Duyuru • May 04
Ardelyx, Inc., Annual General Meeting, Jun 16, 2026 Ardelyx, Inc., Annual General Meeting, Jun 16, 2026. Duyuru • Apr 20
Ardelyx, Inc. Announces Executive Changes Ardelyx, Inc. announced the appointment of Felecia W. Ettenberg, a seasoned leader with more than 25 years of legal experience in the biopharmaceutical industry, as Chief Legal Officer (CLO). She will oversee Ardelyx’s legal, compliance, regulatory, and government affairs operations. Ms. Ettenberg succeeds Elizabeth Grammer, who has chosen to retire after a 16-year career at the company. Prior to joining Ardelyx, Ms. Ettenberg enjoyed a nearly 25-year career at Bristol Myers Squibb, where she held a series of senior leadership roles spanning legal, regulatory, compliance, litigation, and commercialization. In her most recent role, Senior Vice President and Deputy General Counsel, Ms. Ettenberg led legal support across the organization, advised C-suite executives, built and directed diverse, global teams, facilitated creative risk-mitigation, and drove operational excellence across the U.S. and more than 40 international markets. Prior to BMS, she practiced law at Goodwin Procter LLP and Heidell, Pittoni, Murphy & Bach, P.C., focusing on pharmaceutical litigation. Ms. Ettenberg earned a Bachelor of Arts from Cornell University magna cum laude and a Juris Doctor from Boston University School of Law. She has also completed specialized programming at The Wharton School, University of Pennsylvania, and Columbia University. Duyuru • Apr 17
Ardelyx, Inc. to Report Q1, 2026 Results on Apr 30, 2026 Ardelyx, Inc. announced that they will report Q1, 2026 results on Apr 30, 2026 Duyuru • Apr 01
Ardelyx, Inc. Appoints Rajani Dinavahi, MD, as Chief Medical Officer, Effective April 1, 2026 Ardelyx, Inc. announced the appointment of Rajani Dinavahi, MD, as Chief Medical Officer effective April 1, 2026. Dr. Dinavahi brings more than two decades of experience in healthcare and biotechnology, spanning multiple therapeutic areas and modalities. She has extensive experience across immuno-oncology, autoimmune diseases, metabolic disease, nephrology and transplantation, with a track record of advancing programs from early development through Phase 3 and regulatory approval. Dr. Dinavahi most recently served as Senior Vice President, Chief Medical Officer at Atara Biotherapeutics. As Chief Medical Officer at Atara Biotherapeutics, Dr. Dinavahi’s responsibilities spanned leading pre-clinical and translational sciences through global development and medical affairs of their lead T-cell directed therapy asset and allo-CART program. Prior to becoming CMO, Dr. Dinavahi held senior leadership positions at Atara across clinical sciences, program team leadership and medical affairs, where she built and led global teams to deliver on the first allogeneic T-cell therapy to be approved and launched globally. Earlier, she spent seven years at Amgen, contributing to multiple global development programs and regulatory filings for products approved across the U.S., Europe and Japan. Dr. Dinavahi began her career in academic medicine as an Assistant Professor of Medicine (Nephrology) at Mount Sinai School of Medicine and a principal investigator in transplant research. She is board-certified in Internal Medicine and Nephrology, a Fellow of the American Society of Nephrology, and has authored numerous scientific publications and presentations. She earned a Bachelor of Science and Doctor of Medicine from the University of Miami and completed her Internal Medicine residency and Nephrology fellowship training at Thomas Jefferson University Hospital, followed by a clinical transplant and post-doctoral fellowship focusing on translational immunology at Mount Sinai Hospital in New York City. Duyuru • Mar 10
Ardelyx, Inc. Announces Rapid And Meaningful Symptom Relief With Tenapanor In IBS-C Ardelyx, Inc. announced the publication of data from its IBS-C clinical development program, “Tenapanor is associated with earlier and sustained symptom relief in IBS-C: a post hoc analysis” in Therapeutic Advances in Gastroenterology, an international, peer-reviewed, open-access journal focused on advancing clinical practice and research in digestive diseases. Tenapanor, branded as IBSRELA (tenapanor), is a first-in-class retainagogue that is approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation (IBS-C) in adults. The post-hoc analysis consisting of pooled data from three clinical trials (one Phase 2b and two Phase 3 studies), supports that tenapanor provides both rapid and sustained relief for adults living with IBS-C, a chronic condition that can disrupt daily life. Patients taking tenapanor reported improvements in bowel movement frequency as early as two weeks, and meaningful relief from abdominal symptoms including pain, discomfort, and bloating within 4–5 weeks. Continued therapy through 12 weeks increased the likelihood of reporting meaningful symptom improvement and maintenance of benefits across multiple symptoms, highlighting the importance of patients remaining on therapy for an adequate amount of time to fully evaluate their individual benefit potential. This research shows that tenapanor delivers a sustained response for some adults with IBS-C, providing both a clear view of symptom improvement and practical insights for clinicians. The analysis demonstrates “sustained response,” defined as improvement maintained over consecutive weeks, may be achieved by some patients and supports that patients who continued therapy were more likely to achieve meaningful improvements across both bowel and abdominal symptoms. There were no new or unexpected safety findings in this post-hoc analysis, and tenapanor was generally well tolerated, with transient, mild-to-moderate diarrhea as the most common adverse event. These findings offer actionable guidance for healthcare providers, helping them tailor treatment plans, educate patients on symptom response over time, and set realistic expectations. Duyuru • Feb 20
Ardelyx, Inc. Provides Revenue Guidance for Full Year 2026 Ardelyx, Inc. provided revenue guidance for full year 2026. Ardelyx expects full-year 2026 revenue for IBSRELA to be between $410 and $430 million, representing at least 50% growth compared to 2025. Ardelyx expects full-year 2026 XPHOZAH revenue to be between $110 and $120 million. Duyuru • Feb 05
