Duyuru • Jun 03

Vaxcyte Doses First Participant In Phase 1 Study Evaluating VAX-A1 For The Prevention Of Disease Caused By Group A Streptococcus In Healthy Adults

Vaxcyte, Inc. announced that the first participant was dosed in the Phase 1, first-in-human study evaluating VAX-A1, the Company’s investigational prophylactic vaccine candidate for the prevention of disease caused by Group A Streptococcus (Group A Strep), in healthy adults aged 18 to 40 years. The Company expects to announce topline data from the study in the second half of 2027. The primary objective of this randomized, double-blind, placebo-controlled, dose-escalation, two-stage study is assessing the safety and tolerability of VAX-A1, along with a secondary objective of evaluating initial immunogenicity data, to support potential further advancement. The Stage 1 portion of the study is evaluating three dose levels (Low, Mid and High) compared to placebo in approximately 12 adults in a controlled, staged enrollment and dose-escalation approach. Following completion of the Stage 1 Month 1 visit, an independent Data Safety Monitoring Board (DSMB) will review unblinded safety and tolerability data. Upon DSMB approval, the Stage 2 portion of the study is expected to proceed and evaluate the same three dose levels compared to placebo in approximately 68 adults. All participants in the study will be evaluated for safety through six months following the second dose. Group A Strep is responsible for approximately 800 million new cases of illness and more than 600,000 deaths annually worldwide, with no approved vaccine and significant public health burden. About the VAX-A1 Adult Phase 1 Study: This randomized, double-blind, placebo-controlled, two-stage, dose-escalation clinical study is evaluating VAX-A1 in approximately 80 healthy adults aged 18 to 40 years. Stage 1 of the study will enroll approximately 12 participants to evaluate VAX-A1 at three dose levels (Low, Mid and High), in a controlled, staged enrollment and dose-escalation approach. Dose escalation for each cohort in Stage 1 will be based on a review of blinded safety and tolerability data by the Company’s Internal Safety Team prior to proceeding with enrolling the next cohort. Following completion of the Stage 1 Month 1 visit, an independent DSMB will review unblinded safety and tolerability data. Upon DSMB approval, Stage 2 is expected to proceed and enroll approximately 68 participants to further evaluate VAX-A1 across the same three dose levels. The study is being conducted at an investigative site in Australia, where Group A Strep has been especially problematic and where there are experienced investigator networks with expertise in Group A Strep. Participant Overview: Stage 1 (n=12): Participants will be randomized 3:1 to receive VAX-A1 or placebo across three dose levels (Low, Mid and High). Stage 2 (n=68): Participants will be randomized 1:1:1:1 to receive VAX-A1 at one of the three dose levels or placebo. All participants are expected to receive two doses administered approximately two months apart. Safety and Immunogenicity Assessments: Primary objectives include evaluation of safety and tolerability, including assessment of solicited and unsolicited adverse events, serious adverse events and adverse events of special interest. Secondary objectives include evaluation of antigen-specific immune responses to Group A Strep antigens, including serum immunoglobulin G (IgG) responses to C5a peptidase (ScpA), streptolysin O (SLO), S. pyogenes adhesion and division protein (SpyAD) and a universal polysaccharide (modified Group A carbohydrate or GACPR). Safety and tolerability will be assessed for approximately six months following the second and final vaccination. About Group A Strep: Group A Strep is one of the leading causes of bacterial infections worldwide, responsible for a broad spectrum of disease ranging from common illnesses such as strep throat and skin infections to severe invasive disease, including necrotizing fasciitis and streptococcal toxic shock syndrome, as well as immune-mediated sequelae such as acute rheumatic fever, rheumatic heart disease and post-streptococcal glomerulonephritis, a form of kidney inflammation. With an estimated 800 million new cases of illness and more than 600,000 deaths annually worldwide, Group A Strep remains a major clinical burden. The economic impact is substantial, exceeding an estimated $6 billion annually in the U.S. alone. The public health challenge associated with Group A Strep is compounded by evolving epidemiology, including increasing rates of invasive disease and the re-emergence of certain manifestations in markets with historically lower disease burden. Group A Strep also drives significant antibiotic use, especially among children, contributing to rising resistance to multiple antibiotic classes. As a result, Group A Strep contributes to the global threat of antimicrobial resistance (AMR), reinforcing the need for preventative approaches such as vaccination. About VAX-A1: VAX-A1 is a prophylactic vaccine candidate designed to provide broad protection against Group A Strep by targeting conserved antigens associated with immune evasion and virulence. The candidate incorporates three protein antigens, including C5a peptidase (ScpA), streptolysin O (SLO) and S. pyogenes adhesion and division protein (SpyAD), as well as a modified Group A carbohydrate (GACPR) designed to remove potentially cross-reactive epitopes historically associated with autoimmune complications. VAX-A1 is being developed using Vaxcyte’s cell-free protein synthesis platform, which enables precise antigen design and site-specific conjugation intended to preserve immunogenicity while avoiding problematic regions. The vaccine is designed to induce functional immune responses against conserved structures of the pathogen and disarm its defense mechanisms, providing broad, strain-independent protection. This approach is intended to address limitations of prior vaccine strategies, including antigen variability and concerns regarding autoimmune cross-reactivity.

