1. FREMONT, Calif., Nov. 23, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that a webcast of Mike Raab, president and chief executive officer of Ardelyx, and Susan Rodriguez, chief commercial officer, participating in a fireside chat at the Piper Sandler 32nd Annual Virtual Healthcare Conference will be available today at 10 a.m. ET.

    To access the webcast of Ardelyx's presentation please visit the Events and Presentations page within the Ardelyx website at https://ir.ardelyx.com/events-and-presentations. A replay of the fireside chat will be available on the Ardelyx website for 60 days following the presentation.

    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's NDA is currently under review by the FDA, with a PDUFA date of April 29, 2021. 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.

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  2. FREMONT, Calif., Nov. 10, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today announced that Mike Raab, president and chief executive officer of Ardelyx, will participate in a fireside chat at the Jefferies Virtual London Healthcare Conference on Tuesday, November 17, 2020 at 1:10 p.m. ET.

    To access the live webcast of Ardelyx's presentation please visit the Events & Presentations page within the Investor section of the Ardelyx website at https://ir.ardelyx.com/events-and-presentations. A replay of the webcast will be available on the Ardelyx website for 60 days following the presentation.

    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's NDA is currently under review by the FDA, with a PDUFA goal date of April 29, 2021. 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.

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  3. FREMONT, Calif., Nov. 6, 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 it will hold a virtual Analyst Day on Thursday, November 12, 2020, from 9:30 a.m. to 12:00 p.m. ET. This year's event will focus on the company's launch and commercialization plans in anticipation of the potential approval of tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. Additionally, the company will review its pipeline therapeutic for hyperkalemia.

    FREMONT, Calif., Nov. 6, 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 it will hold a virtual Analyst Day on Thursday, November 12, 2020, from 9:30 a.m. to 12:00 p.m. ET. This year's event will focus on the company's launch and commercialization plans in anticipation of the potential approval of tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. Additionally, the company will review its pipeline therapeutic for hyperkalemia.

    The management team will be joined by:

    • German Hernandez, M.D., FASN, FACP, associate nephrologist at El Paso Kidney Specialists and clinical associate professor of medicine at Texas Tech University Health Sciences Center, will review tenapanor's unique profile.
    • Jennifer Robinson, president of Spherix Global Insights, will present data on the challenges of treating hyperphosphatemia in patients with CKD on dialysis.
    • Douglas Paul, PharmD, Ph.D., vice president and partner at MME, will discuss value perceptions across payers, patients and healthcare professionals.

    A live webcast of the event will be available on the Ardelyx website via the Events and Presentations page under the investor relations section at https://ir.ardelyx.com/events-and-presentations.

    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's NDA is currently under review by the FDA, with a PDUFA goal date of April 29, 2021. 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.

     

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  4. FREMONT, Calif., Nov. 5, 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 third quarter ended September 30, 2020.

    "The FDA's acceptance of our New Drug Application for tenapanor is a major milestone that continues our progress toward the potential launch of this novel therapeutic for the many dialysis patients who struggle with controlling hyperphosphatemia," said Mike Raab, president and chief executive officer of Ardelyx. "Our commitment to this field was further highlighted in clinical data presented at ASN Kidney Week 2020 generated by Ardelyx and our Japanese partner KKC, supporting the clinical safety and efficacy of tenapanor and reinforcing its potential to transform the treatment landscape for patients."

    Recent Business and Pipeline Updates

    • The United States Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for tenapanor to control serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis with a Prescription Drug User Fee Act ("PDUFA") goal date of April 29, 2021. The filing was 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.

       
    • Presented new clinical data supporting the clinical safety and efficacy of tenapanor at ASN Kidney Week 2020. Three poster presentations highlighted data from Phase 3 trials conducted by Ardelyx, including the BLOCK, AMPLIFY and PHREEDOM studies. Additionally, the company's partner for tenapanor in Japan, Kyowa Kirin Co., Ltd., presented the results from two Phase 2 studies evaluating the efficacy and safety of tenapanor in Japanese patients on hemodialysis.

    Third Quarter 2020 Financial Results

    • Cash Position: As of September 30, 2020, Ardelyx had total cash, cash equivalents and short-term investments of $185.5 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 $2.7 million in revenue during the three months ended September 30, 2020, which primarily represents collaborative development revenue and sales of tenapanor for clinical supply to KKC.

       
    • R&D Expenses: Research and development expenses were $12.2 million for the three months ended September 30, 2020, a decrease of approximately $5.4 million, or 30 percent, compared to $17.6 million for the three months ended September 30, 2019. The decrease was primarily due to the completion of the Phase 3 PHREEDOM and AMPLIFY clinical trials evaluating tenapanor for the control of hyperphosphatemia.

       
    • G&A Expenses: General and administrative expenses were $7.6 million for the three months ended September 30, 2020, an increase of $0.7 million, or approximately 10 percent, compared to $6.9 million for the three months September 30, 2019. The increase was primarily due to an increase in costs associated with building and staffing our commercial infrastructure and teams as we prepare for the anticipated U.S. launch of tenapanor for the control of serum phosphorus in CKD patients on dialysis.

       
    • Net Loss: Net loss for the quarter ended September 30, 2020 was $18.1 million, or ($0.20) per common share, as compared to $23.5 million, or ($0.37) per common share, for the quarter ended September 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's NDA is currently under review by the FDA, with a PDUFA goal date of April 29, 2021. 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 the use of tenapanor as monotherapy and as part of a dual mechanism approach with tenapanor and phosphate binders for the treatment of hyperphosphatemia. 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 to be filed with the Securities and Exchange Commission on November 5, 2020, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

     

     

    Ardelyx, Inc.

    Condensed Balance Sheets

    (In thousands)





















    September 30,

    2020



    December 31,

    2019





    (Unaudited)



    (1)

    Assets













    Cash and cash equivalents



    $

    91,009



    $

    181,133

    Short-term investments





    94,488





    66,379

    Unbilled revenue





    750





    750

    Property and equipment, net





    2,111





    3,436

    Right-of-use assets





    2,402





    3,970

    Prepaid and other assets





    7,795





    4,114

    Total assets



    $

    198,555



    $

    259,782















    Liabilities and stockholders' equity













    Accounts payable



    $

    2,490



    $

    2,187

    Accrued compensation and benefits





    3,722





    4,453

    Current portion of operating lease liability





    2,770





    2,608

    Loan payable, current portion









    1,183

    Deferred revenue





    885





    4,541

    Accrued expenses and other liabilities





    6,667





    7,248

    Operating lease liability, net of current portion









    2,076

    Loan payable, net of current portion





    50,681





    48,831

    Stockholders' equity





    131,340





    186,655

    Total liabilities and stockholders' equity



    $

    198,555



    $

    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

    (Unaudited)

    (In thousands, except share and per share amounts)

































    Three Months Ended September 30, 



    Nine Months Ended September 30, 





    2020



    2019



    2020



    2019

    Revenues:

























    Licensing revenue



    $



    $

    3,000



    $

    706



    $

    3,000

    Collaborative development revenue





    1,356









    3,656





    Other revenue





    1,357





    13





    1,400





    31

    Total revenues





    2,713





    3,013





    5,762





    3,031

    Operating expenses:

























    Cost of revenue









    600





    141





    600

    Research and development





    12,240





    17,580





    46,948





    57,436

    General and administrative





    7,634





    6,922





    21,810





    17,410

    Total operating expenses





    19,874





    25,102





    68,899





    75,446

    Loss from operations





    (17,161)





    (22,089)





    (63,137)





    (72,415)

    Interest expense





    (1,202)





    (1,443)





    (3,785)





    (4,328)

    Other income, net





    255





    294





    1,485





    1,896

    Loss before provision for income taxes





    (18,108)





    (23,238)





    (65,437)





    (74,847)

    Provision for income taxes









    301









    303

    Net loss



    $

    (18,108)



    $

    (23,539)



    $

    (65,437)



    $

    (75,150)

    Net loss per common share, basic and diluted



    $

    (0.20)



    $

    (0.37)



    $

    (0.73)



    $

    (1.20)

    Shares used in computing net loss per share - basic

    and diluted





     

    89,365,798





     

    62,828,513





     

    89,109,772





     

    62,676,591

     

     

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  5. FREMONT, Calif. and TOKYO, Oct. 22, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company developing targeted, first-in-class medicines to improve the lives of patients with kidney and cardiovascular diseases, and Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE: 4151) today highlighted new clinical data presented within five posters at Kidney Week 2020, this year's virtual Annual Meeting of the American Society of Nephrology (ASN) that is now underway.

    Of the posters presented today, three highlight tenapanor clinical data from Ardelyx's Phase 3 trials in the U.S., including the BLOCK, AMPLIFY, and PHREEDOM studies, while two present results from the Phase 2 studies evaluating the efficacy and safety of tenapanor in Japanese patients on hemodialysis conducted by Kyowa Kirin, to whom Ardelyx has licensed exclusive rights to develop and commercialize tenapanor in Japan for the treatment of cardiorenal diseases. In Japan, Kyowa Kirin has conducted three Phase 2 trials of tenapanor as KHK7791. Tenapanor, which was discovered and developed by Ardelyx, is a first-in-class therapy currently under review for potential marketing approval by the U.S. Food and Drug Administration (FDA) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

    Kevin Martin, MD, Professor of Internal Medicine and Director, Division of Nephrology, Saint Louis University commented: "Despite the serious cardiovascular consequences of elevated phosphorus levels, and the development of a variety of phosphate binders, we have made little progress in achieving sustained control of  hyperphosphatemia over the past 30 years. Recent advances in our mechanistic understanding of phosphate absorption have led to a whole new way of thinking about how to manage hyperphosphatemia. With its novel mechanism of action targeting paracellular phosphate transport and comprehensive clinical data continuing to support its efficacy and safety, I believe tenapanor, if approved, has the potential to truly transform the management of hyperphosphatemia."  

