Kidney disease treatment

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TVTX Stock Soars as FDA Waives Advisory Committee for Filspari sNDA
ZACKS· 2025-09-11 15:40
Core Insights - Travere Therapeutics (TVTX) received an encouraging update from the FDA regarding its supplemental new drug application (sNDA) for Filspari (sparsentan) in treating focal segmental glomerulosclerosis (FSGS), with a final decision expected on January 13, 2026, leading to a 26.2% increase in TVTX's shares [1][6] Company Overview - FSGS is a rare kidney disorder affecting over 40,000 patients in the U.S. and a similar number in the EU, characterized by kidney scarring and proteinuria, which can lead to kidney failure [2] - Filspari, if approved, would be the first treatment specifically indicated for FSGS, designed to address podocyte injury, a key factor in the disease's progression [3] Clinical Evidence - The sNDA for Filspari is supported by robust clinical data from the phase III DUPLEX and phase II DUET studies, showing significant reductions in proteinuria compared to Sanofi's Avapro [4][9] - The DUPLEX study demonstrated a 67% to 77% lower risk of kidney failure for patients achieving remission, although it did not meet the primary efficacy endpoint for eGFR slope [8][9] Market Performance - Year-to-date, TVTX stock has increased by 56.8%, significantly outperforming the industry average growth of 4.9% [5] Regulatory Developments - Filspari was previously granted full approval for IgA nephropathy (IgAN), making it the only non-immunosuppressive medication in that space [10] - The FDA recently streamlined the Risk Evaluation and Mitigation Strategies (REMS) for Filspari, reducing monitoring burdens and potentially accelerating physician adoption [13]
Akebia Therapeutics, Inc. (AKBA) Presents at Wells Fargo 20th Annual Healthcare Conference 2025 Transcript
Seeking Alpha· 2025-09-05 05:34
Core Insights - Akebia Therapeutics is a leading commercial stage company focused on kidney disease with two commercial products [3] - Auryxia, a phosphate binder, generated $47 million in revenues in Q2 despite losing IP exclusivity in March [3] - Vafseo, launched in January, targets anemia due to chronic kidney disease in adult dialysis patients, representing a $1 billion market opportunity in the U.S. [4] Product Overview - Auryxia has been on the market for several years and continues to perform well despite recent challenges [3] - Vafseo is positioned for label expansion into the late-stage non-dialysis CKD population, which is expected to be a multibillion-dollar opportunity [4]
Vivoryon Therapeutics N.V. Reports H1 2025 Financial Results and Business Updates
Globenewswire· 2025-09-04 05:00
Core Insights - Vivoryon Therapeutics N.V. reported financial results for H1 2025, highlighting progress in its clinical programs, particularly with varoglutamstat for kidney diseases [2][3][15] Financial Performance - Revenues for the six months ended June 30, 2025, were zero, consistent with the same period in 2024 [15] - Research and development expenses decreased by EUR 7.5 million to EUR 2.8 million compared to EUR 10.3 million in H1 2024, primarily due to reduced clinical development costs [16] - General and administrative expenses were EUR 2.8 million, down from EUR 3.5 million in H1 2024, attributed to lower personnel and consulting costs [17] - The net loss for H1 2025 was EUR 5.5 million, significantly reduced from EUR 13.6 million in H1 2024 [17] - Cash and cash equivalents stood at EUR 4.8 million as of June 30, 2025, down from EUR 9.4 million at the end of 2024 [18] Clinical Developments - The company has made significant advancements in the clinical program for varoglutamstat, including a new patent in the U.S. extending exclusivity through 2044 [3][6] - Compelling data from the VIVIAD and VIVA-MIND studies were presented, showing that varoglutamstat significantly improved eGFR kidney function [7][8] - Pre-clinical data indicated a synergistic effect of varoglutamstat in combination with SGLT-2 inhibitors, suggesting potential for enhanced treatment efficacy [5][11] Strategic Initiatives - Vivoryon plans to initiate a Phase 2b clinical study in diabetic kidney disease (DKD), contingent on additional funding or partnerships [9][21] - The company entered into a Standby Equity Purchase Agreement (SEPA) with Yorkville Advisors for up to EUR 15 million in ordinary shares over the next 36 months, aimed at enhancing financial flexibility [14] Intellectual Property - The company expanded its intellectual property portfolio with a new patent for varoglutamstat, which could provide additional market protection [10][6] Management Updates - Julia Neugebauer was appointed as Chief Operating Officer, overseeing investor relations and corporate functions [20] - CFO Anne Doering will take a temporary leave, with Marcus Irsfeld stepping in as acting CFO [20]
Akebia Therapeutics (AKBA) FY Conference Transcript
2025-07-14 15:00
Summary of Akebia Therapeutics (AKBA) FY Conference Call Company Overview - Akebia Therapeutics is a fully integrated biotech company founded in February 2007, focused on improving the lives of patients with chronic kidney disease (CKD) [2][3] - The company has two commercial products: Auryxia and Vassio [5][6] Core Products Auryxia - Auryxia is a phosphate binder used for controlling serum phosphorus in dialysis patients and treating iron deficiency anemia in non-dialysis adult patients [5][6] - The product lost exclusivity in March 2025, leading to the launch of an authorized generic [35][36] - Despite the competition, Auryxia has maintained strong clinical demand due to its clinical profile and economic value proposition [36][37] Vassio - Vassio is an oral HIF PH inhibitor launched in January 2025, indicated for treating anemia due to CKD in adult patients on dialysis [6][12] - It stimulates the body's natural production of erythropoietin, offering a novel mechanism of action compared to traditional erythropoiesis-stimulating agents (ESAs) [8][9] - Approximately 25% of patients on ESAs struggle to meet hemoglobin