Duyuru • Mar 23

Vaxcyte Inc Completes Enrollment Of OPUS-1 And OPUS-2 Phase 3 Trials Evaluating VAX-31 For The Prevention Of Invasive Pneumococcal Disease And Pneumonia In Adults

Vaxcyte, Inc. announced the completion of enrollment in the VAX-31 OPUS-1 Phase 3 pivotal, noninferiority trial with approximately 4,000 participants and the OPUS-2 Phase 3 trial evaluating VAX-31 concomitantly administered with a seasonal influenza vaccine in approximately 1,300 participants. The Phase 3 program evaluating VAX-31, the Company’s next-generation 31-valent pneumococcal conjugate vaccine (PCV) candidate, for the prevention of invasive pneumococcal disease (IPD) and pneumonia in adults was finalized in consultation and alignment with the U.S. Food and Drug Administration (FDA) and is intended to generate a broad and robust dataset to support a planned Biologics License Application (BLA) submission. Topline safety, tolerability and immunogenicity data from OPUS-1 Phase 3 study are expected in Fourth Quarter of 2026. Results from the OPUS-2 and OPUS-3 trials are expected in the first half of 2027. The pivotal Phase 3 study of VAX-31 is now fully enrolled with approximately 4,000 adults. The randomized, double-blind, active-controlled trial is evaluating the safety, tolerability and immunogenicity of the VAX-31 High Dose, the adult formulation being evaluated in the OPUS Phase 3 program, in healthy, pneumococcal-naïve U.S. adults aged 50 years and older, with a separate cohort of adults aged 18-49 years. In this formulation, all serotypes are dosed at 3.3 mcg, except serotypes 1, 5 and 22F, which are dosed at 4.4 mcg. The study is being conducted at approximately 50 sites across the United States. Adults aged =50 years: Participants in this age group were randomized 1:1:1 to receive a single dose of VAX-31, Capvaxive (PCV21) or Prevnar 20 (PCV20) on Day 1. Adults aged 18-49 years: Participants in this age group were randomized 3:1 to receive a single dose of VAX-31 or PCV20 on Day 1, with PCV20 serving as the safety comparator. For all participants, safety and tolerability will be assessed for six months following initial vaccination of VAX-31, PCV21 or PCV20. Primary immunogenicity objectives: Noninferiority of VAX-31 compared with PCV21 and/or PCV20 for the 28 serotypes shared with either or both comparator vaccines in adults aged 50 years and older (criterion: lower bound (LB) of the two-sided 95% confidence interval (CI) of the OPA GMR is >0.667). Superiority of VAX-31 compared with PCV21 or PCV20 for the three serotypes unique to VAX-31 (2, 7C and 20C) and for serotype 20B in adults aged 50 years and older (criterion: LB of the two-sided 95% CI of the OPA GMR is >2.0). Noninferiority of VAX-31 immune responses in adults aged 18-49 years compared with those in adults aged 50-64 years (criterion: LB of the two-sided 95% CI of the OPA GMR is >0.667). Key secondary immunogenicity objectives: Noninferiority of VAX-31 compared with both PCV21 and PCV20 for the 11 serotypes common to all three vaccines in adults aged 50 years and older (criterion: LB of the two-sided 95% CI of the OPA GMR is >0.5). Statistically greater immune responses elicited by VAX-31 compared with those elicited by PCV21 or PCV20 for the 28 shared serotypes in adults aged 50 years and older (criterion: