Ardelyx Stock Price, News & Analysis

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.

Ardelyx, Inc. reported financial results for Q3 2022, highlighting a net loss of $22.9 million, or $(0.14) per share, down from $43.6 million, or $(0.42) per share, year-over-year. IBSRELA sales reached $4.9 million, reflecting commercial progress. The company anticipates $35 million in milestone payments from a partnership with Kyowa Kirin, as the partner submitted a New Drug Application in Japan. Ardelyx's cash position decreased to $90.6 million from $116.7 million since the end of 2021. R&D expenses fell 68.5% due to reduced clinical study costs.

Ardelyx, Inc. presented new analyses of its drug XPHOZAH (tenapanor) at the ASN Kidney Week 2022. Results showed that XPHOZAH effectively reduced serum phosphorus levels in patients with severe hyperphosphatemia and helped maintain weight in dialysis patients when used alongside phosphate binders. Key findings highlight that about 80% of early responders sustained their phosphorus reduction during treatment. With over 1,100 patients treated, Ardelyx emphasizes the potential of XPHOZAH to address significant needs in chronic kidney disease.

On November 2, 2022, Ardelyx, Inc. (Nasdaq: ARDX) announced the granting of options to purchase 127,907 shares of common stock and 31,875 Restricted Stock Units (RSUs) to three new non-executive employees. The exercise price for stock options is set at $1.40, the closing price on the grant date of October 26, 2022. These grants are compliant with Nasdaq Listing Rule 5635(c)(4) and are designed to incentivize new hires. Each stock option and RSU vesting occurs over four years, indicating a long-term commitment to the company's growth.

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.