Hematuria

Vera Therapeutics Provides Business Update and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, March 20, 2024
Quarter, Disease, Patient, UPCR, Clinical trial, Therapy, EGFR, Proteinuria, FDA, BLA, Hematuria, Pharmaceutical industry

“We believe atacicept 72-week data from the Phase 2b ORIGIN trial are consistent with a profile of true disease modification.

Key Points: 
  • “We believe atacicept 72-week data from the Phase 2b ORIGIN trial are consistent with a profile of true disease modification.
  • The ORIGIN 2b results also provide us with even greater confidence in the ongoing ORIGIN Phase 3 trial, which continues to be on track with regard to enrollment,” stated Robert Brenner, M.D., Chief Medical Officer of Vera Therapeutics.
  • During the year ended December 31, 2023, net cash used in operating activities was $92.2 million, compared to $67.6 million for the same period last year.
  • Vera reported $160.7 million in cash, cash equivalents, and marketable securities as of December 31, 2023.

Vera Therapeutics Presents Positive 72-Week Data Showing eGFR Stabilization in the Phase 2b ORIGIN Clinical Trial OLE in IgA Nephropathy

Retrieved on: 
Thursday, January 25, 2024
PP, Nephrology, Patient, Therapy, Stanford University Medical Center, OLE, PLOS, UPCR, Safety, Hematuria, Disease, Immunoglobulin A, E pluribus unum, EGFR, Pharmaceutical industry

BRISBANE, Calif., Jan. 25, 2024 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late clinical-stage biotechnology company developing and commercializing transformative treatments for patients with serious immunologic diseases, today announced positive 72-week data from the open label extension (OLE) period of its Phase 2b ORIGIN clinical trial of atacicept in participants with IgA nephropathy (IgAN). In aggregate, the 72-week data with atacicept are consistent with a profile of true disease modification in IgAN.

Key Points: 
  • In aggregate, the 72-week data with atacicept are consistent with a profile of true disease modification in IgAN.
  • “Data from the OLE show the consistent and sustained reductions of Gd-lgA1, hematuria, and UPCR, as well as the stability of eGFR over 72 weeks in participants with IgAN.
  • “We are thrilled to present this package of positive new data from the OLE of the Phase 2b ORIGIN clinical trial during our R&D Day, which will be held today in New York.
  • The R&D Day presentation, which includes the OLE 72-Week data slides and commentary, will be available on the Company’s website at the Investor Calendar .

Vesica Health to Present at the Seed Showcase, Part of Biotech Showcase, The Investor Conference for Innovators

Retrieved on: 
Tuesday, January 2, 2024
Conference, Partnership, Bladder cancer, Health, Hematuria, Liquid biopsy, Showcase, HEALTH, Patient

IRVINE, Calif., Jan. 2, 2024 /PRNewswire/ -- VESICA HEALTH, INC., a multi-omics, liquid biopsy company transforming the management of hematuria patients and improving the early detection of bladder cancer, today announced that it has been selected to participate in the Seed Showcase, part of the 2024 Biotech Showcase™.

Key Points: 
  • "We are delighted to share that Vesica Health was chosen to present in the Seed Showcase for investors at the annual Biotech Showcase in San Francisco," reported Christopher Thibodeau, CEO of Vesica Health.
  • "We are delighted that Vesica Health will be joining us in San Francisco and presenting at the Seed Showcase this year," said Sara Demy, CEO of Demy-Colton.
  • The conference takes place each year during one of the industry's largest gatherings and busiest weeks.
  • Registered attendees can attend Vesica Health's live presentation during the in-person event where CEO Christopher Thibodeau will share the company's investor presentation at the Seed Showcase.

Pangea Laboratory Receives FDA Breakthrough Device Designation for the Bladder CARE™ Assay

Retrieved on: 
Wednesday, December 20, 2023
Food, Urinary bladder, UTUC, Real-time, Bladder cancer, FDA, Carcinoma, DNA, Hematuria, Cancer, Neoplasm, Methylation, Biomarker, Patient, Clinical research, USC

TUSTIN, Calif., Dec. 20, 2023 /PRNewswire/ -- Pangea Laboratory has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its non-invasive Bladder CARE™ Assay, intended for the quantitative urine-based diagnosis of bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria and suspected of having either cancer.

Key Points: 
  • TUSTIN, Calif., Dec. 20, 2023 /PRNewswire/ -- Pangea Laboratory has received Breakthrough Device Designation from the US Food and Drug Administration (FDA) for its non-invasive Bladder CARE™ Assay , intended for the quantitative urine-based diagnosis of bladder cancer and upper tract urothelial carcinoma (UTUC) in patients presenting with hematuria and suspected of having either cancer.
  • The Bladder CARE™ Assay measures the methylation levels of three urothelial cancer-specific DNA biomarkers in a single qPCR reaction.
  • "We anticipate further fruitful partnerships with experts in the field to enhance the accessibility of the Bladder CARE™ Assay."
  • Pangea Laboratory is poised to commence multicenter clinical trials as the next step toward obtaining premarket approval for the Bladder CARE™ Assay.

