お知らせ • 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.

お知らせ • 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).

総株主利回り	-1.2%
将来の配当利回り	0%
配当成長	n/a
次回配当支払日	n/a
配当落ち日	n/a
一株当たり配当金	n/a
配当性向	n/a

セグメント	配当利回り
会社 (ARDX)	n/a
市場下位25% (US)	1.4%
市場トップ25% (US)	4.1%
業界平均 (Biotechs)	2.2%
アナリスト予想 (ARDX) (最長3年)	0%

データ	最終更新日（UTC時間）
企業分析	2026/09/15 20:21
終値	2026/09/15 00:00
収益	2026/06/30
年間収益	2025/12/31

パッケージ	データ	タイムフレーム	米国ソース例
会社財務	10年	損益計算書キャッシュ・フロー計算書貸借対照表	SECフォーム10-K SECフォーム10-Q
アナリストのコンセンサス予想	+プラス3年	予想財務アナリストの目標株価	アナリストリサーチレポート Blue Matrix
市場価格	30年	株価配当、分割、措置	ICEマーケットデータ SECフォームS-1
所有権	10年	トップ株主インサイダー取引	SECフォーム4 SECフォーム13D
マネジメント	10年	リーダーシップ・チーム取締役会	SECフォーム10-K SECフォームDEF 14A
主な進展	10年	会社からのお知らせ	SECフォーム8-K

アナリスト	機関
Julian Harrison	BTIG
Prakhar Agrawal	Cantor Fitzgerald & Co.
Yigal Nochomovitz	Citigroup Inc

Ardelyx 配当と自社株買い

配当金 基準チェック /06

主要情報

最近の配当と自社株買いの更新

Recent updates

President notifies of intention to sell stock

ARDX: Payer Constraints Will Shape Future Kidney And IBS Profitability Upside

Ardelyx Faces Securities Probe After IBSRELA Guidance Cut and $750 Million Target Withdrawal

Ardelyx, Inc. Announces Resignation of Eric Foster from Chief Commercial Officer, Effective August 28, 2026

ARDX: Gastrointestinal Franchise Execution Will Drive Multiyear Earnings Turnaround Potential

Price target decreased by 9.4% to US$14.90

Ardelyx, Inc. Updates Earnings Guidance for the Fiscal Year 2026

Ardelyx, Inc. to Report Q2, 2026 Results on Aug 06, 2026

Forecast breakeven date pushed back to 2027

Xphozah to Join Medicare Bundled Payment After Ardelyx Loses Final Court Challenge

ARDX: Expanding Gastrointestinal Franchise And Pipeline Will Support Multiyear Revenue Roadmap

Ardelyx (ARDX) Stock Could Be 65% Undervalued As Growth Hopes Face Reassessment

President notifies of intention to sell stock

ARDX: Kidney And IBS Data Will Support Future Profitability Upside Potential

Ardelyx Targets Profitability as IBSRELA Drives US$500 Million Revenue Outlook

President recently sold US$343k worth of stock

ARDX: Kidney And IBS Data Will Support Longer-Term Upside Potential

Chief Commercial Officer recently sold US$50k worth of stock

President notifies of intention to sell stock

Insufficient new directors

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

Ardelyx: Low Price, But High Implied Valuation

ARDX: Extended 2042 Patent Protection Will Support Longer-Term Upside Potential

Ardelyx, Inc., Annual General Meeting, Jun 16, 2026

Earnings Update: Ardelyx, Inc. (NASDAQ:ARDX) Just Reported Its First-Quarter Results And Analysts Are Updating Their Forecasts

ARDX: Extended 2042 Patent Horizon Will Support Multiyear Revenue Roadmap

Ardelyx, Inc. Announces Executive Changes

Ardelyx, Inc. to Report Q1, 2026 Results on Apr 30, 2026

ARDX: Extended Patent Runway And 2029 Revenue Guidance Will Support Repricing

Ardelyx, Inc. Appoints Rajani Dinavahi, MD, as Chief Medical Officer, Effective April 1, 2026

ARDX: Extended Patent Life And IBS Guidance Are Expected To Unlock Upside

Ardelyx, Inc. Announces Rapid And Meaningful Symptom Relief With Tenapanor In IBS-C