Ardelyx, Inc. to Report Q4, 2025 Results on Feb 19, 2026 Ardelyx, Inc. announced that they will report Q4, 2025 results on Feb 19, 2026 Duyuru • Jan 28
Ardelyx, Inc. Announces First Patient Dosed in ACCEL: Phase 3 Chronic Idiopathic Constipation Study of IBSRELA Ardelyx, Inc. announced that the first patient has been dosed in ACCEL (ten-03-301), a Phase 3 clinical trial designed to assess the safety and efficacy of IBSRELA®? (tenapanor) for the treatment of chronic idiopathic constipation (CIC) in adults. ACCEL is a multicenter, randomized, double-blind, placebo-controlled study to assess the safety and efficacy the safety and efficacy of tenapanor for the treatment of CIC in adults when administered twice daily for 26 consecutive weeks. The Phase 3 clinical trial is designed to enroll approximately 700 patients with CIC. The primary endpoint will evaluate patient-reported outcomes in constipation. Enrollment in ACCEL is expected throughout 2026, with topline data read out in the second half of 2027. The Phase 3 ACCEL clinical trial represents important progress in Ardelyx's goal of expanding the patient population who may benefit from IBSRELA, beyond its lead indication for irritable bowel syndrome with constipation, which demonstrated safety, efficacy and tolerability in a comprehensive clinical development plan. CIC is characterized by difficult, infrequent or incomplete bowel movements, and is associated with significantly impaired quality of life, disrupted productivity and high healthcare-related costs. CIC is estimated to affect more than 34 million Americans. IBSRELA is contraindicated in patients less than 6 years of age; in nonclinical studies in young juvenile rats administration of tenapanor caused deaths consumed to be due to dehydration. Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRE LA in patients 6 years to less more than 12 years of age. While there are no data in older adult rats, given the deaths in younger rats and the lack of clinical Safety and efficacy data iniatric patients, avoid the use ofIBSRELA in patients 6 months to less than 12 years of years of age. Although there is no data in older juvenile rats, given the deaths in older rats and the lack of clinical safe and efficacy data in pediatric patients., avoid the use of IBS RELA in patients 6 years toless than 12 years of age. Duyuru • Jan 23
Zydus Lifesciences Reportedly Eyes Acquisition of Ardelyx for $2.5 Billion Zydus Lifesciences Limited (NSEI:ZYDUSLIFE) is evaluating acquisition of a majority stake in US-based Ardelyx, Inc. (NasdaqGM:ARDX), with the deal likely to be valued at $2.2 billion-$2.5 billion, two people aware of the development told Mint. The proposed transaction would be funded through a INR 50,000 million equity raise via a qualified institutional placement (QIP) and internal cash accruals, the people said. If concluded, the deal would significantly accelerate Zydus's push into global innovative medicine, an avenue that is attracting growing interest from Indian drugmakers. Ardelyx is a biopharmaceutical firm working on first-in-class small-molecule drugs and commercializing novel medicines with a focus mainly on gastrointestinal (GI) and cardio-renal diseases, where there are significant unmet patient needs. The company's market capitalization as of 20 January on Nasdaq is $1.7 billion. It reported a revenue of $378 million in 2025, up 18%. Emailed queries sent to Zydus Lifesciences and Ardelyx remained unanswered until press time. Duyuru • Dec 19
Ardelyx, Inc. Announces Executive Changes Ardelyx, Inc. announced that on December 17, 2025, Elizabeth Grammer informed Ardelyx, Inc. of her resignation as the Company’s Chief Legal and Administrative Officer, effective December 31, 2025 . In connection with Ms. Grammer’s resignation from her executive role with the Company, on December 17, 2025, the Company and Ms. Grammer entered into a Transition and Separation Agreement (the “Agreement”), pursuant to which Ms. Grammer is expected to continue to serve in the non-executive officer position of General Counsel until a successor is appointed, after which Ms. Grammer will serve as a Senior Advisor to the Company for a period of twenty-four (24) months (the “Advisory Period”). Under the Agreement, for so long as Ms. Grammer serves as the Company’s General Counsel, and thereafter, for the first twelve (12) months of the Advisory Period (the “Employment Period”), (i) Ms. Grammer will continue to be employed by the Company and receive her base salary as in effect immediately prior to the Resignation Date (the “Base Salary”), (ii) she will be eligible to receive her annual target bonus of 45% of her Base Salary for the year ending December 31, 2025, but will not be eligible for any ongoing bonus opportunity during her service as a Senior Advisor, and (iii) she will continue to receive benefits consistent with those provided to other senior non-executives. At the end of the Employment Period, if Ms. Grammer provides the Company a general release of claims, she will be paid an amount equal to one month of her annual base salary as in effect prior to the Resignation Date. Edward Conner, M.D. has notified the Company of his decision to resign as Chief Medical Officer of the Company, effective December 31, 2025. Dr. Conner resigned for personal reasons, and his resignation is not a result of any disagreement with the Company. Dr. Laura Williams, the Company’s Chief Patient Officer and former Chief Medical Officer, will serve as interim Chief Medical Officer, assuming key responsibilities, including strategic guidance for the Company’s clinical development programs, until a new Chief Medical Officer is hired. Duyuru • Nov 08
Ardelyx, Inc. Presents Data, Including Results from the First Real-World Study of Xphozah Ardelyx, Inc. announced that the company presented data, including results from the first real-world study of XPHOZAH, at American Society of Nephrology's Kidney Week, currently underway in Houston. XPHOZAH is the first and only phosphate absorption inhibitor (PAI) approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binders or who are tolerant of any dose of phosphate absorption. XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily. Duyuru • Nov 04
Ardelyx, Inc. has filed a Follow-on Equity Offering in the amount of $100 million. Ardelyx, Inc. has filed a Follow-on Equity Offering in the amount of $100 million.
