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]

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]

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]

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]

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]

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 ...