ARDX Ardelyx Inc.

6.06
+0.06  (+1%)
Previous Close 6
Open 6.06
52 Week Low 4.157
52 Week High 8.815
Market Cap $540,191,812
Shares 89,140,563
Float 72,441,326
Enterprise Value $389,235,811
Volume 2,109,786
Av. Daily Volume 540,441
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Upcoming Catalysts

Drug Stage Catalyst Date
Tenapanor
Serum phosphorus - chronic kidney disease (CKD) on dialysis
PDUFA
PDUFA
Premium membership is required to view catalyst dates, analyst ratings, earnings dates and cash burn data. Click here to unlock and sign up to a 14-day FREE TRIAL.

Drug Pipeline

Drug Stage Notes
Tenapanor - AMPLIFY
Hyperphosphatemia - adjunctive therapy to phosphate binders
Phase 3
Phase 3
Phase 3 trial met primary endpoint.
Tenapanor (T3MPO-2)
Constipation-predominant irritable bowel syndrome (IBS-C)
Approved
Approved
FDA approval announced September 12, 2019.
Tenapanor (T3MPO-1)
Constipation-predominant irritable bowel syndrome (IBS-C)
Phase 3
Phase 3
Phase 3 data released May 12, 2017. Primary endpoint met - however, competitive concerns raised.
RDX7675
Hyperkalemia
Phase 2
Phase 2
Onset of action trial data released November 21, 2017 - noted significantly reduced serum potassium in patients. Development to be discontinued.

Latest News

  1. FREMONT, Calif., Sept. 15, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that the U.S. Food and Drug Administration (FDA) has accepted its New Drug Application (NDA) of tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

    "The acceptance of our NDA is extremely exciting as it represents the next critical step towards bringing to market a completely new approach to the management of hyperphosphatemia, an area where a significant unmet need exists," said Mike Raab, president, and chief executive officer of Ardelyx. "With potential approval in the second quarter of 2021, we continue to advance commercial preparations for the launch of tenapanor, a first-in-class, non-binder therapy that targets the primary pathway of phosphorus absorption. This is a special time for the Ardelyx team as we have a clear mission – that we can and should do better for patients. We believe that with tenapanor, we have discovered and developed a therapy that will truly advance care for patients on dialysis."

    The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of April 29, 2021.

    "I look forward to the prospect of having a novel approach to treating hyperphosphatemia, a condition known to be associated with higher morbidity and mortality in patients with chronic kidney disease on dialysis," said Dr. Kam Kalantar-Zadeh, Chief, Division of Nephrology and Hypertension and Kidney Transplantation, University of California, Irvine, School of Medicine. "I believe innovations that enable us to block phosphorus via the primary pathway of absorption will help us more consistently and effectively manage phosphorus, so we can do better for our patients." 

    The NDA is supported by three successful Phase 3 trials involving over 1,000 patients that evaluated the use of tenapanor, which included: two monotherapy trials, including a long-term study, to control serum phosphorus in patients with CKD on dialysis, and one trial using a dual-mechanism approach in dialysis patients who had difficult-to-control hyperphosphatemia (≥5.5 mg/dL) despite phosphate binder therapy.

    About Tenapanor for Hyperphosphatemia

    Tenapanor, discovered and developed by Ardelyx, is a first-in-class, proprietary, oral medicine for which an NDA is under review by the FDA for the control of serum phosphorus in adult patients with CKD on dialysis. Tenapanor has a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3). This results in a conformational change of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate at the primary pathway of phosphate absorption. Ardelyx is conducting NORMALIZE, an ongoing extension study of the PHREEDOM Phase 3 monotherapy study, which is designed to evaluate the ability of tenapanor, as monotherapy or in combination with sevelamer, to achieve serum phosphorus levels in the normal range (2.5 – 4.5 mg/dL) in patients with chronic kidney disease (CKD) on dialysis. Planned analyses have demonstrated that the use of tenapanor as a foundational approach, as monotherapy or in combination with sevelamer carbonate, produces a significant phosphorus-lowering effect.  After ~20 months of treatment with tenapanor alone or with low doses of sevelamer, patients exhibited a mean serum phosphorus reduction of 2.33 mg/dL, from a mean baseline phosphorus of 7.27 mg/dL at the beginning of the PHREEDOM trial to a mean of 4.94 mg/dL. 

