Investors who lost money with shares of Ardelyx, Inc. (NASDAQ: ARDX) should contact the Shareholders Foundation in connection with Lawsuit

An investor, who purchased shares of Ardelyx, Inc. (NASDAQ: ARDX), filed a lawsuit over alleged violations of Federal Securities Laws by Ardelyx, Inc. in connection with certain allegedly false and misleading statements.

Investors who purchased a significant amount of shares of Ardelyx, Inc. (NASDAQ: ARDX) between October 31, 2023 and July 1, 2024, and / or those who purchased any NASDAQ: ARDX shares prior to October 2023 and continue to hold any of those shares, have certain options and for certain investors are short and strict deadlines running. Deadline: October 15, 2024. NASDAQ: ARDX investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Waltham, MA based Ardelyx, Inc. is a biotechnology company focused on developing and commercializing therapies for, among other things, patients with chronic kidney disease ("CKD")..
According to Ardelyx, Inc., 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 3 times a week for 3-5 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, Inc. 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 ("Jan 2025 Deadline"). 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.

With the Jan 2025 Deadline approaching, CMS began to take action to place oral-only drugs into the ESRP PPS bundle. On April 29, 2024, CMS issued guidance concerning inclusion of oral-only drugs in the ESRD PPS bundle effective January 1, 2025. Then 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 PPS bundle beginning January 1, 2025, and to cease separate payment for XPHOZAH and other such drugs under Medicare Part D on such date.
Shifting reimbursement for XPHOZAH into the ESRD PPS bundle-without applying to include XPHOZAH in TDAPA-will have a materially adverse effect on sales of XPHOZAH because if dialysis facilities are forced to pay for an oral-only drug like XPHOZAH using the single bundled payment that they receive from CMS, they will have less wherewithal and incentive to facilitate patients' access to XPHOZAH, and sales of XPHOZAH will suffer.
Ardelyx, Inc., indicated in its Forms 10-Q filed on October 31, 2023, and May 2, 2024, and in its Form 10-K filed on February 22, 2024, that it would apply to include XPHOZAH in TDAPA.
Further, on an earnings call on May 2, 2024, Ardelyx's President, Chief Executive Officer advised analysts that "our intent is to enter TDAPA."

Then on July 2, 2024, Ardelyx, Inc. disclosed that it had decided not to apply to include XPHOZAH in TDAPA.
Shares of Ardelyx, Inc. (NASDAQ: ARDX) declined from $10.13 per share on February 12, 2024, to as low as $5.07 per share on July 02, 2024.

Subsequently, on July 17, 2024, in partnership with the American Association of Kidney Patients and the National Minority Quality Forum Ardelyx, Inc., filed a lawsuit in the U.S. District Court for the District of Columbia against CMS claiming, among other things, that CMS's plan to move XPHOZAH, along with all oral-only drugs, into the ESRD PPS bundle is inconsistent with MIPPA's statutory provision, and contradicts CMS's own regulations.
According to the complaint the plaintiff alleges on behalf of purchasers of Ardelyx, Inc. (NASDAQ: ARDX) common shares between October 31, 2023 and July 1, 2024, that the defendants violated Federal Securities Laws. More specifically, the plaintiff claims that as a result of Defendants' wrongful acts and omissions, and the precipitous decline in the market value of the Company's securities, investors who purchased shares of of Ardelyx, Inc. (NASDAQ: ARDX) between October 31, 2023 and July 1, 2024 have suffered significant losses and damages.

Those who purchased shares of Ardelyx, Inc. (NASDAQ: ARDX) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.