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Real-World Evidence Studies of XPHOZAH® (tenapanor) Demonstrate Patient Satisfaction and Reduction in Serum Phosphate with XPHOZAH in Data Presented at ASN Kidney Week
Globenewswire· 2025-11-07 21:05
Core Insights - Ardelyx, Inc. presented data on XPHOZAH at the American Society of Nephrology's Kidney Week, highlighting its effectiveness in real-world settings for patients with chronic kidney disease on dialysis [1][3] Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on developing innovative medicines to address significant unmet medical needs [1][15] - The company has two commercial products approved in the United States: IBSRELA and XPHOZAH, with ongoing development of next-generation therapies [15][16] Product Information - XPHOZAH is the first phosphate absorption inhibitor approved by the FDA for reducing serum phosphorus in adults with chronic kidney disease on dialysis [2][14] - It is administered as a single tablet taken twice daily and works by blocking phosphate absorption in the gut [2][10] Clinical Study Results - The first real-world study of XPHOZAH showed that patients experienced an average reduction in serum phosphate of nearly 1 mg/dL, with 45.3% of participants achieving a reduction of ≥1 mg/dL [3][4] - A separate survey indicated that 63% of patients reported improved phosphate levels since starting tenapanor, with 69% feeling better about their phosphate control [4] Patient Experience - Positive patient experiences were reported, including improved bowel movements and lower pill burden, with 44% attributing improvements to better phosphate control [4] - Tenapanor also demonstrated effectiveness in improving bowel movements in patients with end-stage kidney disease and constipation [6][7] Economic Analysis - A cost-effectiveness analysis in Japan concluded that tenapanor is cost-effective for hemodialysis patients, meeting the threshold of five million Japanese Yen for willingness to pay [8]
Ardelyx to Participate at the Jefferies Global Healthcare Conference in London
Globenewswire· 2025-11-05 13:00
Core Insights - Ardelyx, Inc. is participating in a fireside chat at the Jefferies Global Healthcare Conference in London on November 19, 2025 [1] - The company focuses on discovering, developing, and commercializing innovative medicines to address significant unmet medical needs [3] Company Overview - Ardelyx has two commercial products approved in the United States: IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) [3] - The company is developing RDX10531, a next-generation NHE3 inhibitor with potential applications across multiple therapeutic areas [3] - Ardelyx has international agreements for the commercialization of tenapanor, including partnerships with Kyowa Kirin in Japan and Fosun Pharma in China [3] - Knight Therapeutics is responsible for commercializing IBSRELA in Canada [3]
Ardelyx President and Chief Executive Officer Mike Raab to Participate in the Wedbush Rewind American Society of Nephrology 2025 Investor Conference
Globenewswire· 2025-11-04 13:00
Core Insights - Ardelyx, Inc. is focused on discovering, developing, and commercializing innovative medicines to address significant unmet medical needs [3] Company Overview - Ardelyx has two commercial products approved in the United States: IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) [3] - The company is developing RDX10531, a next-generation NHE3 inhibitor with potential applications across multiple therapeutic areas [3] - Ardelyx has international agreements for the development and commercialization of tenapanor, including partnerships with Kyowa Kirin in Japan and Fosun Pharma in China [3] - Knight Therapeutics is responsible for commercializing IBSRELA in Canada [3] Upcoming Events - The President and CEO of Ardelyx, Mike Raab, will participate in a fireside chat at the Wedbush Rewind ASN 2025 Conference on November 10, 2025 [1] - A public webcast of the event will be available on the Ardelyx website, with a replay accessible for 30 days post-event [2]
Ardelyx Presents Data that Continues to Support the Benefits of IBSRELA® (tenapanor) at the American College of Gastroenterology's 2025 Annual Meeting
Globenewswire· 2025-10-28 12:01
Core Insights - Ardelyx, Inc. presented data on IBSRELA (tenapanor) at the ACG Annual Scientific Meeting, highlighting its effectiveness in treating IBS-C and improving patient quality of life [1][2] Group 1: Treatment Satisfaction and Effectiveness - A real-world survey indicated that 88% of patients reported treatment satisfaction with tenapanor, with 95% experiencing improvements in constipation, 75% in bloating, and 84% in abdominal pain [2] - More than 70% of patients noted enhanced ability to engage in daily activities, with 76% stating tenapanor is superior to other IBS-C medications they have used [2] Group 2: Impact on Abdominal Bloating - Data from Phase 3 T3MPO-1 and T3MPO-2 studies demonstrated that tenapanor effectively reduces abdominal bloating, with significant reductions observable as early as the first week of treatment [3] Group 3: Healthcare System Burden - Preliminary findings from an electronic health record study showed a substantial decrease in GI-related clinical encounters and patient portal messaging after the initiation of tenapanor, suggesting a reduction in healthcare resource utilization [4]
