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Vaxcyte, Inc. reports clinical-stage vaccine developments focused on bacterial diseases, led by pneumococcal conjugate vaccine candidates in its PCV franchise. Recurring updates cover VAX-31 clinical studies in adult and infant populations, earlier PCV candidates including VAX-24 and VAX-XL, and pipeline programs such as VAX-A1 for Group A Strep and VAX-GI for Shigella.
Company news also addresses the XpressCF cell-free protein synthesis platform licensed from Sutro Biopharma, manufacturing and commercial-readiness activities, equity financings, quarterly financial results, and healthcare conference participation. These releases tie Vaxcyte’s vaccine engineering platform to clinical progress, supply-chain development, and capital resources supporting its pipeline.
Vaxcyte (PCVX) has appointed Dr. Olivier Brandicourt, former CEO of Sanofi S.A., to its Board of Directors. Dr. Brandicourt brings extensive biopharmaceutical expertise, particularly in global vaccine market commercial strategy and execution. During his tenure at Sanofi, he strengthened the company's position as a leading commercial vaccine company. His appointment comes at a crucial time as Vaxcyte advances toward potential global commercialization of its pneumococcal conjugate vaccine (PCV) candidates.
The company also announced that Dr. Peter Hirth, who has served on the Board since 2016, will conclude his tenure in June. Vaxcyte's carrier-sparing platform aims to address unmet needs in bacterial disease prevention and contribute to combating antimicrobial resistance.
Vaxcyte (PCVX) announced positive topline results from its Phase 2 dose-finding study of VAX-24, its 24-valent pneumococcal conjugate vaccine candidate. The study evaluated safety and immunogenicity compared to Prevnar 20® in healthy infants.
The company selected the VAX-24 Mid dose (2.2mcg) for advancement to a potential Phase 3 program. Key findings include:
- Well-tolerated safety profile similar to PCV20 across all doses
- Substantial immune responses after primary three-dose immunization
- Met target non-inferiority criteria for 20 of 24 serotypes
- Demonstrated dose-dependent immune responses with minimal carrier suppression
Pending VAX-31 infant Phase 2 study results in mid-2026, Vaxcyte plans to initiate a Phase 3 study with either VAX-24 or VAX-31. Full post-dose 4 booster data is expected by end of 2025.
Vaxcyte (PCVX) has scheduled a webcast and conference call for March 31, 2025, at 8:00 a.m. Eastern Time to present topline results from the VAX-24 infant Phase 2 study. The study evaluates the safety, tolerability, and immunogenicity of VAX-24, their 24-valent pneumococcal conjugate vaccine candidate, compared to Prevnar 20® in healthy infants.
VAX-24 is designed to prevent invasive pneumococcal disease (IPD). The presentation will be accessible via phone (800-445-7795 domestic, 785-424-1699 international) with conference ID PCVX0331, and through a live webcast on Vaxcyte's investor relations website. The webcast recording will remain available for 30 days after the event.
Vaxcyte (PCVX) reported its Q4 and full year 2024 financial results, highlighting significant progress in its pneumococcal conjugate vaccine (PCV) programs. The company completed a successful VAX-31 Phase 2 adult program and plans to initiate Phase 3 studies by mid-2025.
Key financial highlights include:
- Cash position of $3.1 billion as of December 31, 2024
- Raised $2.2 billion in net proceeds from two equity offerings in 2024
- R&D expenses increased to $476.6 million for full year 2024
- Net loss of $463.9 million for 2024
The company expects multiple clinical milestones in 2025-2026, including topline data from VAX-24 infant Phase 2 study by Q1 2025 end and VAX-31 Phase 3 adult study results in 2026. Vaxcyte also received Breakthrough Therapy Designation from FDA for VAX-31 in November 2024.
Vaxcyte (PCVX), a clinical-stage vaccine innovation company, has scheduled its fourth quarter and full year 2024 financial results announcement for February 25, 2025, after market close. The company will host a conference call and webcast at 4:30 p.m. ET / 1:30 p.m. PT on the same day, where management will discuss financial results and provide a business update. Investors can join the call by dialing 800-225-9448 (domestic) or 203-518-9708 (international) with conference ID PCVXQ424. A live webcast will be available on Vaxcyte's website and will remain archived for 30 days after the event.
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.