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WALTHAM, Mass. - Biopharmaceutical company Ardelyx, Inc. (NASDAQ: ARDX) has presented a new analysis of its OPTIMIZE Study at the National Kidney Foundation's Spring Clinical Meetings in Boston. The study examines the use of XPHOZAH® (tenapanor) in treating hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. According to InvestingPro data, the company has demonstrated impressive revenue growth of 168% over the last twelve months, though analysts anticipate continued investment in research and development will impact profitability this year.
XPHOZAH, recognized as the only approved phosphate absorption inhibitor (PAI) by the U.S. FDA, is prescribed to reduce serum phosphorus levels in adults with CKD on dialysis. It is particularly used as an add-on therapy for those patients who do not respond adequately to phosphate binders or cannot tolerate them.
The post-hoc analysis of the OPTIMIZE study, which included 330 patients, focused on optimizing phosphorus management with XPHOZAH. According to Dr. David Spiegel, senior vice president of nephrology at Ardelyx, the treatment has shown improved phosphate control over a year since its launch. The analysis also indicated that the use of the over-the-counter antidiarrheal agent loperamide could decrease the rate of treatment discontinuation due to diarrhea, a common side effect of XPHOZAH. With a strong gross profit margin of 69% and liquid assets exceeding short-term obligations, the company appears well-positioned to support its commercial expansion. For detailed financial analysis and additional insights, investors can access the comprehensive Pro Research Report available on InvestingPro.
The study found that 9.7% of patients experiencing diarrhea who also used loperamide discontinued tenapanor due to diarrhea compared to 24.6% of patients not using loperamide. This suggests that loperamide may be an effective adjunct treatment to manage diarrhea associated with tenapanor.
In addition to the poster presentation, an Exhibitor Showcase will be held on April 11, 2025, led by Dr. Vincent Carsillo, discussing the clinical application of XPHOZAH as an add-on therapy for dialysis patients.
Hyperphosphatemia, characterized by elevated phosphate levels in the blood, is a common issue among the 550,000 U.S. patients with CKD on maintenance dialysis. XPHOZAH's mechanism of action involves inhibiting the sodium hydrogen exchanger 3 (NHE3) in the gut, thereby reducing phosphate absorption.
Ardelyx has emphasized the importance of ongoing research to enhance the patient experience and adherence to treatment protocols. The company continues to aim for innovative solutions to meet significant unmet medical needs in the field of nephrology. Currently trading near its 52-week low, InvestingPro analysis suggests the stock may be undervalued, with multiple analysts revising their earnings expectations upward for the upcoming period. Investors seeking deeper insights can explore the complete financial health analysis and growth prospects through InvestingPro's extensive metrics and expert commentary.
This article is based on a press release statement from Ardelyx, Inc.
In other recent news, Ardelyx, Inc. announced the approval of its kidney disease drug, tenapanor, by China's Center for Drug Evaluation, sparking a $5 million milestone payment from its partner, Shanghai Fosun Pharmaceutical Industrial Development Co. Ltd. This partnership could potentially yield up to $100 million more in developmental and commercialization milestones, along with tiered royalties on net sales. Meanwhile, analysts have been weighing in on Ardelyx's market prospects. Piper Sandler maintained a Neutral rating with an $8 price target, citing uncertainties with Ardelyx's product Xphozah. In contrast, Scotiabank initiated coverage with a Sector Outperform rating and a $15 price target, expressing optimism about the company's valuation and future sales potential. BTIG also initiated coverage with a Buy rating and a $14 price target, noting the strong market potential for Ardelyx's products, Ibsrela and Xphozah. Additionally, Ardelyx honored five individuals with the Derek Forfang Patient Advocate Award for their contributions to the chronic kidney disease community. These developments highlight Ardelyx's ongoing efforts in drug commercialization and community engagement.
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