Ardelyx Stock Price, News & Analysis

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.

Ardelyx, Inc. (Nasdaq: ARDX) announced its participation in three investor conferences in September 2020. The first event is Citi's 15th Annual BioPharma Virtual Conference on September 9. Then, they will present at the 22nd Annual H.C. Wainwright Global Investment Conference on September 14 at 5:00 p.m. E.T., followed by the Cantor Fitzgerald Global Healthcare Conference on September 17 at 12:40 p.m. E.T. Webcasts of the presentations will be available on Ardelyx's website, with replays for 30 days post-conference.

Ardelyx, Inc. (Nasdaq: ARDX) reported its second quarter results for 2020, with a focus on its first-in-class therapy tenapanor for chronic kidney disease (CKD) patients on dialysis. The company submitted a New Drug Application (NDA) to the FDA for tenapanor and expects feedback by September 2020. Financially, Ardelyx reported $1.8 million in revenue and a net loss of $25 million. R&D expenses decreased by 3% to $18.9 million. The company strengthened its leadership by hiring a new CFO and CCO.

Ardelyx, Inc. announced that its innovative therapy, tenapanor, has been named a finalist in the Fierce Innovation Awards for biotech innovation. This first-in-class treatment, aimed at controlling serum phosphorus levels in chronic kidney disease patients on dialysis, is backed by three successful Phase 3 studies. The awards recognize effectiveness and innovation, as reviewed by industry experts. Ardelyx submitted an NDA for tenapanor to the FDA on June 30, 2020, addressing a significant unmet need among dialysis patients, with a substantial risk of cardiovascular issues and mortality.