doses Being Evaluated in Ongoing Infant Phase 2 Study

GlobeNewsWire • Nov 4, 2025

Vaxcyte to Establish Fill-Finish Manufacturing in North Carolina as Key Element of Long-Term United States Commercial Supply Strategy Representing Up to $1 Billion in Manufacturing and Services

New Agreement with Thermo Fisher Scientific Expands Domestic Capacity to Support Future Commercial Manufacturing of Vaxcyte's Broad-Spectrum Pneumococcal Conjugate Vaccine Candidates

GlobeNewsWire • Sep 30, 2025

Vaxcyte, Inc. (PCVX) Presents At Cantor Global Healthcare Conference 2025 Transcript

Vaxcyte, Inc. (NASDAQ:PCVX ) Cantor Global Healthcare Conference 2025 September 3, 2025 2:45 PM EDT Company Participants Grant Pickering - Co-Founder, CEO & Director Andrew Guggenhime - President & CFO James Wassil - Executive VP & COO Conference Call Participants Carter Gould - Cantor Fitzgerald & Co., Research Division Presentation Carter Gould Research Analyst Okay. Good afternoon.

Seeking Alpha • Sep 8, 2025

Vaxcyte Advances VAX-31 Infant Phase 2 Dose-Finding Study with First Participants Receiving VAX-31 Optimized Dose

VAX-31 Optimized Dose, with Majority of Serotypes Dosed at 4.4mcg and Balance at 3.3mcg, is Designed to Elicit Even Stronger Immune Responses in Infant Population to Protect Against Invasive Pneumococcal Disease (IPD)

GlobeNewsWire • Sep 3, 2025

Vaxcyte (PCVX) Q2 Loss Widens 11%

Vaxcyte (PCVX) Q2 Loss Widens 11%

The Motley Fool • Aug 7, 2025

Vaxcyte Reports Second Quarter 2025 Financial Results and Provides Business Update, Highlighting Key Clinical and Regulatory Progress for VAX-31, a Potential Best-in-Class Pneumococcal Conjugate Vaccine (PCV)

Following Interactions with FDA on VAX-31 Adult Program, Including End-of-Phase 2 Meeting, Company Finalizing Phase 3 Clinical Program to Validate VAX-31 as Potential New Standard-of-Care Adult PCV ; Pivotal, Non-Inferiority Study Expected to be Initiated in Fourth Quarter of 2025 with Topline Data in 2026 FDA Provided Input on VAX-31 Adult CMC Licensure Requirements Facilitating Progression to Phase 3; Company Plans to Seek Ongoing Input as Program Advances Company Expects Multiple VAX-31 Adult Phase 3 Program Data Readouts in 2026 and 2027 to Support Biologics License Application Submission For VAX-31 Pediatric Program, Company Modifies Ongoing Infant Phase 2 Dose-Finding Study to Add a VAX-31 Optimized Dose Arm (4.4mcg/3.3mcg) and Discontinues Enrollment of Low Dose Arm; Enrollment in Modified Study Expected to Proceed by End of Third Quarter of 2025 with Topline Data from Both Primary Immunization Series and Booster Dose by End of First Half of 2027 Company Remains Focused on Disciplined Capital Allocation; Streamlining Early-Stage Pipeline to Prioritize Resources for PCV Programs and Further Extend Cash Runway Approximately $2.8 Billion in Cash, Cash Equivalents and Investments as of June 30, 2025 SAN CARLOS, Calif., Aug. 06, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced financial results for the second quarter ended June 30, 2025, and provided a business update, highlighting key clinical and regulatory progress for VAX-31, a potential best-in-class pneumococcal conjugate vaccine (PCV).

GlobeNewsWire • Aug 6, 2025

Vaxcyte Reports First Quarter 2025 Financial Results and Provides Business Update

-- Company Reported Positive Topline Safety, Tolerability and Immunogenicity Data from Phase 2 Dose-Finding Study of VAX-24 in Healthy Infants; Balance of Data Expected by End of 2025 -- -- Initiated Second and Final Stage of VAX-31 Infant Phase 2 Dose-Finding Study; Topline Safety, Tolerability and Immunogenicity Data from Primary Three-Dose Immunization Series Expected in Mid-2026, With Complete Booster Data Up to Nine Months Later --

GlobeNewsWire • May 7, 2025

Vaxcyte Appoints Dr. Olivier Brandicourt to Board of Directors

SAN CARLOS, Calif., May 01, 2025 (GLOBE NEWSWIRE) -- Vaxcyte, Inc. (Nasdaq: PCVX), a vaccine innovation company engineering high-fidelity vaccines to protect humankind from the consequences of bacterial diseases, today announced it has appointed Dr. Olivier Brandicourt, a veteran biopharmaceutical industry executive and the former Chief Executive Officer of Sanofi S.A., to its Board of Directors.

GlobeNewsWire • May 1, 2025

Vaxcyte Stock Plummets 56% in a Month: Here's the Reason

The downside comes after PCVX reports mixed results from a mid-stage study on its pneumococcal vaccine in infants.

Zacks Investment Research • Apr 10, 2025