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Ardelyx, Inc. (Nasdaq: ARDX) is a biotechnology company focused on the discovery, development, and commercialization of innovative, first-in-class medicines that address significant unmet medical needs. The company's mission is to enhance the treatment of renal and gastrointestinal diseases through its proprietary drug discovery and design platform.
One of Ardelyx's lead products is tenapanor, which has been developed to reduce the absorption of dietary sodium and phosphorus. It is being investigated for multiple conditions, including hyperphosphatemia in patients with end-stage renal disease on dialysis and irritable bowel syndrome with constipation (IBS-C). The company has made significant strides in these areas, recently gaining FDA approval for tenapanor under the brand names IBSRELA® and XPHOZAH®. IBSRELA is targeted at treating IBS-C, while XPHOZAH is aimed at controlling serum phosphorus levels in patients with chronic kidney disease on dialysis.
Ardelyx has also forged strategic partnerships to extend the reach of its therapies globally. This includes collaborations with Kyowa Kirin in Japan, Fosun Pharma in China, and Knight Therapeutics in Canada. Notably, Kyowa Kirin commercializes PHOZEVEL® (tenapanor) for hyperphosphatemia in Japan, while a New Drug Application for the same indication is under review in China.
In its latest financial update, Ardelyx reported strong revenue growth for IBSRELA, achieving approximately $80 million in net product sales revenue for its first full year of commercialization. The company anticipates even higher sales in 2024, projecting revenues between $140 million and $150 million. Additionally, XPHOZAH, which launched in November 2023, recorded $2.5 million in net product sales revenue in its first quarter. To support these products, Ardelyx is investing in expanding its sales team and digital capabilities, as well as enhancing its patient services through the ArdelyxAssist™ program.
As of December 31, 2023, Ardelyx maintained a strong cash position with approximately $184 million in cash, cash equivalents, and short-term investments. The company’s financial stability and continuous investment in its robust R&D pipeline underscore its commitment to advancing the standard of care for patients with renal and gastrointestinal diseases.
Ardelyx continues to engage with the medical community and investors through various platforms, including regular webcasts and conferences. The company remains focused on executing its commercial strategy, expanding market penetration, and exploring new avenues for growth through internal development and external partnerships.
Ardelyx, Inc. (Nasdaq: ARDX) announced the publication of a review article titled 'Review of the Patient Burden and Therapeutic Landscape of Irritable Bowel Syndrome With Constipation in the United States' in Clinical and Experimental Gastroenterology. The article provides an overview of treatment options and disease management for irritable bowel syndrome with constipation (IBS-C) from a U.S. perspective.
Key points from the article include:
- The high disease burden of IBS-C, affecting economic, social, and mental health aspects
- The importance of the patient-healthcare provider relationship in diagnosis and treatment
- Recommendation for a positive diagnostic strategy based on clinical history, physical examination, and minimal laboratory tests
- Review of the treatment journey, from lifestyle interventions to FDA-approved therapies
- Mention of IBSRELA® (tenapanor) as one of the approved therapies, with data from T3MPO-1 and T3MPO-2 studies included
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company focused on developing innovative, first-in-class medicines, has announced its participation in the 2024 Cantor Global Healthcare Conference. Justin Renz, the company's Chief Financial and Operations Officer, will engage in a fireside chat on Thursday, September 19, 2024, at 9:10 A.M. Eastern Time in New York City.
Interested parties can access a live webcast of the panel presentation through the Events and Presentations page on the Ardelyx website. For those unable to attend, a replay of the fireside chat will be available on the company's website for 30 days following the event, providing an opportunity for investors and stakeholders to gain insights into Ardelyx's operations and future plans.
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.
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