Welcome to our dedicated page for Vaxcyte news (Ticker: PCVX), a resource for investors and traders seeking the latest updates and insights on Vaxcyte stock.
Vaxcyte, Inc. (Nasdaq: PCVX) is a clinical-stage vaccine innovation company focused on broad-spectrum bacterial vaccines, and its news flow reflects progress across multiple pneumococcal conjugate vaccine programs and related manufacturing and regulatory milestones. Company announcements frequently highlight clinical trial updates for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV) candidate advancing to a Phase 3 adult program and being evaluated in a Phase 2 infant study, as well as VAX-24, a 24-valent PCV candidate in a Phase 2 infant study.
Investors and observers following PCVX news can expect detailed coverage of Phase 2 and Phase 3 study designs, topline safety, tolerability and immunogenicity data, and dose-selection decisions for both adult and pediatric indications. Recent releases have described the OPUS adult Phase 3 pivotal noninferiority trial for VAX-31, the multi-stage VAX-31 infant dose-finding study, and positive topline results from the VAX-24 infant Phase 2 trial, including IgG and opsonophagocytic assay responses compared with existing PCVs.
Vaxcyte’s news also covers regulatory interactions and designations, such as the U.S. Food and Drug Administration’s Breakthrough Therapy designation for VAX-31 in adults and its expansion to include prevention of pneumonia caused by Streptococcus pneumoniae. In addition, the company reports on manufacturing and supply-chain developments, including a dedicated manufacturing suite at Lonza and a long-term agreement with Thermo Fisher Scientific’s Patheon unit to provide fill-finish capacity in Greenville, North Carolina as part of its U.S. commercial supply strategy.
Other updates include business and financial results, capital allocation priorities, early-stage pipeline decisions involving candidates such as VAX-A1 and VAX-GI, and governance changes such as board and executive appointments. For readers tracking PCVX, this news page offers an ongoing view into Vaxcyte’s clinical progress, regulatory pathway, manufacturing readiness and corporate developments around its pneumococcal and broader bacterial vaccine pipeline.
Vaxcyte (NASDAQ: PCVX) dosed the first participants in the OPUS Phase 3 pivotal, noninferiority trial of VAX-31 for prevention of invasive pneumococcal disease (IPD) and pneumonia in adults. The trial is designed in alignment with the FDA and will enroll ~4,000 participants with topline safety, tolerability and immunogenicity results expected in Q4 2026. VAX-31 is designed to cover ~95% of IPD and ~88% of pneumococcal pneumonia in U.S. adults 50+, and may provide an incremental 14–34% broader IPD coverage and 19–31% broader pneumonia coverage versus current standard-of-care vaccines. Results will support planned BLA timelines and additional Phase 3 studies in 2026 with readouts in 2027.
Vaxcyte (NASDAQ: PCVX) reported Q3 2025 results and a business update on Nov 4, 2025. The company reported $2.67B in cash, cash equivalents and investments as of Sept 30, 2025, and expects this to fund the current operating plan into mid‑2028. Final VAX‑24 infant Phase 2 data were consistent with prior positive interim results, showing robust, dose‑dependent IgG and OPA responses and meeting target non‑inferiority criteria for most serotypes. The modified VAX‑31 infant Phase 2 advanced to its third stage (~900 infants). VAX‑31 adult Phase 3 is expected to start in Dec 2025 with topline data in 2026. Company announced up to $1B U.S. fill‑finish commitment and named Mike Mullette CCO.
Vaxcyte (NASDAQ:PCVX), a clinical-stage vaccine company, has announced a significant manufacturing agreement with Thermo Fisher Scientific to establish fill-finish commercial manufacturing capabilities in Greenville, North Carolina. The long-term agreement, valued at up to $1 billion, focuses on manufacturing Vaxcyte's broad-spectrum pneumococcal conjugate vaccines (PCVs).
This strategic initiative represents a major expansion of Vaxcyte's domestic manufacturing capacity and strengthens its U.S. commercial supply chain. The partnership aligns with the company's commitment to domestic biomanufacturing and aims to enhance commercial readiness while investing in American infrastructure and employment.