LB of the two-sided 95% CI of the OPA GMR is >1.0). Superiority of VAX-31 compared with PCV20 for the eight serotypes common to VAX-31 and PCV21 but not included in PCV20 in adults aged 50 years and older (criterion: LB of the two-sided 95% CI of the OPA GMR is >2.0). Superiority of VAX-31 compared with PCV21 for the nine serotypes common to VAX-31 and PCV20 but not included in PCV21 in adults aged 50 years and older (criterion: LB of the two-sided 95% CI of the OPA GMR is >2.0). VAX-31 serotypes (31): 1, 2, 3, 4, 5, 6A, 6B, 7C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 16F, 17F, 18C, 19A, 19F, 20C, 22F, 23A, 23B, 23F, 31, 33F, 35B. Serotypes common to VAX-31, PCV21 and PCV20 (11): 3, 6A, 7F, 8, 10A, 11A, 12F, 15B, 19A, 22F, 33F. Serotypes common to VAX-31 and PCV20 but not in PCV21 (9): 1, 4, 5, 6B, 9V, 14, 18C, 19F, 23F. Serotypes common to VAX-31 and PCV21 but not in PCV20 (8): 9N, 15A, 16F, 17F, 23A, 23B, 31, 35B. Serotypes unique to VAX-31 (3): 2, 7C, 20C (20B is also being evaluated). OPUS-2 Phase 3 study, which is now fully enrolled with approximately 1,300 adults, is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the safety, tolerability and immunogenicity of VAX-31 when administered either concomitantly with or one month following administration of a licensed seasonal influenza vaccine in pneumococcal-naïve, healthy U.S. adults aged 50 years and older. The results of this descriptive study are intended to inform the design of a potential post-licensure outcomes study that further evaluates VAX-31 in concomitant use with an influenza vaccine and to provide supportive evidence as part of the broader Phase 3 dataset. The study is being conducted at approximately 25 sites in the United States. Participants were randomized 1:1 into one of two groups: Concomitant Administration Group: Participants received a seasonal influenza vaccine administered open-label and concomitantly with VAX-31 administered blinded on Day 1, followed by a blinded placebo injection at Month 1. Sequential Administration Group: Participants received a seasonal influenza vaccine administered open-label with a blinded placebo injection on Day 1, followed by VAX-31 administered blinded at Month 1. This sequential dosing approach allows for evaluation of immune responses to VAX-31 when administered alone, while preserving blinding and controlling for vaccination timing. For all participants, safety and tolerability will be assessed for six months following initial vaccination. Primary immunogenicity objectives: Assessing serotype-specific immune responses (opsonophagocytic activity (OPA) geometric mean titers (GMTs) and geometric mean fold rises (GMFRs)) elicited by VAX-31 across all 31 serotypes and serotype 20B in pneumococcal-naïve adults aged 50 years and older. Comparing strain-specific immune responses (hemagglutination inhibition (HAI) GMTs) elicited by a seasonal influenza vaccine when co-administered with VAX-31 to those elicited by a seasonal influenza vaccine alone. Secondary immunogenicity objective: Comparing immunoglobulin G (IgG) antibody responses (IgG geometric mean concentrations (GMCs)) elicited by VAX-31 across all 31 serotypes and serotype 20B when VAX-31 is co-administered with a seasonal influenza vaccine to those elicited by VAX-31 alone.