Security Name: Common Stock
Security Type: Common Stock
Transaction Features: At the Market Offering Duyuru • Oct 28
Ardelyx, Inc. Presents Data Supporting First-in-Class Retainagogue, IBSRELA at the American College of Gastroenterology's 2025 Annual Meeting Ardelyx, Inc. announced that the company presented data supporting the company's first-in-class retainagogue, IBSRELA®? (tenapanor) at the American College of Gastroenterology's (ACG) Annual Scientific Meeting, now underway in Phoenix. IBSRELA is approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation (IBS-C) in adults. Results from these data build on the established efficacy, safety and tolerability profile of IBS-C and highlight the continued value in helping patients manage the burden of IBS-C. The survey was conducted to assess treatment satisfaction, IBS-C symptom resolution and improvement in quality of life. Overall, the findings support the effectiveness of tenapanor in the management of IBS-C, with a majority of patients reporting treatment satisfaction (88%) and improvements in constipation (95%), bloating (75%), and abdominal pain (84%). Overall, 76% of participants expressed that tenapanor is better than other IBS-C medications they have used. Duyuru • Oct 15
Ardelyx, Inc. Appoints Sue Hohenleitner as Principal Financial Officer, Effective November 4, 2025 On October 13, 2025, the board of directors of Ardelyx, Inc. appointed Sue Hohenleitner as principal financial officer, effective November 4, 2025. Ms. Hohenleitner, age 55, worked at Johnson & Johnson (“J&J”), a publicly traded pharmaceutical, biotechnology, and medical technologies company, in various senior accounting and finance roles prior to joining the Company. Most recently, since August 2022, Ms. Hohenleitner served as the Vice President and Chief Financial Officer of Johnson & Johnson (J&J) Innovative Medicine North America (NA), leading financial strategies for a $36 billion commercial business, and from April 2019 to August 2022, Ms. Hohenleitner served as Vice President of Finance at J&J Innovation. From May 2018 to April 2019, Ms. Hohenleitner was Vice President of Finance, Acquisition and Divestiture Operations at J&J. From December 2015 to May 2018, Ms. Hohenleitner served as Vice President of Finance, J&J Supply Chain Deliver. Ms. Hohenleitner is a Certified Public Accountant in the Commonwealth of Pennsylvania and a Certified Management Accountant. She earned a Bachelor of Science in Accounting from La Salle University and a Master of Business Administration from Villanova. Duyuru • Jul 21
Ardelyx, Inc. to Report Q2, 2025 Results on Aug 04, 2025 Ardelyx, Inc. announced that they will report Q2, 2025 results on Aug 04, 2025 Duyuru • Jun 04
Ardelyx, Inc. Announces Executive Appointments Ardelyx, Inc. announced that Mike Kelliher, formerly Executive Vice President, Corporate Development and Strategy, has been promoted to Chief Business Officer, and James P. Brady has joined the company as Chief Human Resources Officer. Since joining Ardelyx in March 2024, Mr. Kelliher has established himself as important leader driving Ardelyx’s long-term growth and value creation strategies. In his newly expanded role as Chief Business Officer, Mr. Kelliher will be responsible for lifecycle and portfolio management, in addition to his previous responsibilities for business development and corporate strategy. Mr. Brady is a purpose-driven human resources executive with a proven track record of building organizations, leaders and teams in transformational life science and digital innovation technologies. Mr. Brady will be responsible for HR strategy and processes related to building and retaining a high performing team that can effectively support Ardelyx’s continued growth. Prior to joining Ardelyx, Mr. Kelliher served as Group Vice President, M&A and Business Development, at Horizon Therapeutics. Mr. Kelliher joined Horizon in 2014 and held roles of increasing responsibility on the team that led a successful growth and expansion agenda through acquisitions, development collaborations and other transactions, including the acquisition of Horizon by Amgen. Before his time at Horizon, from 2009 to 2014, Mr. Kelliher held financial roles at Elan Corporation (now Perrigo Company) and began his career in banking, public accounting and corporate finance. Mr. Kelliher currently serves on the board of directors of Capricor Therapeutics. Mr. Kelliher earned a Bachelor of Commerce from the University College Cork (Ireland) and is an Associated Chartered Accountant. Mr. Brady has extensive human resources and organizational and talent development experience. Most recently, Mr. Brady served as Chief Human Resources Officer at Spero Therapeutics. While at Spero, Mr. Brady oversaw all aspects of the human resources function and was instrumental in implementing the company’s hybrid work model and earning the company a Best Places to Work recognition by the Boston Business Journal. Prior to Spero, Mr. Brady held the role of Chief Human Resources Officer at uniQure, as well as roles of increasing responsibility at Intarcia Therapeutics, Genzyme Corporation, and Thomson Financial. Mr. Brady earned a Bachelor of Arts in history from Marietta College and a Master of Theological Studies from Harvard University. Duyuru • May 06
