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Ardelyx (NASDAQ:ARDX) stock tumbled 20% Tuesday morning after the company said it has decided not to apply to include its drug Xphozah in the US Centers for Medicare and Medicaid Services’ Transitional Drug Add-on Payment Adjustment, or TDAPA, program for certain renal disease drugs.
The biotech company said in a statement that it made the decision after determining that the CMS policy was 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.”
Ardelyx added that it continues to support the passage of legislation that would “extend the exclusion of oral-only medications from entering the CMS Prospective Payer System.”
The FDA approved Xphozah in October 2023 for the reduction of 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 binder therapy.