Why Ardelyx Stock Is Getting Crushed Today
Shares of the small-cap biotech Ardelyx (NASDAQ: ARDX) fell by a whopping 73.2% in pre-market action Tuesday morning. The drugmaker's stock is tanking today in response to a July 13 letter from the U.S. Food and Drug Administration regarding the company's New Drug Application (NDA) for tenapanor as a treatment for controlling serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
Per a press release from Ardelyx, the letter reportedly stated that the FDA found deficiencies in the NDA that preclude discussion around the would-be labeling and post-marketing requirements for tenapanor. Most importantly, the FDA said it detected issues with both the size and clinical relevance of the drug's treatment effect.
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Source Fool.com