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Ardelyx Announces Changes to the Executive Leadership Team
Globenewswire· 2025-08-04 20:08
Core Insights - Ardelyx, Inc. announced significant changes to its Executive Leadership Team, including the appointment of Edward Conner, M.D. as Chief Medical Officer and John Bishop, Ph.D. as Chief Technical Operations Officer [1][2][3] - Justin Renz, the current Chief Financial and Operations Officer, is expected to transition out of the company, with a commitment to assist during the transition period [4][5] Leadership Changes - Edward Conner, M.D. brings over 20 years of experience in advancing innovative therapies through clinical development and regulatory approval across various therapeutic areas [2] - John Bishop, Ph.D. has over 30 years of experience in leading technical operations, quality assurance, and regulatory activities, reflecting the importance of technical operations in the company's future success [3] - The company has also welcomed other leaders, including Mike Kelliher as Chief Business Officer and Laura Williams as Chief Patient Officer, to enhance its leadership capabilities [4] Company Vision and Future - The leadership changes are part of Ardelyx's strategy to position itself for the next phase of growth, focusing on building a robust pipeline and achieving its vision of creating a healthier tomorrow for patients [4] - Ardelyx has two commercial products approved in the U.S., IBSRELA and XPHOZAH, and has established agreements for the development and commercialization of tenapanor in various international markets [6]
Ardelyx Appoints Mike Kelliher Chief Business Officer and James P. Brady Chief Human Resources Officer
Globenewswire· 2025-06-02 20:05
Core Insights - Ardelyx, Inc. has announced the promotion of Mike Kelliher to Chief Business Officer and the appointment of James P. Brady as Chief Human Resources Officer, indicating a strategic move to enhance leadership for long-term growth and value creation [1][4] Leadership Changes - Mike Kelliher, previously Executive Vice President of Corporate Development and Strategy, will now oversee lifecycle and portfolio management in addition to his existing responsibilities [2] - James P. Brady brings extensive experience in human resources and organizational development, tasked with building and retaining a high-performing team to support Ardelyx's growth [3][5] Executive Backgrounds - Mike Kelliher has a strong background in M&A and business development, having previously served at Horizon Therapeutics and holds a Bachelor of Commerce from University College Cork [4] - James P. Brady has held significant HR roles at companies like Spero Therapeutics and uniQure, and has a Bachelor of Arts from Marietta College and a Master of Theological Studies from Harvard University [5] Company Overview - Ardelyx focuses on discovering, developing, and commercializing innovative medicines to address significant unmet medical needs, with two commercial products approved in the U.S. [6]
Ardelyx to Participate at the Jefferies Global Healthcare Conference 2025
Globenewswire· 2025-05-21 12:00
Company Overview - Ardelyx, Inc. 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 United States: 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] Upcoming Events - Mike Raab, President and CEO of Ardelyx, will participate in a fireside chat at the Jefferies Global Healthcare Conference 2025 on June 4, 2025, at 8:10 am ET in New York [1] - A live webcast of the panel presentation will be accessible on the Ardelyx website, with a replay available for 30 days post-event [2]
Ardelyx Reports First Quarter 2025 Financial Results and Provides Business Update
GlobeNewswire News Room· 2025-05-01 20:01
Financial Performance - Company reported total revenue of $74.1 million for Q1 2025, reflecting a 61% increase year-over-year from $46.0 million in Q1 2024 [9][30] - IBSRELA net product sales revenue was $44.4 million, showing a significant year-over-year growth of approximately 57% from $28.4 million in Q1 2024 [4][9] - XPHOZAH net product sales revenue reached $23.4 million, which is a 54% increase from $15.2 million in Q1 2024 [5][9] - Company ended Q1 2025 with $214.0 million in cash, cash equivalents, and investments, down from $250.1 million at the end of 2024 [7] Strategic Focus - Company aims to accelerate commercial growth for IBSRELA and deepen the adoption of XPHOZAH while building a pipeline of innovative therapies [3] - Management emphasizes maintaining disciplined financial performance to support long-term potential and value creation [3] Corporate Developments - In April 2025, company appointed Merdad Parsey, M.D. Ph.D., to its Board of Directors and Laura A. Williams, M.D., M.P.H., as the first Chief Patient Officer [8] - Company received a $5.0 million milestone payment from Fosun Pharma following the approval of tenapanor in China for hyperphosphatemia [10] Operating Expenses - Research and development expenses for Q1 2025 were $14.9 million, up from $10.6 million in Q1 2024 [14] - Selling, general and administrative expenses increased to $83.2 million from $53.0 million in the same period last year, primarily due to commercialization costs [14] Net Loss - Company reported a net loss of $41.1 million for Q1 2025, compared to a net loss of $26.5 million in Q1 2024 [14][30] - Net loss per share was $(0.17) for Q1 2025, compared to $(0.11) for Q1 2024 [30]
Ardelyx Announces Three Abstracts Accepted for Poster Presentations at Digestive Disease Week 2025 Conference
Globenewswire· 2025-04-24 12:01
WALTHAM, Mass., April 24, 2025 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first- in-class medicines that meet significant unmet medical needs, today announced that the company will present data supporting the company's first-in-class retainagogue, IBSRELA (tenapanor), as well as results from the IBS in America 2024 supplemental survey, at the upcoming Digestive Disease Week Conference (DDW), to be he ...
Ardelyx to Share a Post-Hoc Analysis of the OPTIMIZE Study Supporting XPHOZAH® (tenapanor) at the National Kidney Foundation Spring Clinical Meetings
Globenewswire· 2025-03-31 20:03
Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs [1][12] - The company has two commercial products approved in the United States: IBSRELA and XPHOZAH, both containing the active ingredient tenapanor [12] Product Information - XPHOZAH (tenapanor) is the first and only phosphate absorption inhibitor (PAI) approved by the U.S. FDA for reducing serum phosphorus in adults with chronic kidney disease (CKD) on dialysis [2][11] - It is indicated as add-on therapy for patients who have an inadequate response to phosphate binders or are intolerant to any dose of phosphate binder therapy [11] - XPHOZAH operates through a unique mechanism that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily [2][6] Clinical Study Insights - The OPTIMIZE Study was a randomized, open-label trial involving 330 patients with CKD on dialysis and hyperphosphatemia, aimed at evaluating methods for initiating XPHOZAH to optimize phosphorus management [3] - A post-hoc analysis of this study has been accepted for presentation at the National Kidney Foundation Spring Clinical Meetings [1][4] Safety and Efficacy - Diarrhea was the most common side effect reported in clinical trials, occurring in 43-53% of patients, with severe diarrhea reported in 5% of patients [10] - The majority of diarrhea events were mild-to-moderate and typically resolved over time or with dose reduction [10] Industry Context - Hyperphosphatemia is a serious condition affecting the majority of the 550,000 patients in the U.S. with CKD on maintenance dialysis, necessitating effective management strategies [7] - The KDIGO treatment guidelines recommend lowering elevated phosphate levels toward the normal range of 2.5-4.5 mg/dL [7]