ARDX: Extended Patent Runway And 2029 Revenue Outlook Will Drive Bullish Repricing

ARDX: Extended Patent Runway And 2029 Revenue Path Will Support Bullish Outlook

Ardelyx, Inc. Provides Revenue Guidance for Full Year 2026

ARDX: Multiyear Revenue Roadmap And CIC Expansion Will Drive Upside

Ardelyx, Inc. to Report Q4, 2025 Results on Feb 19, 2026

Ardelyx, Inc. Announces First Patient Dosed in ACCEL: Phase 3 Chronic Idiopathic Constipation Study of IBSRELA

ARDX: Faster Path To 1b Revenue Is Expected To Unlock Upside

Zydus Lifesciences Reportedly Eyes Acquisition of Ardelyx for $2.5 Billion

Ardelyx, Inc. (NASDAQ:ARDX) Stock Catapults 37% Though Its Price And Business Still Lag The Industry

ARDX: Higher Revenue Guidance Is Expected To Support Long Term Upside

ARDX: Long-Term Profitability Improvements Will Drive Stronger Bullish Outlook

Ardelyx, Inc. Announces Executive Changes

ARDX: Upcoming Leadership Transition Will Support Long Term Earnings Upside

ARDX: Commercial Execution Will Drive Shares Higher Under New Leadership

Ardelyx, Inc. Presents Data, Including Results from the First Real-World Study of Xphozah

ARDX: Ongoing Commercial Execution Will Unlock Upside From Discounted Levels

Ardelyx, Inc. has filed a Follow-on Equity Offering in the amount of $100 million.

Analyst Estimates: Here's What Brokers Think Of Ardelyx, Inc. (NASDAQ:ARDX) After Its Third-Quarter Report

Ardelyx, Inc. Presents Data Supporting First-in-Class Retainagogue, IBSRELA at the American College of Gastroenterology's 2025 Annual Meeting

Ardelyx, Inc. Appoints Sue Hohenleitner as Principal Financial Officer, Effective November 4, 2025

Ardelyx, Inc. to Report Q3, 2025 Results on Oct 30, 2025

Ardelyx, Inc. (NASDAQ:ARDX) Looks Inexpensive After Falling 26% But Perhaps Not Attractive Enough

Ardelyx, Inc. Announces Executive Changes

Ardelyx, Inc. to Report Q2, 2025 Results on Aug 04, 2025

There's No Escaping Ardelyx, Inc.'s (NASDAQ:ARDX) Muted Revenues Despite A 26% Share Price Rise

Ardelyx, Inc. Announces Executive Appointments

Benign Growth For Ardelyx, Inc. (NASDAQ:ARDX) Underpins Stock's 28% Plummet

Ardelyx, Inc. Presents Data Supporting IBSRELA (tenapanor) At Digestive Disease Week 2025 Conference

Ardelyx, Inc., Annual General Meeting, Jun 18, 2025

Ardelyx, Inc. Appoints Merdad Parsey to Its Board of Directors, Effective April 28, 2025

Omnichannel Investments And Sales Teams Will Create Future IBSRELA Demand

Ardelyx, Inc. to Report Q1, 2025 Results on May 01, 2025

Ardelyx, Inc. to Present Post-Hoc Analysis of the Optimize Study Supporting XPHOZAH®? (Tenapanor)

Ardelyx, Inc. Announces Approval of A New Drug Application for Tenapano

Ardelyx: Limited Pipeline, Rising Costs, And Uncertain Growth Ahead (Downgrade)

There's No Escaping Ardelyx, Inc.'s (NASDAQ:ARDX) Muted Revenues

Ardelyx, Inc. to Report Q4, 2024 Results on Feb 20, 2025

Ardelyx: A Small Bet Its Latest Setback Will Be Temporary

Ardelyx Lost The Lawsuit, But The Kidney PATIENT Act Will Save It

Ardelyx's Medicare Setback Casts Doubt On Long-Term Viability

Earnings Update: Ardelyx, Inc. (NASDAQ:ARDX) Just Reported Its Third-Quarter Results And Analysts Are Updating Their Forecasts

Ardelyx, Inc.'s (NASDAQ:ARDX) Shares Lagging The Industry But So Is The Business

Ardelyx, Inc. to Report Q3, 2024 Results on Oct 31, 2024

配当金基準チェック /06