Vaxcyte, Inc. Stock Price, News & Analysis

Tentarix Biotherapeutics, a biotech company developing targeted and conditionally active multispecific biologics, announced four key executive appointments to strengthen its leadership team. Ash Khanna, Ph.D. joins as Chief Business Officer, bringing over 20 years of experience and previously co-founding Vaxcyte (NASDAQ: PCVX). Dallas Jones, Ph.D. becomes Senior Vice President of Biology, Tim Noffke joins as VP of Program Management and Chief of Staff, and Ankita Srivastava, Ph.D. is promoted to Senior Vice President of Biotherapeutics.

The strategic appointments aim to accelerate Tentarix's pipeline development of conditional multispecific biologics into clinical stages. The new executives bring extensive experience in business development, translational biology, biologics engineering, and development-stage execution.

Vaxcyte (NASDAQ:PCVX) has advanced to the third and final stage of its modified VAX-31 infant Phase 2 dose-finding study. The study is evaluating a new VAX-31 Optimized Dose, with most serotypes dosed at 4.4mcg and the remainder at 3.3mcg, compared to Prevnar 20 in healthy infants.

The randomized, double-blind study will enroll approximately 900 participants, with topline safety and immunogenicity data expected by the end of H1 2027. VAX-31, a 31-valent pneumococcal conjugate vaccine candidate, aims to become the most broad-spectrum PCV, potentially covering ~92% of invasive pneumococcal disease and ~93% of acute otitis media in U.S. children under five.

Vaxcyte (NASDAQ: PCVX) reported significant progress in Q2 2025 for its VAX-31 pneumococcal conjugate vaccine program. Following FDA interactions, including an End-of-Phase 2 meeting, the company is finalizing its Phase 3 adult program, with the pivotal study set to begin in Q4 2025. The FDA expanded VAX-31's Breakthrough Therapy designation to include pneumonia prevention.

The company modified its infant Phase 2 study to include an optimized dose arm while discontinuing the low dose arm. Financial highlights include $2.8 billion in cash and investments as of June 30, 2025, with an extended cash runway to mid-2028. Q2 2025 resulted in a net loss of $166.6 million, compared to $128.7 million in Q2 2024, with R&D expenses at $194.2 million.

Vaxcyte is streamlining its early-stage pipeline to focus resources on PCV programs and appointed Chris Griffith as Chief Business and Strategy Officer.

Vaxcyte (PCVX) reported Q1 2025 financial results and significant progress in its pneumococcal conjugate vaccine (PCV) pipeline. The company announced positive Phase 2 results for VAX-24 in healthy infants, showing favorable safety and immunogenicity data. Vaxcyte has initiated the final stage of VAX-31 infant Phase 2 study, with topline data expected mid-2026. The company plans to begin VAX-31 adult Phase 3 pivotal trials by mid-2025. They also introduced VAX-XL, their third-generation PCV candidate. Financially, Vaxcyte maintains a strong position with $2.95 billion in cash and investments as of March 31, 2025. Q1 results showed R&D expenses of $148.1M (up from $94.6M YoY) and a net loss of $140.7M (compared to $95.0M YoY). The company continues construction of its commercial manufacturing suite at Lonza, with completion expected by early 2026.

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.