- Ardelyx (NASDAQ:ARDX) is up 7% premarket on modest volume on the heels of its announcement that enrollment will begin shortly in a second Phase 3 study assessing lead candidate tenapanor for the treatment of hyperphosphatemia (excess phosphate in the blood) in end-stage renal disease patients on dialysis. Based on FDA feedback, the new trial will incorporate an active control arm for safety assessment only.
- The company also announces that it has terminated development of #2 candidate RDX7675 for hyperkalemia (excess potassium in the blood) due to an expected side effect of decreased serum bicarbonate that would limit its use in a chronic setting. It will transition its hyperkalemia development efforts to an earlier-stage small molecule program. Lower-than-normal serum bicarbonate leads to the progression of chronic kidney disease.
- Previously: Ardelyx selectively reports results from late-stage study to show treatment effect of lead product candidate tenapanor in ESRD patients with elevated serum phosphate (Feb. 15)
- Now read: The Stock Market Cycle And Implications For Medical Stock Investing
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