    Ardelyx Poster Presentations:

    • ePoster #PO0384, entitled "Long-term Safety and Efficacy of Tenapanor for the Control of Serum Phosphorus in Patients with CKD on Dialysis," further summarizes data from PHREEDOM, a long-term Phase 3 U.S. study evaluating the safety and efficacy of tenapanor for the control of serum phosphorus in patients with CKD on dialysis. New details presented demonstrate that, within the efficacy analysis set, treatment with tenapanor resulted in sustained reductions in serum phosphorus concentrations, decreasing mean serum phosphorus from 7.7 mg/dL at baseline to 5.1 mg/dL at the end of the randomized treatment period.



    • ePoster #PO0374, entitled "Efficacy of Tenapanor for the Control of Serum Phosphorus in Patients with CKD on Dialysis: Novel Mechanism of Action Allows for Both Monotherapy and Dual Mechanism Approach," presents clinical data from two Phase 3 clinical trials, demonstrating that tenapanor reduces serum phosphorus when used as monotherapy in hyperphosphatemia patients with CKD on dialysis (BLOCK trial) and reduces serum phosphorus levels in patients with difficult-to-control hyperphosphatemia when used with phosphate binders as part of a dual-mechanism approach (AMPLIFY trial). The poster highlights the need for new strategies to manage hyperphosphatemia and suggests that tenapanor, with its novel mechanism of action, could offer a new treatment approach for patients with CKD on dialysis.



    • ePoster #PO0376, entitled "Tolerability of Tenapanor, an Investigational, First-in-Class, Non-Binder Therapy for the Control of Serum Phosphorus in Patients with CKD on Dialysis," presents an in-depth analysis of the tolerability profile of tenapanor across three pivotal clinical studies, BLOCK, PHREEDOM, and AMPLIFY, concluding that tenapanor was generally well tolerated in all studies and that the overall gastrointestinal tolerability of tenapanor is consistent with its novel mechanism of action.

    Kyowa Kirin Poster Presentations:

    • ePoster #PO0382, entitled "Dose-Response Efficacy and Tolerability of Tenapanor on Hyperphosphatemia in Japanese Hemodialysis Patients: Results of a Randomized Phase 2 Study," concludes that tenapanor significantly decreased serum phosphorus levels in a dose-dependent manner, and was generally well tolerated across doses in Japanese patients. Compared to placebo, the 30mg BID dosing groups produced a statistically significant 2.6 mg/dL mean reduction (p<0.001) in serum phosphorus from baseline to the end of the six-week treatment period.



    • ePoster #PO0375, entitled "Efficacy and Safety of Add-on Tenapanor to Phosphate Binders for Refractory Hyperphosphatemia in Japanese Patients on Hemodialysis: A Phase 2, Double-Blind Study," concludes that, the efficacy and safety of tenapanor with phosphate binders was consistent with other studies conducted in Japan where tenapanor was administered as a single agent. Compared to placebo and phosphate binders, treatment with tenapanor and phosphate binders achieved a statistically significant 2.1 mg/dL mean reduction (p<0.001) in serum phosphorus, with 87% of patients in the tenapanor group achieving target phosphorus levels.

    All poster presentations are now publicly available and can be accessed on demand HERE.

    In addition to the poster presentations during the ASN Annual Meeting, an Exhibitor Spotlight presentation, sponsored by Ardelyx, provides information on advances in the science of phosphate absorption and clinical data on tenapanor:

    "ADVANCING THE SCIENCE OF PHOSPHATE ABSORPTION: Paracellular Pathway and Implications for Phosphorus Management." Guest speakers focus on the following topics:

    • New Understanding of Phosphate Absorption May Explain Challenges in Phosphorus Management

      PRESENTED BY: KAMYAR KALANTAR-ZADEH, MD, MPH, PhD, Professor of Medicine, Pediatrics, Public Health, Epidemiology, and Nursing Sciences, Chief, Division of Nephrology and Hypertension and Kidney Transplantation, University of California, Irvine, School of Medicine
    • Tenapanor: An Investigational Therapy for the Treatment of Hyperphosphatemia

      PRESENTED BY: GLENN M. CHERTOW, MD, MPH, Chief, Division of Nephrology Stanford University School of Medicine

    To view the full presentation, click on the Ardelyx Exhibitor Spotlight program HERE.

    About Tenapanor for Hyperphosphatemia

    Tenapanor, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor currently under review by the FDA (PDUFA date: April 29, 2021) for the control of serum phosphorus in adult patients with CKD on dialysis. Tenapanor has a unique mechanism of action that 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. Tenapanor has been studied in three Phase 3 clinical trials in the U.S., all of which have met their primary endpoint and support the potential role of tenapanor as a foundational treatment in the management of hyperphosphatemia. In 2017, Ardelyx and Kyowa Kirin entered into a license agreement that provides Kyowa Kirin exclusive rights to develop and commercialize tenapanor in Japan for the treatment of cardiorenal diseases. In Japan, Kyowa Kirin has conducted three Phase 2 trials of tenapanor as KHK7791.

    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), 77% of CKD patients on dialysis are unable to consistently maintain phosphorus levels ≤5.5 mg/dL over a six-month period (Spherix Global Insights: RealWorld Dynamix, Dialysis 2019). 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 translating scientific breakthroughs into promise for patients, driven to advance targeted therapies where significant medical needs persist. We have developed a unique and innovative platform that has enabled the discovery of new biological mechanisms and pathways to create targeted, first-in-class, oral, small molecule therapies to meet these needs. Our lead candidate, tenapanor, is currently under FDA review for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis. Our discovery platform has also led us to the discovery of a lead candidate in our RDX013 program for the potential treatment of high potassium, or hyperkalemia, a common condition in patients with kidney and/or heart disease. For more information, please visit https://ardelyx.com/.

    About Kyowa Kirin Co., Ltd.

    Kyowa Kirin commits to innovative drug discovery driven by state-of-the-art technologies. The company focuses on creating new values in the four therapeutic areas: nephrology, oncology, immunology/allergy and neurology. Under the Kyowa Kirin brand, the employees from 40 group companies across North America, EMEA, and Asia/Oceania unite to champion the interests of patients and their caregivers in discovering solutions wherever there are unmet medical needs. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com.

    Ardelyx 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. 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.

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  6. FREMONT, Calif., Oct. 22, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company developing targeted, first-in-class medicines to improve the lives of patients with kidney and cardiovascular diseases, today announced the launch of its 'Can We Do Better?' Campaign at Kidney Week 2020, this year's virtual Annual Meeting of the American Society of Nephrology (ASN) that is now underway. With a new and deeper mechanistic understanding of phosphate absorption, Ardelyx is developing a new approach to advance patient care.

    THE PROBLEM: Hyperphosphatemia has been shown to be an independent risk factor for high rates of cardiovascular morbidity and mortality in patients with chronic kidney disease (CKD) on dialysis. Unfortunately, most of these patients are unable to consistently achieve target phosphorus levels with the use of phosphate binders, the only currently available medications approved for the treatment of hyperphosphatemia:

    • IN ANY GIVEN MONTH: ~42% of phosphate binder-treated patients on dialysis have phosphorus levels greater than the recommended target level of 5.5 mg/dL.*
    • OVER A 6-MONTH PERIOD: ~77% of phosphate binder-treated patients on dialysis are unable to consistently maintain phosphorus levels <5.5 mg/dL.*

    THE REASON FOR THE PROBLEM: There are limitations implicit to the mechanism of action of phosphate binders, the only class of medication approved for the treatment of hyperphosphatemia. Phosphate binders act by binding dietary phosphorus in the gut and because of how they work, must be taken with every meal, are large in size, and often require many pills per dose. These limitations make consistently achieving target phosphate levels extremely challenging for a large proportion of patients.

    ADVANCING THE SCIENCE: It's time to look deeper into the science of phosphate absorption:

    • NEW SCIENCE: Scientists at Ardelyx have discovered that dietary phosphate absorption occurs primarily through the paracellular pathway.
    • THE OPPORTUNITY: With this new knowledge comes great opportunity - to develop novel mechanism, non-binder, targeted therapies that could provide a completely new approach to the treatment of hyperphosphatemia.

    The full campaign can be viewed at https://www.advancingphosphatecontrol.com/.

    About Ardelyx, Inc.

    Ardelyx is a biopharmaceutical company translating scientific breakthroughs into promise for patients, driven to advance targeted therapies where significant medical needs persist. We have developed a unique and innovative platform that has enabled the discovery of new biological mechanisms and pathways to create targeted, first-in-class, oral, small molecule therapies to meet these needs. Our lead candidate, tenapanor, is currently under FDA review for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis. Our discovery platform has also led us to the discovery of a lead candidate in our RDX013 program for the potential treatment of high potassium, or hyperkalemia, a common condition in patients with kidney and/or heart disease. For more information, please visit https://ardelyx.com/.

    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. 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.

    *Source: Spherix Global Insights: RealWorld Dynamix, Dialysis 2019

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  7. FREMONT, Calif., Oct. 12, 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 five abstracts on tenapanor have been accepted for presentation at Kidney Week 2020, the American Society of Nephrology's (ASN) Annual Meeting, to be held October 22-25, 2020. Tenapanor, which was discovered and developed by Ardelyx, is a first-in-class therapy under review for potential marketing approval by the U.S. Food and Drug Administration (FDA) for the control of serum phosphorus in adult patients with CKD on dialysis.

