Business
Ardelyx Reports Third Quarter 2020 Financial Results and Business Highlights
Tenapanor NDA Accepted for Review by FDA; PDUFA Goal Date set for April 29, 2021 Maintains strong balance sheet with $185.5 million in cash, cash equivalents
About this update from Ardelyx, Inc.
[{"type":"text","content":"Tenapanor NDA Accepted for Review by FDA; PDUFA Goal Date set for April 29, 2021\n Maintains strong balance sheet with $185.5 million in cash, cash equivalents and short-term investments\n\n\nFREMONT, Calif., Nov. 5, 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 third quarter ended September 30, 2020.\n\n \n \n \n \n \n \n\n \n\"The FDA's acceptance of our New Drug Application for tenapanor is a major milestone that continues our progress toward the potential launch of this novel therapeutic for the many dialysis patients who struggle with controlling hyperphosphatemia,\" said Mike Raab, president and chief executive officer of Ardelyx. \"Our commitment to this field was further highlighted in clinical data presented at ASN Kidney Week 2020 generated by Ardelyx and our Japanese partner KKC, supporting the clinical safety and efficacy of tenapanor and reinforcing its potential to transform the treatment landscape for patients.\"\nRecent Business and Pipeline Updates\nThe United States Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for tenapanor to control serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis with a Prescription Drug User Fee Act (\"PDUFA\") goal date of April 29, 2021. The filing was 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. Presented new clinical data supporting the clinical safety and efficacy of tenapanor at ASN Kidney Week 2020. Three poster presentations highlighted data from Phase 3 trials conducted by Ardelyx, including the BLOCK, AMPLIFY and PHREEDOM studies. Additionally, the company's partner for tenapanor in Japan, Kyowa Kirin Co., Ltd., presented the results from two Phase 2 studies evaluating the efficacy and safety of tenapanor in Japanese patients on hemodialysis.Third Quarter 2020 Financial Results\nCash Position: As of September 30, 2020, Ardelyx had total cash, cash equivalents and short-term ...