Core Viewpoint - Ardelyx, Inc. has faced a legal setback as the U.S. District Court has granted a motion to dismiss a lawsuit that would have protected patient access to its drug XPHOZAH, allowing the Centers for Medicare and Medicaid Services (CMS) to include phosphate lowering therapies in the Medicare End-Stage Renal Disease Prospective Payment System starting January 1, 2025 [1][2][3] Company Overview - Ardelyx, Inc. is a biopharmaceutical company focused on developing innovative medicines to address significant unmet medical needs, with two commercial products approved in the U.S., including XPHOZAH and IBSRELA [9] Product Information - XPHOZAH (tenapanor) was approved by the FDA in October 2023 to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis, particularly for those who do not respond adequately to phosphate binders [4][8] - The drug is taken as a single tablet twice daily and offers a first-in-class mechanism that blocks phosphate absorption [4] Market Context - Hyperphosphatemia, characterized by elevated phosphate levels in the blood, affects the majority of the 550,000 patients in the U.S. with CKD on maintenance dialysis, necessitating effective treatment options [5] - The current treatment guidelines recommend lowering elevated phosphate levels to a normal range of 2.5-4.5 mg/dL [5] Legal and Regulatory Developments - The court's decision allows CMS to implement a bundled payment system that may restrict access to essential medications for dialysis patients, which has raised concerns among patient advocates and the company [2][3] - Ardelyx is exploring all options related to the lawsuit and is committed to protecting patient access to XPHOZAH [3]

WALTHAM, Mass., Nov. 05, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, first-in-class medicines that meet significant unmet medical needs, today announced that Michael Raab, President and CEO, Justin Renz, Chief Financial and Operations Officer and Eric Foster, Chief Commercial Officer, will participate in a fireside chat at the 2024 Jefferies London Healthcare Conference on Tuesday, November 19, 2 ...

Ardelyx, Inc. (NASDAQ:ARDX) Q3 2024 Earnings Conference Call October 31, 2024 4:30 PM ET Company Participants Caitlin Lowie - Vice President of Corporate Communications & Investor Relations Michael Raab - President & Chief Executive Officer Eric Foster - Chief Commercial Officer Justin Renz - Chief Financial Officer & Chief Operations Officer Conference Call Participants Louise Chen - Cantor Fitzgerald Dennis Ding - Jefferies Roanna Ruiz - Leerink Partners Laura Chico - Wedbush Joseph Thome - TD Cowen Ryan ...

Ardelyx (ARDX) reported $98.24 million in revenue for the quarter ended September 2024, representing a year-over-year increase of 74.2%. EPS of $0.00 for the same period compares to $0.03 a year ago.The reported revenue compares to the Zacks Consensus Estimate of $86.26 million, representing a surprise of +13.89%. The company delivered an EPS surprise of +100.00%, with the consensus EPS estimate being -$0.05.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings -- ...

Ardelyx (ARDX) reported break-even quarterly earnings per share versus the Zacks Consensus Estimate of a loss of $0.05. This compares to earnings of $0.03 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 100%. A quarter ago, it was expected that this biotechnology company would post a loss of $0.10 per share when it actually produced a loss of $0.07, delivering a surprise of 30%.Over the last four quarters, the company has surp ...

Table of Contents Non-accelerated filer ☐ Smaller reporting company ☐ UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number: 001-36485 ARDELYX, INC. (Exact Name of Registrant as Specif ...

Exhibit 99.1 Ardelyx Reports Third Quarter 2024 Financial Results and Provides Business Update IBSRELA generates $40.6 million in net product sales revenue; Company expects full year 2024 IBSRELA net sales revenue to be between $145 and $150 million XPHOZAH generates $51.5 million in net product sales revenue Company ends Q3 with approximately $190 million in cash, cash equivalents and investments Conference call scheduled for 4:30 PM Eastern Time WALTHAM, Mass., October 31, 2024 - Ardelyx, Inc. (Nasdaq: AR ...

IBSRELA generates $40.6 million in net product sales revenue; Company expects full year 2024 IBSRELA net sales revenue to be between $145 and $150 million XPHOZAH generates $51.5 million in net product sales revenue Company ends Q3 with approximately $190 million in cash, cash equivalents and investments Conference call scheduled for 4:30 PM Eastern Time WALTHAM, Mass., Oct. 31, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and ...

Ninety percent of survey participants reported "some" or "significant" negative impact of IBS-C on their life Survey results presented in two poster presentations WALTHAM, Mass., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative, firstin-class medicines that meet significant unmet medical needs, today announced that results from the IBS in America 2024 supplemental survey, in partnership with H ...

Core Viewpoint - Bragar Eagel & Squire, P.C. is investigating potential claims against Ardelyx, Inc. due to a class action complaint alleging breaches of fiduciary duties by the board of directors following a significant stock price drop after the company announced it would not apply to include XPHOZAH in TDAPA as previously indicated [1][2]. Company Summary - Ardelyx, Inc. is facing legal scrutiny from shareholders after a class action complaint was filed on August 16, 2024, concerning the period from October 31, 2023, to July 1, 2024 [1]. - The complaint highlights that Ardelyx had previously stated its intent to apply for XPHOZAH's inclusion in TDAPA in its Forms 10-Q and 10-K, but later retracted this statement on July 2, 2024, leading to a significant drop in stock price [1]. - Following the announcement on July 2, 2024, Ardelyx's stock price fell by $2.29 per share, or 30.25%, closing at $5.28 per share [2].