    FREMONT, Calif., Oct. 12, 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 five abstracts on tenapanor have been accepted for presentation at Kidney Week 2020, the American Society of Nephrology's (ASN) Annual Meeting, to be held October 22-25, 2020. Tenapanor, which was discovered and developed by Ardelyx, is a first-in-class therapy under review for potential marketing approval by the U.S. Food and Drug Administration (FDA) for the control of serum phosphorus in adult patients with CKD on dialysis.

    Three poster presentations highlight data from several Phase 3 trials in the U.S., including the BLOCK, AMPLIFY and PHREEDOM studies. Additionally, the company's partner for tenapanor in Japan, Kyowa Kirin Co., Ltd. (Kyowa Kirin, TSE:4151), will present results from two Phase 2 studies evaluating the efficacy and safety of tenapanor in Japanese patients on hemodialysis.

    Information regarding ASN's Kidney Week, including copies of presentation abstracts, can be found at https://www.asn-online.org/education/kidneyweek.

    Ardelyx Poster Presentations:





    Title:

    Long-term Safety and Efficacy of Tenapanor for the Control of

    Serum Phosphorus in Patients with CKD on Dialysis

    Abstract Number:

    3450189

    ePoster Number:

    PO0384

    Date/Time:

    Thursday, October 22, 10:00 a.m. EDT





    Title:

    Efficacy of Tenapanor for the Control of Serum Phosphorus in

    Patients with CKD on Dialysis: Novel Mechanism of Action Allows

    for Both Monotherapy and Dual Mechanism Approach

    Abstract Number:

    3450673

    ePoster Number:

    PO0374

    Date/Time:

    Thursday, October 22, 10:00 a.m. EDT













    Title:

    Tolerability of Tenapanor, an Investigational, First-in-Class, Non-

    Binder Therapy for the Control of Serum Phosphorus in Patients

    with CKD on Dialysis

    Abstract Number:

    3450921

    ePoster Number:

    PO0376

    Date/Time:

    Thursday, October 22, 10:00 a.m. EDT









    Kyowa Kirin Poster Presentations:

    Title:

    Dose-Response Efficacy and Tolerability of Tenapanor on

    Hyperphosphatemia in Japanese Hemodialysis Patients: Results of a

    Randomized Phase 2 Study

    Abstract Number:

    3435825

    ePoster Number:

    PO0382

    Date/Time:

    Thursday, October 22, 10:00 a.m. EDT









    Title:

    Efficacy and Safety of Add-on Tenapanor to Phosphate Binders for

    Refractory Hyperphosphatemia in Japanese Patients on

    Hemodialysis: A Phase 2, Double-Blind Study

    Abstract Number:

    3439266

    ePoster Number:

    PO0375

    Date/Time:

    Thursday, October 22, 10:00 a.m. EDT

    About our Partnership with Kyowa Kirin

    Kyowa Kirin is a Japan-based global specialty pharmaceutical company committed to innovative drug discovery driven by state-of-the-art technologies. The company focuses on discovering and creating new value through advances in four therapeutic areas: nephrology, oncology, immunology/allergy and neurology. In 2017, Ardelyx entered into a license agreement that provides Kyowa Kirin exclusive rights to develop and commercialize tenapanor in Japan for the treatment of cardiorenal diseases. In addition, in 2019, the companies established a two-year research collaboration to advance two of Ardelyx's ongoing research programs focused on the identification and design of compounds for two undisclosed targets.

    About Tenapanor for Hyperphosphatemia

    Tenapanor, discovered and developed by Ardelyx, is a first-in-class, phosphate absorption inhibitor, for which an NDA is currently under review by the FDA (PDUFA date: April 29, 2021), for the control of serum phosphorus in adult patients with CKD on dialysis. Tenapanor has a unique mechanism of action that 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. Tenapanor has been studied in three Phase 3 clinical trials in the U.S., all of which have met their primary endpoint, and support the role of tenapanor as foundational treatment in the management of hyperphosphatemia. 

    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), 77% of CKD patients on dialysis are unable to consistently maintain phosphorus levels ≤5.5 mg/dL over a six-month period (Spherix Global Insights: RealWorld Dynamix, Dialysis 2019). 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 dedicated to improving the lives of patients by discovering, developing and commercializing first-in-class targeted therapies that advance patient care.  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.

    About Kyowa Kirin Co., Ltd.

    Kyowa Kirin commits to innovative drug discovery driven by state-of-the-art technologies. The company focuses on creating new values in the four therapeutic areas: nephrology, oncology, immunology/allergy and neurology. Under the Kyowa Kirin brand, the employees from 40 group companies across North America, EMEA, and Asia/Oceania unite to champion the interests of patients and their caregivers in discovering solutions wherever there are unmet medical needs. You can learn more about the business of Kyowa Kirin at: https://www.kyowakirin.com.

    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. 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-data-supporting-efficacy-and-safety-of-tenapanor-a-first-in-class-phosphate-absorption-inhibitor-to-be-presented-at-asns-kidney-week-2020-301149661.html

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  8. 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.

     

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  9. 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.

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  10. 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

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  11. 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.

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  12. 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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  13. FREMONT, Calif., June 15, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today reported positive data from its ongoing NORMALIZE 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. Tenapanor is an investigational, first-in-class, phosphate absorption inhibitor which, if approved, will provide a completely new approach for the control of serum phosphorus in patients with CKD on dialysis, blocking…

    FREMONT, Calif., June 15, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with kidney and cardiovascular diseases, today reported positive data from its ongoing NORMALIZE 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. Tenapanor is an investigational, first-in-class, phosphate absorption inhibitor which, if approved, will provide a completely new approach for the control of serum phosphorus in patients with CKD on dialysis, blocking the absorption of phosphorus at the primary pathway of uptake.

    "These data from the NORMALIZE study are unprecedented in terms of the proportion of patients able to achieve serum phosphorus levels < 4.6mg/dL with foundational use of tenapanor," said Stuart Sprague DO, FASN, chief of the Division of Nephrology and Hypertension at Northshore University Health System. "This represents an important advancement in the management of hyperphosphatemia for patients on dialysis. The ability of tenapanor to drive phosphorus levels closer to normal has the potential to completely change the hyperphosphatemia treatment paradigm."

    The NORMALIZE extension study allowed patients from PHREEDOM, the positive Phase 3 long-term monotherapy study, to continue therapy with tenapanor, and enabled those in the safety control arm receiving sevelamer, to transition to tenapanor. The planned second analysis demonstrated that the foundational use of tenapanor as monotherapy or in combination with sevelamer carbonate produces a significant phosphorus-lowering effect with a mean serum phosphorous 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 at the time of this analysis. Of the 171 patients in this interim analysis who completed up to 9 months of treatment in this extension study, up to 47.4% achieved a normal serum phosphorus level, and of those, the majority were on tenapanor alone or tenapanor with low dose sevelamer of ≤3 sevelamer tablets per day. These data represent a 58% improvement in the rate of patients who achieve a normal serum phosphorus level, as compared to current treatment practice data as reported in the April 2020 Dialysis Outcomes Practice Patterns Study (DOPPS) Practice Monitor. The DOPPS data demonstrate that, with current standard of care treatment of phosphate binders alone, only 30% of patients have serum phosphorous levels < 4.6 mg/dL. The only adverse event reported in >5% of patients in NORMALIZE was diarrhea, with an incidence rate of 23.3%.

    Separately, Kyowa Kirin Co., Ltd., a Japan-based global specialty pharmaceutical company exclusively developing tenapanor in Japan, presented results from a Phase 2 trial of tenapanor at the European Renal Association-European Dialysis and Transplant Association annual meeting (ERA-EDTA 2020). The abstract was entitled:

    A Phase 2 Open-label, Single-arm, First Japanese Study of Tenapanor, a Novel Phosphate Absorption Inhibitor, Focusing on Pill Burden Decrease in Patients with Hyperphosphatemia Undergoing Hemodialysis. 

    The trial was designed to evaluate if, with tenapanor, patients could achieve at least a 30% decrease in mean pill burden while maintaining their serum phosphorus level. The study results were statistically significant, with 71.6% (p<0.001) of patients achieving at least a 30% reduction in mean pill burden. The overall mean reduction in phosphate binder usage was 80% (reduction from 14.7 to 3.0 pills per day), while maintaining serum phosphorus control. The mean phosphorus level of patients entering the study on treatment with binders was 5.2 mg/dL at baseline and 4.7 mg/dL at the end of the 26-week study.

    "The compelling results of the NORMALIZE study enhance our robust dataset demonstrating tenapanor's ability to significantly decrease serum phosphorous levels, both as a monotherapy and as part of a dual mechanism approach with phosphate binders," said David Rosenbaum, Ph.D., chief development officer of Ardelyx. "The Phase 2 data reported by our partner in Japan, Kyowa Kirin, shows that with tenapanor we are able to control serum phosphorus with a reduced pill burden as compared to treatment with binders. Together, these data continue to advance our understanding of tenapanor and its potential as a transformative treatment for patients with hyperphosphatemia. Of note, we are in the final stages of preparing our New Drug Application for tenapanor for the control of serum phosphorus, which is on track to be submitted mid-year."

    NORMALIZE Study Design

    Patients completing the Phase 3 PHREEDOM trial from both the tenapanor arm and the sevelamer safety control arm had the option to participate in NORMALIZE, an ongoing open-label 18-month extension study.

