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. announced that its partner, Kyowa Kirin, has submitted a New Drug Application (NDA) to the Japanese Ministry of Health for tenapanor, aimed at treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. This submission triggers $35 million in milestone payments for Ardelyx. The NDA is underpinned by data from four Phase 3 trials demonstrating tenapanor's efficacy in lowering serum phosphorus levels. In the U.S., Ardelyx continues to pursue approval for tenapanor, branded as XPHOZAH, with a review scheduled for November 16, 2022.
Ardelyx, Inc. (Nasdaq: ARDX) will hold a conference call on November 3, 2022, at 4:30 p.m. Eastern Time to discuss its third quarter 2022 financial results and provide a business overview. This call can be accessed by dialing (866) 374-5140 domestically or (404) 400-0571 internationally, with a pin code of 79680409#. The audio will also be webcasted and archived for 30 days on the company's website. Ardelyx’s first product, IBSRELA®, is available in the U.S. and Canada, and it is developing additional medicines to address unmet medical needs.
Ardelyx, Inc. (Nasdaq: ARDX) announced the presentation of post-hoc analyses from its Phase 3 T3MPO trials at the ACG 2022 Annual Scientific Meeting in Charlotte, NC, from October 21-26, 2022. The studies highlight the benefits of IBSRELA (tenapanor) in treating Irritable Bowel Syndrome with Constipation (IBS-C), including improved abdominal symptom scores and spontaneous bowel movement responses. Two posters will be presented on October 24 and 25, 2022, while a Product Theater session will discuss IBSRELA's safety and efficacy on October 24, 2022.
Ardelyx, Inc. (Nasdaq: ARDX) announced three poster presentations for its investigational phosphate absorption inhibitor, XPHOZAH (tenapanor), at the American Society of Nephrology Kidney Week 2022 from November 3-6 in Orlando, Florida. These posters will detail results from three Phase 3 trials involving adult patients with chronic kidney disease on dialysis. Collaborator Kyowa Kirin will also present findings from two Phase 3 trials in Japan. Tenapanor aims to manage hyperphosphatemia, affecting over 745,000 dialysis patients globally.
Ardelyx, Inc. (Nasdaq: ARDX) announced on Sept. 26, 2022, that its compensation committee granted options for 56,250 shares and 26,000 Restricted Stock Units (RSUs) to four new non-executive employees. Each stock option has an exercise price of $1.13 per share, equal to the trading price on the date of grant. The options and RSUs serve as inducements for employment, with vesting schedules over four years. Ardelyx's work includes innovative treatments for unmet medical needs such as IBSRELA and candidates like XPHOZAH for CKD patients.
Ardelyx, Inc. (Nasdaq: ARDX) announced its upcoming participation in several significant investor conferences. These include Citi's 17th Annual BioPharma Conference on September 8, 2022, in Boston, MA, and the H.C. Wainwright 24th Annual Global Investment Conference on September 13, 2022, in New York City/Virtual, where a presentation will be available on-demand. Additionally, the Ladenburg Thalmann 2022 Healthcare Conference will take place on September 29, 2022, in New York City. Ardelyx aims to develop innovative treatments for unmet medical needs, including products like IBSRELA® and XPHOZAH®.
Ardelyx reported its Q2 2022 results, highlighting a successful launch of IBSRELA for IBS-C, with net product sales of $1.6 million. The company enjoys strong market visibility, with 41% of surveyed GIs already using IBSRELA. R&D expenses significantly decreased by 62.6% to $9.7 million, while SG&A expenses fell by 6.3% to $18.9 million. The net loss improved to $26.9 million or $0.19 per share, compared to $45.2 million or $0.45 per share in Q2 2021. Additionally, a $20 million financing agreement was secured with HealthCare Royalty Partners.
Ardelyx, Inc. (Nasdaq: ARDX) announced that CEO Mike Raab will participate in a virtual fireside chat at the 2022 Wedbush PacGrow Healthcare Conference. The chat is scheduled for August 9, 2022, at 4:40 p.m. ET. Interested parties can access the live webcast through the Investor section of the Ardelyx website, with a replay available for 30 days post-conference. Ardelyx focuses on developing innovative medicines to address significant medical needs, including their approved product IBSRELA and products in development for conditions like CKD and hyperkalemia.
Ardelyx, Inc. (Nasdaq: ARDX) will hold a conference call on August 4, 2022, at 4:30 p.m. Eastern Time to discuss its second quarter 2022 financial results and provide a business overview. The call will be accessible via telephone registration through an online form, and a live audio webcast will also be available on Ardelyx's website. Ardelyx focuses on developing innovative medicines, including its approved product IBSRELA® and the pipeline candidates XPHOZAH® and RDX013, targeting significant medical needs.
On June 28, 2022, Ardelyx, Inc. (Nasdaq: ARDX) announced the granting of stock options and Restricted Stock Units (RSUs) to six new non-executive employees as employment inducements. The options total 332,483 shares, priced at $0.57, the closing stock price on the grant date, while RSUs amount to 83,375 shares. Both stock options and RSUs vest over four years. Ardelyx focuses on developing innovative medicines, including IBSRELA® and XPHOZAH®, with partnerships in Japan, China, and Canada.
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