공시 • May 09

Ardelyx Inc Presents Analysis Supporting Long-Term Safety of Xphozah At Nkf’S Spring Clinical Meetings

Ardelyx, Inc. announced the presentation of a data analysis evaluating the long-term impact of XPHOZAH (tenapanor) on serum electrolytes and selected nutrition biomarkers at the National Kidney Foundation’s Spring Clinical Meetings, currently underway in New Orleans. XPHOZAH is the first and only phosphate absorption inhibitor (PAI) approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action that blocks phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily. Previous analysis found that tenapanor inhibition of the sodium hydrogen exchanger (NEH3) did not affect serum electrolyte concentrations other than phosphate. The poster, titled “Tenapanor Decreases Serum Phosphate Without Altering Other Serum Electrolytes in Patients with Chronic Kidney Disease with Hyperphosphatemia on Dialysis,” further supports that analysis over an extended period of time. Using data from two open-label trials, an 18-month extension study (NORMALIZE) and a 26-week study (OPTIMIZE), the analysis showed that tenapanor treatment resulted in no clinically meaningful changes in measured serum electrolyte concentrations, other than phosphate reduction, and no significant changes in nutrition, body mass, or blood pressure. These findings support effectiveness of tenapanor for management of serum phosphate in patients with chronic kidney disease and hyperphosphatemia on dialysis, while also reinforcing reported safety data. In addition to the poster presentation during NKF Spring Clinical Meetings, Ardelyx is sponsoring a Peer Exchange, titled “Treating Hyperphosphatemia and Side Effect Management,” on May 8 at 12:15 PM CT, where Lisa Gutekunst, MSEd, RD, CSR, CDN, will facilitate a peer exchange session discussing first-in-class PAI XPHOZAH. The session will review the XPHOZAH mechanism of action, efficacy and safety data, and practical considerations for XPHOZAH as add-on therapy for the many dialysis patients on a phosphate binder with serum phosphorus levels above guideline-established targets. XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Patients completing the Phase 3 PHREEDOM trial from both the XPHOZAH arm and the sevelamer safety control arm had the option to participate in NORMALIZE, an open-label 18-month extension study. Patients entering the study from the XPHOZAH arm with serum phosphate levels in the normal range were followed with no medication changes. Patients entering the study from the XPHOZAH arm with serum phosphate greater than 4.5 mg/dL had sevelamer tablets added incrementally to achieve normal serum phosphate levels. Patients entering the study from the sevelamer safety control arm had XPHOZAH tablets added to their treatment regimen while reducing sevelamer tablets based on their serum phosphate value to achieve normal serum phosphate levels. The primary objective of the study was to evaluate the ability of XPHOZAH alone or in combination with sevelamer to achieve serum phosphate levels within the normal range (2.5 to 4.5 mg/dL) in patients with CKD on maintenance dialysis whose serum phosphate levels were greater than 6.0 mg/dL at baseline. OPTIMIZE was a randomized, open label study, which included 330 patients with chronic kidney disease (CKD) on dialysis with hyperphosphatemia. The study was designed to evaluate different methods of initiating XPHOZAH to optimize phosphorus management in both binder-naïve and binder-treated patients. The objective was to evaluate the ability of XPHOZAH, with its novel blocking mechanism, administered as core therapy for the treatment of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis, alone or in combination with phosphate binders, to achieve target serum phosphorus (s-P) levels =5.5 mg/dL. The study enrolled patients with s-P >5.5 and =10.0 mg/dL during stable phosphate binder treatment which were randomized in a 1:1 ratio to two different treatment cohorts, as well as patients who were phosphate binder naïve with s-P >4.5 and =10.0 mg/dL in a third cohort. Hyperphosphatemia is a serious condition, defined as elevated levels of phosphate in the blood, which affects the vast majority of the 550,000 patients in the United States with chronic kidney disease (CKD) on maintenance dialysis. The kidneys are responsible for eliminating excess phosphate and as kidney function declines, phosphate is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on maintenance dialysis, with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL). XPHOZAH is contraindicated in pediatric patients under 6 years of age and patients with known or suspected mechanical gastrointestinal obstruction. Patients may experience severe diarrhea. Treatment with XPHOZAH should be discontinued in patients who develop severe diarrhea. Diarrhea, which occurred in 43-53% of patients, was the only adverse reaction reported in at least 5% of XPHOZAH-treated patients with CKD on dialysis across trials. The majority of diarrhea events in the XPHOZAH-treated patients were reported to be mild-to-moderate in severity and resolved over time, or with dose reduction. Diarrhea was typically reported soon after initiation but could occur at any time during treatment with XPHOZAH. Severe diarrhea was reported in 5% of XPHOZAH-treated patients in these trials. XPHOZAH (tenapanor), 30 mg BID, is indicated to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