    Patients entering the study from the tenapanor arm with serum phosphorus levels in the normal range are followed with no medication changes. Patients entering the study from the tenapanor arm with serum phosphorus > 4.5 mg/dL have sevelamer tablets added incrementally to achieve normal serum phosphorus levels. Patients entering the study from the sevelamer safety control arm have tenapanor tablets added to their treatment regimen while reducing sevelamer tablets based on their serum phosphorus value, to achieve normal serum phosphorus levels.

    The primary objective of the study is to evaluate the ability of tenapanor alone or in combination with sevelamer to achieve serum phosphorus levels within the normal range (2.5 to 4.5 mg/dL) in patients with chronic kidney disease on dialysis whose serum phosphorus levels were greater than 6.0 mg/dL at baseline.

    Kyowa Kirin's Phase 2 Study Design

    A multicenter, open-label, single-arm Phase 2 study consisted of a screening period, a 3-week observation period, and a 26-week treatment period. Patients whose serum phosphorus level was 3.5 to 7.0 mg/dL, taking at least two phosphate binder pills three times a day were enrolled. Patients received 30 mg of tenapanor twice daily. Phosphate binder treatment was continued according to individual regimens; however, the dose was adjusted to maintain serum phosphorus level within ±0.5 mg/dL from baseline. The primary endpoint was the achievement of at least a 30% decrease in the mean total number of phosphate binder and tenapanor pills compared to the number of phosphate binder pills at baseline.

    About Tenapanor for Hyperphosphatemia

    Tenapanor, discovered and developed by Ardelyx, is a first-in-class, proprietary, oral medicine for which the Company is preparing a New Drug Application for submission to the FDA in mid-2020 for the control of serum phosphorus in 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 and especially those 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 enhancing the way people with kidney and cardiovascular diseases are treated by developing innovative first-in-class medicines. Ardelyx's pipeline includes tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, for which the Company is preparing for NDA submission mid-year, 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 the use of tenapanor as monotherapy and as part of a dual mechanism approach with phosphate binders for the control of serum phosphorus in adult chronic kidney disease patients on dialysis; the potential for tenapanor with binders to achieve serum phosphorus levels of less than 4.6 mg/dL; and Ardelyx's expectation regarding the timing of the submission of a NDA to the FDA seeking approval for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease on dialysis. 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 clinical development process, including the regulatory approval 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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  14. FREMONT, Calif., June 9, 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 on June 8, 2020, the compensation committee of the Company's Board of Directors granted a non-qualified stock option award to purchase 195,017 shares of its common stock and a restricted stock unit award for 10,000 shares in connection with the commencement of employment of its new Chief Financial Officer, Justin Renz, under the Company's 2016 Employment Commencement Incentive Plan (the "Inducement Plan").  The stock options and restricted stock units were granted as an inducement…

    FREMONT, Calif., June 9, 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 on June 8, 2020, the compensation committee of the Company's Board of Directors granted a non-qualified stock option award to purchase 195,017 shares of its common stock and a restricted stock unit award for 10,000 shares in connection with the commencement of employment of its new Chief Financial Officer, Justin Renz, under the Company's 2016 Employment Commencement Incentive Plan (the "Inducement Plan").  The stock options and restricted stock units were granted as an inducement material to Mr. Renz becoming an employee of the Company in accordance with Nasdaq Listing Rule 5635(c)(4). 

    The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of the Company (or following a bona fide period of non-employment), as an inducement material to such individuals entering into employment with Ardelyx pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

    The option has an exercise price of $7.35 per share, which is equal to the closing price of Ardelyx' common stock on the Nasdaq Global Select Market on June 8, 2020.  The option will vest over a four-year period, with 25% of the shares vesting on the one year anniversary of the date of grant, and thereafter the remaining shares will vest monthly over period of 36 months, subject to the employee's continued service to the Company on such vesting dates.  The restricted stock units will vest upon the achievement of specified performance conditions, subject to the employee's continued service to the Company on such vesting date. 

    About Ardelyx, Inc.

    Ardelyx is focused on enhancing the way people with kidney and cardiovascular diseases are treated by developing innovative first-in-class medicines. Ardelyx's pipeline includes tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, for which the Company is preparing for NDA submission mid-year, 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.

     

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  15. FREMONT, Calif., June 8, 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 the appointment of Justin Renz to the position of Chief Financial Officer. Mr. Renz, a highly accomplished leader with over 20 years of experience in the biopharmaceutical industry, brings an extensive array of financial and operational experience to Ardelyx.

    "It is a real pleasure to welcome Justin to the Ardelyx management team as we enter a critical period of significant growth and momentum," said Mike Raab, president and chief executive officer of Ardelyx. "Justin's vast biopharmaceutical executive experience and his proven track record of leading finance and key general and administrative functions within commercial organizations are critical capabilities needed for our success as we transition from a development stage to a successful commercial organization. We are excited to welcome Justin to the team."

    "Ardelyx is a compelling opportunity given its position at the forefront of advancing novel therapies for the renal community, beginning with its lead product candidate tenapanor," said Mr. Renz. "As the company prepares for the forthcoming submission of a New Drug Application for tenapanor, I will be working alongside an accomplished leadership team to enhance our operational infrastructure to support the company's expected maturation into a sales-generating organization. I look forward to helping with that exciting evolution and contributing to the company's success."

    Mr. Renz has extensive experience in the biopharmaceutical industry. He most recently served as the president and chief financial officer of Correvio Pharma, a global specialty pharmaceutical company dedicated to the commercialization of cardiovascular and infectious disease products, where he led the sale of the company to ADVANZ PHARMA in May 2020. Prior to Correvio, Mr. Renz was executive vice president, chief financial officer and treasurer of Karyopharm Pharmaceuticals, where he led core business and finance functions and multiple financings. Before Karyopharm, Mr. Renz was executive vice president and chief financial officer at Zalicus Inc. (formerly CombinatoRx, Inc.), which he joined in 2006. At Zalicus, Mr. Renz oversaw multiple rounds of equity and debt financings, led the company's asset monetization strategy and was instrumental in the reverse merger and sale of Zalicus to EPIRUS Biopharmaceuticals Inc. in July 2014. Earlier in his career, Mr. Renz held numerous positions of increasing responsibility at ArQule, Inc. and Millipore Corporation. Mr. Renz began his career with Arthur Andersen LLP in 1993. He received a Bachelor of Arts in Economics and Accounting from the College of the Holy Cross, a Master of Science in Taxation from Northeastern University and a Master of Business Administration from Suffolk University. 

    About Ardelyx, Inc.

    Ardelyx is focused on enhancing the way people with kidney and cardiovascular diseases are treated by developing innovative first-in-class medicines. Ardelyx's pipeline includes tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, for which the Company is preparing for NDA submission mid-year, 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 IBSRELAâ (tenapanor) on September 12, 2019. Ardelyx has established agreements with Kyowa Kirin Corporation 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, and the potential for tenapanor to be successfully commercialized for such indication. 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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  16. FREMONT, Calif., May 26, 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 Mike Raab, president and chief executive officer of Ardelyx, will participate in a fireside chat at the Jefferies Virtual Healthcare Conference on Tuesday, June 2, 2020 at 3:00 p.m. ET.

    To access the live webcast of Ardelyx's presentation please visit the Events & Presentations page within the Investor section of the Ardelyx website at ir.ardelyx.com. A replay of the webcast will be available on the Ardelyx website for 60 days following the conference.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with kidney and cardiovascular diseases are treated by developing innovative first-in-class medicines. Ardelyx's pipeline includes tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, for which the Company is preparing for NDA submission mid-year, 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 Corporation in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in the respective territories.

     

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  17. FREMONT, Calif., May 21, 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 on  May 18, 2020, the compensation committee of the Company's Board of Directors granted a non-qualified stock option award to purchase 232,750 shares of its common stock and a restricted stock unit award for 20,000 shares in connection with the commencement of employment of its new Chief Commercial Officer, Susan Rodriguez, under the Company's 2016 Employment Commencement Incentive Plan (the "Inducement Plan"). The stock options and restricted stock units were granted as an inducement…

    FREMONT, Calif., May 21, 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 on  May 18, 2020, the compensation committee of the Company's Board of Directors granted a non-qualified stock option award to purchase 232,750 shares of its common stock and a restricted stock unit award for 20,000 shares in connection with the commencement of employment of its new Chief Commercial Officer, Susan Rodriguez, under the Company's 2016 Employment Commencement Incentive Plan (the "Inducement Plan"). The stock options and restricted stock units were granted as an inducement material to Ms. Rodriguez becoming an employee of the Company in accordance with Nasdaq Listing Rule 5635(c)(4). 

    The Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously employees of the Company (or following a bona fide period of non-employment), as an inducement material to such individual's entering employment with Ardelyx pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.

    The option has an exercise price of $7.70 per share, which is equal to the closing price of Ardelyx' common stock on the Nasdaq Global Select Market on May 18, 2020.  The option will vest over a four-year period, with 25% of the shares vesting on the one-year anniversary of the date of grant, and thereafter the remaining shares will vest monthly over period of 36 months, subject to the employee's continued service to the Company on such vesting dates.  The restricted stock units will vest upon the achievement of specified performance conditions, subject to the employee's continued service to the Company on such vesting date. 

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with kidney and cardiovascular diseases are treated by developing innovative first-in-class medicines. Ardelyx's pipeline includes tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, for which the Company is preparing for NDA filing mid-year, 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 Corporation in Japan, Fosun Pharma in China and Knight Therapeutics in Canada for the development and commercialization of tenapanor in the respective territories.

