Ardelyx, Inc. (NASDAQ: ARDX) Securities Fraud Class Action

LEAD PLAINTIFF DEADLINE IS OCTOBER 15, 2024.

If you have suffered losses and would like to discuss your rights, please fill out this form or you may contact Jonathan Naji, Esq. at (484) 270-1453 or via e-mail at info@ktmc.com.

Case Background:
On October 17, 2023, Ardelyx announced that XPHOZAH, a drug that blocks phosphate absorption for chronic kidney disease (“CKD”) patients on dialysis who either cannot tolerate or did not adequately respond to other phosphate binder therapies, was approved by the FDA.  XPHOZAH can only be taken orally. In 2008, Congress passed the Medicare Improvements for Patients and Providers Act, which directed and authorized the Centers for Medicare and Medicaid Services (“CMS”) to create a bundled payment system for “renal dialysis services” known as the End-Stage Renal Disease (“ESRD”) Prospective Payment System (the “ESRD PPS bundle”) under which a single bundle payment is made under Medicare Part B to dialysis facilities to reimburse them for dialysis services, and dialysis-related drugs, laboratory tests, and other products and services, with reimbursements limited to injectable drugs or biologicals, or their oral equivalent, which by definition would exclude drugs like XPHOZAH that are oral-only and have no injectable form.  Nevertheless, in 2009, CMS proposed to include oral-only drugs with no injectable equivalent in the ESRD PPS bundle.  However, Congress has delayed the inclusion of oral-only drugs until January 1, 2025, with pending legislation to further delay inclusion until 2033.  Critically, therapies included in the ESRD PPS bundle payment are reimbursed at a lower rate due to the fixed nature of the payment.

In 2016, CMS introduced the ESRD PPS Transitional Drug Add-on Payment Adjustment (“TDAPA”) program to pay for new ESRD-related therapies not yet in the ESRD PPS bundle.  The TDAPA provides additional payment for two years on top of the single bundled payment to enable CMS to gather sufficient claims data to incorporate the new therapy into the bundle and adjust the base payment rate.  In 2024, CMS introduced a reduced add-on payment for an additional three years beyond the initial two years for therapies admitted into the TDAPA program, potentially making the program a total of five years.  In order to have their drugs subjected to reimbursement, manufacturers, like Ardelyx, must apply to include their therapies in TDAPA.  On June 27, 2024, CMS released the proposed Calendar Year 2025 ESRD PPS rule in which it confirmed its intention to bring XPHOZAH and other oral-only ESRD-related drugs into the ESRD bundle beginning January 1, 2025, and its intention to cease separate payments under Medicare Part D on such date.  While Defendants consistently told investors throughout the Class Period that Ardelyx would apply to include XPHOZAH in TDAPA, on July 2, 2024, Ardelyx shocked investors when it disclosed that it had decided not to apply to include XPHOZAH in TDAPA.    

The Complaint alleges that, during the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the company’s business, operations, and prospects.  Specifically, Defendants misrepresented and/or failed to disclose that: (1) contrary to Defendants’ public statements, the company had not yet reached a firm decision concerning whether or not to apply to include XPHOZAH in TDAPA; (2) the company could not, in fact, decide whether or not to submit such an application to CMS until after the company first reviewed the CMS’s proposed Calendar Year 2025 ESRD PPS rule, which was only issued on June 27, 2024; and (3) as a result, Defendants’ statements about the company’s business, operations, and prospects were materially false and misleading and/or lacked a reasonable basis at all relevant times.

As a result of Ardelyx’s announcement that it had decided not to apply to include XPHOZAH in TDAPA, which would significantly limit or entirely eliminate access to the drug for most patients, the price of Ardelyx common stock declined $2.29 per share, or approximately 30.25%, from a close of $7.57 per share on July 1, 2024, to close at $5.28 per share on July 2, 2024.

What is a Lead Plaintiff?

A lead plaintiff is a representative party that acts on behalf of other class members in directing the litigation. In order to be appointed lead plaintiff, the Court must determine that the class member’s claim is typical of the claims of other class members, and that the class member will adequately represent the class. Your ability to share in any recovery is not, however, affected by the decision whether or not to serve as a lead plaintiff. Filling out the online form above or communicating with any counsel is not necessary to participate or share in any recovery achieved in this case.  Any member of the purported class may move the court to serve as a lead plaintiff through counsel of his/her choice, or may choose to do nothing and remain an inactive class member.