Ardelyx down 3% premarket on late-stage tenapanor data

Ardelyx (NASDAQ:ARDX) is down 3% premarket on modestly higher volume in response to results from the Phase 3 PHREEDOM study evaluating tenapanor for the treatment of hyperphosphatemia (excess levels of phosphate in the blood) in chronic kidney disease (CKD) patients on dialysis.

The trial met the primary endpoint of a statistically significant change in serum phosphate levels in the responder population during the placebo-controlled randomized withdrawal period (12 weeks) (-1.4 mg/dL, p<0.0001). Responders were defined as those with at least a 1.2 mg/dL decrease in serum phosphorus during the first 26 weeks of the study (open-label phase).

On the safety front, the most frequent treatment-related adverse event was loose stools/diarrhea (52.5%), most (90%) considered mild or moderate. The discontinuation rate due to diarrhea was 16% in the open-label portion, but dropped to 0.8% during the withdrawal period. 17.2% of treated patients in the open-label phase experienced a serious adverse event compared to 22.6% for Sanofi’s (NASDAQ:SNY) Renvela (sevelamer carbonate).

The company plans to file a marketing application in the U.S. by mid-2020.

https://seekingalpha.com/news/3523306-ardelyx-down-3-premarket-on-late-stage-tenapanor-data