Ardelyx, Inc. Presents Data Supporting IBSRELA (tenapanor) At Digestive Disease Week 2025 Conference Ardelyx, Inc. announced that the company presented 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 Digestive Disease Week Conference (DDW), now underway in San Diego. IBSRELA is approved by the U.S. Food and Drug Administration to treat irritable bowel syndrome with constipation (IBS-C) in adults. IBSRELA (tenapanor) is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. By inhibiting NHE3 on the apical surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, thus retaining luminal water content, which accelerates intestinal transit time and results in a softer stool consistency. IBSRELA has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models. In a rat model of colonic hypersensitivity, tenapanor reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability. Irritable bowel syndrome with constipation (IBS-C) is a gastrointestinal disorder characterized by both abdominal pain and altered bowel movements, estimated to affect 12 million people in the U.S. IBS-C is associated with significantly impaired quality of life, reduced productivity, and substantial economic burden. Duyuru • May 01
Ardelyx, Inc., Annual General Meeting, Jun 18, 2025 Ardelyx, Inc., Annual General Meeting, Jun 18, 2025. Duyuru • Apr 30
Ardelyx, Inc. Appoints Merdad Parsey to Its Board of Directors, Effective April 28, 2025 On April 28, 2025, the Company appointed Merdad Parsey, M.D., Ph.D, as a member of the Board of Directors (the “Board”) of Ardelyx, Inc., a Delaware corporation (the “Company”), effective immediately, to serve as a Class I director until the Company’s 2027 Annual Meeting of Stockholders and until his successor is duly elected and qualified, or until his earlier death, resignation or removal. Following Dr. Parsey’s appointment, the Class I directors will consist of William Bertrand, Jr., Esq., Onaiza Cadoret-Manier and Dr. Parsey. Dr. Parsey was also appointed to serve as a member of the Nominating and Corporate Governance Committee of the Board effective June 18, 2025. Following Dr. Parsey’s appointment, the Nominating and Corporate Governance Committee will consist of William Bertrand, Jr., Esq., as chairman, Onaiza Cadoret-Manier and Dr. Parsey. Dr. Parsey brings more than 25 years of experience in the pharmaceutical and biopharma industries in a variety of clinical development and leadership roles. Most recently, Dr. Parsey served as the chief medical officer at Gilead Sciences, Inc. from 2019 until his retirement in 2025. Prior to Gilead, from 2015 to 2019, Dr. Parsey served as senior vice president of early clinical development at Genentech, Inc. From 2010 to 2015, Dr. Parsey served as the chief executive officer of 3-V Biosciences (now Sagimet Biosciences). Earlier in his career, Dr. Parsey held roles of increasing responsibility in the field of clinical development at companies including Sepracor, Regeneron and Merck. Dr. Parsey currently serves on the board of directors of Sagimet Biosciences Inc. and ArriVent Biopharma, Inc. Dr. Parsey received his B.S. in microbiology and biochemistry at the University of Maryland and his M.D. and Ph.D. in immunology at the University of Maryland at Baltimore. He completed his internal medicine residency at Stanford University and his pulmonary and critical care fellowship at the University of Colorado. Dr. Parsey was Assistant Professor of Medicine and Director of Critical Care Medicine at the NYU School of Medicine. Duyuru • Apr 17
Ardelyx, Inc. to Report Q1, 2025 Results on May 01, 2025 Ardelyx, Inc. announced that they will report Q1, 2025 results on May 01, 2025 Duyuru • Apr 11
Ardelyx, Inc. to Present Post-Hoc Analysis of the Optimize Study Supporting XPHOZAH®? (Tenapanor) Ardelyx, Inc. announced that the company will present a post-hoc analysis of the OPTIMIZE Study, an open-label clinical trial of XPHOZAH®? (tenapanor), as a poster at the National Kidney Foundation (NKF) Spring Clinical Meetings, now underway in Boston. Ardelyx is also hosting an Exhibitor Showcase discussing hyperphosphatemia management. XPHOZAH is the first and only phosphate absorption inhibitor (PAI) approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily. OPTIMIZE was a randomized, open label study which included 330 patients with chronic kidney disease (C KD) on dialysis with hyperphosphatemia. The study was designed to evaluate different methods of optimizing phosphorus management with XPHOZAH in both binder-naive and binder-treated patients.oster #G-310, entitled "Tenapanor-Treated Patients Using Over-the-Counter Antidiarrheal Agents Saw Decreased Stool Frequency and Improved Stool Consistency," is a post hoc analysis of the OPTIMIZE study and evaluated discontinuation rates and changes in stool frequency and consistency in patients receiving tenapanor who self-medicated with the over-the-counter antidiarrheal agent loperamide. The analysis found that among the 40% of patients with reported diarrhea, 9.7% of patients that were also using loperamide discontinued tenapanor due to diarrhea compared to 24.6% of patients not using loperamide. In conclusion, loperamide was identified as a treatment option to improve diarrhea emergent with tenapanor treatment. In addition to the poster presentation during NKF Spring Clinical Meetings, Ardelyx is sponsoring an Exhibitor Showcase titled: "A Different Perspective on Hyperphosphatemia Management: Evaluating Current Strategies" on April 11, 2025, from 12:00-12:35 PM EDT, where Dr. Vincent Carsillo, will discuss first-in-class PAI, XPHOZAH. The presentation will review the XPHOZAH mechanism of action, efficacy and safety data from the Phase 3 clinical trial program and will include a discussion about the clinical application of XPHOZAH as add-on therapy for the many dialysis patients on a phosphate binder with serum phosphorus levels above guideline-established targets. XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH are a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Please see additional full Prescribing Information. Hyperphosphatemia is a serious condition, defined as elevated levels of phosphate in the blood, which affects the vast majority of the 550,000 patients in the United States with chronic kidney disease (CkD) on maintenance dialysis. Duyuru • Feb 26
