(NASDAQ GM: ARDX)
Rigrodsky Law, P.A. is investigating potential claims against the officers and directors of Ardelyx, Inc. ("Ardelyx" or the "Company") on behalf of stockholders. A class action complaint has been filed against Ardelyx. In September 2020, the FDA accepted Ardelyx’s new drug application ("NDA") for the Company's lead product candidate, tenapanor, and set a Prescription Drug User Fee Act date of April 29, 2021. The complaint alleges that Ardelyx repeatedly lauded this development, highlighting the FDA's acceptance and review of the NDA, supported by so-called "successful" Phase 3 studies, in each subsequently filed quarterly report and in the Company's 2020 Annual Report. However, defendants made materially false and misleading statements regarding tenapanor and the likelihood that it would be approved by the FDA. Specifically, defendants possessed, were in control over, and, as a result, knew or had reason to know that the data submitted to support the NDA was insufficient in that it showed a lack of clinical relevance of the drug's treatment effect, making it foreseeably likely, if not certain, that the FDA would not approve the drug.