targets, highlighting a significant unmet need in the market [9][10] Market Dynamics - The dialysis market is characterized by a slow adoption process, with small to mid-sized dialysis organizations adopting new therapies before larger organizations [24][26] - The TDAPA (Transitional Drug Add-On Payment Adjustment) mechanism incentivizes dialysis organizations to adopt innovative therapies like Vassio [28][30] - Vassio's pricing post-TDAPA is set at approximately $2,500 per year, which is significantly lower than the initial starting dose price of $15,500, making it a billion-dollar market opportunity [30][31] Launch Progress and Adoption - In the first quarter post-launch, over 640 physicians prescribed Vassio, averaging 12 prescriptions per physician [18][21] - The company anticipates that larger dialysis organizations will begin to adopt Vassio more significantly in the second half of the year [26][34] - A pilot program with a large dialysis organization is expected to start in Q3 2025, testing operational systems for Vassio [31][34] Future Opportunities - The non-dialysis (NDD) market represents a significant opportunity, with a potential market size four to five times greater than dialysis [46][48] - The company plans to initiate a phase three study for NDD in the second half of the year, following FDA feedback on the protocol [48][49] Key Catalysts - Near-term catalysts include successful pilot program execution, full enrollment in the voice study aimed at reducing hospitalization and mortality, and progress on NDD studies [57][61] - The company is focused on Vassio as the primary growth driver, with plans to leverage its clinical differentiation and real-world physician experience to establish it as the standard of care [40][41] Underappreciated Aspects - Akebia has a pipeline of early-stage HIF assets, including studies for acute kidney injury and retinopathy of prematurity, which are significant unmet needs [62][63] - While investor focus is primarily on Vassio, the company aims to highlight its broader pipeline once Vassio demonstrates continued success [63]
Vivoryon Therapeutics N.V. Q1 2025 Financial Results and Operational Progress
Globenewswire· 2025-06-17 05:00
Core Insights - Vivoryon Therapeutics N.V. reported its Q1 2025 financial results and operational progress, focusing on the development of varoglutamstat for kidney diseases, particularly diabetic kidney disease (DKD) [2][3] Financial Performance - Revenues for Q1 2025 were zero, consistent with Q1 2024 [14] - Research and development expenses decreased by EUR 6.2 million to EUR 1.2 million in Q1 2025 from EUR 7.4 million in Q1 2024, primarily due to lower third-party expenses [14][16] - General and administrative expenses were EUR 1.3 million in Q1 2025, down from EUR 2.1 million in Q1 2024 [16] - Net loss for Q1 2025 was EUR 2.5 million, compared to EUR 9.3 million in Q1 2024 [17] - Cash and cash equivalents as of March 31, 2025, were EUR 7.0 million, down from EUR 9.4 million as of December 31, 2024 [17] Clinical Development - The company is advancing varoglutamstat in kidney disease, with a planned Phase 2b study in DKD as a priority for 2025 [9] - A meta-analysis confirmed that varoglutamstat at 600mg twice daily significantly improved eGFR kidney function, with effects sustained until week 96 [7] - Preclinical data showed a synergistic effect of varoglutamstat in combination with SGLT-2 inhibitors, indicating potential for enhanced treatment regimens [5][6] Intellectual Property - A new composition of matter patent for varoglutamstat was granted in the U.S., providing exclusivity through 2044, with potential extensions [10] - The company is actively pursuing additional patents related to varoglutamstat and its applications in kidney disease [10] Corporate Developments - Vivoryon entered into a Standby Equity Purchase Agreement (SEPA) with Yorkville Advisors for up to EUR 15 million in ordinary shares over the next 36 months, enhancing financial flexibility [12] - Julia Neugebauer was appointed as Chief Operating Officer, effective May 1, 2025, to oversee investor relations and corporate functions [13] Pipeline Updates - The company has nominated a new candidate, VY2149, a next-generation QPCT/L inhibitor, expected to enter late-stage preclinical development [11]
Halberd, Athena GTX, Inc. & Athena Telemedicine Partnership, LLC Clinical Study Updates
Globenewswire· 2025-05-28 12:00
Core Insights - Halberd Corporation, in collaboration with Athena Telemedicine Partners, is conducting a 100-patient study to evaluate the efficacy of its patent-pending LDX compound for treating dialysis-borne neuropathy and pruritis [1][5] - The global kidney disease market is substantial, with approximately 850 million people affected worldwide, highlighting a significant opportunity for LDX's applications [3][4] - The global dialysis treatment market was valued at approximately $116.1 billion in 2024 and is projected to reach $198.2 billion by 2033, growing at a CAGR of 5.4% [4] Company Developments - The LDX compound has shown promising results in managing various conditions, including addiction and chronic inflammatory disorders, indicating a multibillion-dollar market potential [2] - A case report demonstrated that a 63-year-old female patient with Stage 4 chronic renal failure experienced immediate symptom relief after being treated with LDX [5][6] - The company plans to offer a 90-day trial for clinicians to assess the safety and efficacy of LDX in dialysis patients [7] Industry Context - As of 2023, approximately 4.2 million people worldwide are undergoing dialysis treatments for end-stage kidney failure, with a notable increase in home dialysis services since the COVID-19 pandemic [4] - The International Society of Nephrology estimates that 13.3 million people experience acute kidney injury annually, which can lead to chronic kidney disease or kidney failure if not managed properly [4] - The partnership with Athena GTX includes the use of wearable monitoring technologies to collect objective data on symptom relief for patients [8]