Faiz karşılama oranı	n/a
Nakit	US$1.49b
Eşitlik	US$2.76b
Toplam yükümlülükler	US$380.21m
Toplam varlıklar	US$3.14b

Veri	Son Güncelleme (UTC saati)
Şirket Analizi	2026/09/13 00:28
Gün Sonu Hisse Fiyatı	2026/09/11 00:00
Kazançlar	2026/06/30
Yıllık Kazançlar	2025/12/31

Paket	Veri	Zaman Çerçevesi	Örnek ABD Kaynağı ^*
Şirket Finansalları	10 yıl	Gelir tablosu Nakit akış tablosu Bilanço	SEC Form 10-K SEC Form 10-Q
Analist Konsensüs Tahminleri	+3 yıl	Finansal tahminler Analist fiyat hedefleri	Analist Araştırma Raporları Blue Matrix
Piyasa Fiyatları	30 yıl	Hisse senedi fiyatları Temettüler, Bölünmeler ve Eylemler	ICE Piyasa Verileri SEC Form S-1
Sahiplik	10 yıl	En büyük hissedarlar İçeriden öğrenenlerin ticareti	SEC Form 4 SEC Form 13D
Yönetim	10 yıl	Liderlik ekibi Yönetim Kurulu	SEC Form 10-K SEC Form DEF 14A
Önemli Gelişmeler	10 yıl	Şirket duyuruları	SEC Form 8-K

Analist	Kurum
Jason Matthew Gerberry	BofA Global Research
Thomas Shrader	BTIG
Carter Gould	Cantor Fitzgerald & Co.

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Recent updates

Vaxcyte Announces Update of Topline Safety, Tolerability and Immunogenicity Data from the Vax-31 Adult Phase 3 Opus-1 Trial

Vaxcyte: Not Enough Safety Margin With Current Price

Vaxcyte, Inc. Provides A Business Update

Co-Founder notifies of intention to sell stock

Vaxcyte, Inc. Announces Board Changes, Effective July 16, 2026

President & CFO notifies of intention to sell stock

Vaxcyte Updates VAX-A1 Group A Strep Vaccine Trial in Healthy Adults

New minor risk - Insider selling

Vaxcyte, Inc. Announces Board Changes, Effective June 17, 2026

Insufficient new directors

Vaxcyte (PCVX) Stock Could Be 52.8% Undervalued After VAX A1 Enters Phase 1

Co-Founder notifies of intention to sell stock

Vaxcyte Stock in Focus as Phase 1 VAX-A1 Streptococcus Vaccine Trial Begins

Vaxcyte Doses First Participant In Phase 1 Study Evaluating VAX-A1 For The Prevention Of Disease Caused By Group A Streptococcus In Healthy Adults

Vaxcyte Advances VAX-31 With Phase 3 Enrollment Complete and Expands Vaccine Pipeline

Vaxcyte, Inc., Annual General Meeting, Jun 15, 2026

Vaxcyte Inc Completes Enrollment Of OPUS-1 And OPUS-2 Phase 3 Trials Evaluating VAX-31 For The Prevention Of Invasive Pneumococcal Disease And Pneumonia In Adults

Vaxcyte, Inc. Publishes Positive Phase 1/2 Adult Data For VAX-31 Pneumococcal Conjugate Vaccine Candidate

Future Late Stage Vaccine Programs And Manufacturing Capacity Will Drive Long Term Opportunity

Executive VP & COO notifies of intention to sell stock

Executive VP & COO notifies of intention to sell stock

Late Stage Vaccine Programs And New Manufacturing Capacity Will Underpin Long Term Upside

Late Stage Vaccine Trials And Manufacturing Buildout Will Shape Balanced Long Term Outlook

Vaxcyte, Inc. has completed a Follow-on Equity Offering in the amount of $408.1 million.

