Business
Ardelyx Reports Third Quarter 2021 Financial Results
FREMONT, Calif. and WALTHAM, Mass., Nov. 12, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery,
About this update from Ardelyx, Inc.
[{"type":"text","content":"FREMONT, Calif. and WALTHAM, Mass., Nov. 12, 2021 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today reported business events and financial results for the third quarter ended September 30, 2021. \n\n \n \n \n \n \n \n\n \nRecent Business Events\nThe company presented four posters at the American Society of Nephrology Kidney Week 2021 (ASN Kidney Week), which took place virtually on November 4 – November 7, 2021, highlighting additional positive clinical observations with tenapanor, a first-in-class phosphate absorption inhibitor which has completed three successful Phase 3 clinical trials for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The company also shared important data focusing on the patient experience with tenapanor from the Phase 4 OPTIMIZE trial, which is designed to optimize the treatment of hyperphosphatemia in patients with CKD on dialysis. On November 4, 2021, the company announced that it expects to submit a Formal Dispute Resolution Request (FDRR) by the end of the fourth quarter 2021 to appeal the issuance of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis. On October 13, 2021, the company announced the results of an End of Review Type A meeting with FDA's Division of Cardiology and Nephrology, noting that the meeting did not provide clarity regarding a reasonable path forward for the resubmission of the company's NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis. On October 12, 2021, the company announced that it began implementing a restructuring plan to reduce operating costs and better align the company's workforce with the needs of its business following the receipt of the CRL from the FDA on July 28, 2021, and the outcome of the End of Review Type A meeting. The restructuring plan is expected to be completed in December 2021. On September 3, 2021, the company announced the publication of the company's long term 52-week Phase 3 PHREEDOM trial in the Ame...