    About Hyperphosphatemia

    Hyperphosphatemia is a serious condition resulting in an abnormally elevated level of phosphorus in the blood that is estimated to affect more than 745,000 dialysis patients in major developed countries. The kidney is the organ responsible for regulating phosphorus levels, but when kidney function is significantly impaired, phosphorus is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on dialysis. Despite treatment with phosphate binders (the only approved therapy for hyperphosphatemia), approximately 70% of CKD patients on dialysis continue to experience elevated phosphorus levels at any point in time (Spherix Global Insights: RealWorld Dynamix, Dialysis 2018). Phosphorus levels greater than 5.5 mg/dL have been shown to be an independent risk factor for cardiovascular morbidity and mortality in patients requiring dialysis (Block 2004), and internationally recognized treatment guidelines recommend lowering elevated phosphate levels toward the normal range (<4.6mg/dL).

    About Ardelyx, Inc.

    Ardelyx is a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases. The Ardelyx pipeline includes tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, for which an NDA is under review by the FDA, and RDX013, a potassium secretagogue program for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease. In addition, Ardelyx received FDA approval of IBSRELA® (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in the respective territories.

    Forward Looking Statements

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including the potential for tenapanor to be approved for marketing by the FDA for the control of serum phosphorus in chronic kidney disease patients on dialysis, the potential for the use of tenapanor as monotherapy and as part of a dual mechanism approach with tenapanor and phosphate binders for the treatment of hyperphosphatemia, the potential for tenapanor alone or with small doses of phosphate binders to achieve target serum phosphorus levels, and Ardelyx's expected timing of the review of its NDA for tenapanor for the control of serum phosphorus. Such forward-looking statements involve substantial risks and uncertainties that could cause the development of Ardelyx's product candidates or Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties associated with the regulatory approval process, and uncertainties in the drug commercialization process. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's quarterly report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2020, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ardelyx-announces-fda-acceptance-for-filing-of-its-new-drug-application-of-tenapanor-for-the-control-of-serum-phosphorus-in-adult-patients-with-ckd-on-dialysis-301130860.html

    SOURCE Ardelyx

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  2. FREMONT, Calif., Sept. 8, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that Ardelyx management will participate in three upcoming investor conferences in September including:

    • Citi's 15th Annual BioPharma Virtual Conference on Wednesday, September 9th
    • 22nd Annual H.C. Wainwright Global Investment Conference on Monday, September 14th with a presentation at 5:00 p.m. E.T.
    • Cantor Fitzgerald Global Healthcare Conference 2020 on Thursday, September 17th with a presentation at 12:40 p.m. E.T.

    Both the H.C. Wainwright and Cantor Fitzgerald conference presentations will be available via webcast. To access the live webcasts of Ardelyx's presentations, please visit the Events & Presentations page within the Investor section of the Ardelyx website at ir.ardelyx.com. A replay of the webcasts will be available on the Ardelyx website for 30 days following each conference.

    About Ardelyx, Inc.

    Ardelyx is a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases. The Ardelyx pipeline includes tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, for which an NDA is under review by the FDA, and RDX013, a potassium secretagogue program for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease. In addition, Ardelyx received FDA approval of IBSRELA® (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in the respective territories.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ardelyx-to-participate-in-three-upcoming-investor-conferences-in-september-301124705.html

    SOURCE Ardelyx

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  3. FREMONT, Calif., Aug. 6, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today reported business highlights and financial results for the second quarter ended June 30, 2020.

    "Over the last quarter, we continued to make critical progress towards our goal of providing our first-in-class therapy tenapanor to adult CKD patients on dialysis with elevated serum phosphorus, a condition, despite traditional therapies, that has been associated with poor survival outcomes," said Mike Raab, president and chief executive officer of Ardelyx. "This past June, we submitted a New Drug Application to the FDA for this indication, and we expect to receive notification of its acceptance for substantive review and our PDUFA date by early September. As part of our filing, we included additional, robust data reconfirming tenapanor's ability to lower and control serum phosphorous levels at a rate better than those reported with phosphate binders alone. In addition, during the quarter, we augmented our senior leadership team with the hiring of an experienced chief commercial officer and chief financial officer as we prepare for launch and evolving into a revenue-generating company." 

