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Why Ardelyx Stock Is Sinking Today | The Motley Fool

Author Bio Keith began writing for the Fool in 2012 and focuses primarily on healthcare investing topics. His background includes serving in management and consulting for the healthcare technology, health insurance, medical device, and pharmacy benefits management industries. Follow @keithspeights What happened Shares of Ardelyx (NASDAQ:ARDX) were sinking 13% lower as of 11 a.m. EDT on Friday. The decline came after the company announced Thursday evening that the U.S. Food and Drug Administration (FDA) is pushing back its review period for tenapanor by three months. So what Ardelyx originally hoped for an FDA approval of tenapanor in controlling serum phosphorus in adults with chronic kidney disease (CKD) on dialysis by yesterday. However, the agency requested additional analyses to help it better understand the drug s mechanism of action.

Ardelyx Announces Extension of the PDUFA Review Period for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis

Ardelyx (ARDX) Announces Extension of the PDUFA Review Period for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis

Ardelyx (ARDX) Announces Extension of the PDUFA Review Period for Tenapanor for the Control of Serum Phosphorus in Adult Patients with CKD on Dialysis
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Ardelyx to Receive $5M Milestone Payment as Japan Partner Initiates Phase 3

Ardelyx to Receive $5M Milestone Payment as Japan Partner Initiates Phase 3 Source: Streetwise Reports  (4/15/21) Ardelyx Inc. shares traded 11% higher after Kyowa Kirin Co. Ltd., its collaborative partner in Japan, initiated four Phase 3 clinical trials of tenapanor for treatment of hyperphosphatemia. Biopharmaceutical company Ardelyx Inc. (ARDX:NASDAQ), which concentrates its efforts on the development of medicines to treat kidney and cardiorenal diseases, today announced that its collaboration partner in Japan, Kyowa Kirin Co., Ltd. (4151:TSE) has initiated four Phase 3 clinical studies in Japan evaluating tenapanor for hyperphosphatemia. The firm noted that by Kyowa Kirin s moving forward into the various clinical trials, under the terms outlined in the agreement between the companies, Ardelyx is now entitled to receive a $5 million payment for reaching this important development milestone.

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