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 (Nasdaq: PCVX) has announced the pricing of a $1.3 billion public offering of common stock and pre-funded warrants. The company is selling 10,194,175 shares of common stock at $103.00 per share and 2,427,184 pre-funded warrants at $102.999 each. The exercise price for the warrants is $0.001 per share. Vaxcyte has granted underwriters a 30-day option to purchase up to 1,893,203 additional shares. The offering is expected to close on September 6, 2024. Major financial institutions are acting as joint book-running managers for the offering.
Vaxcyte (Nasdaq: PCVX), a clinical-stage vaccine innovation company, has announced the commencement of a $1.0 billion underwritten public offering of its common stock and pre-funded warrants. The company plans to grant underwriters a 30-day option to purchase up to an additional $150.0 million of shares. BofA Securities, Jefferies, Leerink Partners, Goldman Sachs & Co. , Evercore ISI, Guggenheim Securities, and Mizuho are acting as joint book-running managers for the offering. The offering is subject to market conditions, and its completion, size, and terms are not guaranteed. A shelf registration statement has been filed with the SEC, and a preliminary prospectus supplement and accompanying prospectus will be available on the SEC's website.
Vaxcyte (NASDAQ: PCVX) announced positive topline results from its Phase 1/2 study of VAX-31, a 31-valent pneumococcal conjugate vaccine candidate, in adults aged 50 and older. The study demonstrated robust immune responses for all 31 serotypes at all doses, with middle and high doses meeting or exceeding regulatory immunogenicity criteria. VAX-31 showed a safety profile similar to Prevnar 20® and was well-tolerated. Based on these results, Vaxcyte has selected VAX-31 to advance to an adult Phase 3 program, with plans to initiate a pivotal, non-inferiority study by mid-2025 and announce topline data in 2026. The company also plans to initiate a VAX-31 infant Phase 2 study in Q1 2025 for the pediatric indication.
Vaxcyte (Nasdaq: PCVX) announced a webcast and conference call on September 3, 2024, at 8:00 a.m. Eastern Time to present topline results from the Phase 1/2 study of VAX-31, their 31-valent pneumococcal conjugate vaccine (PCV) candidate. The study evaluated the safety, tolerability, and immunogenicity of VAX-31 in healthy adults aged 50 and older. VAX-31 is designed to prevent invasive pneumococcal disease (IPD). Interested parties can participate via phone (800-225-9448 domestic, 203-518-9708 international) using conference ID PCVX0903 or through a live webcast on Vaxcyte's investor relations page. The webcast will be archived for 30 days after the event.
Vaxcyte (PCVX) reported Q2 2024 financial results and provided a business update. Key highlights include:
- VAX-31 adult Phase 1/2 study topline data expected in September 2024
- VAX-24 infant Phase 2 study topline data expected by Q1 2025
- $1.9 billion in cash and investments as of June 30, 2024
- R&D expenses increased to $131.5 million in Q2 2024
- Net loss widened to $128.7 million in Q2 2024
The company plans to advance either VAX-24 or VAX-31 to Phase 3 in adults following the VAX-31 data readout. Vaxcyte also appointed John Furey to its Board of Directors and received a $9.5 million NIAID grant for Chlamydia vaccine development.
Vaxcyte has appointed John Furey to its Board of Directors, effective July 2, 2024. Furey brings extensive experience in the biopharmaceutical and vaccine sectors, especially in the manufacture, supply, and commercialization of pneumococcal conjugate vaccines (PCVs). This addition comes as Vaxcyte advances its PCV candidates, VAX-24 and VAX-31, towards late-stage clinical development. Furey's expertise is expected to provide strategic insights and strengthen the company’s efforts in developing innovative vaccines using a cell-free technology platform.
Vaxcyte, Inc. (Nasdaq: PCVX) reported Q1 2024 financial results, highlighting completion of enrollment for VAX-31 Adult Phase 1/2 study and VAX-24 Infant Phase 2 study. They expect data by Q3 2024 and Q1 2025 respectively. The company had $1.9 billion in cash as of March 31, 2024, following a successful $816.5 million public offering in February. The company is progressing its PCV franchise and early-stage pipeline, focusing on preventing bacterial diseases.
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