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Item 8.01 Other Events
On April 29, 2021, Ardelyx, Inc. (the “Company”) announced that, in connection with the ongoing review of the Company’s New Drug Application (NDA) for tenapanor for the control of serum phosphorus in chronic kidney disease (CKD) patients on dialysis, the U.S. Food and Drug Administration (FDA) made a recent information request that required the Company to submit additional analyses of its clinical data to help the agency better understand the clinical data in light of tenapanor’s novel mechanism of action as compared to approved therapies. In response, the Company submitted the requested analyses which constitute a major amendment to the NDA, resulting in an extension of the PDUFA date by three months to July 29, 2021. Tenapanor has a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3, or NHE3. This results in the tightening of the epithelial cell junctions and reducing paracellular uptake of phosphate, the primary pathway of phosphate absorption.
Item 9.01 Financial Statements and Exhibits.
Cover Page Interactive Data File (embedded within the Inline XBRL document).
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Date: April 30, 2021
/s/ Elizabeth Grammer
Chief Legal and Administrative Officer