Ardelyx, Inc. Announces Approval of A New Drug Application for Tenapano Ardelyx, Inc. announced the approval of a New Drug Application (NDA) by China’s Center for Drug Evaluation of the National Medical Products Administration for tenapanor to control serum phosphorus levels in dialysis patients with chronic kidney disease (CKD) who have an inadequate response or are intolerant to phosphorus binders. This approval triggers a $5 million milestone payment to Ardelyx under the terms of the license agreement between Ardelyx and its collaboration partner in China, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. (Fosun Pharma). Under the terms of its agreement, Ardelyx is eligible to receive additional developmental and commercialization milestones of up to $100 million and tiered royalty payments on net sales ranging from the mid-teens to 20%. Data indicate that at the end of 2023, there were more than one million patients on maintenance hemodialysis in China, with an annual growth rate of approximately 12%. Among these patients, 76% have hyperphosphatemia, and the rate of achieving target phosphate levels is only 39% (according to China’s hemodialysis quality control standards: serum phosphate 1.13–1.78 mmol/L). If the target range for serum phosphate is set at 0.87–1.45 mmol/L, as stipulated by the Chinese guidelines for the diagnosis and treatment of Chronic Kidney Disease Mineral and Bone Disorder, the achievement rate decreases to 26.7%. The NDA in China was supported by data from two studies undertaken by Fosun Pharma, a single pharmacokinetic study and a single pivotal trial in patients with CKD on dialysis, in addition to Ardelyx clinical studies. Fosun Pharma has the exclusive rights to market and sell tenapanor in China, Hong Kong and Macau. Tenapanor will be marketed with the Chinese trade name Wan Ti Le. Duyuru • Jan 31
Ardelyx, Inc. to Report Q4, 2024 Results on Feb 20, 2025 Ardelyx, Inc. announced that they will report Q4, 2024 results on Feb 20, 2025 Duyuru • Oct 17
Ardelyx, Inc. to Report Q3, 2024 Results on Oct 31, 2024 Ardelyx, Inc. announced that they will report Q3, 2024 results on Oct 31, 2024 Duyuru • Oct 16
Ardelyx, Inc. to Present Additional Data Supporting First-In-Class XPHOZAH (tenapanor) for Adults with Chronic Kidney Disease on Dialysis at the American Society of Nephrology's Kidney Week Ardelyx, Inc. announced that additional data supporting XPHOZAH (tenapanor) will be presented at the American Society of Nephrology's (ASN) Kidney Week, to be held October 24-27, 2024, in San Diego. XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily. In addition to the poster presentations during ASN Kidney Week, Ardelyx is sponsoring an Exhibitor Spotlight titled: “A Different Perspective on Hyperphosphatemia Management: Evaluating Current Strategies,” on October 25, 2024, from 11:00 – 11:45 AM PDT, where Steven Fishbane, MD, will discuss first-in-class PAI, XPHOZAH. The presentation will review the XPHOZAH mechanism of action, efficacy and safety data from the Phase 3 clinical trial program and will include a discussion about the clinical application of XPHOZAH as add-on therapy for the many dialysis patients on a phosphate binder with serum phosphorus levels above guideline-established targets. XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Hyperphosphatemia is a serious condition, defined as elevated levels of phosphate in the blood, which affects the vast majority of the 550,000 patients in the United States with chronic kidney disease (CKD) on maintenance dialysis. The kidneys are responsible for eliminating excess phosphate and as kidney function declines, phosphate is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on maintenance dialysis, with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL). Duyuru • Oct 09
Ardelyx, Inc. Announces Publication of A Review Article Exploring the Patient Burden and Therapeutic Landscape of IBS-C in the U.S. in Clinical and Experimental Gastroenterology Ardelyx, Inc. announced the recent publication of a review article, titled “Review of the Patient Burden and Therapeutic Landscape of Irritable Bowel Syndrome With Constipation in the United States” in Clinical and Experimental Gastroenterology, an international, peer reviewed, open access journal focusing on all aspects of gastroenterology research, as well as clinical results in human, animal and in vitro studies that shed light on disease processes and potential new therapies. The article provides an overview of treatment options and disease management for irritable bowel syndrome with constipation (IBS-C) from a U.S. perspective and discusses the importance of the relationship between patient and health care provider in diagnosis and treatment. It recommends a positive diagnostic strategy for IBS-C, based on clinical history, physical examination, and minimal laboratory tests. The authors review the substantial societal burden in terms of health care costs, opportunity costs and decreased quality of life that comes with IBS-C. The article also reviews the treatment journey a patient with IBS-C may experience, beginning with lifestyle interventions and nonpharmacologic options, with progression to a U.S. FDA-approved therapy. IBSRELA® (tenapanor) is identified as one of the currently approved therapies, with data from the T3MPO-1 and T3MPO-2 studies included within the review. IBSRELA is a first-in-class treatment for IBS-C in adults that is approved by the U.S. Food and Drug Administration. Duyuru • Aug 19