Vera Therapeutics Provides Business Update and Reports Third Quarter Financial Results

Retrieved on: 
Thursday, November 9, 2023
APRIL, Hematuria, EGFR, Quarter, Society, American Society of Nephrology, BAFF, Disease, Risk, Serum, Kidney disease, Kidney, Vera, Therapy, Patient, Death, Immunoglobulin A, Proteinuria, Pharmaceutical industry, Cryptocurrency, IgA nephropathy

“Vera presented additional positive data from the Phase 2b ORIGIN trial at Kidney Week 2023, which support the potential of atacicept as a disease-modifying treatment for patients with IgAN.

Key Points: 
  • “Vera presented additional positive data from the Phase 2b ORIGIN trial at Kidney Week 2023, which support the potential of atacicept as a disease-modifying treatment for patients with IgAN.
  • We showed that patients on atacicept achieved durable and significant Gd-IgA1 reduction over 36 weeks regardless of baseline quartile.
  • High serum levels of galactose-deficient IgA1 (Gd-IgA1) are associated with greater risk of end-stage renal disease or death.
  • Vera reported $159.9 million in cash, cash equivalents, and marketable securities as of September 30, 2023.

Vera Therapeutics Presents Positive Data from Phase 2b ORIGIN Study Showing Resolution of Hematuria in Majority of Patients at the American Society of Nephrology Kidney Week 2023

Retrieved on: 
Saturday, November 4, 2023
Patient, APRIL, Hematuria, EGFR, Tetanus, Diphtheria, Immunoglobulin A, Poster, Society, American Society of Nephrology, BAFF, Disease, COVID-19, Risk, Immunity, ASN, Kidney disease, Safety, Overalls, UPCR, Therapy, Kidney, Death, Infection, Proteinuria, Mineral wool, Pharmaceutical industry, Vaccine, IgA nephropathy

BRISBANE, Calif., Nov. 04, 2023 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced the presentation of three posters – including an additional analysis of week 36 data from the Phase 2b ORIGIN study demonstrating resolution of hematuria in the majority of patients – on the Company’s product candidate atacicept in patients with immunoglobulin A nephropathy (IgAN) at the American Society of Nephrology (ASN) Kidney Week 2023, in Philadelphia, PA.

Key Points: 
  • Analysis of week 36 data from Phase 2b ORIGIN study shows atacicept 150 mg substantially reduces serum Gd-IgA1 and resolves hematuria in the majority of patients.
  • Additional poster presentations provide further safety analysis of Phase 2b and details of pivotal Phase 3 clinical trial design, which is currently enrolling.
  • At week 36 of the ORIGIN Phase 2b study of atacicept in patients with IgAN, hematuria resolved in 80% of patients (n=12/15) receiving atacicept 150 mg compared to 5% (n=1/19) in the placebo group.
  • Through the randomized, placebo-controlled period, infections were balanced between atacicept and placebo in both the Phase 2a JANUS and Phase 2b ORIGIN studies.

Natera’s Landmark RenaCARE Study Demonstrates Significant Diagnostic and Clinical Utility of Renasight™ in Chronic Kidney Disease

Retrieved on: 
Thursday, November 2, 2023
Biotechnology, Medical Devices, Health, Genetics, Oncology, Genetic testing, Patient, Journal of the American Society of Nephrology, Kidney disease, Columbia University Irving Medical Center, Hematuria, Therapy, Medicare, Physician, AUC, Diabetes, NTRA, Journal, Society, Chronic kidney disease, Disease, Division, Medicine, Hypertension, Histology, Biopsy, Nephrology, CKD, Diagnosis, DNA, Pharmaceutical industry, Medical imaging, Dietary supplement

Genetic testing can address many of these limitations by identifying the underlying origin of disease, enabling physicians to properly diagnose and stratify CKD patients.

Key Points: 
  • Genetic testing can address many of these limitations by identifying the underlying origin of disease, enabling physicians to properly diagnose and stratify CKD patients.
  • In the RenaCARE study, 20.8% of CKD patients had a positive genetic finding.
  • Of those, 48.8% of patients received a new or reclassified diagnosis and 34% received information on disease subtype.
  • In the study, 35.5% of patients with positive results received a diagnosis that could make them eligible for available therapeutics.

