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 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) 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.
Ardelyx, Inc. (Nasdaq: ARDX) announced that Nasdaq has halted trading of its common stock in light of ongoing discussions by the FDA's Cardiovascular and Renal Drugs Advisory Committee regarding its New Drug Application for XPHOZAH (tenapanor). This meeting, scheduled for November 16, 2022, will evaluate XPHOZAH's efficacy in managing serum phosphorus in adult patients with chronic kidney disease on dialysis. The outcome of this meeting could significantly impact Ardelyx's market position and future developments.
FAQ
What is the current stock price of Ardelyx (ARDX)?
What is the market cap of Ardelyx (ARDX)?
What is Ardelyx, Inc. focused on?
What are the main products of Ardelyx?
How has Ardelyx performed financially in recent years?
What strategic partnerships does Ardelyx have?
What is tenapanor used for?
What is the ArdelyxAssist™ program?
What is the financial status of Ardelyx?
Where can investors find more information about Ardelyx?
What recent achievements has Ardelyx made?
What future plans does Ardelyx have?
