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 (PCVX) has advanced to Stage 2 of its Phase 2 study for VAX-31, a 31-valent pneumococcal conjugate vaccine (PCV), following a successful review of Stage 1 safety and tolerability data. The study evaluates VAX-31's effectiveness in preventing invasive pneumococcal disease in healthy infants.
VAX-31 is designed to provide coverage for approximately 94% of invasive pneumococcal disease and 93% of acute otitis media in U.S. children under five. The company expects to announce topline safety, tolerability, and immunogenicity data from the primary immunization series in mid-2026, with booster dose data following nine months later.
Additionally, Vaxcyte remains on schedule to announce VAX-24 Phase 2 infant study topline data by the end of Q1 2025. Both VAX-31 and VAX-24 aim to provide enhanced protection against current and historically prevalent strains compared to standard-of-care vaccines.
Vaxcyte (Nasdaq: PCVX), a clinical-stage vaccine innovation company, has announced its participation in the Guggenheim SMID Cap Biotech Conference in New York. The company's management will engage in a fireside chat scheduled for Thursday, February 6, 2025 at 9:30 a.m. ET / 6:30 a.m. PT.
Investors and interested parties can access a live webcast of the presentation through the Investors & Media section of Vaxcyte's website at investors.vaxcyte.com. The webcast recording will remain available for approximately 30 days after the conference.
Vaxcyte has initiated a Phase 2 study of VAX-31, a 31-valent pneumococcal conjugate vaccine candidate, in healthy infants. The study aims to evaluate safety, tolerability, and immunogenicity of VAX-31, designed to prevent invasive pneumococcal disease. The vaccine candidate offers potential coverage of 94% of invasive pneumococcal disease and 93% of acute otitis media in U.S. children under five. Topline data from the primary immunization series is expected in mid-2026, with booster dose data following approximately nine months later. The company also maintains its timeline for VAX-24 Phase 2 infant study topline data by Q1 2025.
Vaxcyte announced significant regulatory updates for its VAX-31 pneumococcal conjugate vaccine (PCV) program. The FDA cleared the VAX-31 infant Investigational New Drug application and granted Breakthrough Therapy designation for adult indication. VAX-31, a 31-valent PCV candidate, is designed to cover approximately 94% of invasive pneumococcal disease (IPD) in U.S. children under five and over 95% of IPD in U.S. adults. The company plans to initiate the infant Phase 2 study by end of January 2025 and the adult Phase 3 pivotal study by mid-2025. Topline data from these studies are expected in 2026.
Vaxcyte (PCVX) reported Q3 2024 financial results and significant progress in its pneumococcal conjugate vaccine (PCV) programs. The company announced positive Phase 1/2 results for VAX-31, its 31-valent PCV candidate, in adults aged 50+. Based on these results, VAX-31 will advance to Phase 3 by mid-2025. Financial highlights include $3.3 billion in cash position, including $1.4 billion from a September public offering. Q3 R&D expenses were $116.9 million, G&A expenses $23.0 million, and net loss $103.1 million. The company expects key milestones including VAX-24 infant Phase 2 data by Q1 2025 and VAX-31 infant Phase 2 study initiation in Q1 2025.
Vaxcyte (Nasdaq: PCVX), a clinical-stage vaccine innovation company, has announced its participation in the 2024 Cantor Global Healthcare Conference. The company's management will engage in a fireside chat on Wednesday, September 18, at 10:20 a.m. ET / 7:20 a.m. PT.
Interested parties can access a live webcast of the discussion through the Investors & Media section of Vaxcyte's website at http://investors.vaxcyte.com. For those unable to attend the live event, a replay of the webcast will be available for approximately 30 days following the conference.
This presentation offers an opportunity for investors and analysts to gain insights into Vaxcyte's progress in developing high-fidelity vaccines aimed at protecting against bacterial diseases.
Vaxcyte (Nasdaq: PCVX) has successfully closed its previously announced public offering, raising approximately $1.5 billion in gross proceeds. The offering included 12,087,378 shares of common stock at $103.00 per share and pre-funded warrants to purchase 2,427,184 shares at $102.999 per warrant. Underwriters fully exercised their option to purchase an additional 1,893,203 shares. The offering was managed by several prominent financial institutions, including BofA Securities, Jefferies, and Leerink Partners. Vaxcyte, a clinical-stage vaccine innovation company, plans to use the funds to advance its high-fidelity vaccines aimed at protecting against bacterial diseases.
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.