Robbins LLP Informs Ardelyx, Inc. Stockholders of the Class Action Robbins LLP informed investors that a shareholder filed a class action on behalf of all persons and entities that purchased or otherwise acquired Ardelyx, Inc. securities between October 31, 2023 and July 1, 2024. Ardelyx is a biotechnology company focused on developing and commercializing therapies for, among other things, patients with chronic kidney disease (“CKD”). According to the complaint, during the class period, in its Forms 10-Q filed on October 31, 2023, and May 2, 2024, and in its Form 10-K filed on February 22, 2024, Ardelyx indicated that it would apply to include XPHOZAH (its drug that reduces elevated levels of phosphorus in the bloodstream in CKD patients on dialysis who either cannot tolerate or did not adequately respond to other therapies) in TDAPA. Further, on an earnings call on May 2, 2024, defendant Michael Raab advised analysts that "our intent is to enter TDAPA." On July 2, 2024, Ardelyx issued a press release announcing that it had chosen not to apply to include XPHOZAH in TDAPA. Duyuru • Aug 08
Ardelyx, Inc. Appoints Eric Foster as Chief Commercial Officer Ardelyx, Inc. announced the appointment of Eric Foster as the company’s Chief Commercial Officer. Mr. Foster is an experienced leader with more than 23 years of commercial experience for significant global biotech and pharmaceutical companies across numerous complex rare disease and specialty markets. Mr. Foster will be responsible for leading all commercial strategies for the company’s two first-in-class medicines, IBSRELA® (tenapanor) and XPHOZAH® (tenapanor), as well as supporting the development and launch of future commercial products. Most recently, Mr. Foster served as Senior Vice President and U.S. General Manager at Amgen following the acquisition of Horizon Therapeutics in October 2023 where he served as Senior Vice President and General Manager of the Gout and Ophthalmology Business Units. While at Horizon, Mr. Foster established a new market strategy and transformed the pricing and access strategies, creating customer stability and record growth. Prior to his time at Horizon Therapeutics, from 2010 to 2021, Mr. Foster held roles of increasing responsibility within the sales and marketing organization at GlaxoSmithKline across a variety of immunology and rare disease products, including serving as Vice President of Immunology Marketing, Senior Global Marketing Director and Field Sales Vice President. Mr. Foster began his career in sales and market access at Johnson & Johnson. Mr. Foster holds a Bachelor of Arts in Economics degree from the University of Georgia and a Master of Business Administration from Auburn University. Duyuru • Jul 31
Ardelyx, Inc. Announces Publication of Two Plain Language Summaries from XPHOZAH®? (tenapanor) Clinical Trials in Current Medical Research and Opinion Ardelyx, Inc. announced the publication of plain language summaries of results from two clinical trials on XPHOZAH®? (tenapanor), NORMALIZE and OPTIMIZE, in Current Medical Research and Opinion. The plain language summaries were developed by the authors to help adult patients with chronic kidney disease receiving dialysis, and their family members and caregivers, better understand some of the safety and efficacy data related to XPHOZAH. XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action, blocking phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily. Current Medical Research and Opinion is an international journal that publishes research focused on new and existing drugs and therapies, best practices in patient care, developments in diagnostic medicine and medical technology, and innovations in medical and scientific publishing. XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Patients completing the Phase 3 PHREEDOM trial from both the XPHOZAH arm and the sevelamer safety control arm had the option to participate in NORMALIZE, an open-label 18-month extension study. Patients entering the study from the XPHOZAH arm with serum phosphate levels in the normal range were followed with no medication changes. Patients entering the study from the XPHOZAH arm with serum phosphate greater than 4.5 mg/dL had sevelamer tablets added incrementally to achieve normal serum phosphate levels. Patients entering the study from the sevelamer safety control arm had XPHOZAH tablets added to their treatment regimen while reducing sevelamer tablets based on their serum phosphate value to achieve normal serum phosphate levels. The primary objective of the study was to evaluate the ability of XPHOZAH alone or in combination with sevelamer to achieve serum phosphate levels within the normal range (2.5 to 4.5 mg/dL) in patients with CKD on maintenance dialysis whose serum phosphate levels were greater than 6.0 mg/dL at baseline. OPTIMIZE was a randomized, open label study, which included 330 patients with chronic kidney disease (CKD) on dialysis with hyperphosphatemia. The study was designed to evaluate different methods of initiating XPHOZAH to optimize phosphorus management in both binder-naïve and binder-treated patients. The objective was to evaluate the ability of XPHOZAH, with its novel blocking mechanism, administered as core therapy for the treatment of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis, alone or in combination with phosphate binders, to achieve target serum phosphorus (s-P) levels =5.5 mg/dL. The study enrolled patients with s-P >5.5 and =10.0 mg/dL during stable phosphate binder treatment which were randomized in a 1:1 ratio to two different treatment cohorts, as well as patients who were phosphate binder naïve with s-P >4.5 and =10.0 mg/dL in a third cohort. Hyperphosphatemia is a serious condition, defined as elevated levels of phosphate in the blood, which affects the vast majority of the 550,000 patients in the United States with chronic kidney disease (CKD) on maintenance dialysis. The kidneys are responsible for eliminating excess phosphate and as kidney function declines, phosphate is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on maintenance dialysis, with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL). Duyuru • Jul 18
