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. announced it may receive up to $20 million from HealthCare Royalty Partners for future royalties from its collaboration with Kyowa Kirin on tenapanor for hyperphosphatemia. This financing validates the potential of tenapanor in Japan. Ardelyx will get $10 million upfront, $5 million post-regulatory approval, and another $5 million upon meeting sales targets. Overall, Ardelyx could gain $85 million in non-dilutive capital from Kyowa Kirin's development progress, despite reduced royalty rates from high teens to mid-single digits during the agreement period.
Ardelyx, Inc. (Nasdaq: ARDX) announced that the FDA has scheduled a meeting of the Cardiovascular and Renal Drugs Advisory Committee on November 16, 2022. This meeting will review the New Drug Application (NDA) for XPHOZAH, which aims to control serum phosphorus in adult patients with chronic kidney disease on dialysis. The FDA highlighted the need for expert input regarding the phosphate-lowering effect observed in Ardelyx's Phase 3 trials. A formal response to Ardelyx's appeal is expected within 30 days post-meeting.
Ardelyx, Inc. (Nasdaq: ARDX) has announced that CEO Mike Raab will participate in a fireside chat at the Jefferies Healthcare Conference on June 10, 2022, at 8:30 a.m. ET in New York City. The event aims to showcase Ardelyx's innovative biopharmaceutical developments, including its approved product IBSRELA and the candidate XPHOZAH, which targets serum phosphorus control in CKD patients. A live webcast of the presentation will be available on the company’s investor website, with a replay accessible for 30 days.
On May 24, 2022, Ardelyx presented new data on IBSRELA from Phase 3 trials T3MPO-1 and T3MPO-2 at the Digestive Disease Week Conference. The presentations highlighted IBSRELA's safety and efficacy in adults with irritable bowel syndrome with constipation (IBS-C). Results showed significant symptom relief, treatment satisfaction, and quality of life improvements compared to placebo. IBSRELA is FDA-approved for treating IBS-C and offers a novel mechanism for addressing this condition, impacting millions in the US.
Ardelyx, Inc. (Nasdaq: ARDX) announced that new data highlighting the efficacy and safety of IBSRELA will be presented at the 2022 Digestive Disease Week Conference from May 21-24, 2022. Key presentations include findings on long-term treatment with Tenapanor for IBS-C and its impact on patient satisfaction and early onset of action. Additionally, Ardelyx is sponsoring a Product Theater featuring expert discussions on IBSRELA’s innovative treatment approach and trial efficacy data. Safety warnings for pediatric use are emphasized due to dehydration risks.
Ardelyx, Inc. (Nasdaq: ARDX) announced that new data showcasing the efficacy and safety of IBSRELA (tenapanor) will be presented at the 2022 Digestive Disease Week Conference (DDW) from May 21-24 in San Diego, California. The presentations include three posters focusing on long-term treatment benefits and patient quality of life. Additionally, Ardelyx will sponsor a Product Theater on May 23, discussing IBSRELA's innovative approach in treating Irritable Bowel Syndrome with Constipation (IBS-C). IBSRELA is indicated for adults and has demonstrated promise in improving symptoms.
On May 16, 2022, Ardelyx, Inc. (NASDAQ: ARDX) announced the granting of stock options and Restricted Stock Units (RSUs) to new non-executive employees as part of their employment inducements. A total of 26,953 stock options and 29,250 RSUs were granted, with each stock option priced at $0.72, the company's closing stock price on the grant date. The options vest over four years, while RSUs follow a similar vesting schedule. Ardelyx continues its mission to develop innovative medicines, with ongoing programs targeting significant medical needs.
Ardelyx, Inc. (Nasdaq: ARDX) reported its first quarter 2022 results, showing a cash position of $89.7 million, down from $116.7 million in Q4 2021. The company recognized $0.5 million in product sales from IBSRELA, its first FDA-approved product for IBS-C. Collaboration revenue decreased to $18,000 from $6.6 million year-over-year. R&D expenses fell by 56.7% to $8.9 million, while SG&A expenses rose 12.9% to $19.3 million. The net loss for Q1 2022 was $28.1 million ($0.21 per share), an improvement from a $33.2 million loss in Q1 2021. A conference call was scheduled for 4:30 PM ET today.
Ardelyx, Inc. (NASDAQ: ARDX) will hold a conference call on May 5, 2022, at 4:30 PM ET to discuss its first quarter 2022 financial results and provide a business update. The company, focused on developing innovative medicines, has completed three successful Phase 3 trials for its product candidate XPHOZAH (tenapanor) designed to control serum phosphorus in CKD patients on dialysis. Ardelyx is also advancing treatments for potassium management and metabolic acidosis, with partnered development in Japan, China, and Canada.
Ardelyx announced an interim response from the FDA regarding its appeal for XPHOZAH's New Drug Application (NDA), initially denied in July 2021. The FDA's Office of New Drugs emphasized the need for input from expert clinicians through an Advisory Committee meeting to evaluate the phosphate-lowering effects demonstrated in the Phase 3 trials for XPHOZAH, intended for patients with chronic kidney disease on dialysis. Ardelyx expects a response within 30 days post-meeting.
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