Overview

A class action lawsuit has been filed against Ardelyx, Inc. (“Ardelyx” or the “Company”) (NASDAQ: ARDX) and certain of the Company’s former senior executive officers alleging violations of the federal securities laws.  The Ardelyx class action lawsuit is brought on behalf of all persons and entities who purchased or otherwise acquired Ardelyx securities between October 31, 2023, and July 1, 2024, both dates inclusive (the “Class Period”).  Investors have until October 15, 2024, to seek appointment as lead plaintiff of the Ardelyx class action lawsuit.

Ardelyx is a biotechnology company focused on developing and commercializing therapies for, among other things, patients with chronic kidney disease (“CKD”).  According to Ardelyx, 550,000 people in the United States suffer from end-stage renal disease (“ESRD”), which is the final stage of CKD characterized by a progressive loss of kidney function.  Patients suffering from ESRD must undergo regular dialysis treatment – typically three times a week for three to five hours – in order to survive due to the critically important role the kidneys play in filtering waste from the bloodstream.

Over the last decade, Ardelyx has developed a novel active ingredient called tenapanor.  On October 17, 2023, Ardelyx announced that tenapanor, branded as XPHOZAH®, was approved by the U.S. Food and Drug Administration to reduce elevated levels of phosphorus in the bloodstream in CKD patients on dialysis who either cannot tolerate or did not adequately respond to other therapies.  XPHOZAH is a single tablet taken twice daily that blocks phosphate absorption (i.e., it is a phosphorus inhibitor).  It can only be taken orally because its mechanism of action involves blocking uptake of phosphorus in the gastrointestinal tract.  As such, there is no injectable version of XPHOZAH.  This mechanism is relevant to how XPHOZAH is covered by Medicare.

In 2008, Congress passed the Medicare Improvements for Patients and Providers Act (“MIPPA”), which, among other things, directed and authorized the Centers for Medicare and Medicaid Services (“CMS”) (an agency within the U.S. Department of Health and Human Services) to create a bundled payment system for “renal dialysis services” known as the ESRD Prospective Payment System (“ESRD PPS bundle”) under which a single bundled 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 that were previously billed separately.

When Congress created the ESRD PPS bundle payment system for “renal dialysis services,” it limited the reach of the bundled payment to injectable drugs or biologicals, or their oral equivalent.  In 2009, however, CMS proposed to include oral-only drugs with no injectable equivalent in the ESRD PPS bundle.  In 2012, Congress delayed the inclusion of oral-only drugs in the ESRD PPS bundle until January 1, 2016.  Then in 2014, Congress further delayed such inclusion until January 1, 2025.  There is presently legislation pending – The Kidney PATIENT Act (H.R. 5074) – to further delay the inclusion until 2033.

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.  TDAPA provides for an additional payment for two years for new ESRD-related therapies 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.

The Ardelyx class action lawsuit alleges that Defendants intentionally or recklessly indicated that Ardelyx would apply to include XPHOZAH in TDAPA when, in fact, Defendants knew or recklessly disregarded that Ardelyx had not yet reached a firm decision concerning whether or not to apply to include XPHOZAH in TDAPA and could in fact decide not to submit such an application to CMS, which would materially affect sales of XPHOZAH.

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If you purchased or otherwise acquired Ardelyx securities between October 31, 2023, and July 1, 2024, both dates inclusive, and you wish to serve as lead plaintiff in this lawsuit, we encourage you to submit your information to DiCello Levitt LLP via the form on this page. 

You can also contact DiCello Levitt partner Brian O’Mara by calling (888) 287-9005 or at investors@dicellolevitt.com. 

The deadline to apply to the Court to serve as a lead plaintiff in the Ardelyx class action lawsuit is October 15, 2024.