공시 • Jul 31

Ardelyx, Inc. Announces Publication of Two Plain Language Summaries from XPHOZAH®? (tenapanor) Clinical Trials in Current Medical Research and Opinion

Ardelyx, Inc. announced the publication of plain language summaries of results from two clinical trials on XPHOZAH®? (tenapanor), NORMALIZE and OPTIMIZE, in Current Medical Research and Opinion. The plain language summaries were developed by the authors to help adult patients with chronic kidney disease receiving dialysis, and their family members and caregivers, better understand some of the safety and efficacy data related to XPHOZAH. XPHOZAH, the first and only phosphate absorption inhibitor (PAI), is approved by the U.S. Food and Drug Administration to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy. XPHOZAH offers a different mechanism of action, blocking phosphate absorption at the primary pathway and is administered as a single tablet taken twice daily. Current Medical Research and Opinion is an international journal that publishes research focused on new and existing drugs and therapies, best practices in patient care, developments in diagnostic medicine and medical technology, and innovations in medical and scientific publishing. XPHOZAH, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor with a differentiated mechanism of action that acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), thereby reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. XPHOZAH is a single tablet, taken twice daily. Diarrhea was the most common side effect experienced by patients taking XPHOZAH in clinical trials. Patients completing the Phase 3 PHREEDOM trial from both the XPHOZAH arm and the sevelamer safety control arm had the option to participate in NORMALIZE, an open-label 18-month extension study. Patients entering the study from the XPHOZAH arm with serum phosphate levels in the normal range were followed with no medication changes. Patients entering the study from the XPHOZAH arm with serum phosphate greater than 4.5 mg/dL had sevelamer tablets added incrementally to achieve normal serum phosphate levels. Patients entering the study from the sevelamer safety control arm had XPHOZAH tablets added to their treatment regimen while reducing sevelamer tablets based on their serum phosphate value to achieve normal serum phosphate levels. The primary objective of the study was to evaluate the ability of XPHOZAH alone or in combination with sevelamer to achieve serum phosphate levels within the normal range (2.5 to 4.5 mg/dL) in patients with CKD on maintenance dialysis whose serum phosphate levels were greater than 6.0 mg/dL at baseline. OPTIMIZE was a randomized, open label study, which included 330 patients with chronic kidney disease (CKD) on dialysis with hyperphosphatemia. The study was designed to evaluate different methods of initiating XPHOZAH to optimize phosphorus management in both binder-naïve and binder-treated patients. The objective was to evaluate the ability of XPHOZAH, with its novel blocking mechanism, administered as core therapy for the treatment of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis, alone or in combination with phosphate binders, to achieve target serum phosphorus (s-P) levels =5.5 mg/dL. The study enrolled patients with s-P >5.5 and =10.0 mg/dL during stable phosphate binder treatment which were randomized in a 1:1 ratio to two different treatment cohorts, as well as patients who were phosphate binder naïve with s-P >4.5 and =10.0 mg/dL in a third cohort. Hyperphosphatemia is a serious condition, defined as elevated levels of phosphate in the blood, which affects the vast majority of the 550,000 patients in the United States with chronic kidney disease (CKD) on maintenance dialysis. The kidneys are responsible for eliminating excess phosphate and as kidney function declines, phosphate is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on maintenance dialysis, with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL).

이자보상배율	n/a
현금	US$238.07m
자본	US$148.62m
총부채	US$355.89m
총자산	US$504.51m

데이터	최종 업데이트 (UTC 시간)
기업 분석	2026/05/31 21:50
종가	2026/05/29 00:00
수익	2026/03/31
연간 수익	2025/12/31

패키지	데이터	기간	미국 소스 예시 ^*
기업 재무제표	10년	손익계산서 현금흐름표 대차대조표	SEC 양식 10-K SEC 양식 10-Q
분석가 컨센서스 추정치	+3년	재무 예측 분석가 목표주가	분석가 리서치 보고서 Blue Matrix
시장 가격	30년	주가 배당, 분할 및 기타 조치	ICE 시장 데이터 SEC 양식 S-1
지분 구조	10년	주요 주주 내부자 거래	SEC 양식 4 SEC 양식 13D
경영진	10년	리더십 팀 이사회	SEC 양식 10-K SEC 양식 DEF 14A
주요 개발	10년	회사 공시	SEC 양식 8-K

분석가	기관
Julian Harrison	BTIG
Prakhar Agrawal	Cantor Fitzgerald & Co.
Yigal Nochomovitz	Citigroup Inc

Ardelyx 대차대조표 건전성

재무 건전성 기준 점검 4/6

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