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  18. FREMONT, Calif., May 18, 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 the appointment of Susan Rodriguez, an industry veteran with over 25 years of global pharmaceutical experience, as the company's first chief commercial officer. Ms. Rodriguez will be responsible for leading the commercial organization, including launch planning and strategy, as well as alliance management and business development.  

    "We are very fortunate to have someone of Susan's caliber and successful track record join our management team," said Mike Raab, president and chief executive officer of Ardelyx. "Susan has a remarkable history of global marketing and sales leadership and has built commercial teams responsible for multi-billion-dollar drugs and portfolios. During her tenure at Abbott, she led the establishment of its U.S. renal commercial organization and oversaw numerous successful product launches. The implementation of her strategies resulted in favorable reimbursement and market access for patients. The breadth and depth of her relevant experience will serve us extremely well as we approach the potential approval of tenapanor in mid-2021. Ultimately, Susan's energy and strategic orientation, and her expertise and leadership will be instrumental to help advance us towards our goal of making tenapanor available to the many chronic kidney disease patients on dialysis whose serum phosphorus levels are uncontrolled."

    Susan Rodriguez added, "I am thrilled to join Ardelyx at this exciting juncture as we approach the potential launch of tenapanor, the first non-binder treatment option for dialysis patients suffering from chronic kidney disease. The company is in a unique position with compelling clinical data for a drug candidate that is wholly-owned in major markets such as the U.S. and Europe. My passion is launching, establishing and building global brands and I look forward to leveraging the solid foundation the Ardelyx team has already built to position tenapanor for commercial success."

    Ms. Rodriguez is a seasoned healthcare executive with extensive leadership experience across pharmaceutical, biopharma, hospital products, and nutrition segments in U.S. and international markets. Previously, Ms. Rodriguez served as the founding chief executive officer of Tolmar Pharmaceuticals, a U.S. commercial entity of marketed products, that was later merged with sister companies where she served as president of the branded division. Prior to Tolmar, Ms. Rodriguez held various positions at Abbott Laboratories, most recently divisional vice president of global marketing, establishing a global marketing function for a $3.8 billion international portfolio of nutrition brands. As divisional vice president, she directed strategic brand planning and commercial go-to-market strategies and programs for 11 global product launches. Earlier in her career, Ms. Rodriguez held several sales, marketing and commercial positions including, director, managed care at TAP Pharmaceuticals, professional sales representative at Merck Human Health Division and client manager at ARBOR, a pharmaceutical market research firm. Ms. Rodriguez holds a Master's and Bachelor's degree in Psychology from the University of Pennsylvania.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with kidney and cardiovascular diseases are treated by developing innovative first-in-class medicines. Ardelyx's pipeline includes tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, for which the Company is preparing for NDA filing mid-year, 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 Corporation 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, and the potential for tenapanor to be successfully commercialized for such indication. 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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  19. FREMONT, Calif., May 7, 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 first quarter ended March 31, 2020.

    "During these unprecedented times, our priorities are focused on the well-being and safety of our employees, patients, and communities, while continuing on our mission to provide patients with first-in-class, disruptive medicines based on our breakthrough science," said Mike Raab, president and chief executive officer of Ardelyx. "We are fortunate that much of our clinical work has been completed, with minimal impact of the pandemic on our business, and we are on track to submit our NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis by mid-year. In preparation for potential approval in mid-2021, we are laying the foundation for launch with important pre-commercial activities underway."

    Recent Business and Pipeline Updates

    • Initial data from NORMALIZE released in December 2019 demonstrated that of the 73 patients, treated for more than one month, 42% achieved normal phosphorus levels of less than 4.6 mg/dL and of those, 58% accomplished this with either tenapanor alone or with tenapanor in combination with only one to three sevelamer tablets per day. These early and exciting data represent a 45% improvement over current phosphate binder data from the 2019 Dialysis Outcomes and Practice Patterns Study (DOPPS), an ongoing, national prospective study of hemodialysis practice.
    • Appointed industry veteran, Onaiza Cadoret-Manier to the company's board of directors.
    • Our collaboration partner in Canada, Knight Therapeutics, received approval from Health Canada for IBSRELA® for the treatment of IBS-C in adults.
    • Planned initiation of the OPTIMIZE clinical trial in 2020, a study to inform physicians on the integration of tenapanor into clinical practice.

    Expected 2020 Milestones

    • Preparing NDA Submission for Tenapanor for the Control of Serum Phosphorus in mid-2020: With strong data from its clinical program for tenapanor, Ardelyx is preparing a New Drug Application for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, which the company currently intends to submit to the U.S. Food and Drug Administration in mid-2020.
    • Reporting AMPLIFY and PHREEDOM Phase 3 results and NORMALIZE Phase 4 results at upcoming medical conferences. 

    First Quarter 2020 Financial Results

    • Cash Position: As of March 31, 2020, Ardelyx had total cash, cash equivalents and short-term investments of $223.2 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 $1.2 million in revenue, which primarily represents collaborative development revenue, for the quarter ended March 31, 2020.
    • R&D Expenses: Research and development expenses were $15.8 million for the three months ended March 31, 2020, a decrease of $4.6 million, or 22.3 percent, compared to $20.4 million for the three months ended March 31, 2019. The decrease was due primarily to a decrease in external R&D expenses, with a $5.1 million decrease in tenapanor-related expenses, as well as a $0.8 million decrease in RDX013 program-related expenses, partially offset by $0.8 million of higher expenses attributable to research conducted under the Research Collaboration and Option Agreement entered into with Kyowa Kirin Co., Ltd., in November 2019 and general R&D expenses. Of the overall tenapanor-related decrease, approximately $4.1 million relates to lower clinical study costs and approximately $1.4 million relates to lower manufacturing expenses.
    • G&A Expenses: General and administrative expenses were $7.1 million for the three months ended March 31, 2020, an increase of $2.0 million, or 39.5 percent, compared to $5.1 million for the three months ended March 31, 2019. The increase in general and administrative expenses was primarily due to an increase in headcount and related personnel costs, including stock-based compensation costs related to option vesting and performance-based restricted stock units, severance expenses related to the departure of the company's former chief financial officer in March 2020, and an increase in professional services.
    • Net Loss: Net loss for the quarter ended March 31, 2020 was $22.4 million, as compared to $26.1 million for the quarter ended March 31, 2019.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with kidney and cardiovascular diseases are treated by developing innovative first-in-class medicines. Ardelyx's pipeline includes tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis, preparing for NDA filing mid-year, 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 Corporation 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 for the control of serum phosphorus in chronic kidney disease (CKD) patients on dialysis, and Ardelyx's expectation regarding the timing of the company's submission to the FDA of a NDA for tenapanor for the control of serum phosphorus in adult CKD patients on dialysis. 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 inherent in the clinical development process, and the uncertainties associated with the regulatory approval 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.

    Ardelyx, Inc.

    Condensed Balance Sheets

    (In thousands)










    March 31,
    2020


    December 31,
    2019



    (Unaudited)


    (1)

    Assets







    Cash and cash equivalents


    $

    105,895


    $

    181,133

    Short-term investments



    117,312



    66,379

    Unbilled revenue



    750



    750

    Property and equipment, net



    2,968



    3,436

    Right-of-use assets



    3,468



    3,970

    Prepaid and other assets



    4,929



    4,114

    Total assets


    $

    235,322


    $

    259,782








    Liabilities and stockholders' equity







    Accounts payable


    $

    1,012


    $

    2,187

    Accrued compensation and benefits



    1,951



    4,453

    Current portion of operating lease liability



    2,715



    2,608

    Loan payable, current portion



    7,437



    1,183

    Deferred revenue



    3,366



    4,541

    Accrued expenses and other liabilities



    6,936



    7,248

    Operating lease liability, net of current portion



    1,355



    2,076

    Loan payable, net of current portion



    42,793



    48,831

    Stockholders' equity



    167,757



    186,655

    Total liabilities and stockholders' equity


    $

    235,322


    $

    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 March 31,



    2020


    2019



    (Unaudited)


    (Unaudited)

    Revenues:







    Collaborative development revenue


    $

    1,175


    $

    Other revenue



    38



    Total revenues



    1,213



    Operating expenses:







    Research and development



    15,844



    20,381

    General and administrative



    7,138



    5,117

    Total operating expenses



    22,982



    25,498

    Loss from operations



    (21,769)



    (25,498)

    Interest expense



    (1,357)



    (1,434)

    Other income, net



    753



    790

    Loss before provision for income taxes



    (22,373)



    (26,142)

    Provision for income taxes





    2

    Net loss


    $

    (22,373)


    $

    (26,144)

    Net loss per common share, basic and diluted


    $

    (0.25)


    $

    (0.42)

    Shares used in computing net loss per share - basic and diluted



    88,880,658



    62,546,295

    Comprehensive loss:







    Net loss



    (22,373)



    (26,144)

    Unrealized (losses) gains on available-for-sale securities



    (64)



    50

    Comprehensive loss


    $

    (22,437)


    $

    (26,094)

     

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  20. MONTREAL, April 17, 2020 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX:GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced that Health Canada has approved IBSRELA™ (tenapanor) for the treatment  of irritable bowel syndrome with constipation (IBS-C) in adults.  Knight and Ardelyx, Inc. (NASDAQ:ARDX) signed an agreement in March 2018 granting Knight the exclusive right to distribute IBSRELA™ in Canada for IBS-C and hyperphosphatemia.