    Recent Business and Pipeline Updates

    • Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the review of tenapanor as a first-in-class therapy to control serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The filing is supported by three successful Phase 3 studies demonstrating tenapanor's ability to reduce phosphate levels, with two trials evaluating tenapanor as a monotherapy and the third evaluating tenapanor as part of a dual mechanism approach with phosphate binders.
    • Released additional positive data from the ongoing NORMALIZE Phase 4 study, which showed that foundational use of tenapanor as monotherapy or with sevelamer enabled up to 47.4% of CKD patients on dialysis to achieve normal serum phosphorus levels (<4.6 mg/dL), a 58% improvement over current standard of care.
    • Announced that Ardelyx's collaboration partner in Japan, Kyowa Kirin Co., Ltd. (KKC), presented data at the European Renal Association-European Dialysis and Transplant Association annual meeting (ERA-EDTA 2020) from a Phase 2 study designed to evaluate if, with tenapanor, patients with hyperphosphatemia undergoing hemodialysis could achieve at least a 30% decrease in mean pill burden while maintaining their serum phosphorus level. The results demonstrated that tenapanor enabled a significant reduction in overall pill burden (mean reduction in phosphate binder pill usage by 80%), while maintaining serum phosphorus control.
    • Strengthened leadership team with the appointment of two senior executives:
      • Justin Renz, a veteran biopharma executive with over 20 years of experience, as chief financial officer; and
      • Susan Rodriguez, a highly experienced global biopharma marketing and sales executive with a proven track record of building commercial organizations and leading successful new product launches, as chief commercial officer

    Expected 2020 Milestones

    • Receive notification from the FDA regarding the acceptance for substantive review of the NDA submission and PDUFA date in September 2020
    • Initiate the OPTIMIZE clinical trial, a study designed to inform physicians on the integration of tenapanor as a foundational therapy into clinical practice, this year
    • Present AMPLIFY and PHREEDOM Phase 3 clinical trial results at upcoming medical congresses
    • Report completed NORMALIZE Phase 4 clinical trial results at an upcoming medical conference

    Second Quarter 2020 Financial Results

    • Cash Position: As of June 30, 2020, Ardelyx had total cash, cash equivalents and short-term investments of $204.8 million, as compared to total cash, cash equivalents and short-term investments of $247.5 million as of December 31, 2019.
    • Revenue: The company generated $1.8 million in revenue, which primarily represents collaborative development revenue, for the three months ended June 30, 2020.
    • R&D Expenses: Research and development expenses were $18.9 million for the three months ended June 30, 2020, a decrease of $0.6 million, or approximately 3 percent, compared to $19.5 million for the three months ended June 30, 2019. The decrease was due primarily to a decrease in external R&D expenses, with a $1.1 million decrease in tenapanor-related expenses, as well as a $0.6 million decrease in RDX013 program-related expenses, partially offset by $0.7 million of higher expenses attributable to the research programs being conducted under the Research Collaboration and Option Agreement entered into between Ardelyx and KKC in 2019 and general R&D expenses. Of the overall tenapanor-related decrease, approximately $7.9 million was related to lower clinical study costs due to the winding down of expenses associated with the Phase 3 clinical program for tenapanor for the control of hyperphosphatemia, offset by an out-of-period adjustment that reduced clinical trial expenses by $4.1 million; and an approximately $2.1 million decrease in validation-related manufacturing expenses; offset by increase of $4.6 million related to regulatory expenses that included $2.9 million paid to the FDA for the filing of the NDA for tenapanor for control of serum phosphorus.
    • G&A Expenses: General and administrative expenses were $7.0 million for the three months ended June 30, 2020, an increase of $1.6 million, or approximately 31 percent, compared to $5.4 million for the three months ended June 30, 2019. The increase was primarily due to an increase in headcount and related personnel costs, including stock-based compensation costs, and an increase in professional services.
    • Net Loss: Net loss for the quarter ended June 30, 2020 was $25.0 million, as compared to $25.5 million for the quarter ended June 30, 2019.

    About Ardelyx, Inc.

    Ardelyx is focused on developing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiovascular diseases. Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company submitted an NDA to the FDA on June 30, 2020. Ardelyx is also advancing RDX013, a potassium secretagogue program, for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease. In addition, Ardelyx received FDA approval of IBSRELA® (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in the respective territories.