Vaxcyte, Inc. Doses First Participants in OPUS-3 Phase 3 Trial Evaluating VAX-31 in Adults Previously Vaccinated with Lower-Valency Pneumococcal Vaccines

Vaxcyte, Inc. to Report Q4, 2025 Results on Feb 24, 2026

New minor risk - Shareholder dilution

Price target increased by 11% to US$102

Vaxcyte, Inc. has completed a Follow-on Equity Offering in the amount of $550 million.

Vaxcyte, Inc. Advances Adult and Infant Programs for VAX-31, a Potential Best-In-Class, Next-Generation Pneumococcal Conjugate Vaccine

Price target increased by 11% to US$102

Senior Vice President of Finance recently sold US$557k worth of stock

Vaxcyte, Inc. Doses First Participants in the OPUS Phase 3, Noninferiority Trial Evaluating VAX-31 for the Prevention of Invasive Pneumococcal Disease and Pneumonia in Adults

Vaxcyte, Inc. Advances VAX-31 Infant Phase 2 Dose- finding Study with First Participants Receiving VAX-31 Optimized Dose

Price target decreased by 9.7% to US$119

Vaxcyte, Inc.(NasdaqGS:PCVX) dropped from Russell 2000 Growth Index

Vaxcyte, Inc. Appoints Dr. Olivier Brandicourt to Board of Directors

Vaxcyte, Inc., Annual General Meeting, Jun 12, 2025

Price target decreased by 14% to US$128

New minor risk - Share price stability

Vaxcyte: Plunge On FDA Top Regulator Resigning Generates Buying Opportunity

Vaxcyte Announces Positive Topline Results from VAX-24 Infant Phase 2 Dose-Finding Study

Executive VP & COO notifies of intention to sell stock

New minor risk - Shareholder dilution

President & CFO notifies of intention to sell stock

Vaxcyte, Inc. to Report Q4, 2024 Results on Feb 25, 2025

Vaxcyte, Inc. Advances to Second Stage of Ongoing Phase 2 Study Evaluating VAX-31 for Prevention of Invasive Pneumococcal Disease in Infants

Executive VP & COO notifies of intention to sell stock

President & CFO notifies of intention to sell stock

New major risk - Shareholder dilution

Vaxcyte Aims To Outshine Pfizer With Bold VAX-31 Strategy

Executive VP & COO notifies of intention to sell stock

President & CFO notifies of intention to sell stock

Co-Founder notifies of intention to sell stock

Vaxcyte, Inc. Initiates Phase 2 Study Evaluating Vax-31 for the Prevention of Invasive Pneumococcal Disease in Infants

President & CFO notifies of intention to sell stock

Vaxcyte, Inc. Provides Positive Regulatory Updates on VAX-31 Pediatric and Adult Programs

Co-Founder notifies of intention to sell stock

Insufficient new directors

President & CFO notifies of intention to sell stock

Co-Founder notifies of intention to sell stock

Executive VP & COO notifies of intention to sell stock

Vaxcyte: Stunning PCV Data Readout Suggests Vaccine Maker Is A Strong Buy

Vaxcyte, Inc. has completed a Follow-on Equity Offering in the amount of $1.299998 billion.

Executive VP & COO notifies of intention to sell stock

Vaxcyte, Inc. has filed a Follow-on Equity Offering.

New major risk - Revenue and earnings growth

Price target increased by 27% to US$131

Vaxcyte Reports Positive Topline Data from Phase 1/2 Study of VAX-31, its 31-Valent Pneumococcal Conjugate Vaccine Candidate, in Adults Aged 50 and Older

President & CFO notifies of intention to sell stock

President & CFO notifies of intention to sell stock

Vaxcyte Appoints John Furey to Board of Directors

President & CFO notifies of intention to sell stock

Independent Director notifies of intention to sell stock

President & CFO notifies of intention to sell stock