Hematuria | Jotup

Vera Therapeutics Provides Business Update and Reports First Quarter 2024 Financial Results

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星期四, 五月 9, 2024

Congress, Risk, Kidney failure, Abstract, Hematuria, UPCR, EGFR, Patient, Pivotal, Quarter, Nephritis, Therapy, Pharmaceutical industry

“This quarter, we shared results from our Phase 2b clinical trial that demonstrated for the first time in this field that atacicept can resolve kidney inflammation and stop kidney function decline in young patients with IgAN who are at risk of kidney failure, offering a potentially transformative treatment for these young patients,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics.

Key Points:

“This quarter, we shared results from our Phase 2b clinical trial that demonstrated for the first time in this field that atacicept can resolve kidney inflammation and stop kidney function decline in young patients with IgAN who are at risk of kidney failure, offering a potentially transformative treatment for these young patients,” said Marshall Fordyce, M.D., Founder and CEO of Vera Therapeutics.
“Later this year we plan to announce long-term 96-week clinical data from our ORIGIN 2b trial, and in the first half 2025 we anticipate reading out the primary endpoint results from our pivotal ORIGIN Phase 3 trial, which are expected to support our submission for regulatory approval of atacicept.
During the quarter ended March 31, 2024, net cash used in operating activities was $33.8 million, compared to $26.3 million for the same period last year.
Vera reported $403.7 million in cash, cash equivalents, and marketable securities as of March 31, 2024, which the Company believes to be sufficient to fund operations through approval and US commercial launch of atacicept.

Cretostimogene Monotherapy Demonstrated 75.2% Complete Response Rate in High-Risk, BCG-Unresponsive Non-Muscle Invasive Bladder Cancer

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星期五, 五月 3, 2024

IRVINE, Calif., May 03, 2024 (GLOBE NEWSWIRE) -- CG Oncology, Inc. today announced that data from the Phase 3 BOND-003 study evaluating the efficacy and safety of cretostimogene monotherapy in patients with high-risk Non-Muscle Invasive Bladder Cancer (NMIBC) unresponsive to Bacillus Calmette Guerin (BCG), showed that 75.2% of patients (79 out of 105 [95% confidence interval (CI), 65-83]) achieved a complete response (CR) at any time, as of the cutoff date of April 1, 2024. These data were featured today at the Paradigm-Shifting, Practice-Changing Clinical Trials in Urology Plenary Session as an oral presentation (Abstract #24-11358) by Dr. Mark D. Tyson, Urologic Oncologist at Mayo Clinic, at the 2024 American Urological Association (AUA) Annual Meeting, in San Antonio, TX. In addition, cretostimogene has shown durable responses over time with twenty-nine patients maintaining a complete response for 12 months or more, pending evaluation and assessment of ongoing responses in twenty-two patients as of the data cutoff. Median duration of response (DOR) was not reached. 92.4% cystectomy-free survival was observed and none of the patients with a complete response had undergone radical cystectomy or showed nodal or metastatic progression.

Key Points:

92.4% cystectomy-free survival was observed and none of the patients with a complete response had undergone radical cystectomy or showed nodal or metastatic progression.
“The positive 12-month BOND-003 data presented at AUA 2024, with a notable duration of response, reinforces cretostimogene monotherapy as a potential backbone therapy in the NMIBC treatment landscape for BCG-unresponsive patients.
“Cretostimogene reported remarkable interim efficacy results, with over half of the patients experiencing complete responses upon repeat induction.
A webcast replay will be available in the investor relations section on the company's website following the completion of the call.

Vesica Health Announces Launch of AssureMDx Test to Improve Bladder Cancer Detection

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星期五, 五月 3, 2024

Health, HEALTH, Standard of care, Patient, Bladder cancer, Hematuria, MPH, Physician

IRVINE, Calif., May 3, 2024 /PRNewswire/ -- VESICA HEALTH, INC., a leading multi-omics liquid biopsy company dedicated to improving the management of hematuria patients and the early detection of bladder cancer, today announced the launch of its laboratory-developed AssureMDx™ test.

Key Points:

IRVINE, Calif., May 3, 2024 /PRNewswire/ -- VESICA HEALTH, INC., a leading multi-omics liquid biopsy company dedicated to improving the management of hematuria patients and the early detection of bladder cancer, today announced the launch of its laboratory-developed AssureMDx™ test.
Christopher Thibodeau, Chief Executive Officer of Vesica Health, expressed his enthusiasm, stating, "We are delighted to officially introduce AssureMDx for patient testing.
Laura Caba, MPH, President of Vesica Health, underscored the significance of this innovation, declaring, "We are reshaping the landscape of early bladder cancer detection and fulfilling our commitment to elevating patient care and clinical outcomes."
AssureMDx represents a significant leap forward in bladder cancer diagnostics, offering unparalleled accuracy and reliability backed by rigorous scientific validation.

Alpine Immune Sciences Shares Updated Clinical Data from Povetacicept in IgA Nephropathy

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星期三, 四月 10, 2024

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today shared updated clinical data for povetacicept in IgA nephropathy (IgAN) which will be presented as a late breaking poster at the World Congress of Nephrology (WCN) April 13-16, 2024 in Buenos Aires, Argentina.

Key Points:

Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for autoimmune and inflammatory diseases, today shared updated clinical data for povetacicept in IgA nephropathy (IgAN) which will be presented as a late breaking poster at the World Congress of Nephrology (WCN) April 13-16, 2024 in Buenos Aires, Argentina.
RUBY-3 is a multiple ascending dose, multi-cohort, open label, phase 1b/2a study of povetacicept in autoimmune glomerulonephritis, including IgA nephropathy, where povetacicept is administered subcutaneously (SC) once every four weeks.
As of March 01, 2024, 41 patients with IgAN had received povetacicept 80 or 240 mg subcutaneously every 4 weeks.
These data strongly support the inhibition of APRIL/BAFF pathways by povetacicept and its efficacy in the treatment of IgAN as well as the need for further clinical development.

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

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星期三, 三月 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

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星期四, 一月 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

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星期二, 一月 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

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星期三, 十二月 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

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星期四, 十一月 9, 2023

“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

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星期六, 十一月 4, 2023

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.