Ardelyx Responds to District Court Decision Granting Motion to Dismiss

Core Viewpoint - Ardelyx, Inc. has faced a legal setback as the U.S. District Court has granted a motion to dismiss a lawsuit that would have protected patient access to its drug XPHOZAH, allowing the Centers for Medicare and Medicaid Services (CMS) to include phosphate lowering therapies in the Medicare End-Stage Renal Disease Prospective Payment System starting January 1, 2025 [1][2][3] 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., including XPHOZAH and IBSRELA [9] Product Information - XPHOZAH (tenapanor) was approved by the FDA in October 2023 to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis, particularly for those who do not respond adequately to phosphate binders [4][8] - The drug is taken as a single tablet twice daily and offers a first-in-class mechanism that blocks phosphate absorption [4] Market Context - Hyperphosphatemia, characterized by elevated phosphate levels in the blood, affects the majority of the 550,000 patients in the U.S. with CKD on maintenance dialysis, necessitating effective treatment options [5] - The current treatment guidelines recommend lowering elevated phosphate levels to a normal range of 2.5-4.5 mg/dL [5] Legal and Regulatory Developments - The court's decision allows CMS to implement a bundled payment system that may restrict access to essential medications for dialysis patients, which has raised concerns among patient advocates and the company [2][3] - Ardelyx is exploring all options related to the lawsuit and is committed to protecting patient access to XPHOZAH [3]