- The FDA has issued a Complete Response Letter (CRL) to Ardelyx Inc's ARDX marketing application seeking approval for tenapanor to control serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
- While the FDA agrees that "the submitted data provide substantial evidence that tenapanor is effective in reducing serum phosphorus in CKD patients on dialysis," they characterize the magnitude of the treatment effect as "small and of unclear clinical significance."
- Additionally, FDA asked Ardelyx to conduct an additional adequate and well-controlled trial demonstrating a clinically relevant treatment effect.
- There were no safety, clinical pharmacology/biopharmaceutics, CMC, or non-clinical issues identified in the CRL.
- At the end of the second quarter ended June 30, 2021, Ardelyx had $171.8 million in cash and cash equivalents.
- Price Action: ARDX shares are trading 15.8% higher at $1.98 during the market session on the last check Friday.
- Related content: Benzinga's Full FDA Calendar.
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