Ardelyx is a clinical-stage biopharmaceutical company that focuses on kidney and cardiovascular diseases. Its lead product, tenapanor, is designed to help patients with chronic kidney disease (CKD) on dialysis. The company is listed on the NASDAQ Global Market and currently has a market capitalisation of $624 million.
On 30 June, Ardelyx announced that it had submitted a New Drug Application (NDA) for tenapanor to the US Food and Drug Administration (FDA). The submission was supported by three successful Phase 3 trials involving over 1,000 patients that evaluated the use of tenapanor. "The submission of our NDA is a significant milestone for Ardelyx, positioning us well to fulfill our promise to offer an innovative first-in-class therapeutic for patients with CKD on dialysis with elevated serum phosphorus," said Mike Raab, president and chief executive officer of Ardelyx. The company advised that, based on standard FDA review timelines, it expects to receive notification from the FDA on the acceptance of the filing for substantive review in late August 2020.
Source: 2iQ Research
What looks interesting here is that between 22 June and 25 June, Chairman David Mott increased his holding in Ardelyx substantially. Over three separate transactions, the insider purchased 145,644 ARDX shares, lifting his holding from 101,640 shares to 247,284 shares – an increase of 143%. We see these purchases – which cost the insider a total of $997,427 – as a bullish signal. They suggest that Mott is confident about the future and that he expects the stock to rise.