    Forward Looking Statements

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including statements regarding the potential for Ardelyx's product candidates in treating the diseases and conditions for which they are being developed, the potential for the use of tenapanor as monotherapy and as part of a dual mechanism approach with tenapanor and phosphate binders for the treatment of hyperphosphatemia, the potential for tenapanor alone or with adjunctive use of phosphate binders to achieve normal serum phosphorus levels, Ardelyx's expectations regarding the potential receipt, and the timing thereof, of notification from the FDA of the acceptance for substantive review of its NDA for tenapanor, and Ardelyx's expectations regarding the presentation of its clinical data at medical congresses in 2020. Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties associated with the regulatory approval process and uncertainties in the drug commercialization process. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 6, 2020, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

     

    Ardelyx, Inc.

    Condensed Balance Sheets

    (In thousands)







    June 30,

    2020



    December 31,

    2019





    (Unaudited)



    (1)

    Assets













    Cash and cash equivalents



    $

    100,494



    $

    181,133

    Short-term investments





    104,347





    66,379

    Unbilled revenue





    750





    750

    Property and equipment, net





    2,501





    3,436

    Right-of-use assets





    2,945





    3,970

    Prepaid and other assets





    6,306





    4,114

    Total assets



    $

    217,343



    $

    259,782















    Liabilities and stockholders' equity













    Accounts payable



    $

    4,212



    $

    2,187

    Accrued compensation and benefits





    3,081





    4,453

    Current portion of operating lease liability





    2,826





    2,608

    Loan payable, current portion





    13,716





    1,183

    Deferred revenue





    2,241





    4,541

    Accrued expenses and other liabilities





    7,574





    7,248

    Operating lease liability, net of current portion





    608





    2,076

    Loan payable, net of current portion





    36,735





    48,831

    Stockholders' equity





    146,350





    186,655

    Total liabilities and stockholders' equity



    $

    217,343



    $

    259,782

    ________________

    (1)

    Derived from the audited financial statements included in the Company's Annual Report on Form 10–K for the year ended December 31, 2019.

     

    Ardelyx, Inc.

    Condensed Statements of Operations and Comprehensive Loss

    (In thousands, except share and per share amounts)







    Three Months Ended June 30, 



    Six Months Ended June 30, 







    2020



    2019



    2020



    2019







    (Unaudited)



    (Unaudited)



    (Unaudited)



    (Unaudited)



    Revenues:



























    Licensing revenue



    $

    706



    $



    $

    706



    $



    Collaborative development revenue





    1,125









    2,300







    Other revenue





    5





    18





    43





    18



    Total revenues





    1,836





    18





    3,049





    18



    Operating expenses:



























    Cost of revenue





    141









    141







    Research and development





    18,864





    19,475





    34,708





    39,856



    General and administrative





    7,038





    5,371





    14,176





    10,488



    Total operating expenses





    26,043





    24,846





    49,025





    50,344



    Loss from operations





    (24,207)





    (24,828)





    (45,976)





    (50,326)



    Interest expense





    (1,226)





    (1,451)





    (2,583)





    (2,885)



    Other income, net





    477





    812





    1,230





    1,602



    Loss before provision for income taxes





    (24,956)





    (25,467)





    (47,329)





    (51,609)



    Provision for income taxes

















    2



    Net loss



    $

    (24,956)



    $

    (25,467)



    $

    (47,329)



    $

    (51,611)



    Net loss per common share, basic and diluted



    $

    (0.28)



    $

    (0.41)



    $

    (0.53)



    $

    (0.82)



    Shares used in computing net loss per share - basic

    and diluted





    89,080,046





    62,651,863





    88,980,353





    62,599,371



    Comprehensive loss:



























    Net loss



    $

    (24,956)



    $

    (25,467)



    $

    (47,329)



    $

    (51,611)



    Unrealized gains on available-for-sale securities





    361





    4





    297





    54



    Comprehensive loss



    $

    (24,595)



    $

    (25,463)



    $

    (47,032)



    $

    (51,557)



     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ardelyx-reports-second-quarter-2020-financial-results-and-recent-business-highlights-301107201.html

