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, Inc. (Nasdaq: PCVX), reported a successful enrollment of the Phase 2 study for its 24-valent pneumococcal conjugate vaccine, VAX-24, in adults. Topline results are expected by late 2022. The company received FDA Fast Track designation for VAX-24, facilitating quicker clinical progression. Financially, Vaxcyte's cash reserves stood at $361.4 million as of June 30, 2022, with increased R&D expenses totaling $38.5 million, leading to a net loss of $48.5 million for the quarter.
Vaxcyte (Nasdaq: PCVX) announced that its 24-valent pneumococcal conjugate vaccine, VAX-24, received Fast Track designation from the FDA for adults aged 18 and older. This designation aims to expedite the vaccine's development and review due to its potential to address an unmet medical need. Additionally, following a successful pre-IND meeting, the company obtained positive feedback for initiating a pediatric study targeting infants, contingent on results from ongoing adult trials. VAX-24 aims to enhance protection against invasive pneumococcal disease, particularly in vulnerable populations.
Vaxcyte, Inc. (Nasdaq: PCVX) completed enrollment for the Phase 2 portion of its Phase 1/2 proof-of-concept study for VAX-24, a 24-valent pneumococcal conjugate vaccine, targeting adults aged 50-64. Topline results on safety, tolerability, and immunogenicity are anticipated in October or November 2022. Additionally, the first participants have been dosed in a separate Phase 2 study of VAX-24 for adults 65 and older, with results expected in the first half of 2023. The vaccine aims to broaden protection against invasive pneumococcal disease and pneumonia.
Astellas Pharma and Sutro Biopharma have entered a worldwide collaboration to develop immunostimulatory antibody-drug conjugates (iADCs), targeting cold tumors resistant to current therapies. Sutro will receive an upfront payment of US$90 million and could earn up to US$422.5 million in additional milestones per product. Astellas aims to enhance its oncology pipeline through this partnership, leveraging both companies' strengths in drug development and commercialization.
Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine company, will participate in a fireside chat at the Jefferies Healthcare Conference in New York City on June 9, 2022, at 8:30 a.m. ET. The event aims to highlight Vaxcyte's innovative approach to vaccine development, particularly its lead candidate, VAX-24, a broad-spectrum pneumococcal conjugate vaccine. A live webcast will be available on the company's website, with a replay accessible for 30 days post-conference.
Vaxcyte, Inc. (Nasdaq: PCVX) reported its financial results for Q1 2022, highlighting a cash position of $352.3 million, which includes net proceeds of approximately $107.6 million from a recent public offering. The company is advancing its Phase 1/2 clinical study for VAX-24, a 24-valent pneumococcal conjugate vaccine, with topline results expected by the end of 2022. Additionally, a separate Phase 2 study for adults aged 65 and older is anticipated to begin mid-2022. Total operating expenses for the quarter were $39.2 million, resulting in a net loss of $39.0 million.
Vaxcyte, Inc. (Nasdaq: PCVX) announced its participation in notable investor conferences, including the BofA Securities 2022 Healthcare Conference from May 10-13 in Las Vegas and the UBS Global Healthcare Conference from May 23-25 in New York. At the BofA conference, a fireside chat is scheduled for May 10 at 5:40 p.m. ET, with one-on-one meetings on May 10 and 11. Webcast access is available on the company’s website. Vaxcyte is focused on developing high-fidelity vaccines to combat bacterial diseases, including its lead candidate VAX-24.
Vaxcyte, Inc. (Nasdaq: PCVX) announced its participation in the 21st Annual Needham Virtual Healthcare Conference on April 12, 2022, at 12:45 p.m. ET. The event will feature a fireside chat with company management, accessible via a live webcast on Vaxcyte's website. The presentation will be available for replay for 30 days after the conference. Vaxcyte focuses on developing innovative vaccines for bacterial diseases, including its lead candidate, VAX-24, aimed at preventing invasive pneumococcal disease and pneumonia.
Vaxcyte announced the dosing of the first participants in the Phase 2 portion of its Phase 1/2 clinical trial for VAX-24, a 24-valent pneumococcal conjugate vaccine. The independent Data Monitoring Committee recommended proceeding after reviewing Phase 1 safety data. Vaxcyte aims to deliver broader protection against invasive pneumococcal disease and pneumonia. Topline results from both trial phases are expected by the end of 2022, highlighting the candidate's potential to improve standard vaccination practices.
Vaxcyte, Inc. (PCVX) announced the initiation of a Phase 1/2 clinical study for its 24-valent pneumococcal conjugate vaccine, VAX-24, aimed at preventing invasive pneumococcal disease in adults. The study's topline safety and immunogenicity results are expected by the end of 2022. The company reported a cash position of $273.1 million as of December 31, 2021, excluding $107.6 million from a recent public offering. Vaxcyte also highlighted increased R&D costs and a net loss of $100.1 million for 2021, signaling ongoing investment in its vaccine pipeline.
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