Ardelyx Stock Price, News & Analysis

Ardelyx, Inc. (Nasdaq: ARDX) has announced the resubmission of a New Drug Application (NDA) for XPHOZAH (tenapanor) targeting serum phosphate control in adults with chronic kidney disease (CKD) on dialysis. This NDA supports over 1,200 patients' data from three successful Phase 3 trials and two Phase 4 trials, all meeting critical endpoints. Confirmation of the resubmission's completeness from the FDA is anticipated by mid-May. XPHOZAH functions as a phosphate absorption inhibitor, requiring a simple dosing regimen of one 30mg tablet twice daily. Hyperphosphatemia, affecting many CKD patients, underscores the drug's potential significance. Ardelyx continues to pursue innovative treatments for unmet medical needs.

Ardelyx, Inc. (Nasdaq: ARDX) announced on April 10, 2023, that its compensation committee granted stock options and Restricted Stock Units (RSUs) to seven new non-executive employees. A total of 238,426 shares in stock options and 89,250 RSUs were awarded, with the exercise price set at $4.26 per share, corresponding to the company's closing stock price on the grant date. The stock options will vest over four years, while the RSUs will also vest over the same period, with varying percentages vesting at specified intervals. This move is in compliance with Nasdaq Listing Rule 5635(c)(4) and is intended to incentivize new employees.

Ardelyx is focused on developing innovative medicines, including its FDA-approved product IBSRELA and ongoing studies for its candidates targeting kidney-related health issues.

Ardelyx, Inc. (Nasdaq: ARDX) announced positive clinical findings for XPHOZAH at the National Kidney Foundation 2023 Spring Clinical Meetings. XPHOZAH, a novel phosphate absorption inhibitor, demonstrated efficacy in lowering serum phosphate levels in patients with chronic kidney disease (CKD) on maintenance dialysis. Data from three Phase 3 pivotal trials showed that XPHOZAH reduced serum phosphate consistently across diverse patient demographics, with results comparable to sevelamer. Additionally, XPHOZAH effectively lowered elevated fibroblast growth factor 23 (iFGF23) levels. Notably, the medication's dosing regimen of one tablet twice daily reduces pill burden for patients. The most common adverse effect reported was diarrhea, consistent with previous studies.

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.