    IBSRELA™ is a minimally-absorbed small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients. On September 12, 2019, the U.S…

    MONTREAL, April 17, 2020 (GLOBE NEWSWIRE) -- Knight Therapeutics Inc., (TSX:GUD) ("Knight") a pan-American (ex-USA) specialty pharmaceutical company, announced that Health Canada has approved IBSRELA™ (tenapanor) for the treatment  of irritable bowel syndrome with constipation (IBS-C) in adults.  Knight and Ardelyx, Inc. (NASDAQ:ARDX) signed an agreement in March 2018 granting Knight the exclusive right to distribute IBSRELA™ in Canada for IBS-C and hyperphosphatemia.

    IBSRELA™ is a minimally-absorbed small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients. On September 12, 2019, the U.S. Food and Drug Administration (FDA) approved IBSRELA™ for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

    "We are excited to receive approval for this promising new treatment option for patients suffering from IBS-C," said Jonathan Ross Goodman, chief executive officer of Knight. "With its unique mechanism of action, IBSRELA™ offers patients a novel, safe and efficacious option for their treatment of IBS-C."

    About Tenapanor

    IBSRELA (tenapanor) is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. In vitro and animal studies indicate its major metabolite, M1, is not active against NHE3. By inhibiting NHE3 on the apical surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, resulting in an increase in water secretion into the intestinal lumen, which accelerates intestinal transit time and results in a softer stool consistency.

    Tenapanor has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models. In rat model of colonic hypersensitivity, tenapanor reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability.

    Tenapanor is also being evaluated to reduce phosphate absorption and lower elevated serum phosphate concentrations in patients with chronic kidney disease (CKD) on dialysis. Tenapanor's unique mechanism of action results in the tightening of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate, the primary pathway of phosphate absorption.  Ardelyx reported positive topline results from PHREEDOM, a long-term Phase 3 study evaluating the efficacy and safety of tenapanor as monotherapy for the treatment of hyperphosphatemia in patients with CKD on dialysis as well as  positive results from AMPLIFY, a pivotal Phase 3 study of tenapanor evaluating the dual mechanism of tenapanor in combination with phosphate binders in patients with CKD on dialysis whose hyperphosphatemia was not  controlled with binders alone. Ardelyx is planning to submit their NDA to the FDA in the United States mid-2020 with expected approval in mid-2021.

    About Knight

    Knight Therapeutics Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing and commercializing innovative pharmaceutical products for Canada and Latin America. Knight owns a controlling stake in Grupo Biotoscana, a pan-Latin American specialty pharmaceutical company. Knight Therapeutics Inc.'s shares trade on TSX under the symbol GUD. For more information about Knight Therapeutics Inc., please visit the company's web site at www.gud-knight.com or www.sedar.com

    Forward-Looking Statement

    This document contains forward-looking statements for Knight Therapeutics Inc. and its subsidiaries. These forward-looking statements, by their nature, necessarily involve risks and uncertainties that could cause actual results to differ materially from those contemplated by the forward-looking statements. Knight Therapeutics Inc. considers the assumptions on which these forward-looking statements are based to be reasonable at the time they were prepared but cautions the reader that these assumptions regarding future events, many of which are beyond the control of Knight Therapeutics Inc. and its subsidiaries, may ultimately prove to be incorrect. Factors and risks, which could cause actual results to differ materially from current expectations are discussed in Knight Therapeutics Inc.'s Annual Report for the year ended December 31, 2019 and in Knight Therapeutics Inc.'s latest Annual Information Form filed on www.sedar.com. Knight Therapeutics Inc. disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information or future events, except as required by law.


    For further information, please contact:

    Knight Therapeutics Inc.
    Samira Sakhia
    President
    T: 514-678-8930
    F: 514-481-4116

    www.gudknight.com

    Knight Therapeutics Inc.
    Arvind Utchanah
    Chief Financial Officer
    T. 514.484.4483 ext. 115
    F. 514.481.4116

    www.gudknight.com

    Primary Logo

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  21. FREMONT, Calif., March 16, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced that Onaiza Cadoret-Manier, an industry veteran with deep biopharmaceutical commercial experience, has joined the Company's Board of Directors. Ms. Cadoret-Manier replaces Annalisa Jenkins, who stepped down from the board effective March 12, 2020 in order to be closer and more involved with her Board responsibilities in Europe.

    "We are pleased to welcome Onaiza to our board of directors," said Mike Raab, president and chief executive officer of Ardelyx. "Her wealth of experience, including commercialization and strategic planning for products at our stage, will be invaluable as we advance towards the potential launch and commercialization of tenapanor for the control of serum phosphorus in chronic kidney disease patients (CKD) on dialysis."

    "With three successful Phase 3 trials for their lead therapeutic, tenapanor, this is an extremely exciting time for Ardelyx," said Ms. Cadoret-Mainer. "I believe tenapanor has the potential to change the landscape for the control of serum phosphorus– finally, a fresh approach to phosphate control for patients. I'm looking forward to serving on the board and helping to guide the company through its transformation into a commercial organization with potential approval of its first marketed drug."

    Mike Raab added, "I want to thank Annalisa for her friendship, leadership and guidance over the past five years. She has been an extremely valuable member of the board of directors and it's been my pleasure to work with her."

    Annalisa Jenkins joined the company's board of directors in 2015. Since joining the board, she has provided important contributions to help advance the company's clinical development programs with her broad range of industry experience.

    Ms. Cadoret-Manier is an international commercialization and operations executive and life sciences industry veteran with over 30 years of experience driving growth for start-up and Fortune 500 companies. She has led and directed multiple new product launches with responsibility for product planning and commercialization through all phases of the product life cycle and across multiple therapeutic areas to heightened success in highly competitive markets. Ms. Cadoret-Manier currently serves as chief corporate development and commercial officer at Ionis Pharmaceuticals and previously was the chief commercial officer for Grail Biosciences, an early detection genomics company, where she developed the commercial strategy and business model. Prior to Grail, she was vice president of the respiratory franchise at Genentech, where she built and managed a team of more than 400 employees responsible for successfully commercializing medicines that generated approximately $3 billion in revenue. Ms. Cadoret-Manier also has held multiple senior management positions overseeing corporate strategy, alliances, and marketing and sales for numerous disease areas for Genentech, Pfizer and Amylin Pharmaceuticals. She has an MBA from the University of Chicago and a bachelor's degree in economics and accounting from City University of New York Queens College.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the control of serum phosphorus in patients with CKD on dialysis, 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.

    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 and commercialized for the control of serum phosphorus in chronic kidney disease patients on dialysis. 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 inherent in the clinical development process, 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 annual report on Form 10-K filed with the Securities and Exchange Commission on March 6, 2020, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

     

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  22. FREMONT, Calif., March 6, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment choices for people with cardiorenal diseases, today reported business highlights and financial results for the fourth quarter and full year ended December 31, 2019.

    "2019 was a year of significant progress at Ardelyx. We successfully hit all of our key milestones bringing us closer to submitting a New Drug Application to the FDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis in mid-2020 and potentially providing this first in class agent to patients in need," said Mike Raab, president and chief executive officer of Ardelyx. "We enter 2020 well-positioned with data from three successful Phase 3 trials for tenapanor in hyperphosphatemia, key ex-U.S. partnerships and two years of cash on hand to prepare for U.S. commercialization of our novel therapy."

    Key Accomplishments in 2019

    • Published positive Phase 3 results of tenapanor for the treatment of hyperphosphatemia in the Journal of the American Society of Nephrology.
    • Appointed renowned nephrologist, Geoffery A. Block, M.D., to the company's board of directors.
    • Began the process of building a highly talented and experienced cardiorenal commercial team.
    • Announced positive, statistically significant results from the Phase 3 AMPLIFY study evaluating tenapanor in dialysis patients who have uncontrolled hyperphosphatemia despite phosphate binder treatment.
    • Received FDA approval for IBSRELA® (tenapanor). The company continues to seek a strategic partner to market IBSRELA in the United States.
    • Expanded collaborative partnership with Kyowa Kirin Co., Ltd (KKC) with a new research agreement and a $20.0 million equity investment in Ardelyx under a Stock Purchase Agreement.
    • Announced positive topline results from the PHREEDOM study evaluating tenapanor as a monotherapy for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. The PHREEDOM study met its primary endpoint demonstrating a statistically significant difference in least square (LS) mean serum phosphorus change (-1.4 mg/dL, p<0.0001), as compared to placebo.
    • Raised approximately $135 million, net of underwriting discounts and commissions, following a successful underwritten public offering of 23,000,000 shares of common stock to support commercial launch preparation for tenapanor for the control of serum phosphorus in patients with CKD on dialysis. The capital raised in the fourth quarter of 2019 extends the company's cash runway into early 2022, based on its current operating plan.
    • Initiated the Phase 4 NORMALIZE study and announced initial results demonstrating that a significant number of patients achieved normal serum phosphorus levels with tenapanor alone or with tenapanor and only one to three sevelamer tablets a day.

    On-Track to Submit NDA for Tenapanor for the Control of Serum Phosphorus in mid-2020: Ardelyx is on-track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for tenapanor for the control of serum phosphorus in mid-2020.

