The law firm of Kessler Topaz Meltzer & Check, LLP reminds investors that a securities fraud class action lawsuit has been filed against Ardelyx Inc. on behalf of those who purchased or acquired Ardelyx securities between August 6, 2020 and July 19, 2021, inclusive (the “Class Period”).
Ardelyx is a specialized biopharmaceutical company that focuses on developing first-in-class medicine to improve treatment for people with cardiorenal disease. This includes patients with chronic kidney disease (“CKD”) on dialysis suffering from elevated serum phosphorus, or hyperphosphatemia; and CKD patients and/or heart failure patients with elevated serum potassium, or hyperkalemia.
In June 2020, the defendants submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for Ardelyx’s lead product candidate, tenapanor, a supposedly first-in-class medicine for the control of serum phosphorus in adult patients with CKD on dialysis. According to Ardelyx, tenapanor has “a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3, or NHE3.” If approved, tenapanor “would be the first therapy for phosphate management that blocks phosphorus absorption at the primary pathway of uptake[,]” and “could greatly improve patient adherence and compliance with one single pill dosed twice daily in contrast to current therapies where typically multiple pills are taken before every meal.” Thus, tenapanor was widely touted by the defendants.
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 FDA accepted Ardelyx’s NDA in September 2020 and set a Prescription Drug User Fee Act date of April 29, 2021. Ardelyx repeatedly lauded this development, highlighting the FDA’s acceptance and review of the NDA, supported by so-called “successful” Phase 3 studies.
However, the truth was revealed after the markets closed on July 19, 2021, when the defendants announced that Ardelyx received a letter from the FDA on July 13, 2021, stating that “the FDA has identified deficiencies that preclude discussion of labeling and post-marketing requirements/commitments.” In particular, the FDA noted that “a key issue is the size of the treatment effect and its clinical relevance.”
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.
Kessler Topaz Meltzer & Check, LLP prosecutes class actions in state and federal courts throughout the country involving securities fraud, breaches of fiduciary duties and other violations of state and federal law. Kessler Topaz Meltzer & Check, LLP is a driving force behind corporate governance reform, and has recovered billions of dollars on behalf of institutional and individual investors from the United States and around the world. The firm represents investors, consumers and whistleblowers (private citizens who report fraudulent practices against the government and share in the recovery of government dollars). The complaint in this action was not filed by Kessler Topaz Meltzer & Check, LLP. For more information about Kessler Topaz Meltzer & Check, LLP please visit www.ktmc.com.
Kessler Topaz Meltzer & Check, LLP
James Maro, Jr., Esq.
280 King of Prussia Road
Radnor, PA 19087
(844) 887-9500 (toll free)