    SOURCE Ardelyx

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  4. FREMONT, Calif., Aug. 3, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that tenapanor has been named a finalist in the Fierce Innovation Awards in the category of biotech innovation in a class of therapies identified by experts to have potential for significant impact in the industry. Tenapanor, discovered and developed by Ardelyx, is a first-in-class therapy for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis that is supported by three successful Phase 3 studies. The selection criteria for the award included…

    FREMONT, Calif., Aug. 3, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that tenapanor has been named a finalist in the Fierce Innovation Awards in the category of biotech innovation in a class of therapies identified by experts to have potential for significant impact in the industry. Tenapanor, discovered and developed by Ardelyx, is a first-in-class therapy for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis that is supported by three successful Phase 3 studies. The selection criteria for the award included: effectiveness, technical innovation, competitive advantage, financial impact, and true innovation. 

    "We are thrilled to be recognized for the scientific innovation that exemplifies tenapanor, especially by the group of distinguished drug developers from major biopharmaceutical companies that participated in the award review," said Mike Raab, president and chief executive officer of Ardelyx. "It is especially rewarding to see that the novel technological approach underlying tenapanor has translated into a promising therapeutic for the many patients with hyperphosphatemia. There is a high unmet need for new therapies that can effectively control phosphorus levels in patients with CKD on dialysis. These patients have up to a 38% increase in the relative risk of hospitalization due to cardiovascular events and up to a 102% increase in the relative risk of mortality. We are motivated and inspired by the possibility to help these patients with tenapanor." 

    The Fierce Innovation Awards – Life Sciences Edition 2020 is a peer reviewed awards program from the publisher of Fierce Biotech and Fierce Pharma. The competition highlights companies that demonstrated innovative solutions, technologies, and services that have the potential to make the greatest impact for biotech and pharma companies. The awards program's applications were reviewed by an exclusive panel of executives from major biotech and pharma companies including Astellas, Accenture, AstraZeneca, Angiocrine Bioscience, Biotech Research Group, NIHR Clinical Research Network, Medidata Solutions and PPD. Winners will be announced in the 2020 Innovation Report set to publish by Fierce Life Sciences on September 14, 2020.   

    About Tenapanor for Hyperphosphatemia

    Tenapanor, discovered and developed by Ardelyx, is a first-in-class, proprietary, oral medicine for which the company has submitted an NDA to the FDA for the control of serum phosphorus in adult patients with CKD on dialysis. Tenapanor has a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3). This results in a conformational change of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate at the primary pathway of phosphate absorption. Three successful Phase 3 studies demonstrating tenapanor's ability to reduce phosphate levels, as either monotherapy or as part of a dual mechanism approach with phosphate binders, have been reported.

    About Hyperphosphatemia

    Hyperphosphatemia is a serious condition resulting in an abnormally elevated level of phosphorus in the blood that is estimated to affect more than 745,000 dialysis patients in major developed countries. The kidney is the organ responsible for regulating phosphorus levels, but when kidney function is significantly impaired, phosphorus is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on dialysis. Despite treatment with phosphate binders (the only approved therapy for hyperphosphatemia), approximately 70% of CKD patients on dialysis continue to experience elevated phosphorus levels at any point in time (Spherix Global Insights: RealWorld Dynamix, Dialysis 2018). Phosphorus levels greater than 5.5 mg/dL have been shown to be an independent risk factor for cardiovascular morbidity and mortality in patients requiring dialysis (Block 2004), and internationally recognized treatment guidelines recommend lowering elevated phosphate levels toward the normal range (<4.6mg/dL).

    About Ardelyx, Inc.

    Ardelyx is focused on developing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiovascular diseases. Ardelyx is advancing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, for which the company submitted an NDA to the FDA on June 30, 2020. Ardelyx is also advancing RDX013, a potassium secretagogue program, for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease. In addition, Ardelyx received FDA approval of IBSRELA® (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in the respective territories.