    Full Year 2019 Financial Results

    • Cash Position: As of December 31, 2019, Ardelyx had total capital resources including cash, cash equivalents and short-term investments of $247.5 million compared to total capital resources including cash, cash equivalents and short-term investments of $168.1 million as of December 31, 2018.
    • Revenue and Cost of Revenue: Total revenues were $5.3 million for the year ended December 31, 2019 related to the company's ex-U.S. collaboration partnerships, and cost of revenues was $0.6 million related to payments due to AstraZeneca in accordance with the company's termination agreement entered into with AstraZeneca in June 2015 compared to total revenues of $2.6 million and cost of revenues of $0.5 million for the year ended December 31, 2018.
    • R&D Expenses: Research and development expenses were $71.7 million for the year ended December 31, 2019, an increase of $2.3 million, or 3%, compared to $69.4 million for the year ended December 31, 2018. The increase consisted of a $3.7 million increase in our internal program costs and a $1.4 million decrease in our external program costs. The increase in our internal costs of $3.7 million was primarily due to an increase in headcount and related personnel costs and an increase in stock-based compensation expenses. The decrease in our external program costs of $1.4 million included a $4.6 million decrease in expenses primarily related to manufacturing of tenapanor and regulatory expenses related to our IBS-C NDA in 2018, partially offset by $2.5 million increase in clinical development expenses related to our RDX013 program and a $0.7 million increase primarily related to our tenapanor clinical trial expenses that includes an out-of-period adjustment recorded during the second quarter of 2019 that reduced clinical trial expenses by $3.6 million related to our tenapanor clinical trials.
    • G&A Expenses: General and administrative expenses were $24.3 million for the year ended December 31, 2019, an increase of $0.6 million, or 2%, compared to $23.7 million for the year ended December 31, 2018.
    • Net Loss: Net loss for the year ended December 31, 2019, was $94.9 million compared to a net loss of $91.3 million for the year ended December 31, 2018.

    Financial Guidance

    Ardelyx maintains its expectation that its cash, cash equivalents and short-term investments will be sufficient to fund the company's operations until early 2022 based on its current operating plans.

    About Ardelyx, Inc.

    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the control of serum phosphorus in patients with CKD on dialysis, 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.

    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 Ardelyx's expected use of proceeds from the public offering completed in December 2019, the potential for Ardelyx's products and product candidates in treating the diseases and conditions for which they are approved and being developed, the potential for the use of tenapanor as monotherapy and in combination with phosphate binders for the control of serum phosphorus, Ardelyx's ability to enter into strategic collaborations to commercialize its product candidates, and Ardelyx's expectation regarding the exhaustion of its current capital resources. 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 inherent in the clinical development process, 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 annual report on Form 10-K filed with the Securities and Exchange Commission on March 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)












    December 31,


    December 31,




    2019


    2018




    (Unaudited)


    (1)


    Assets








    Cash and cash equivalents


    $

    181,133


    $

    78,768


    Short-term investments



    66,379



    89,321


    Accounts receivable





    85


    Unbilled revenue



    750



    5,000


    Prepaid expenses and other assets



    4,114



    4,547


    Property and equipment, net



    3,436



    5,611


    Right-of-use assets



    3,970




    Total Assets


    $

    259,782


    $

    183,332










    Liabilities and stockholders' equity








    Accounts payable


    $

    2,187


    $

    1,148


    Accrued compensation and benefits



    4,453



    2,723


    Uncharged license fees





    1,000


    Current portion of operating lease liability



    2,608




    Loan payable, current portion



    1,183




    Deferred revenue



    4,541




    Accrued expenses and other liabilities



    7,248



    13,439


    Operating lease liability, net of current portion



    2,076




    Loan payable, net of current portion



    48,831



    49,209


    Stockholders' equity



    186,655



    115,813


    Total liabilities and stockholders' equity


    $

    259,782


    $

    183,332




    (1)

    Derived from the audited financial statements included on Form 10-K for the year ended December 31, 2018.

     

    Ardelyx, Inc.

    Statements of Operations

    (In thousands, except share and per share amounts)


















    Three Months Ended
    December 31,


    Twelve Months Ended
    December 31,




    2019


    2018


    2019


    2018




    (Unaudited)


    (Unaudited)


    (Unaudited)


    (1)


    Revenue:














    Licensing revenue


    $

    1,500


    $


    $

    4,500


    $

    2,320


    Collaborative development revenue



    459





    459




    Other revenue



    291



    85



    322



    287


    Total revenues



    2,250



    85



    5,281



    2,607


    Cost of revenue







    600



    466


    Gross Profit



    2,250



    85



    4,681



    2,141


    Operating expenses:














    Research and development


    $

    14,241


    $

    22,036


    $

    71,677


    $

    69,373


    General and administrative



    6,857



    5,425



    24,267



    23,715


    Total operating expenses



    21,098



    27,461



    95,944



    93,088


    Loss from operations



    (18,848)



    (27,376)



    (91,263)



    (90,947)


    Interest expense



    (1,398)



    (1,438)



    (5,726)



    (3,534)


    Other income, net



    456



    950



    2,352



    3,187


    Benefit from (provision for) income taxes





    2



    (303)



    (4)


    Net loss


    $

    (19,790)


    $

    (27,862)


    $

    (94,940)


    $

    (91,298)


    Net loss per common share, basic and diluted


    $

    (0.27)


    $

    (0.45)


    $

    (1.47)


    $

    (1.62)


    Shares used in computing net loss per share, basic and diluted



    69,823,746



    62,108,906



    64,478,066



    56,219,919




    (1)

    Derived from the audited financial statements included on Form 10-K for the year ended December 31, 2018.

     

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  23. FREMONT, Calif, Feb. 26, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX) today announced that Mike Raab, president and chief executive officer of Ardelyx, will present at the Cowen and Company 40th Annual Health Care Conference at 8:00 a.m. ET on Wednesday, March 4, 2020 in Boston, MA.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    To access the live webcast of Ardelyx's presentation please visit the Events & Presentations page within the Investor section of the Ardelyx website at ir.ardelyx.com. A replay of the webcast will be available on the Ardelyx website for 60 days following the conference.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the…

    FREMONT, Calif, Feb. 26, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX) today announced that Mike Raab, president and chief executive officer of Ardelyx, will present at the Cowen and Company 40th Annual Health Care Conference at 8:00 a.m. ET on Wednesday, March 4, 2020 in Boston, MA.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    To access the live webcast of Ardelyx's presentation please visit the Events & Presentations page within the Investor section of the Ardelyx website at ir.ardelyx.com. A replay of the webcast will be available on the Ardelyx website for 60 days following the conference.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in patients with CKD on dialysis, 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 has received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for IBSRELA for IBS-C and tenapanor for hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada.

     

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  24. FREMONT, Calif., Feb. 19, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX) today announced that Mike Raab, president and chief executive officer of Ardelyx, will present at the 9th Annual SVB Leerink Global Healthcare Conference at 3:30 p.m. ET on Wednesday, Feb. 26, 2020 in New York City.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    To access the live webcast of Ardelyx's presentation please visit the Events & Presentations page within the Investor section of the Ardelyx website at ir.ardelyx.com. A replay of the webcast will be available on the Ardelyx website for 60 days following the conference.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the…

    FREMONT, Calif., Feb. 19, 2020 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX) today announced that Mike Raab, president and chief executive officer of Ardelyx, will present at the 9th Annual SVB Leerink Global Healthcare Conference at 3:30 p.m. ET on Wednesday, Feb. 26, 2020 in New York City.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    To access the live webcast of Ardelyx's presentation please visit the Events & Presentations page within the Investor section of the Ardelyx website at ir.ardelyx.com. A replay of the webcast will be available on the Ardelyx website for 60 days following the conference.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in patients with CKD on dialysis, 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 has received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for IBSRELA for IBS-C and tenapanor for hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada.

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    SOURCE Ardelyx

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  25. FREMONT, Calif., Dec. 4, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $6.25 per share, before underwriting discounts and commissions, for gross proceeds of $125,000,000. In addition, Ardelyx has granted the underwriters of the offering the right for a period of 30 days to purchase up to an additional 3,000,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about…

    FREMONT, Calif., Dec. 4, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced the pricing of an underwritten public offering of 20,000,000 shares of its common stock at a public offering price of $6.25 per share, before underwriting discounts and commissions, for gross proceeds of $125,000,000. In addition, Ardelyx has granted the underwriters of the offering the right for a period of 30 days to purchase up to an additional 3,000,000 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about December 9, 2019, subject to customary closing conditions.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    Ardelyx currently expects to use its existing cash, cash equivalents and short-term investments and the net proceeds from the offering to support its activities for the clinical development and potential commercialization of tenapanor for the treatment of hyperphosphatemia in patients with chronic kidney disease, or CKD, on dialysis, for regulatory activities to support the submission of a New Drug Application, in such indication, as well as for clinical trials and nonclinical studies for other product candidates, and for general corporate purposes and working capital.

    Citigroup, Cowen, SVB Leerink and Piper Jaffray are acting as joint book-running managers for the offering.

    A registration statement on Form S-3 (File No. 333-217441) relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on May 4, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement,  copies of which may be obtained when available by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, by email at or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at ; or Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by e-mail at .

    This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Ardelyx, Inc.

    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in patients with CKD on dialysis, 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 has received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for IBSRELA for IBS-C and tenapanor for hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada.

