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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) will host a webcast and conference call on April 17, 2023, at 7:30 a.m. ET to discuss results from its Phase 2 study of VAX-24, a 24-valent pneumococcal conjugate vaccine candidate, targeting adults aged 65 and older. The discussion will include detailed six-month safety data from adult Phase 2 studies. VAX-24 aims to provide broad-spectrum protection against invasive pneumococcal diseases. Vaxcyte is utilizing modern synthetic techniques like the XpressCF™ cell-free protein synthesis platform to create high-fidelity vaccines efficiently. The company's pipeline also features candidates such as VAX-31, VAX-A1, VAX-PG, and VAX-GI, addressing various bacterial infections.
Vaxcyte, Inc. (Nasdaq: PCVX) has initiated a Phase 2 clinical study of its lead vaccine candidate, VAX-24, in healthy infants. This broad-spectrum 24-valent pneumococcal conjugate vaccine aims to prevent invasive pneumococcal disease (IPD). The study will assess safety, tolerability, and immunogenicity compared to the current standard, PCV15. The first stage involves 48 infants, while the second stage will expand to approximately 750 infants. Vaxcyte expects to share topline results by 2025, highlighting VAX-24’s potential to enhance coverage against 20-25% more strains of IPD than existing vaccines.
Vaxcyte, Inc. (Nasdaq: PCVX) has received FDA clearance for its VAX-24 IND application aimed at preventing invasive pneumococcal disease (IPD) in infants, with a Phase 2 study expected to start in Q2 2023. The company also reported positive topline results from the Phase 1/2 study of VAX-24 in adults 18-64, showing its potential as a best-in-class vaccine. In 2022, Vaxcyte raised approximately $805 million through equity offerings, strengthening its financial position with cash reserves of $957.9 million as of December 31, 2022. The company anticipates significant milestones in 2023, including the submission of a new IND application for VAX-31.
Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, has received FDA clearance for its infant IND application for VAX-24, a 24-valent pneumococcal conjugate vaccine aimed at preventing invasive pneumococcal disease (IPD). The Phase 2 infant study is set to begin in Q2 2023, with topline safety and immunogenicity results expected by 2025. The vaccine aims to address significant health concerns related to IPD, particularly in infants and young children. The Phase 2 study will evaluate safety and efficacy across different dosage levels, compared to existing vaccines, targeting improved immune responses and broader coverage.
Vaxcyte, Inc. (Nasdaq: PCVX) will report its financial results for Q4 and full year 2022 on February 27, 2023, post-market close. A conference call and webcast will follow at 4:30 p.m. ET to discuss the results and provide a business update. Vaxcyte partners with advanced synthetic techniques to develop high-fidelity vaccines targeting bacterial diseases. Their lead candidate, VAX-24, is a 24-valent pneumococcal conjugate vaccine aimed at preventing invasive pneumococcal disease. Their pipeline includes other vaccine candidates aimed at various bacterial infections, enhancing their commitment to addressing significant health concerns.
Vaxcyte, Inc. (Nasdaq: PCVX), a clinical-stage vaccine innovation company, will participate in a fireside chat at the SVB Securities Global Biopharma Conference on February 14, 2023, at 3:00 p.m. ET. The live presentation will be available via webcast on the company's website, with a replay accessible for 30 days post-conference. Vaxcyte focuses on engineering high-fidelity vaccines to combat bacterial diseases. Its lead candidate, VAX-24, is a 24-valent pneumococcal conjugate vaccine aimed at preventing invasive pneumococcal disease. The company employs advanced synthetic techniques to improve vaccine development efficiency.
Vaxcyte announces that the FDA has granted Breakthrough Therapy designation for its investigational VAX-24, a 24-valent pneumococcal conjugate vaccine targeting invasive pneumococcal disease (IPD) in adults. The decision follows positive topline results from a Phase 1/2 study in adults aged 18-64, meeting safety, tolerability, and immunogenicity goals. Topline data for a Phase 2 study in adults 65 and older is expected in Q2 2023, with plans for a Phase 3 program thereafter. This designation facilitates accelerated development and regulatory support for Vaxcyte's vaccine candidates.
Vaxcyte reported positive topline data from its Phase 1/2 proof-of-concept study of VAX-24, a 24-valent pneumococcal conjugate vaccine. The study met objectives for safety, tolerability, and immunogenicity, suggesting a best-in-class profile. The company has $366.2 million in cash and announced approximately $650.7 million in net proceeds from a recent follow-on offering. Key milestones for 2023 include further Phase 2 studies and IND applications for both VAX-24 and its VAX-XP candidate.
Vaxcyte, Inc. (Nasdaq: PCVX) announced participation in several investor conferences, including the Guggenheim 4th Annual Immunology and Neurology Conference from November 14-15, 2022, the Jefferies London Healthcare Conference from November 15-17, 2022, and the Evercore ISI 5th Annual HealthCONx Conference from November 29-December 1, 2022.
Live fireside chats will be held on November 14 at 1:35 PM ET, November 16 at 12:20 PM GMT, and November 30 at 12:10 PM ET. Webcasts will be available on Vaxcyte's website for 30 days post-conference.
Vaxcyte (Nasdaq: PCVX) announced the completion of an underwritten public offering of 17,812,500 shares of common stock at $32.00 per share, along with pre-funded warrants for 3,750,000 shares at $31.999 each. The offering raised approximately $690 million in gross proceeds. The transaction included the underwriters' full exercise of their option for an additional 2,812,500 shares. BofA Securities and others acted as joint book-running managers. Vaxcyte focuses on innovative vaccines to combat bacterial diseases, with its lead candidate VAX-24 targeting invasive pneumococcal disease.
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