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Shares of Ardelyx (NASDAQ:ARDX) were down 17% in afternoon trading Wednesday ahead of an expected FDA decision on its kidney disease treatment candidate Xphozah and amid a market-moving update from Novo Nordisk (NVO) on its GLP-1 drug Ozempic in the treatment of kidney failure.
The FDA’s goal date for making a decision on whether to approve Xphozah, also known as tenapanor, is Oct. 17. Ardelyx resubmitted the drug’s market application in April after the agency declined to approve the product for a kidney disease indication in 2021, citing the need for more supporting data.
Ardelx is seeking to have Xphozah approved for the control of serum phosphate levels in patients with chronic kidney disease on dialysis who have not responded well to phosphate binder therapy. Tenapanor is already on the market under the brand name Ibsrela for the treatment of irritable bowel syndrome with constipation.
Several companies working in the dialysis and kidney disease space saw their shares put under pressure Wednesday in the wake of news that Novo Nordisk (NVO) had stopped a clinical study for its GLP-1 drug Ozempic early because it had met its efficacy criteria. Novo is testing Ozempic for the prevention of renal impairment progression in patients with type 2 diabetes and chronic kidney disease.
Novo Nordisk markets Ozempic, also known as semaglutide, as a treatment for type 2 diabetes. It also markets semaglutide for as a weight-loss drug under the name Wegovy.
SA analyst Stephen Ayers upgraded his rating of Ardelyx to buy on Tuesday, commenting that the recent “Japanese approval of tenapanor is a pivotal catalyst, targeting unmet needs in chronic kidney disease-related hyperphosphatemia and fortifying its U.S. FDA approval prospects.”