Ardelyx Inc.

Case Details

Class Period: September 6, 2020 - July 19, 2021
Date Filed: July 30, 2021
Case Number: 4:21cv05868
Jurisdiction: California Northern District Court
icon-casetype Case Type: Securities Case
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Case Summary

Ardelyx is a specialized biopharmaceutical company focused on developing medicine to improve treatment for people with cardiorenal disease, including patients with chronic kidney disease (CKD) on dialysis suffering from elevated serum phosphorus, or hyperphosphatemia. In June 2020, Ardelyx submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, tenapanor, a supposedly first-in-class medicine for the control of serum phosphorus in adult patients with CKD on dialysis. Ardelyxs NDA was purportedly supported by successful Phase 3 studies, which, according to the complaint, showed improvements over current treatments and supported tenapanors clinical safety and efficacy, reinforcing its potential to be a transformative treatment. After the market closed on July 19, 2021, however, Ardelyx revealed that it had received a letter from the FDA stating that it had detected issues with both the size and clinical relevance of the drugs treatment effect. On this news, the Companys share price declined, falling $9.71 per share, or nearly 74%, to close at $2.01 per share on July 20, 2021. According to the complaint, Ardelyx and the other named defendants made materially false and misleading statements regarding tenapanor and the likelihood that it would be approved by the FDA during the Class Period, which led investors to suffer significant losses.