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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) reported its fourth quarter and full-year financial results for 2020, highlighting a net loss of $94.3 million, a slight improvement from $94.9 million in 2019. Total revenue reached $7.6 million, reflecting an increase from $5.3 million year-over-year, mainly due to collaboration partnerships. The company anticipates the FDA’s decision on tenapanor, a phosphate absorption inhibitor, by April 29, 2021. Ardelyx's cash resources stand at $188.6 million, projected to fund operations into the second half of 2022.
Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical firm specializing in treatments for kidney and cardiovascular diseases, will have its CEO, Mike Raab, participate in a fireside chat at the 10th Annual SVB Leerink Global Healthcare Conference on February 24, 2021, at 3:00 p.m. ET. The event can be accessed through Ardelyx's Events and Presentations page, with a replay available for 60 days post-event. Ardelyx is advancing tenapanor, aimed at controlling serum phosphorus in CKD dialysis patients, with an NDA under FDA review and a PDUFA date set for April 29, 2021.
Ardelyx, Inc. (Nasdaq: ARDX) announced that a webcast featuring CEO Mike Raab and CCO Susan Rodriguez will take place at the Piper Sandler 32nd Annual Virtual Healthcare Conference today at 10 a.m. ET. The webcast can be accessed on the Ardelyx website under the Events and Presentations section, with a replay available for 60 days post-presentation. Ardelyx is currently advancing tenapanor for controlling serum phosphorus in CKD patients on dialysis, with an FDA NDA review and a PDUFA date set for April 29, 2021. The company also focuses on hyperkalemia treatments and has established international partnerships.
Ardelyx, Inc., a biopharmaceutical company, announced that Mike Raab, CEO, will participate in a fireside chat at the Jefferies Virtual London Healthcare Conference on November 17, 2020, at 1:10 p.m. ET. The live webcast can be accessed via the Investor section of the Ardelyx website, with replays available for 60 days post-event. Ardelyx focuses on innovative therapies for kidney and cardiovascular diseases, including tenapanor, currently under FDA review with a PDUFA date of April 29, 2021, and has established international partnerships for its development.
Ardelyx, Inc. (Nasdaq: ARDX) announces a virtual Analyst Day on November 12, 2020, from 9:30 a.m. to 12:00 p.m. ET. This event will focus on the company's plans for the launch of tenapanor, aimed at controlling serum phosphorus in adults with chronic kidney disease (CKD) on dialysis, pending FDA approval. Experts such as German Hernandez, M.D., and Jennifer Robinson will present insights on the drug's profile and challenges in treating hyperphosphatemia. Live streaming will be available on Ardelyx's investor relations webpage.
Ardelyx, Inc. (Nasdaq: ARDX) reported its third-quarter 2020 financial results, highlighting key advancements in its drug development pipeline. The FDA accepted its New Drug Application for tenapanor, aiming for a potential launch by April 29, 2021, to treat hyperphosphatemia in dialysis patients. Three successful Phase 3 trials supported this application. The company reported $2.7 million in revenue but a net loss of $18.1 million for the quarter. Cash reserves declined to $185.5 million, while R&D expenses decreased by 30% to $12.2 million, reflecting the completion of several clinical trials.
Ardelyx, Inc. (Nasdaq: ARDX) and Kyowa Kirin Co., Ltd. presented new clinical data on tenapanor at Kidney Week 2020. The posters include results from Ardelyx's Phase 3 trials (BLOCK, AMPLIFY, PHREEDOM) and Kyowa Kirin's Phase 2 Japanese studies. Tenapanor is under FDA review for controlling serum phosphorus in chronic kidney disease (CKD) patients on dialysis. Notable findings include significant reductions in serum phosphorus levels and good tolerability. The PDUFA date is set for April 29, 2021.
Ardelyx, Inc. (Nasdaq: ARDX) launched its 'Can We Do Better?' campaign at Kidney Week 2020, highlighting the challenges of hyperphosphatemia in chronic kidney disease patients on dialysis. The campaign emphasizes the limitations of current phosphate binders, which fail to maintain target phosphorus levels for 77% of patients over six months. Ardelyx aims to develop targeted therapies based on new insights into phosphate absorption mechanisms. The lead candidate, tenapanor, is under FDA review for controlling serum phosphorus levels.
Ardelyx, Inc. (Nasdaq: ARDX) announced the acceptance of five abstracts on tenapanor for presentation at ASN's Kidney Week 2020 from October 22-25, 2020. Tenapanor is under FDA review for controlling serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Notably, three posters will present data from pivotal Phase 3 trials, including BLOCK, AMPLIFY, and PHREEDOM. Their partner in Japan, Kyowa Kirin, will also present data from two Phase 2 studies on tenapanor's efficacy in Japanese hemodialysis patients.
Ardelyx, Inc. (Nasdaq: ARDX) announced the FDA's acceptance of its New Drug Application (NDA) for tenapanor, aimed at controlling serum phosphorus in adults with chronic kidney disease (CKD) on dialysis. The NDA is backed by three successful Phase 3 trials involving over 1,000 patients. The FDA set a Prescription Drug User Fee Act (PDUFA) goal date of April 29, 2021. Ardelyx promotes tenapanor as a first-in-class, oral treatment that addresses hyperphosphatemia, a condition affecting over 745,000 dialysis patients and linked to higher morbidity and mortality rates.
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