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Vaxcyte, Inc. (Nasdaq: PCVX) is a pioneering biopharmaceutical company based in San Carlos, California, dedicated to developing high-fidelity vaccines to protect against serious bacterial infections. Vaxcyte aims to improve global health through innovative vaccines designed to prevent diseases that conventional options fail to address effectively.
The company's flagship product, VAX-24, is a 24-valent pneumococcal conjugate vaccine (PCV) designed to provide broad-spectrum protection against invasive pneumococcal disease (IPD). VAX-24 is engineered to cover more strains than the current leading vaccines, addressing a significant unmet need in both adult and pediatric populations. Vaxcyte's advanced cell-free protein synthesis platform, XpressCF™, is pivotal in developing these complex conjugate vaccines, allowing for efficient production and enhanced immunogenicity.
Vaxcyte's pipeline includes VAX-31, a next-generation 31-valent PCV, currently in Phase 1/2 clinical trials. VAX-31 aims to achieve the broadest coverage of any PCV to date, targeting 95% of IPD strains circulating in the U.S. adult population. Additionally, the company is developing other promising vaccine candidates such as VAX-A1 for Group A Strep infections, VAX-PG for periodontal disease, and VAX-GI for Shigella prevention.
Recent milestones include the successful completion of enrollment in the VAX-31 Phase 1/2 trial and the VAX-24 infant Phase 2 study. The FDA granted Breakthrough Therapy designation to VAX-24, reflecting its potential to offer substantial improvements over existing treatments. Vaxcyte is on track to advance VAX-24 into Phase 3 trials, with topline data anticipated by 2025.
Financially, Vaxcyte is robust, supported by $1.4 billion in recent follow-on equity financings to advance its vaccine candidates and expand its manufacturing capabilities.
For more information, visit www.vaxcyte.com.
Vaxcyte, Inc. (Nasdaq: PCVX) has initiated an underwritten public offering of common stock and pre-funded warrants. The company plans to grant underwriters a 30-day option to acquire an additional 15% of offered shares. The offering's completion is contingent on market conditions. BofA Securities, Jefferies, SVB Securities, Evercore ISI, and Guggenheim Securities are the main managers for this offering. A shelf registration statement was filed with the SEC, and a preliminary prospectus will be available. No offers are to be made in jurisdictions where unlawful.
Vaxcyte announced positive topline results from its Phase 1/2 clinical study of VAX-24, a 24-valent pneumococcal conjugate vaccine, demonstrating a strong safety and tolerability profile similar to Prevnar 20 (PCV20). At the 2.2mcg dose, VAX-24 met or exceeded regulatory immunogenicity standards for all 24 serotypes and showed higher immune responses for 16 of the 20 serotypes common with PCV20. Vaxcyte intends to advance VAX-24 into a Phase 3 program.
The FDA granted Fast Track Designation to VAX-24 for the adult indication, underscoring its potential in preventing invasive pneumococcal disease.
Vaxcyte, Inc. (Nasdaq: PCVX) announced a webcast on October 24, 2022, at 8:00 a.m. Eastern Time to discuss topline results from its Phase 1/2 proof-of-concept study for VAX-24, a 24-valent pneumococcal conjugate vaccine. The study evaluates safety, tolerability, and immunogenicity in healthy adults aged 18-64. Vaxcyte aims to innovate vaccine development using the XpressCF™ platform, striving to combat invasive bacterial infections with high-fidelity vaccines. The results will inform next steps for VAX-24 and Vaxcyte's broader vaccine portfolio.
Vaxcyte, Inc. (Nasdaq: PCVX) has announced the appointments of Mark Wiggins as Chief Business Officer and Jakub Simon as Chief Medical Officer to enhance its management team. With extensive experience in the biopharmaceutical sector, both leaders aim to drive the company’s growth and advance its lead vaccine candidate, VAX-24, a 24-valent pneumococcal conjugate vaccine. Vaxcyte anticipates announcing topline results from VAX-24's proof-of-concept study by late 2022, positioning the company for significant progress in vaccine development.
Vaxcyte, Inc. (Nasdaq: PCVX) has completed enrollment for its Phase 2 study of VAX-24, a 24-valent pneumococcal conjugate vaccine, targeting adults aged 65 and older. This study aims to assess the safety, tolerability, and immunogenicity of the vaccine, crucial for preventing invasive pneumococcal disease (IPD). Approximately 200 participants are involved, with topline results expected in H1 2023. VAX-24 has received Fast Track designation from the FDA, highlighting its potential to meet unmet medical needs in preventing pneumococcal disease, particularly in older adults.
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.
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