Business
Ardelyx Reports First Quarter 2020 Financial Results and Recent Business Highlights
Company maintains strong balance sheet with $223.2 million in cash, cash equivalents and short-term investments FREMONT, Calif., May 7, 2020 /PRNewswire/ --
About this update from Ardelyx, Inc.
[{"type":"text","content":"Company maintains strong balance sheet with $223.2 million in cash, cash equivalents and short-term investments\n\n\nFREMONT, Calif., May 7, 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 first quarter ended March 31, 2020. \n\n \n \n \n \n \n \n\n \n\"During these unprecedented times, our priorities are focused on the well-being and safety of our employees, patients, and communities, while continuing on our mission to provide patients with first-in-class, disruptive medicines based on our breakthrough science,\" said Mike Raab, president and chief executive officer of Ardelyx. \"We are fortunate that much of our clinical work has been completed, with minimal impact of the pandemic on our business, and we are on track to submit our NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis by mid-year. In preparation for potential approval in mid-2021, we are laying the foundation for launch with important pre-commercial activities underway.\"\nRecent Business and Pipeline Updates\nInitial data from NORMALIZE released in December 2019 demonstrated that of the 73 patients, treated for more than one month, 42% achieved normal phosphorus levels of less than 4.6 mg/dL and of those, 58% accomplished this with either tenapanor alone or with tenapanor in combination with only one to three sevelamer tablets per day. These early and exciting data represent a 45% improvement over current phosphate binder data from the 2019 Dialysis Outcomes and Practice Patterns Study (DOPPS), an ongoing, national prospective study of hemodialysis practice. Appointed industry veteran, Onaiza Cadoret-Manier to the company's board of directors. Our collaboration partner in Canada, Knight Therapeutics, received approval from Health Canada for IBSRELA® for the treatment of IBS-C in adults. Planned initiation of the OPTIMIZE clinical trial in 2020, a study to inform physicians on the integration of tenapanor into clinical practice.Expected 2020 Milestones\nPreparing NDA Submission for Tenapanor for the Control of Serum Phosphorus in mid-2020: With strong data from its clinical program for te...