Business
Ardelyx Provides Corporate Update Following Type A Meeting with FDA
- Despite Type A Meeting, Ardelyx continues to await clarity from FDA on path forward for approval of tenapanor for hyperphosphatemia - Company reduces staff
About this update from Ardelyx, Inc.
[{"type":"text","content":"- Despite Type A Meeting, Ardelyx continues to await clarity from FDA on path forward for approval of tenapanor for hyperphosphatemia\n - Company reduces staff by 65%\n\n\nFREMONT, Calif. and WALTHAM, Mass., Oct. 13, 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 announced that the company has met with the U.S. Food and Drug Administration (FDA) in a Type A meeting, but was not provided sufficient clarity on what constitutes \"clinical relevance of the magnitude of treatment effect\" and continues to await additional information regarding the path forward for the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. \n\n \n \n \n \n \n \n\n \n\"Given that we have conducted the requisite registration studies, which met all primary and key secondary endpoints with no safety or other identified issues, we continue to be extremely disappointed and surprised by the lack of clarity from the FDA on the next steps to resubmit our NDA,\" said Mike Raab, president and chief executive officer of Ardelyx. \"In order to preserve our cash resources and extend our cash runway, we have made the extremely difficult decision to implement a restructuring plan that includes a significant reduction in force. We have retained key employees needed to continue to support the regulatory process and work to achieve our goal to gain approval for tenapanor for hyperphosphatemia. While a setback for our company, we believe the delay in approval represents a more significant hardship for patients who are being denied access to tenapanor, a much-needed, novel therapeutic alternative with a different mechanism of action. We remain dedicated to providing these underserved patients, of which 77% are unable to maintain target phosphorus levels despite active treatment with currently available therapies, another treatment option.\"\nThe company announced that on October 12, 2021, it began implementing a restructuring plan to further reduce operating costs and better align the company's workforce with the needs of its business following the receipt of a complete re...