Robbins Geller Rudman & Dowd LLP announces that purchasers of Ardelyx Inc. (NASDAQ: ARDX) securities between August 6, 2020 and July 19, 2021, inclusive (“Class Period”) have until September 28, 2021 to seek appointment as lead plaintiff in the Ardelyx class action lawsuit. The Ardelyx class action lawsuit charges Ardelyx and certain of its top executives with violations of the Securities Exchange Act of 1934. The Ardelyx class action lawsuit (Strezsak v. Ardelyx Inc., No. 21-cv-05868) was commenced on July 30, 2021 in the Northern District of California.

If you wish to serve as lead plaintiff of the Ardelyx class action lawsuit, please provide your information by clicking here. You can also contact attorney J.C. Sanchez of Robbins Geller by calling 800/449-4900 or via e-mail at jsanchez@rgrdlaw.com. Lead plaintiff motions for the Ardelyx class action lawsuit must be filed with the court no later than September 28, 2021.

CASE ALLEGATIONS: In June 2020, Ardelyx 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 chronic kidney disease on dialysis. The FDA accepted Ardelyx’s NDA in September 2020 and set a Prescription Drug User Fee Act date of April 29, 2021.

The Ardelyx class action lawsuit 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, the Ardelyx class action lawsuit further alleges that, throughout the Class Period, defendants made materially false and misleading statements regarding tenapanor and the likelihood that it would be approved by the FDA. Specifically, the Ardelyx class action lawsuit alleges that 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.

On July 19, 2021, Ardelyx announced that it had received a letter from the FDA, dated July 13, 2021, that said the FDA had found deficiencies that precluded discussion around the would-be labeling and post-marketing requirements for tenapanor. The FDA revealed that it detected issues with both the size and clinical relevance of the drug’s treatment effect. On this news, Ardelyx’s stock price fell nearly 74%, damaging investors.

THE LEAD PLAINTIFF PROCESS: The Private Securities Litigation Reform Act of 1995 permits any investor who purchased Ardelyx securities during the Class Period to seek appointment as lead plaintiff in the Ardelyx class action lawsuit. A lead plaintiff is generally the movant with the greatest financial interest in the relief sought by the putative class who is also typical and adequate of the putative class. A lead plaintiff acts on behalf of all other class members in directing the Ardelyx class action lawsuit. The lead plaintiff can select a law firm of its choice to litigate the Ardelyx class action lawsuit. An investor’s ability to share in any potential future recovery of the Ardelyx class action lawsuit is not dependent upon serving as lead plaintiff.

ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: With 200 lawyers in 9 offices nationwide, Robbins Geller Rudman & Dowd LLP is the largest U.S. law firm representing investors in securities class actions. Robbins Geller attorneys have obtained many of the largest shareholder recoveries in history, including the largest securities class action recovery ever – $7.2 billion – in In re Enron Corp. Sec. Litig. The 2020 ISS Securities Class Action Services Top 50 Report ranked Robbins Geller first for recovering $1.6 billion for investors last year, more than double the amount recovered by any other securities plaintiffs’ firm. Please visit https://www.rgrdlaw.com/firm.html for more information.

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