Ardelyx to Report Second Quarter 2025 Financial Results on August 4, 2025
GlobeNewswire News Room· 2025-07-21 12:00
Core Insights - Ardelyx, Inc. is set to hold a conference call on August 4, 2025, to discuss its financial results and provide a business update for Q2 2025 [1] Company Overview - Ardelyx is a biopharmaceutical company focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs [3] - The company has two commercial products approved in the U.S.: IBSRELA® (tenapanor) and XPHOZAH® (tenapanor) [3] - Ardelyx has international agreements for the development and commercialization of tenapanor, including partnerships with Kyowa Kirin in Japan and Fosun Pharma in China [3] - Knight Therapeutics is responsible for commercializing IBSRELA in Canada [3]
Ardelyx Presents Data Supporting IBSRELA® (tenapanor) at Digestive Disease Week 2025 Conference
Globenewswire· 2025-05-06 12:01
Core Insights - Ardelyx, Inc. presented data on IBSRELA (tenapanor) and findings from the IBS in America 2024 Real-World Survey at the Digestive Disease Week Conference, highlighting the correlation between IBS-C symptom severity and financial hardship [1][2] Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on developing innovative medicines to address significant unmet medical needs, with two commercial products approved in the U.S.: IBSRELA and XPHOZAH [13] Product Information - IBSRELA (tenapanor) is approved by the FDA for treating irritable bowel syndrome with constipation (IBS-C) in adults, acting as a sodium/hydrogen exchanger 3 (NHE3) inhibitor to improve intestinal transit and stool consistency [1][6][12] - The drug has shown efficacy in reducing abdominal pain and improving gastrointestinal symptoms in clinical studies [6] Survey Findings - The IBS in America 2024 Real-World Survey revealed that higher severity of IBS-C symptoms is linked to increased financial burden, assessed using the Functional Assessment of Chronic Illness Therapy Measure of Financial Toxicity (FACIT-COST®) [2] - The survey utilized Patient-Reported Outcomes Measurement Information System® (PROMIS®) gastrointestinal symptom scales to evaluate the impact of IBS on patients' quality of life [2] Safety and Tolerability - Interim results from a Phase 3 study indicated that tenapanor was well-tolerated in pediatric patients aged 12 to 18, with diarrhea being the only adverse event related to the drug [3] - A separate pharmacokinetic study found that tenapanor and its major metabolite were not detectable in the breast milk of lactating females after four days of dosing, indicating a favorable safety profile [4] Market Context - IBS-C affects an estimated 12 million people in the U.S., leading to significant economic burden and impaired quality of life, highlighting the need for effective treatments like IBSRELA [7]
Ardelyx Appoints Merdad Parsey, M.D., Ph.D. to its Board of Directors
GlobeNewswire News Room· 2025-04-29 12:00
Core Insights - Ardelyx, Inc. has appointed Merdad Parsey, M.D., Ph.D. to its board of directors, enhancing its leadership team with a veteran biotech expert [1][2] Company Overview - Ardelyx is focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs [4] - The company has two commercial products approved in the U.S.: IBSRELA® (tenapanor) and XPHOZAH® (tenapanor), along with early-stage pipeline candidates [4] - Ardelyx has international agreements for the development and commercialization of tenapanor, including partnerships with Kyowa Kirin in Japan and Fosun Pharma in China [4] Leadership Experience - Dr. Parsey brings over 25 years of experience in the pharmaceutical and biopharma industries, having held various clinical development and leadership roles [2][3] - His recent position was Chief Medical Officer at Gilead Sciences from 2019 until his retirement in 2025 [2] - Dr. Parsey has also served in senior roles at Genentech and as CEO of 3-V Biosciences, contributing to his extensive expertise in clinical strategy and development [2] Educational Background - Dr. Parsey holds a B.S. in microbiology and biochemistry, an M.D., and a Ph.D. in immunology from the University of Maryland [3] - He completed his internal medicine residency at Stanford University and a fellowship in pulmonary and critical care at the University of Colorado [3]