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Vaxcyte, Inc. reports clinical-stage vaccine developments focused on bacterial diseases, led by pneumococcal conjugate vaccine candidates in its PCV franchise. Recurring updates cover VAX-31 clinical studies in adult and infant populations, earlier PCV candidates including VAX-24 and VAX-XL, and pipeline programs such as VAX-A1 for Group A Strep and VAX-GI for Shigella.
Company news also addresses the XpressCF cell-free protein synthesis platform licensed from Sutro Biopharma, manufacturing and commercial-readiness activities, equity financings, quarterly financial results, and healthcare conference participation. These releases tie Vaxcyte’s vaccine engineering platform to clinical progress, supply-chain development, and capital resources supporting its pipeline.
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.
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.