Ardelyx, Inc. to Report Q2, 2024 Results on Aug 01, 2024 Ardelyx, Inc. announced that they will report Q2, 2024 results on Aug 01, 2024 Duyuru • Jul 02
Ardelyx, Inc. Chooses Not to File for TDAPA to Preserve Patient Access to XPHOZAH Ardelyx, Inc. announced that, in an effort to preserve patient access to its phosphate absorption inhibitor XPHOZAH (tenapanor), the Company has chosen not to apply to include XPHOZAH in the Centers for Medicare & Medicaid Services (CMS) End-Stage Renal Disease (ESRD) Prospective Payment System (PPS) Transitional Drug Add-on Payment Adjustment (TDAPA). Ardelyx’s analysis of the CMS policy to include oral-only medicines in the PPS and the Calendar Year 2025 ESRD PPS Proposed Rule released on June 27, 2024, revealed that the policy and the manner in which CMS intends to implement it are likely to cause significant restrictions on the use of XPHOZAH for all patients, irrespective of insurance coverage, because it interferes with the essential and appropriate shared decision-making between healthcare professionals and their patients. XPHOZAH was approved by the U.S. Food and Drug Administration in October 2023 to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. 80% of patients with CKD on dialysis require prescription therapy to lower elevated levels of serum phosphorus. Phosphate binders are not sufficient for a majority of patients to achieve and maintain phosphorus levels within target range. XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway. Duyuru • May 25
Ardelyx, Inc. Announces Rodriguez Would Resign as Chief Commercial Officer On May 22, 2024, Susan Rodriguez and Ardelyx, Inc. mutually determined that Ms. Rodriguez would resign as the Company’s Chief Commercial Officer. To support the transition, Ms. Rodriguez will remain in an advisory role to the Company through the end of 2024. Recent Insider Transactions • May 25
President recently sold US$246k worth of stock On the 21st of May, Michael Raab sold around 31k shares on-market at roughly US$7.81 per share. This transaction amounted to 2.4% of their direct individual holding at the time of the trade. In the last 3 months, there was an even bigger sale from another insider worth US$782k. Michael has been a net seller over the last 12 months, reducing personal holdings by US$537k. Recent Insider Transactions • May 12
Insider recently sold US$782k worth of stock On the 6th of May, Robert Felsch sold around 89k shares on-market at roughly US$8.80 per share. This transaction amounted to 48% of their direct individual holding at the time of the trade. This was the largest sale by an insider in the last 3 months. Insiders have been net sellers, collectively disposing of US$2.5m more than they bought in the last 12 months. Major Estimate Revision • May 09
Consensus revenue estimates increase by 18% The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$208.8m to US$245.7m. EPS estimate unchanged from -US$0.34 at last update. Biotechs industry in the US expected to see average net income decline 9.8% next year. Consensus price target of US$13.83 unchanged from last update. Share price rose 28% to US$8.48 over the past week. Recent Insider Transactions Derivative • May 06
Insider notifies of intention to sell stock Elizabeth Grammer intends to sell 45k shares in the next 90 days after lodging an Intent To Sell Form on the 3rd of May. If the sale is conducted around the recent share price of US$9.00, it would amount to US$405k. Since June 2023, Elizabeth's direct individual holding has decreased from 333.42k shares to 312.99k. Company insiders have collectively sold US$1.7m more than they bought, via options and on-market transactions in the last 12 months. Reported Earnings • May 03
First quarter 2024 earnings: EPS and revenues exceed analyst expectations First quarter 2024 results: US$0.11 loss per share (improved from US$0.13 loss in 1Q 2023). Revenue: US$46.0m (up 305% from 1Q 2023). Net loss: US$26.5m (loss narrowed 1.0% from 1Q 2023). Revenue exceeded analyst estimates by 26%. Earnings per share (EPS) also surpassed analyst estimates by 26%. Revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 18% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 60% per year but the company’s share price has only increased by 9% per year, which means it is significantly lagging earnings growth. Breakeven Date Change • May 03
Forecast breakeven date pushed back to 2026 The 9 analysts covering Ardelyx previously expected the company to break even in 2025. New consensus forecast suggests losses will reduce by 61% per year to 2025. The company is expected to make a profit of US$138.0m in 2026. Average annual earnings growth of 63% is required to achieve expected profit on schedule. Recent Insider Transactions Derivative • May 01
President notifies of intention to sell stock Michael Raab intends to sell 30k shares in the next 90 days after lodging an Intent To Sell Form on the 29th of April. If the sale is conducted around the recent share price of US$6.40, it would amount to US$192k. For the year to December 2017, Michael's total compensation was 33% salary and 67% other compensation. This indicates that these sales could comprise a meaningful part of their income for the year. Since June 2023, Michael's direct individual holding has increased from 913.02k shares to 1.34m. Company insiders have collectively sold US$1.5m more than they bought, via options and on-market transactions in the last 12 months. Duyuru • May 01
