LOS ALTOS, Calif., Nov. 25, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company” or “Unicycive”), today announced that Shalabh Gupta, M.D., Chief Executive Officer, will participate in two investor events in December. Event: Piper Sandler 37th Annual Healthcare ConferenceType: Fireside chatDate/Time: Wednesday, December 3, 2025, at 10:00 a.m. ET Event: Noble Capital Markets Virtual Pr ...

Summary of Akebia Therapeutics FY Conference Call Company Overview - **Company**: Akebia Therapeutics (NasdaqCM:AKBA) - **Focus**: Kidney disease treatment - **Products**: - **Auryxia**: A mature phosphate binder, past patent expiry - **Vafseo**: A hypoxia-inducible factor prolyl hydroxylase inhibitor approved for treating anemia in chronic kidney disease (CKD) patients on dialysis, launched at the beginning of the year [2][3] Financial Performance - **Recent Revenue**: Reported $14.3 million in revenue for the quarter, which was below expectations despite positive underlying metrics [5] - **Market Access**: Initially had access to about 40,000 patients, which has now grown to approximately 260,000 patients due to expanded access through major dialysis providers [6] Market Dynamics - **Dialysis Providers**: - **U.S. Renal Care**: Strong clinical advocacy, significant part of revenue base - **DaVita**: Expanded access from 100 to over 4,000 dialysis centers, indicating a successful pilot program [6][14] - **Fresenius**: More challenging engagement, but potential for significant patient access if they broaden availability [20] Clinical Insights - **Patient Management**: Emphasis on educating healthcare providers about the unique dosing and administration of Vafseo compared to traditional treatments [10][12] - **Clinical Data**: Recent data presented at ASN showed a 1% decrease in mortality and an 8% lower hospitalization rate for Vafseo compared to traditional treatments [19][23] Regulatory and Reimbursement Landscape - **TDAPA**: Transitional Drug Add-on Payment Adjustment allows billing for Vafseo outside the dialysis bundle for two years, providing a higher price point and facilitating access [25][26] - **Market Size**: The anemia treatment market in dialysis is estimated at $1 billion, with potential for Vafseo to capture a significant share if it becomes standard of care [26][29] Future Outlook - **Clinical Trials**: Ongoing studies (VOICE and VOCAL) aim to provide further evidence of Vafseo's efficacy and differentiate it from existing treatments [31][32] - **Pipeline Development**: Plans to explore additional indications for HIF-PHI, including acute kidney injury and retinopathy of prematurity [38][39] Financial Position - **Cash Reserves**: Ended the quarter with $166 million, indicating a solid balance sheet and guidance towards profitability [42]

Core Insights - Vertex Pharmaceuticals is presenting updates on its kidney programs at the American Society of Nephrology Kidney Week 2025 [1][2] - The company has three kidney programs in pivotal development and one in a proof-of-concept study [2] Company Overview - The presentation is led by Susie Lisa, Senior Vice President of Investor Relations, and includes an overview from CEO Dr. Reshma Kewalramani [1] - The company expresses gratitude for the participation of three physician thought leaders who will discuss recent data on kidney disease treatments [2] Research and Development - The RUBY-3 data in IgAN will be recapped by Dr. James A. Tumlin, a prominent figure in nephrology [3] - The RAINIER Phase III study of IgAN has recently completed full enrollment in record time, indicating strong progress in clinical trials [2]

Core Insights - Arch Biopartners Inc. has received approval from the Fraser Health Research Ethics Board for the Royal Columbian Hospital to participate in the Phase II trial of LSALT peptide aimed at preventing and treating cardiac surgery-associated acute kidney injury [1][2] - The company is actively expanding its clinical trial sites, with Royal Columbian Hospital being the eighth site globally and the fourth in Canada to recruit patients [2][3] - Arch Biopartners has completed the acquisition of Lipdro Therapeutics Inc., which includes a CKD drug candidate platform, in exchange for 250,000 common shares and a royalty on future net sales [4] - The Board of Directors has granted 750,000 stock options to directors and officers, exercisable at $1.70 per share for ten years, as part of their remuneration [5] Company Developments - The ongoing Phase II trial for LSALT peptide is part of a broader initiative to address acute kidney injury, with additional sites being evaluated in Canada and the U.S. [3][9] - The acquisition of Lipdro Therapeutics enhances the company's capabilities in developing treatments for chronic kidney disease, targeting IL-32 [4] - Arch Biopartners is focused on developing novel drugs for both acute and chronic kidney diseases, addressing significant unmet medical needs globally [6]

Core Insights - Akebia Therapeutics Inc. is experiencing a decline in stock price following an unsuccessful meeting with the U.S. FDA regarding the VALOR trial design for vadadustat, aimed at treating anemia in late-stage chronic kidney disease patients not on dialysis [1][4]. Company Developments - The company has decided not to initiate the VALOR trial and will not pursue a broad label for Vafseo for non-dialysis dependent chronic kidney disease patients [2]. - Vafseo is currently approved in the U.S. for treating anemia due to chronic kidney disease in adults who have been on dialysis for at least three months, with prescriptions starting in January 2025 [2]. Regulatory Feedback - Akebia completed a Type C meeting with the FDA, which indicated that regulatory alignment for the VALOR trial would necessitate a significantly larger patient population than initially proposed, leading to increased time and costs [3]. - The CEO of Akebia expressed disappointment with the meeting's outcome but stated that the decision not to pursue a broad label is in the best interests of shareholders [4]. Market Reaction - Following the news, Akebia Therapeutics shares fell by 25.71%, trading at $2.29 at the time of publication [4].

Core Insights - XORTX Therapeutics Inc. has entered into a binding term sheet to acquire a Renal Anti-Fibrotic Therapeutic Program from Vectus Biosystems Limited, which includes the novel compound VB4-P5 and associated intellectual property [1][2] - The VB4-P5 program is at the pre-IND stage and aims to address both rare and common forms of kidney disease, which have significant unmet medical needs [1][2] Company Overview - XORTX is focused on developing innovative therapies for gout and progressive kidney disease, with a mission to provide new treatment options for patients suffering from rare renal disorders [2][8] - The company has three clinically advanced products: XRx-026 for gout, XRx-008 for autosomal dominant polycystic kidney disease (ADPKD), and XRx-101 for acute kidney injury related to respiratory virus infections [8] Acquisition Details - The acquisition consideration for Vectus is USD $3.0 million, payable in common shares or equivalents at a deemed issue price of USD $0.86 per Security [2][3] - The closing of the acquisition is expected to occur within 90 days, subject to typical conditions including regulatory approvals [3] Kidney Disease Context - Chronic kidney disease (CKD) affects approximately 14% of adults globally, translating to around 35–37 million individuals in the United States [4] - Kidney fibrosis is a key factor in CKD progression, leading to significant morbidity and mortality, with current treatments primarily focusing on blood pressure control and dietary changes [5] VB4-P5 Program Insights - Early preclinical data suggest that VB4-P5 has the potential to inhibit and possibly reverse kidney fibrosis, with patent protection covering over 30 global jurisdictions [6]

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]

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]

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]

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]