Vesica Health Appoints Distinguished Urologic Oncologist Dr. William T. Lowrance to Chief Medical Officer

Retrieved on: 
Tuesday, October 31, 2023
Education minister, Harvard School of Dental Medicine, Survival, Huntsman Cancer Institute, Lee University, Hematuria, MPH, American Urological Association, Public health, Master of Business Administration, Hope, Memorial Sloan Kettering Cancer Center, Medical degree, Prostate cancer, Medical University of South Carolina, Bladder cancer, Bon, MBA, Health, Vesica, Memorial, Disease, Risk, Business administration, Business, University, Public, David Eccles School of Business, Medical school, HEALTH, Lowrance Electronics, Liquid biopsy, Patient, Diagnosis, Associate, Vanderbilt University Medical Center, Harvard T.H. Chan School of Public Health, Pharmaceutical industry, Nursing, Urology, MD, Chemistry

Dr. Lowrance brings more than 20 years of clinical experience, as a professor of urology and a practicing urologic oncologist, treating patients and conducting clinical trials.

Key Points: 
  • Dr. Lowrance brings more than 20 years of clinical experience, as a professor of urology and a practicing urologic oncologist, treating patients and conducting clinical trials.
  • "I have devoted my career to researching and treating urologic cancers, striving to improve patient care and ultimately, survival," said Dr. William T. Lowrance, Chief Medical Officer of Vesica Health.
  • Dr. Lowrance is an attending urologic oncologist at Bon Secours Mercy Health, specializing in the treatment of urologic malignancies, with a focus on bladder cancer.
  • While serving as the Chief Medical Officer of Vesica Health, Dr. Lowrance will continue his medical practice at Bon Secours Mercy Health.

Vesica Health Announces the Appointment of Recognized Industry Leaders to Newly Formed Board of Directors

Retrieved on: 
Tuesday, October 17, 2023
Quest Diagnostics, Breast cancer, Harvard University, HEALTH, Communications officer, USS, Liquid biopsy, Research, Quality of life, IVD, NL, USS Fletcher (DD-992), US, Swidler Berlin Shereff Friedman, National Institute for Public Health and the Environment, AkzoNobel, Invitae, Bladder cancer, Corporate development, PCR, Biotechnology, DE, FDA, Berlin, Ventana Medical Systems, Erasmus MC, Genomics, Morgan Stanley Wealth Management, Public health, Sale, International law, Vaccine, General counsel, RIVM, Hematuria, Labcorp, Independent, Duke University, Executive, Roche, Patient, Management, Vesica, EU

"It is with great pleasure that we announce the appointment of Dr. Jan Groen, Mark McDonough, and Joe Sollee to our Board of Directors.

Key Points: 
  • "It is with great pleasure that we announce the appointment of Dr. Jan Groen, Mark McDonough, and Joe Sollee to our Board of Directors.
  • "Based on my experience, Vesica has a singular opportunity to not only take market share but drive widespread clinical adoption of its AssureDx test."
  • "Vesica is uniquely positioned with an impressive portfolio of intellectual property issued both domestically and internationally," commented Joe Sollee.
  • "Speaking on behalf of my fellow Board members, we are excited to be joining Vesica's Board at this important time for the company.

Vesica Health Announces Publication of Study Demonstrating AssureDx Meaningfully Improves Identification of Hematuria Patients at High Risk for Bladder Cancer

Retrieved on: 
Monday, October 9, 2023
OTX1, Probability, AUA, Physician, Department of Urology, University of Virginia, National Capital FreeNet, American Urological Association, TERT, Johns Hopkins University, DNA, Risk, AUC, Capital city, Microhematuria, Urology, Hematuria, Health, HEALTH, Cancer, Carcinoma, TWIST1, Alvin J. Siteman Cancer Center, HRAS, DNA methylation, European Urology, Medical school, Patient, Bladder cancer, FGFR3, Liquid biopsy, Risk assessment, Barnes-Jewish Hospital

The study titled "A Urine-based Genomic Assay Improves Risk Stratification for Patients with High-risk Hematuria Stratified According to the American Urological Association Guidelines" was published in the journal European Urology Oncology.

Key Points: 
  • The study titled "A Urine-based Genomic Assay Improves Risk Stratification for Patients with High-risk Hematuria Stratified According to the American Urological Association Guidelines" was published in the journal European Urology Oncology.
  • The study analyzed a prospectively collected cohort of 838 hematuria subjects previously tested by AssureDx.
  • Subjects were classified into the AUA risk categories for bladder cancer based on their sex, age, and type of hematuria, also known as urothelial carcinoma (UC).
  • "Publication of this pivotal study in a leading international urology journal, demonstrating AssureDx enhances the AUA Guidelines, underscores the importance of the test for risk stratification of hematuria patients and identification of those at increased risk for bladder cancer," stated Christopher Thibodeau, Chief Executive Officer of Vesica Health.