Ardelyx ‘disappointed’ by court decision granting motion to dismiss

Ardelyx (ARDX) confirmed that Judge Beryl Howell from the U.S. District Court for Washington, D.C. has granted defendants’ motion to dismiss the lawsuit filed by Ardelyx, the American Association of Kidney Patients and the National Minority Quality Forum, permitting the Centers for Medicare and Medicaid Services to proceed with its plan to include Xphozah and other oral-only phosphate lowering therapies in the End-Stage Renal Disease Prospective Payment System. The company said, “We are disappointed and saddened by the Court’s decision to grant defendants’ motion to dismiss allowing CMS to bring PLTs into the Medicare ESRD PPS beginning on January 1, 2025. This will result in incredible harm to dialysis patients who, as a result of the bundled payment system, are unable to access the best care and medicine they require. Dialysis patients are among those who have historically experienced poorer health outcomes due to negative social determinants of health. And, while addressing health disparities has been a stated goal for CMS, this policy moves us in the opposite direction, resulting in severely restricted access to important medications.” Ardelyx added that it is currently reviewing the District Court’s decision and will consider all options related to the lawsuit.