Case Background:
This is a federal securities fraud class action lawsuit on behalf of those who purchased or otherwise acquired Ardelyx Inc. (“Ardelyx”) (NASDAQ: ARDX) securities between August 6, 2020 and July 19, 2021, inclusive (the “Class Period”).
The Class Period commences on August 6, 2020, when Ardelyx issued a press release announcing that it submitted an NDA to the FDA for the review of tenapanor as a first-in-class therapy to control serum phosphorus in adult patients with CKD on dialysis.
The complaint alleges that, throughout the Class Period, the Defendants made materially false and misleading statements regarding tenapanor and the likelihood that it would be approved by the FDA. The complaint further alleges that the 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.
Current Status of Case:
On September 12, 2024, the Court granted Defendants’ Motion to Dismiss, and Plaintiffs appealed this decision to the Ninth Circuit Court of Appeals. On March 5, 2025, Plaintiffs filed to Voluntarily Dismiss the Appeal. This action has concluded.
If you wish to discuss this action or have any questions, please contact Kessler Topaz Meltzer & Check, LLP: Jon Naji, Esq. (484) 270-1453; toll-free at (844) 887-9500; or via e-mail at info@ktmc.com. If you would like additional information about the suit, please click on the link "Submit Your Information" above and fill out the form as promptly as possible.