    Forward Looking Statements

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including statements regarding the potential for tenapanor to reduce phosphate levels as either monotherapy or as part of a dual mechanism approach with phosphate binders. Such forward-looking statements involve substantial risks and uncertainties that could cause Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties associated with the regulatory approval process and uncertainties in the drug commercialization process. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2020, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ardelyx-selected-as-a-finalist-in-the-fierce-innovation-awards-for-the-development-of-its-first-in-class-product-candidate-tenapanor-301104270.html

    SOURCE Ardelyx

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  5. FREMONT, Calif., June 30, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced the submission of a New Drug Application (NDA) for tenapanor to the U.S. Food and Drug Administration (FDA) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

    "The submission of our NDA is a significant milestone for Ardelyx, positioning us well to fulfill our promise to offer an innovative first-in-class therapeutic for patients with CKD on dialysis with elevated serum phosphorus," said Mike Raab, president and chief executive officer of Ardelyx. "The clinical results we've generated throughout the development program support the potential for tenapanor to serve as the foundational therapy in the management of hyperphosphatemia based on its unique mechanism of blocking phosphorus at the primary pathway of uptake. In addition to the positive monotherapy results demonstrated in our trials, our NORMALIZE and AMPLIFY trials have demonstrated that with tenapanor alone or with adjunctive use of phosphate binders, a far greater percentage of patients are able to achieve, and maintain, target serum phosphorus levels – a goal which has proven to be unattainable for the majority of patients with currently available treatments. We look forward to working with the FDA through the review process and will continue advancing our preparations for launch."

    Based on standard FDA review timelines, the company expects to receive notification from the FDA on the acceptance of the filing for substantive review in late August 2020.

    The submission is supported by three successful Phase 3 trials involving over 1,000 patients that evaluated the use of tenapanor, which included: two monotherapy trials, including a long-term study, to control serum phosphorus in patients with CKD on dialysis, and one trial using a dual-mechanism approach in dialysis patients who had difficult-to-control hyperphosphatemia (≥5.5 mg/dL) despite phosphate binder therapy.

    About Tenapanor for Hyperphosphatemia

    Tenapanor, discovered and developed by Ardelyx, is a first-in-class, proprietary, oral medicine for which the company has submitted an NDA to the FDA for the control of serum phosphorus in adult patients with CKD on dialysis. Tenapanor has a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3). This results in a conformational change of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate at the primary pathway of phosphate absorption. Three successful Phase 3 studies demonstrating tenapanor's ability to reduce phosphate levels, as monotherapy and as part of a dual mechanism approach with phosphate binders, have been reported. 

    About Hyperphosphatemia

    Hyperphosphatemia is a serious condition resulting in an abnormally elevated level of phosphorus in the blood that is estimated to affect more than 745,000 dialysis patients in major developed countries. The kidney is the organ responsible for regulating phosphorus levels, but when kidney function is significantly impaired, phosphorus is not adequately eliminated from the body. As a result, hyperphosphatemia is a nearly universal condition among people with CKD on dialysis. Despite treatment with phosphate binders (the only approved therapy for hyperphosphatemia), approximately 70% of CKD patients on dialysis continue to experience elevated phosphorus levels at any point in time (Spherix Global Insights: RealWorld Dynamix, Dialysis 2018). Phosphorus levels greater than 5.5 mg/dL have been shown to be an independent risk factor for cardiovascular morbidity and mortality in patients requiring dialysis (Block 2004), and internationally recognized treatment guidelines recommend lowering elevated phosphate levels toward the normal range (<4.6mg/dL).

    About Ardelyx, Inc.

    Ardelyx is a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases. The Ardelyx pipeline includes tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, for which the company has submitted an NDA, and RDX013, a potassium secretagogue program for the potential treatment of high potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease. In addition, Ardelyx received FDA approval of IBSRELA® (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in the respective territories.

    Forward Looking Statements

    To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including the potential for tenapanor to be approved for marketing by the FDA for the control of serum phosphorus in chronic kidney disease patients on dialysis, the potential for the use of tenapanor as monotherapy and as part of a dual mechanism approach with tenapanor and phosphate binders for the treatment of hyperphosphatemia, the potential for tenapanor alone or with small doses of phosphate binders to achieve target serum phosphorus levels, and Ardelyx's expected timing of acceptance for substantive review of its NDA for tenapanor for the control of serum phosphorus. Such forward-looking statements involve substantial risks and uncertainties that could cause the development of Ardelyx's product candidates or Ardelyx's future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties associated with the regulatory approval process, and uncertainties in the drug commercialization process. Ardelyx undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx's business in general, please refer to Ardelyx's quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 7, 2020, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

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    SOURCE Ardelyx

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