Business
Ardelyx Reports Second Quarter 2020 Financial Results and Recent Business Highlights
Submitted a New Drug Application to the U.S. Food and Drug Administration for the review of tenapanor as a first-in-class therapy to control serum phosphorus
About this update from Ardelyx, Inc.
[{"type":"text","content":"Submitted a New Drug Application to the U.S. Food and Drug Administration for the review of tenapanor as a first-in-class therapy to control serum phosphorus in adult patients with chronic kidney disease on dialysis\n Maintains strong balance sheet with $204.8 million in cash, cash equivalents and short-term investments\n\n\nFREMONT, Calif., Aug. 6, 2020 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today reported business highlights and financial results for the second quarter ended June 30, 2020. \n\n \n \n \n \n \n \n\n \n\"Over the last quarter, we continued to make critical progress towards our goal of providing our first-in-class therapy tenapanor to adult CKD patients on dialysis with elevated serum phosphorus, a condition, despite traditional therapies, that has been associated with poor survival outcomes,\" said Mike Raab, president and chief executive officer of Ardelyx. \"This past June, we submitted a New Drug Application to the FDA for this indication, and we expect to receive notification of its acceptance for substantive review and our PDUFA date by early September. As part of our filing, we included additional, robust data reconfirming tenapanor's ability to lower and control serum phosphorous levels at a rate better than those reported with phosphate binders alone. In addition, during the quarter, we augmented our senior leadership team with the hiring of an experienced chief commercial officer and chief financial officer as we prepare for launch and evolving into a revenue-generating company.\" \nRecent Business and Pipeline Updates\nSubmitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the review of tenapanor as a first-in-class therapy to control serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The filing is supported by three successful Phase 3 studies demonstrating tenapanor's ability to reduce phosphate levels, with two trials evaluating tenapanor as a monotherapy and the third evaluating tenapanor as part of a dual mechanism approach with phosphate binders. Released additional positive data from the ongoing NORMALIZE Phase 4 study, which showed that foundational use of ...