The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed in the U.S. District Court for the Northern District of California on behalf of those who acquired Ardelyx, Inc. (“Ardelyx” or the “Company”) (NASDAQ: ARDX) securities from August 6, 2020 through July 19, 2021, inclusive (the “Class Period”). Investors have until September 28, 2021 to apply to the Court to be appointed as lead plaintiff in the lawsuit.
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. Ardelyx’s NDA was purportedly supported by successful Phase 3 studies, which, according to the complaint, showed “improvements” over current treatments and supported tenapanor’s “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 drug’s treatment effect. On this news, the Company’s share price declined by $5.69 per share, or approximately 73.9%, from $7.70 per share to close at $2.01 per share on July 20, 2021.
The lawsuit alleges the throughout the Class Period, Defendants made false and/or misleading statements and/or failed to disclose material adverse facts including: (1) 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; (2) the likelihood that tenapanor would be approved by the FDA; (3) 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.
If you purchased or otherwise acquired Ardelyx securities, have information, or would like to learn more about these claims, please contact Thomas W. Elrod of Kirby McInerney LLP at 212-371-6600, by email at email@example.com, or by filling out this contact form, to discuss your rights or interests with respect to these matters without any cost to you.