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 OPUS-3, a Phase 3 trial of its 31-valent pneumococcal conjugate vaccine, VAX-31, in adults previously vaccinated with lower-valency pneumococcal vaccines. The adult Phase 3 program totals ~6,000 participants, ~3,400 expected to receive VAX-31, and is aligned with the FDA to support a planned BLA.
Topline timing: OPUS-1 topline expected in Q4 2026; OPUS-2 and OPUS-3 topline data expected in H1 2027. VAX-31 is designed to cover ~95% of IPD and ~88% of pneumococcal pneumonia in U.S. adults 50+, with incremental coverage vs. standard-of-care of 14–34% (IPD) and 19–31% (pneumonia).
Vaxcyte (Nasdaq: PCVX) will report Q4 and full-year 2025 financial results and provide a business update on February 24, 2026 after market close. Management will host a conference call and webcast at 4:30 p.m. ET / 1:30 p.m. PT.
A live webcast will be available on the company website and a replay will be accessible for about 30 days.
Vaxcyte (Nasdaq: PCVX) management will participate in a fireside chat at the Guggenheim Emerging Outlook: Biotech Summit in New York on Thursday, February 12, 2026 at 1:30 p.m. ET / 10:30 a.m. PT.
A live webcast will be available via the company Investor site and a replay will be accessible for approximately 30 days after the conference.
Vaxcyte (Nasdaq: PCVX) closed an underwritten public offering of 12,650,000 shares at $50.00 per share, including full exercise of a 1,650,000-share underwriter option. The aggregate gross proceeds were $632.5 million, before underwriting discounts, commissions, and offering expenses. A shelf registration was effective May 24, 2024.
Vaxcyte (Nasdaq: PCVX) priced an underwritten public offering of 11,000,000 common shares at $50.00 per share, for aggregate gross proceeds of $550 million before fees. The company granted a 30-day option for up to 1,650,000 additional shares.
The offering is expected to close on February 2, 2026, subject to customary closing conditions, and a final prospectus will be filed with the SEC.
Vaxcyte (Nasdaq: PCVX) announced the commencement of a proposed underwritten public offering of $500,000,000 of common stock and pre-funded warrants, with a 30-day underwriter option to purchase up to an additional $75,000,000.
The offering is subject to market and other conditions; a shelf registration was automatically effective May 24, 2024, and a preliminary prospectus supplement will be filed with the SEC.
Vaxcyte (Nasdaq: PCVX) reported advancement of its 31‑valent pneumococcal conjugate vaccine candidate VAX-31 across adult and infant programs. Key actions: dosing begun in the adult OPUS-2 Phase 3 trial (concomitant with seasonal influenza vaccine), OPUS-3 Phase 3 in previously vaccinated adults planned to start in Q1 2026, and completion of enrollment (n=905) in the infant Phase 2 dose‑finding study. Across three adult Phase 3 trials ~6,000 adults are expected (≈3,400 to receive VAX-31). Company expects OPUS-1 topline in Q4 2026 and OPUS-2/OPUS-3 and infant Phase 2 toplines in H1 2027. Vaxcyte also plans North Carolina fill‑finish buildout beginning Q1 2026 as part of a long‑term commitment of up to $1 billion in U.S. manufacturing and services.
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.
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