Welcome to our dedicated page for Ardelyx news (Ticker: ARDX), a resource for investors and traders seeking the latest updates and insights on Ardelyx stock.
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 (ARDX) has received approval from China's Center for Drug Evaluation for tenapanor, a treatment to control serum phosphorus levels in dialysis patients with chronic kidney disease who have inadequate response or intolerance to phosphorus binders. The approval triggers a $5 million milestone payment from their Chinese partner Fosun Pharma.
Under the agreement, Ardelyx is eligible for additional milestones up to $100 million and tiered royalties of mid-teens to 20% on net sales. The drug will be marketed in China as 'Wan Ti Le'. The approval is particularly significant given that China has over one million maintenance hemodialysis patients, growing at 12% annually, with 76% experiencing hyperphosphatemia. Currently, only 39% of patients achieve target phosphate levels under China's hemodialysis standards.
Ardelyx (NASDAQ: ARDX) has announced its participation in three major healthcare investor conferences in March 2025. The company will present at the Leerink Partners 2025 Global Healthcare Conference on March 11 at 8:00 a.m. ET, attend the Jefferies Biotech on the Beach Summit on March 12, and participate in a fireside chat at the Barclays 27th Annual Global Healthcare Conference on March 13 at 10:00 a.m. ET.
All events will take place in Miami, FL. Live webcasts of the Leerink presentation and Barclays fireside chat will be available on the Events and Presentations page of the Ardelyx website (ir.ardelyx.com), with replays accessible for 30 days following each event. The company will also conduct one-on-one meetings during all three conferences.
Ardelyx (ARDX) reported strong financial results for FY 2024, with total revenue reaching $333.6 million, including $319.2 million in U.S. Net Product Sales. IBSRELA achieved $158.3 million in net product sales, while XPHOZAH recorded $160.9 million in its first full year of commercialization.
The company ended 2024 with $250.1 million in cash and investments, up from $184.3 million in 2023. Net loss for 2024 was $39.1 million ($0.17 per share), improved from $66.1 million ($0.30 per share) in 2023. Ardelyx reaffirms combined peak sales expectations of $1.75 billion for both products, with IBSRELA projected to achieve over $1 billion and XPHOZAH expected to reach $750 million in annual U.S. net product sales before patent expiration.
Ardelyx (ARDX) has announced its upcoming participation at TD Cowen's 45th Annual Health Care Conference. The company's management will deliver a presentation on Monday, March 3, 2025, at 9:50am ET in Boston.
The presentation will be accessible via live webcast through the Events and Presentations page on Ardelyx's investor relations website. Interested parties can view a replay of the panel presentation on the company's website for 30 days following the event.
Ardelyx is a biopharmaceutical company focused on discovering, developing, and commercializing innovative, first-in-class medicines addressing significant unmet medical needs.
Ardelyx (ARDX) has scheduled a conference call for Thursday, February 20, 2025, at 8:00 a.m. Eastern Time to discuss its full year and fourth quarter 2024 financial results and provide a business update. Participants can join via phone by dialing (877) 346-6112 (domestic) or (848) 280-6350 (international). The call will also be webcast live on the company's website under the Investors section, with a replay available for 30 days following the call.
Ardelyx (ARDX) reported strong commercial performance for 2024, with total U.S. net product sales of approximately $319 million. IBSRELA achieved approximately $158 million in net product sales, with $54 million in Q4 alone. The company expects 2025 IBSRELA sales between $240-250 million, reaffirming its peak sales potential of over $1 billion.
XPHOZAH recorded approximately $161 million in net product sales during its first full year, including $57 million in Q4. The company projects peak annual sales of $750 million for XPHOZAH. As of December 31, 2024, Ardelyx maintained a strong financial position with approximately $250 million in cash, cash equivalents, and investments, with approximately 238 million shares outstanding.
Ardelyx, a biopharmaceutical company, announced that its President and CEO, Mike Raab, will present at the 43rd Annual J.P. Morgan Healthcare Conference. The presentation is scheduled for Wednesday, January 15, 2025 at 4:30pm PT in San Francisco.
Ardelyx is focused on discovering, developing, and commercializing innovative, first-in-class medicines to address significant unmet medical needs. Interested parties can access the live webcast of the presentation on the Ardelyx website. A replay will be available for 30 days post-event.
Ardelyx (ARDX) has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company's Chief Financial and Operations Officer, Justin Renz, and Chief Commercial Officer, Eric Foster, will engage in a fireside chat on Wednesday, December 4, 2024, at 12:30pm EST in New York City.
The presentation will be accessible via live webcast on the Events and Presentations page of Ardelyx's website, with a replay available for 30 days following the event.
Ardelyx (ARDX) faces a setback as the U.S. District Court dismisses their lawsuit against CMS's decision to include oral-only phosphate-lowering therapies in the ESRD PPS starting January 1, 2025. This decision affects XPHOZAH, Ardelyx's FDA-approved therapy for reducing serum phosphorus in adults with chronic kidney disease on dialysis. The company argues this inclusion in the bundled payment system will restrict patient access to essential medications. CEO Mike Raab expressed disappointment, stating the decision could harm dialysis patients' access to optimal care. Ardelyx is reviewing the court's decision and considering all legal options while urging Congress to pass the Kidney PATIENT Act.
Ardelyx (ARDX) has announced its participation in the 2024 Jefferies London Healthcare Conference. The company's leadership team, including President and CEO Michael Raab, CFO Justin Renz, and CCO Eric Foster, will engage in a fireside chat on Tuesday, November 19, 2024, at 12:30pm GMT / 7:30am EST in London.
The presentation will be accessible via live webcast on the Events and Presentations page of Ardelyx's website, with a replay available for 30 days following the event.
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