Ardelyx, Inc. develops and sells therapeutics for the treatment of cardio renal and gastrointestinal diseases in the United States. Its lead product candidate is tenapanor, which is in Phase III clinical trial for the treatment of patients with irritable bowel syndrome with constipation, as well as in Phase III clinical trial for the treatment of hyperphosphatemia in end-stage renal disease patients on dialysis. The company is also developing RDX7675, which is in Phase III clinical trial for the treatment of people with hyperkalemia; and RDX8940 in Phase I clinical trial for the treatment of patients with NASH and other gastrointestinal indications. Its drug candidates in the stages of resea...
34175 Ardenwood Boulevard
Fremont, CA 94555
Founded in 2007
Ardelyx, Inc. Announces Unaudited Consolidated Earnings Results for the Fourth Quarter and Full Year Ended December 31, 2016
Feb 17 17
Ardelyx, Inc. announced unaudited consolidated earnings results for the fourth quarter and full year ended December 31, 2016. For the quarter, the company reported Loss from operations was $31,476,000 against loss from operations of $16,876,000 a year ago. Net loss was $31,276,000 against net loss of $17,000,000 a year ago. Net loss per common share, basic & diluted was $0.66 against net loss per common share, basic & diluted of $0.65 a year ago.
For the full year, the company reported Loss from operations was $112,895,000 against loss from operations of $29,389,000 a year ago. Net loss was $112,387,000 against net loss of $29,621,000 a year ago. Net loss per common share, basic & diluted was $2.8 against net loss per common share, basic & diluted of $1.29 a year ago.
Ardelyx Announces Successful Phase 3 Trial of Tenapanor for Hyperphosphatemia in Patients with End-Stage Renal Disease
Feb 15 17
Ardelyx, Inc. reported that the Phase 3 clinical trial evaluating the efficacy and safety of tenapanor as a treatment for hyperphosphatemia in patients with end-stage renal disease (ESRD) who are on dialysis met its primary endpoint and was generally well-tolerated. The responder population (n=80 out of 164) had a mean reduction in serum phosphorus from baseline to the end of the eight-week treatment period of 2.56 mg/dL, with a reduction of up to 5.7 mg/dL. Notably, in this group, 33% of patients had a reduction in serum phosphorus of greater than 3 mg/dL. The study demonstrated a statistically significant difference in serum phosphorus levels from the end of the eight-week treatment period to the end of the four-week randomized withdrawal period between the tenapanor-treated group and the placebo-treated group in the responder patient population (mean -1.01 mg/dL, median of -1.3 mg/dL) and met its primary endpoint (95% CI -1.44, -0.21; LSmean -0.82 mg/dL; p=0.01). Only 7.8% of patients discontinued treatment due to GI side effects. Hyperphosphatemia is a condition of higher than normal levels of serum phosphorus in the blood that is estimated to affect more than 745,000 people with ESRD who are on dialysis in major developed countries. The results from this trial support Ardelyx's plans to initiate the second Phase 3 study of tenapanor for the treatment of hyperphosphatemia in ESRD patients on dialysis in mid-2017. This Phase 3 study will include a 26-week open-label treatment period, with a randomized withdrawal period followed by an additional 26-week long-term safety extension.
Ardelyx, Inc. - Special Call
Feb 15 17
To discuss the Phase 3 findings