Ardelyx Stock Price, News & Analysis

Ardelyx, Inc. (Nasdaq: ARDX) has appointed Eric Foster as Chief Commercial Officer. With over 23 years of commercial experience in biotech and pharmaceuticals, Foster will lead commercial strategies for Ardelyx's first-in-class medicines, IBSRELA® and XPHOZAH®. His extensive background includes leadership roles at Amgen, Horizon Therapeutics, GlaxoSmithKline, and Johnson & Johnson.

Mike Raab, CEO of Ardelyx, praised Foster's expertise and track record in developing businesses across multiple therapeutic areas. Foster expressed excitement about joining Ardelyx, highlighting the company's strong culture, commercial execution, and financial position. He aims to advance Ardelyx's commercial strategy and expand patient access to their innovative medicines.

Ardelyx reported strong Q2 2024 financial results, with significant revenue growth from its two key products. IBSRELA generated $35.4 million in net product sales, showing 25% quarter-over-quarter growth. XPHOZAH recorded $37.1 million in net product sales, up from $15.2 million in Q1. The company ended Q2 with approximately $186 million in cash and investments.

Total revenue for Q2 2024 was $73.2 million, compared to $22.3 million in Q2 2023. Net loss for Q2 2024 was $16.5 million, or $(0.07) per share. Ardelyx continues to expect full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.

The company is taking legal action against CMS to protect patient access to XPHOZAH, following concerns about potential access restrictions due to proposed policy changes.

Ardelyx, Inc. (Nasdaq: ARDX) has published plain language summaries of two clinical trials for XPHOZAH® (tenapanor) in Current Medical Research and Opinion. These summaries, from the NORMALIZE and OPTIMIZE studies, aim to help patients with chronic kidney disease on dialysis understand the safety and efficacy data of XPHOZAH. The FDA-approved drug is the first and only phosphate absorption inhibitor designed to reduce serum phosphorus in adult CKD patients on dialysis. It's used as an add-on therapy for patients with inadequate response to or intolerance of phosphate binders. XPHOZAH's unique mechanism blocks phosphate absorption at the primary pathway and is administered as a single tablet twice daily. The summaries provide accessible information about XPHOZAH's potential impact on lowering serum phosphorus levels, helping patients and caregivers make informed decisions about treatment options.

Ardelyx (Nasdaq: ARDX) has announced a conference call scheduled for August 1, 2024, at 4:30 p.m. Eastern Time to discuss its second quarter 2024 financial results and provide a business update. Interested parties can participate by dialing (844) 481-2838 (domestic) or (412) 317-1858 (international) and asking to join the Ardelyx call. A live audio webcast will be available on the company's website under the Investors section, with a 30-day archive available after the call. Ardelyx is a biopharmaceutical company focused on developing innovative, first-in-class medicines for significant unmet medical needs.

Ardelyx, along with AAKP and NMQF, has filed a lawsuit against the U.S. Department of Health and Human Services and CMS. The lawsuit challenges CMS's plan to include XPHOZAH and other oral-only phosphate lowering therapies (PLTs) in the End-Stage Renal Disease Prospective Payment System (ESRD PPS).

The plaintiffs argue that this move violates statutory authority under MIPPA and will negatively impact patient choice and timely access to important medications. They seek to prevent CMS from including XPHOZAH in the ESRD PPS and eliminating coverage under Medicare Part D starting January 1, 2025.

XPHOZAH, approved by the FDA in October 2023, is a first-in-class phosphate absorption inhibitor for adults with chronic kidney disease on dialysis. The lawsuit aims to protect dialysis patients' access to new therapies and maintain incentives for developing innovative medicines in this underserved therapeutic area.

Ardelyx has decided not to apply for the CMS TDAPA for its phosphate absorption inhibitor, XPHOZAH (tenapanor), to maintain patient access. The company supports bipartisan legislation that aims to extend the exclusion of oral-only medications from the CMS Prospective Payment System. This decision follows Ardelyx's analysis of the CMS policy, determining that including XPHOZAH in the Medicare PPS would significantly restrict its usage and hinder patient access. XPHOZAH, approved by the FDA in October 2023, is the only therapy for patients with inadequate response to phosphate binders, offering a unique mechanism to reduce serum phosphorus in CKD patients on dialysis. A conference call is scheduled for July 2, 2024, at 8:00 AM ET to discuss the announcement.

Ardelyx (Nasdaq: ARDX) presented new data on the educational needs related to the management of irritable bowel syndrome with constipation (IBS-C) across healthcare disciplines at the 2024 American Association of Nurse Practitioners (AANP) Annual Conference.

The findings, based on a survey of 410 healthcare professionals, highlighted significant differences in diagnostic criteria, testing methodologies, referral tendencies, and pain assessment approaches between nurse practitioners/physician assistants and physicians.

Additionally, the data showed that gastroenterology specialists are more likely to prescribe medications like linaclotide, plecanatide, or tenapanor for IBS-C patients avoiding social events due to discomfort, whereas primary care physicians prefer neuromodulators.

These insights underscore the need for tailored educational programs to address the specific requirements of various healthcare roles.

Ardelyx (Nasdaq: ARDX), a biopharmaceutical company, announced on May 30, 2024, that its compensation committee granted stock options and Restricted Stock Units (RSUs) to 23 new non-executive employees on May 23, 2024. A total of 210,000 stock options and 179,050 RSUs were awarded. The options have an exercise price of $7.44 per share, reflecting the closing price on the grant date. Both stock options and RSUs vest over four years with specific vesting schedules. These grants were made under Nasdaq Listing Rule 5635(c)(4) to incentivize employment.

Ardelyx, a biopharmaceutical company (Nasdaq: ARDX), will participate in the 2024 Jefferies Global Healthcare Conference. Michael Raab, President and CEO, alongside Justin Renz, Chief Financial and Operations Officer, will engage in a fireside chat on June 5, 2024, at 10:00 A.M. Eastern Time in New York City. The event will be accessible via live webcast on the Ardelyx website, with a replay available for 30 days after the event.