Vaxcyte, Inc. (formerly SutroVax, Inc.)
Clinical-stage vaccine innovation company developing conjugate and novel protein vaccines to prevent or treat bacterial infectious diseases; renamed from SutroVax, Inc. in May 2020 and listed on NASDAQ (PCVX) the following month.
Clinical Trials
9
4 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2013
Active, not recruiting
4
44.4%
Completed
4
44.4%
Recruiting
1
11.1%
No approval data available
- Seth Klarman's Baupost Group eliminated its entire 800,000-share stake in Vaxcyte (PCVX) during Q2 2026, disclosed in a 13F filed August 13, 2026. - Vaxcyte's lead candidate VAX-31, a 31-valent pneumococcal conjugate vaccine, faces a binary catalyst with topline Phase 3 OPUS-1 data expected in Q4 2026. - The exit was corroborated by Assenagon Asset Management's 91.3% position reduction, though Bank of New York Mellon increased its stake by 5.6%. - A cluster of four C-suite executives sold shares in late July and early August 2026, while all 11 covering analysts maintain a "Buy" rating with an $89.00 median price target.
- The U.S. federal government ended recommendations for children to receive vaccines against flu and five other diseases, reducing the routine schedule from 17 diseases to 11 in a unilateral move made Monday. - The changes will impact Merck's rotavirus vaccine RotaTeq and reduce recommended Gardasil HPV vaccine doses from two shots to one, while pneumococcal vaccines remain recommended. - Public health groups universally criticized the changes, citing concerns about ongoing outbreaks of vaccine-preventable diseases and lack of clear evidence supporting the policy shift. - Vaccine investors are expected to remain cautious given policy headwinds, with analysts noting too much uncertainty for excitement about vaccine investments under the current administration.
- Vaxcyte has begun dosing participants in OPUS, its FDA-aligned Phase 3 pivotal noninferiority trial of VAX-31 for preventing invasive pneumococcal disease and pneumonia in adults. - The trial will enroll approximately 4,000 participants across two age groups and directly compare VAX-31 head-to-head with both Capvaxive (PCV21) and Prevnar 20 (PCV20) across 31 serotypes. - Major institutional investors including Maverick Capital and Eventide have significantly increased their stakes in Vaxcyte, with the company maintaining $2.67 billion in cash to fund operations through mid-2028. - Wall Street analysts maintain a "Strong Buy" consensus rating with an average price target of $101.67, with topline results from the OPUS study expected in 2026.
- Vaxcyte has dosed the first participants in its OPUS Phase 3 pivotal trial evaluating VAX-31, a 31-valent pneumococcal conjugate vaccine designed to prevent invasive pneumococcal disease and pneumonia in adults. - The trial will enroll approximately 4,000 participants and compare VAX-31 head-to-head with current standard-of-care vaccines Capvaxive (PCV21) and Prevnar 20 (PCV20) in terms of safety, tolerability, and immunogenicity. - VAX-31 is designed to provide 14-34% broader coverage for invasive pneumococcal disease and 19-31% broader coverage for pneumococcal pneumonia compared to existing vaccines in U.S. adults aged 50 and older. - Topline results from the OPUS trial are expected in the fourth quarter of 2026, supporting the company's planned Biologics License Application submission and maintaining timelines for potential U.S. market launch.
- Dr. Vinay Prasad, head of FDA's Center for Biologics Evaluation and Research, claimed in an internal memo that at least 10 children died "after and because of receiving" COVID-19 vaccines, linking deaths to myocarditis. - The memo lacked supporting evidence and relied on unsubstantiated VAERS data, prompting criticism from vaccine experts who questioned the transparency and scientific rigor of the claims. - Vaccine maker stocks declined significantly following the news, with Moderna falling 7%, BioNTech down 6%, and other manufacturers experiencing similar drops amid concerns about stricter regulatory oversight. - Prasad announced plans to revise vaccine guidelines beyond COVID-19, including influenza vaccines and policies for pregnant women, while demanding staff compliance or resignation.
- Medicxi successfully raised €500 million ($581 million) for its sixth fund, demonstrating strong investor confidence in its asset-centric investment approach. - The fund will support biotechnology companies at all stages of drug development, focusing on single-asset companies with clear product visions to transform patient care. - Since its previous fund, Medicxi has created 16 new companies, achieved over 20 positive clinical data readouts, and realized more than $1 billion in returns across its portfolio. - The firm's total capital commitments now exceed €2 billion over the past decade, with notable portfolio successes including acquisitions of Merus, ProfoundBio, and ViceBio.
- The pneumococcal disease pipeline features over 20 drugs from 18+ companies in various clinical and preclinical stages, addressing a significant global health threat. - Sanofi's PCV21, a 21-valent pneumococcal conjugate vaccine in Phase III, leads the late-stage pipeline targeting both pediatric and adult populations worldwide. - Vaxcyte's VAX-31 received FDA Breakthrough Therapy designation and showed strong immune responses in Phase I/II trials involving 1,015 adults aged 50 and older. - The market is driven by high global disease burden, rising antimicrobial resistance, and expanded immunization initiatives, particularly in developing regions.
- Vaxcyte's Phase 2 study of VAX-24 pneumococcal vaccine missed four serotypes compared to Prevnar20 in infant data, causing a 50% drop in share price despite overall promising safety and immunogenicity profile. - Evercore ISI maintains an "Outperform" rating on Vaxcyte, noting that three of the four serotype misses were narrow and likely to be resolved in the larger upcoming Phase 3 trial. - The 24-valent pneumococcal conjugate vaccine candidate is designed to prevent invasive pneumococcal disease, with analysts suggesting timing of results coinciding with FDA official Peter Marks' resignation created additional market uncertainty.
- Vaxcyte has initiated the final stage of Phase II trials for VAX-31, its 31-valent pneumococcal conjugate vaccine, following successful safety review of Stage 1 data in infants. - VAX-31 demonstrates potential to provide approximately 94% coverage against invasive pneumococcal disease and 93% coverage for acute otitis media in U.S. children under five years. - The company expects to report topline data from the primary three-dose immunization series by mid-2026, with booster dose results following approximately nine months later.
• Novo Nordisk's liraglutide demonstrated a significant reduction in BMI in a Phase III trial involving children aged 6-11, showing potential for pediatric obesity treatment. • Vaxcyte's VAX-31 pneumonia vaccine showed positive Phase I/II topline data, increasing its Phase Transition Success Rate (PTSR) in streptococcal pneumonia. • Pfizer terminated a Phase I trial of maplirpacept, leading to a decrease in its PTSR for peripheral T cell lymphoma and B cell Hodgkin lymphoma. • Les Laboratoires Servier's oncology drug trial was terminated due to business reasons, impacting the PTSR of S-64315 and S-65487 in multiple myeloma and leukemia.