Ardelyx, Inc., Annual General Meeting, Jun 14, 2024 Ardelyx, Inc., Annual General Meeting, Jun 14, 2024, at 08:30 US Eastern Standard Time. Agenda: To elect two class i directors to hold office until the 2027 annual meeting of stockholders and until their successors are elected and qualified; to approve the amended and restated 2014 equity incentive award plan; to approve the amended and restated 2014 employee stock purchase plan; to approve, on a non-binding, advisory basis, the compensation of named executive officers; to ratify the selection, by the audit and compliance committee of board of directors, of Ernst & Young LLP as the independent registered public accounting firm of the company for the fiscal year ending December 31, 2024; and to transact other business. Duyuru • Apr 20
Ardelyx, Inc. to Report Q1, 2024 Results on May 02, 2024 Ardelyx, Inc. announced that they will report Q1, 2024 results on May 02, 2024 Price Target Changed • Apr 05
Price target increased by 7.1% to US$13.39 Up from US$12.50, the current price target is an average from 9 analysts. New target price is 79% above last closing price of US$7.50. Stock is up 70% over the past year. The company is forecast to post a net loss per share of US$0.44 next year compared to a net loss per share of US$0.30 last year. Duyuru • Mar 26
Ardelyx, Inc. Announces the Appointment of Mike Kelliher as Executive Vice President, Corporate Development and Strategy Ardelyx, Inc. announced the appointment of Mike Kelliher as Executive Vice President, Corporate Development and Strategy. Mr. Kelliher, an accomplished leader with more than 20 years of experience in the biopharmaceutical industry, brings to Ardelyx an extensive array of mergers and acquisitions, business development, strategy, finance and operational leadership expertise from leading biotechnology and global pharmaceutical companies. Most recently, Mr. Kelliher served as Group Vice President, M&A and Business Development, at Horizon Therapeutics, a global biotechnology company focused on researching, developing and commercializing medicines for rare, autoimmune and severe inflammatory diseases. Mr. Kelliher joined Horizon in 2014 and held roles of increasing responsibility on the team that led an aggressive growth and expansion agenda through acquisitions, development collaborations and other transactions, including the acquisition of Horizon by Amgen. He was instrumental in transforming Horizon into a $28 billion innovation-driven biotech company. Prior to his time at Horizon, from 2009 to 2014, Mr. Kelliher held financial roles at Elan Corporation (now Perrigo Company), a leading global pharmaceutical company where he oversaw strategic partnerships and collaborations and advised its Board of Directors and senior leadership on investments, business development, product commercialization and asset monetization. Mr. Kelliher began his career in banking, public accounting and corporate finance and holds a Bachelor of Commerce degree from the University College Cork (Ireland). He is also an Associated Chartered Accountant. Recent Insider Transactions Derivative • Mar 23
Insider notifies of intention to sell stock Elizabeth Grammer intends to sell 86k shares in the next 90 days after lodging an Intent To Sell Form on the 20th of March. If the sale is conducted around the recent share price of US$7.73, it would amount to US$665k. Since June 2023, Elizabeth's direct individual holding has increased from 333.42k shares to 398.99k. Company insiders have collectively sold US$1.5m more than they bought, via options and on-market transactions in the last 12 months. Duyuru • Mar 06
Ardelyx, Inc. announced that it has received $50 million in funding On March 5, 2024, Ardelyx, Inc. closed the transaction. The company has received $50 million in the transaction. As part of the transaction, SLR Investment Corp. as a collateral agent. Major Estimate Revision • Feb 29
Consensus EPS estimates fall by 95%, revenue upgraded The consensus outlook for fiscal year 2024 has been updated. 2024 revenue forecast increased from US$206.8m to US$211.0m. Forecast EPS reduced from -US$0.229 to -US$0.446 per share. Biotechs industry in the US expected to see average net income decline 8.6% next year. Consensus price target up from US$12.50 to US$13.31. Share price rose 11% to US$9.46 over the past week. Reported Earnings • Feb 24
Full year 2023 earnings: EPS misses analyst expectations Full year 2023 results: US$0.30 loss per share (improved from US$0.42 loss in FY 2022). Revenue: US$124.5m (up 139% from FY 2022). Net loss: US$66.1m (loss narrowed 1.7% from FY 2022). Revenue was in line with analyst estimates. Earnings per share (EPS) missed analyst estimates by 11%. Revenue is forecast to grow 33% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Over the last 3 years on average, earnings per share has increased by 50% per year but the company’s share price has only increased by 10% per year, which means it is significantly lagging earnings growth. Duyuru • Feb 02
Ardelyx, Inc. to Report Q4, 2023 Results on Feb 22, 2024 Ardelyx, Inc. announced that they will report Q4, 2023 results on Feb 22, 2024 Major Estimate Revision • Jan 22
Consensus estimates of losses per share improve by 10% The consensus outlook for earnings per share (EPS) in fiscal year 2023 has improved. 2023 revenue forecast increased from US$119.0m to US$124.5m. EPS estimate increased from -US$0.299 per share to -US$0.269 per share. Biotechs industry in the US expected to see average net income growth of 8.6% next year. Consensus price target up from US$11.79 to US$12.50. Share price fell 8.3% to US$8.28 over the past week. 
