ARDX ALERT: Investors with Substantial Losses Have Opportunity to Lead the Ardelyx Inc. Class Action Lawsuit

SAN DIEGO–(BUSINESS WIRE) – Robbins Geller Rudman & Dowd LLP announces that buyers of Ardelyx Inc. (NASDAQ: ARDX) securities will have until September 28, 2021, between August 6, 2020 and July 19, 2021, inclusive an appointment as lead plaintiff in the Ardelyx class action. The Ardelyx class lawsuit charges Ardelyx and some of its officers with violations of the Securities Exchange Act of 1934. The Ardelyx class action lawsuit, which was initiated in the Northern District of California on July 30, 2021, is entitled Strezsak v. Ardelyx Inc., No. 21-cv-05868.

If you would like to act as the lead plaintiff in the Ardelyx class action, please provide your information by clicking here. You can also contact Attorney JC Sanchez of Robbins Geller by phone at 800 / 449-4900 or by email at jsanchez@rgrdlaw.com. Motions by the lead plaintiffs for the Ardelyx class action must be filed with the court no later than September 28, 2021.

CASE ALLEGES: In June 2020, Ardelyx filed a new drug application (“NDA”) with the US Food and Drug Administration (FDA) for Ardelyx’s lead product candidate, Tenapanor, a supposedly world-class drug used to control serum phosphate in adult patients chronic kidney disease on dialysis. The FDA accepted Ardelyx’s NDA in September 2020, setting the date of the Prescription Drug Fee Act to April 29, 2021.

The Ardelyx class action lawsuit alleges that Ardelyx has repeatedly praised this development and highlighted the acceptance and review of the NDA by the FDA, supported by so-called “successful” phase 3 studies, in each of the company’s subsequent quarterly and 2020 annual reports. However, the Ardelyx class action continues to allege that defendants made essentially false and misleading statements about Tenapanor and the likelihood of FDA approval during the class action period. Specifically, the Ardelyx class lawsuit alleges that the defendants owned, had control over and, as a result, knew (or had reason to know) that the data presented in support of the NDA were inadequate because they had no clinical relevance to the drug’s treatment effects which makes it foreseeable (if not certain) that the FDA will not approve the drug.

On July 19, 2021, Ardelyx announced that it had received a letter from the FDA dated July 13, 2021 stating the FDA had identified deficiencies that led to a discussion of the alleged labeling and post-marketing requirements for tenapanor excluded. The FDA announced that it has identified issues with the size and clinical relevance of the drug’s treatment effects. Because of this news, Ardelyx’s share price fell nearly 74%, which harmed investors.

LEAD APPLICATION: The Private Securities Litigation Reform Act of 1995 allows any investor who purchased Ardelyx securities during the class action period to seek appointment as the lead plaintiff in the Ardelyx class action. A lead plaintiff is usually the applicant with the greatest financial interest in the legal protection sought by the alleged class, which is also typical and appropriate for the alleged class. A lead plaintiff is acting on behalf of all other group members in directing the Ardelyx class action. The lead plaintiff can choose a law firm of their choice to bring the Ardelyx class action lawsuit. An investor’s ability to participate in a possible future collection of the Ardelyx class action lawsuit does not depend on whether or not they are the lead plaintiff.

ABOUT ROBBINS GELLER RUDMAN & DOWD LLP: With 200 attorneys in 9 offices across the country, Robbins Geller Rudman & Dowd LLP is the largest US law firm serving investors in securities class actions. Robbins Geller’s attorneys have secured many of the largest shareholder reclaims in history, including the largest securities class action of all time – $ 7.2 billion – in In re Enron Corp. Sec. Lit. The 2020 ISS Securities Class Action Services Top 50 Report ranked Robbins Geller first for getting $ 1.6 billion back for investors last year, more than double the amount paid by any other securities plaintiff firm was drafted. Please visit https://www.rgrdlaw.com/firm.html for more information.

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