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 biopharmaceutical company pioneering first-in-class therapies for renal and gastrointestinal disorders. This news hub provides investors and healthcare professionals with essential updates on clinical trials, regulatory milestones, and strategic partnerships.
Discover official press releases covering tenapanor developments, hyperphosphatemia research breakthroughs, and international collaboration updates with partners in Japan and China. Our curated collection includes financial results, manufacturing announcements, and expert analyses of ARDX's novel drug discovery platform.
Key content categories include FDA regulatory updates, phase 3 clinical trial results, partnership expansions, and financial performance reports. All materials maintain strict compliance with financial disclosure regulations while presenting complex medical information in accessible language.
Bookmark this page for real-time updates on ARDX's progress in developing treatments for chronic kidney disease and IBS-C. Regularly refreshed content ensures you stay informed about this innovative biotech leader's contributions to renal care and gastrointestinal health.
Ardelyx, Inc. (Nasdaq: ARDX) announced that its partner Kyowa Kirin has begun four Phase 3 clinical trials in Japan for tenapanor, aimed at treating hyperphosphatemia. This milestone triggers a $5 million payment to Ardelyx. The trials include various study designs assessing tenapanor's effectiveness in patients with chronic kidney disease (CKD) on dialysis. Ardelyx is expecting a PDUFA date on April 29, 2021, for tenapanor's review by the FDA. The collaboration could yield up to $55 million in total development milestones and significant sales royalties.
Ardelyx, Inc. (Nasdaq: ARDX) announced the presentation of a poster at the ISN World Congress of Nephrology 2021, highlighting data from its NORMALIZE Phase 4 trial. This study evaluates the efficacy of tenapanor alone or with sevelamer in achieving normal serum phosphorus levels in chronic kidney disease patients on dialysis. The virtual event will occur from April 16-19, 2021. Additionally, Ardelyx is advancing tenapanor for FDA review, with a PDUFA date of April 29, 2021, and has received FDA approval for IBSRELA (tenapanor) on September 12, 2019.
Ardelyx, Inc. (Nasdaq: ARDX) announced its participation in the National Kidney Foundation 2021 Spring Clinical Meeting, taking place virtually from April 6-10, 2021. The company will present two posters focused on phosphate absorption and hyperphosphatemia management. Additionally, Ardelyx is sponsoring an educational session on hyperphosphatemia management and an exhibitor showcase. Their product candidate, tenapanor, is under review by the FDA, with a PDUFA date of April 29, 2021, aimed at controlling serum phosphorus in chronic kidney disease patients on dialysis.
Ardelyx, Inc. (Nasdaq: ARDX) appointed Muna Bhanji, R.Ph, to its board of directors on March 11, 2021, while Gordon Ringold, Ph.D., stepped down the same day. Bhanji, with over 30 years of experience in biopharmaceuticals, previously held leadership roles at Merck and focuses on drug access and affordability. Her guidance is expected to aid Ardelyx as it approaches the potential launch of tenapanor, a treatment for chronic kidney disease patients on dialysis, with FDA review ongoing ahead of a PDUFA date of April 29, 2021. Ardelyx aims to enhance patient access while continuing to advance innovative therapies.
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.