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 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.
Vaxcyte, Inc. (Nasdaq: PCVX) has priced an underwritten public offering of 15,000,000 shares of common stock and pre-funded warrants to purchase 3,750,000 shares at $32.00 and $31.999 per share, respectively. The offering aims to raise approximately $600 million, closing on October 28, 2022, subject to customary conditions. Vaxcyte’s lead vaccine candidate, VAX-24, targets invasive pneumococcal diseases, while its innovative protein synthesis methods enhance vaccine production. The underwriters have a 30-day option to purchase an additional 2,812,500 shares.
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.
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