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. reported a successful year for 2022, highlighted by $15.6 million in net product sales for its IBS treatment, IBSRELA. The company ended Q4 2022 with $123.9 million in cash and investments. Ardelyx announced plans to resubmit the XPHOZAH New Drug Application in early Q2 2023, following favorable discussions with the FDA. Collaboration revenue surged to $36.6 million, a significant increase from $10.1 million in 2021. However, the company recorded a net loss of $67.2 million for 2022, an improvement from the previous year's loss of $158.2 million. Ardelyx continues to focus on expanding its product offerings and achieving growth in 2023.
Ardelyx, Inc. (Nasdaq: ARDX) announced participation by CEO Mike Raab in a GI/Microbiome panel at the Cowen 43rd Annual Health Care Conference on March 6, 2023, at 9:10 A.M. ET in Boston, MA. The event will be accessible via a live webcast on the Ardelyx website.
Ardelyx focuses on developing innovative medicines addressing unmet medical needs. Its products include IBSRELA (tenapanor) and XPHOZAH (for chronic kidney disease), which has completed three Phase 3 trials. Ardelyx collaborates with Kyowa Kirin, Fosun Pharma, and Knight Therapeutics for product development globally.
Ardelyx, Inc. (Nasdaq: ARDX) announced a conference call on March 2, 2023, at 4:30 p.m. Eastern Time to discuss its fourth quarter and full year 2022 financial results and provide a business update. The call will be accessible via phone or webcast, with an archive available for 30 days after. Ardelyx is focused on developing innovative medicines for unmet medical needs, including its first product, IBSRELA® (tenapanor), and other candidates like XPHOZAH® and RDX013. The company has established international agreements for tenapanor's development and commercialization.
On January 27, 2023, Ardelyx, Inc. (Nasdaq: ARDX) granted stock options and Restricted Stock Units (RSUs) to 23 new non-executive employees. The total awarded includes 614,064 stock options with an exercise price of $2.85, matching the closing price on the grant date, and 236,333 RSUs. The stock options vest over four years, with 25% vesting on the first anniversary and the rest monthly. The RSUs follow a similar vesting schedule, with 25% vesting on the first quarterly RSU date after the first anniversary. These grants were made as inducements to attract new talent in accordance with Nasdaq rules.
Ardelyx has announced that the FDA's Office of New Drugs has approved its appeal for the NDA of XPHOZAH, aimed at treating hyperphosphatemia in chronic kidney disease patients. This decision directs the FDA's Division of Cardiology and Nephrology to collaborate with Ardelyx on labeling for commercialization. XPHOZAH would be the first phosphate absorption inhibitor, providing a new treatment option for over 400,000 dialysis patients struggling with phosphorus control. The company plans to resubmit the NDA in the first half of 2023.
On December 16, 2022, Ardelyx, Inc. (Nasdaq: ARDX) announced employment inducement grants for 17 non-executive employees, totaling 271,735 stock options and 123,375 Restricted Stock Units (RSUs). The stock options have an exercise price of $1.96, aligning with the company's closing stock price on the grant date. Both stock options and RSUs will vest over four years. Ardelyx is dedicated to developing innovative treatments for unmet medical needs, with products like IBSRELA and ongoing clinical trials for other candidates.
Ardelyx, Inc. (Nasdaq: ARDX) provided an update on its appeal regarding the Complete Response Letter for its New Drug Application for XPHOZAH (tenapanor). A meeting was held with Peter Stein, M.D. from the FDA, who indicated that the review of the appeal is being finalized and may take a few more weeks. Ardelyx's focus is on innovative medicines for unmet medical needs, including XPHOZAH for controlling serum phosphorus in chronic kidney disease patients on dialysis, following three successful Phase 3 trials.
Ardelyx, Inc. (Nasdaq: ARDX) announced its participation in the 34th Annual Piper Sandler Healthcare Conference on December 1, 2022, at 10:00 a.m. ET in New York City. The management will engage in a fireside discussion, highlighting the company’s mission to innovate first-in-class medicines for unmet medical needs. Ardelyx's first product, IBSRELA® (tenapanor), is already available in the U.S. and Canada. The company is also advancing its product candidate, XPHOZAH® (tenapanor), for treating serum phosphorus in CKD patients on dialysis, following successful Phase 3 trials.
Ardelyx, Inc. announced positive outcomes from the FDA's Cardiovascular and Renal Drugs Advisory Committee (CRDAC) for its drug XPHOZAH. The committee voted 9:4 in favor of XPHOZAH as a monotherapy and 10:2 for its use with phosphate binders. If approved, XPHOZAH will become the first phosphate absorption inhibitor available. The Office of New Drugs will respond to Ardelyx's appeal within 30 days. The committee's support is based on three Phase 3 trials involving over 1,200 patients, which met primary and secondary endpoints.
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