Tentarix Biotherapeutics, a biotech company developing targeted and conditionally active multispecific biologics, announced four key executive appointments to strengthen its leadership team. Ash Khanna, Ph.D. joins as Chief Business Officer, bringing over 20 years of experience and previously co-founding Vaxcyte (NASDAQ: PCVX). Dallas Jones, Ph.D. becomes Senior Vice President of Biology, Tim Noffke joins as VP of Program Management and Chief of Staff, and Ankita Srivastava, Ph.D. is promoted to Senior Vice President of Biotherapeutics.
The strategic appointments aim to accelerate Tentarix's pipeline development of conditional multispecific biologics into clinical stages. The new executives bring extensive experience in business development, translational biology, biologics engineering, and development-stage execution.
Vaxcyte (NASDAQ:PCVX) has advanced to the third and final stage of its modified VAX-31 infant Phase 2 dose-finding study. The study is evaluating a new VAX-31 Optimized Dose, with most serotypes dosed at 4.4mcg and the remainder at 3.3mcg, compared to Prevnar 20 in healthy infants.
The randomized, double-blind study will enroll approximately 900 participants, with topline safety and immunogenicity data expected by the end of H1 2027. VAX-31, a 31-valent pneumococcal conjugate vaccine candidate, aims to become the most broad-spectrum PCV, potentially covering ~92% of invasive pneumococcal disease and ~93% of acute otitis media in U.S. children under five.
Vaxcyte (NASDAQ: PCVX) reported significant progress in Q2 2025 for its VAX-31 pneumococcal conjugate vaccine program. Following FDA interactions, including an End-of-Phase 2 meeting, the company is finalizing its Phase 3 adult program, with the pivotal study set to begin in Q4 2025. The FDA expanded VAX-31's Breakthrough Therapy designation to include pneumonia prevention.
The company modified its infant Phase 2 study to include an optimized dose arm while discontinuing the low dose arm. Financial highlights include $2.8 billion in cash and investments as of June 30, 2025, with an extended cash runway to mid-2028. Q2 2025 resulted in a net loss of $166.6 million, compared to $128.7 million in Q2 2024, with R&D expenses at $194.2 million.
Vaxcyte is streamlining its early-stage pipeline to focus resources on PCV programs and appointed Chris Griffith as Chief Business and Strategy Officer.
Vaxcyte (PCVX) has appointed Dr. Olivier Brandicourt, former CEO of Sanofi S.A., to its Board of Directors. Dr. Brandicourt brings extensive biopharmaceutical expertise, particularly in global vaccine market commercial strategy and execution. During his tenure at Sanofi, he strengthened the company's position as a leading commercial vaccine company. His appointment comes at a crucial time as Vaxcyte advances toward potential global commercialization of its pneumococcal conjugate vaccine (PCV) candidates.
The company also announced that Dr. Peter Hirth, who has served on the Board since 2016, will conclude his tenure in June. Vaxcyte's carrier-sparing platform aims to address unmet needs in bacterial disease prevention and contribute to combating antimicrobial resistance.
Vaxcyte (PCVX) announced positive topline results from its Phase 2 dose-finding study of VAX-24, its 24-valent pneumococcal conjugate vaccine candidate. The study evaluated safety and immunogenicity compared to Prevnar 20® in healthy infants.
The company selected the VAX-24 Mid dose (2.2mcg) for advancement to a potential Phase 3 program. Key findings include:
- Well-tolerated safety profile similar to PCV20 across all doses
- Substantial immune responses after primary three-dose immunization
- Met target non-inferiority criteria for 20 of 24 serotypes
- Demonstrated dose-dependent immune responses with minimal carrier suppression
Pending VAX-31 infant Phase 2 study results in mid-2026, Vaxcyte plans to initiate a Phase 3 study with either VAX-24 or VAX-31. Full post-dose 4 booster data is expected by end of 2025.
Vaxcyte (PCVX) has scheduled a webcast and conference call for March 31, 2025, at 8:00 a.m. Eastern Time to present topline results from the VAX-24 infant Phase 2 study. The study evaluates the safety, tolerability, and immunogenicity of VAX-24, their 24-valent pneumococcal conjugate vaccine candidate, compared to Prevnar 20® in healthy infants.
VAX-24 is designed to prevent invasive pneumococcal disease (IPD). The presentation will be accessible via phone (800-445-7795 domestic, 785-424-1699 international) with conference ID PCVX0331, and through a live webcast on Vaxcyte's investor relations website. The webcast recording will remain available for 30 days after the event.