    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 expected closing of the public offering, Ardelyx's expected use of proceeds from the public offering, Ardelyx's future development plans for its product candidates and the timing and costs thereof and Ardelyx's ability to enter into strategic collaborations to commercialize its product candidates. 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 related to market conditions and the completion of the public offering on the anticipated terms or at all, the uncertainties inherent in research and the clinical development process, 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 preliminary prospectus supplement dated December 4, 2019 filed with the Securities and Exchange Commission and the final prospectus supplement related to the offering to be filed with the Securities Exchange Commission, each including the accompanying base prospectus and the documents incorporated by reference therein, which includes Ardelyx's annual report on Form 10-K filed with the Securities and Exchange Commission on March 6, 2019, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 filed with the Securities and Exchange Commission on May 7, 2019, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 filed with the Securities and Exchange Commission on August 9, 2019, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities and Exchange Commission on November 6, 2019, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

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  26. FREMONT, Calif., Dec. 4, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced that it has commenced an underwritten public offering of up to $80,000,000 of shares of its common stock. All shares of common stock to be sold in the offering will be offered by Ardelyx. In addition, Ardelyx intends to grant the underwriters of the offering the right for a period of 30 days to purchase up to an additional $12,000,000 of shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no…

    FREMONT, Calif., Dec. 4, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced that it has commenced an underwritten public offering of up to $80,000,000 of shares of its common stock. All shares of common stock to be sold in the offering will be offered by Ardelyx. In addition, Ardelyx intends to grant the underwriters of the offering the right for a period of 30 days to purchase up to an additional $12,000,000 of shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    Ardelyx intends to use its existing cash, cash equivalents and short-term investments and the net proceeds from the offering to support its activities for the clinical development and potential commercialization of tenapanor for the treatment of hyperphosphatemia in patients with chronic kidney disease, or CKD, on dialysis, for regulatory activities to support the submission of a New Drug Application, in such indication, as well as for clinical trials and nonclinical studies for other product candidates, and for general corporate purposes and working capital.

    Citigroup, Cowen, SVB Leerink and Piper Jaffray are acting as joint book-running managers for the proposed offering.

    A registration statement on Form S-3 (File No. 333-217441) relating to these securities has been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on May 4, 2017. The offering is being made only by means of a written prospectus and prospectus supplement that will form a part of the registration statement. A preliminary prospectus supplement and the accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC's website at http://www.sec.gov. When available, copies of the preliminary prospectus supplement and accompanying prospectus can be obtained by contacting Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; Cowen and Company, LLC c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, by email at or by telephone at (833) 297-2926; SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6132 or by e-mail at ; or Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by telephone at 800-747-3924, or by e-mail at .

    This press release does not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or jurisdiction.

    About Ardelyx, Inc.

    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in patients with CKD on dialysis, 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 has received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for IBSRELA for IBS-C and tenapanor for hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada.

    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 Ardelyx's expected use of proceeds from the proposed public offering, Ardelyx's future development plans for its product candidates and the timing and costs thereof, and Ardelyx's ability to enter into strategic collaborations to commercialize its product candidates, as well as the completion of the proposed public offering. 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 related to market conditions and the completion of the public offering on the anticipated terms or at all, the uncertainties inherent in the clinical development process, 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 preliminary prospectus supplement related to the offering to be filed with the Securities and Exchange Commission, including the accompanying base prospectus and the documents incorporated by reference therein, which includes Ardelyx's annual report on Form 10-K filed with the Securities and Exchange Commission on March 14, 2019, its Quarterly Report on Form 10-Q for the quarter ended March 31, 2019 filed with the Securities and Exchange Commission on May 7, 2019, its Quarterly Report on Form 10-Q for the quarter ended June 30, 2019 filed with the Securities and Exchange Commission on August 9, 2019, its Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 filed with the Securities and Exchange Commission on November 6, 2019, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

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  27. FREMONT, Calif., Dec. 3, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today reported positive topline results from PHREEDOM, a long-term Phase 3 study evaluating the efficacy and safety of tenapanor as monotherapy for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. In the study, patients randomized to the tenapanor arm were treated in a 26-week open-label treatment period and were then re-randomized to a 12-week double-blind, placebo-controlled randomized withdrawal period. The PHREEDOM study met its primary endpoint demonstrating a statistically significant…

    FREMONT, Calif., Dec. 3, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today reported positive topline results from PHREEDOM, a long-term Phase 3 study evaluating the efficacy and safety of tenapanor as monotherapy for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. In the study, patients randomized to the tenapanor arm were treated in a 26-week open-label treatment period and were then re-randomized to a 12-week double-blind, placebo-controlled randomized withdrawal period. The PHREEDOM study met its primary endpoint demonstrating a statistically significant difference in least square (LS) mean serum phosphorus change (-1.4 mg/dL, p<0.0001), as compared to placebo. During the 26-week treatment period, 77% of tenapanor-treated patients in the intent-to-treat population (n=408) had a decrease in serum phosphorus, with a mean reduction from baseline of 2.0 mg/dL. Tenapanor is an investigational, first-in-class, phosphate absorption inhibitor being developed to treat hyperphosphatemia in patients with CKD on dialysis. If approved, tenapanor will be the only non-binder treatment for the control of serum phosphorus in patients with CKD on dialysis.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    "If approved, tenapanor is poised to change the way we manage hyperphosphatemia in patients on dialysis," said Myles Wolf, M.D., MMSc, Charles Johnson, M.D. professor of medicine and chief of Duke Nephrology. "Tenapanor would be a first-in-class therapy that targets the primary pathway of phosphate absorption to significantly lower serum phosphate while requiring patients to take just one small pill twice per day. This would make tenapanor an important innovation and potentially an ideal first-line therapy for patients receiving dialysis for whom new effective treatments are desperately needed."

    "These results are very exciting and represent a capstone to our tenapanor clinical development program, which is focused on the development of a new and important therapy for patients with hyperphosphatemia," said Mike Raab, president and chief executive officer of Ardelyx. "Based on the PHREEDOM data that demonstrate tenapanor as an effective monotherapy, and the previously released AMPLIFY data that demonstrate the benefits of a dual mechanism approach with tenapanor plus binders in those who require more aggressive phosphate management, it is clear that tenapanor has a role to play in the management of all dialysis patients with hyperphosphatemia. With these results in hand, our focus will now turn to completing and submitting our NDA, which we expect in mid-2020."

    PHREEDOM
    Key Topline Results

    Primary Endpoint:

    As compared to patients treated with placebo, patients in the efficacy analysis set treated with tenapanor had a statistically significant difference in LS mean serum phosphorus change from the end of the 26-week treatment period to the endpoint visit in the 12-week randomized withdrawal period (-1.4 mg/dL, p<0.0001). 

    Safety:

    Tenapanor was generally well-tolerated. As anticipated due to the mechanism of action, the most common self-reported adverse event was loose stools/diarrhea at an incidence rate of 52.5%, with approximately 90% of these events judged by the investigator to be mild to moderate in nature. The majority of the events were reported within the first five days of treatment and were transient notwithstanding continued treatment with tenapanor. In the 26-week open-label treatment period, 16% of the tenapanor-treated patients discontinued treatment due to diarrhea. Additionally, during the randomized withdrawal period, only 0.8% of tenapanor-treated patients discontinued due to diarrhea.

    In the safety analysis set of the 26-week open-label treatment period, which included tenapanor (n=419) and sevelamer (n=137), 17.2% of tenapanor-treated patients compared to 22.6% of sevelamer-treated patients experienced a serious adverse event. The median dose for tenapanor was 60 milligrams per day throughout the study and the median dose for sevelamer was 4.8 grams per day after randomization and increased to 7.2 grams per day by the end of the 26-week open-label treatment period.

    NORMALIZE
    Initial Results

    Patients completing the PHREEDOM trial from both the tenapanor arm and the sevelamer active safety control arm had the option to participate in NORMALIZE, an ongoing open-label 18-month extension study. The goal of this study is to obtain real-world evidence regarding the dual mechanism of tenapanor and sevelamer to reduce patients' serum phosphorus levels to normal (<4.6 mg/dL) while minimizing medication burden.

    Patients entering the study from the tenapanor arm with serum phosphorus levels in the normal range are followed with no medication changes. Patients entering the study from the tenapanor arm with serum phosphorus ³4.6 mg/dL have sevelamer tablets added incrementally to achieve normal serum phosphorus levels. Patients entering the study from the sevelamer active safety control arm have tenapanor tablets added to their treatment regimen and have sevelamer tablets withdrawn based on their serum phosphorus value, to achieve normal serum phosphorus levels.

    In this initial analysis, 96% of eligible patients have chosen to enroll into NORMALIZE. Of the 73 patients thus far treated for more than one month of treatment, 42% have achieved normal serum phosphorus of less than 4.6 mg/dL and of those, 58% have accomplished this with either tenapanor alone or with tenapanor in combination with only one to three sevelamer tablets per day. These data represent a 45% improvement compared to current treatment practice data reported in the June 2019 Dialysis Outcomes Practice Patterns Study (DOPPS) Practice Monitor.

    PHREEDOM Study Design

    PHREEDOM is a one-year study with a 26-week open-label treatment period and a 12-week double-blind, placebo-controlled randomized withdrawal period followed by a 14-week open-label safety extension period. The study randomized a total of 564 patients with CKD on dialysis who had a serum phosphorus level between 6.0 mg/dL and 10.0 mg/dL and had an increase in serum phosphorous of at least 1.5 mg/dL after an up to 3-week phosphate binder wash-out period. Patients were randomized 3:1 to either the tenapanor arm (n=423, n=408 intent to treat) or the active safety control arm (sevelamer n=141). Those patients randomized to the active safety control arm are treated with sevelamer for 52 weeks. Patients in the tenapanor arm received tenapanor twice daily at a starting dose of 30 mg with dose adjustments allowed based on serum phosphorus level and gastrointestinal tolerability. At the end of the 26-week treatment period, patients in the tenapanor arm were randomized 1:1 to enter the randomized withdrawal period and either remain on the tenapanor dose they were taking or receive placebo for up to an additional 12 weeks. After the randomized withdrawal period, patients then continued on the study for an additional three months as part of the long-term safety extension. Patients in the active safety control arm received sevelamer at an initial dose based on its package insert with dose changes allowed at the discretion of the principal investigator for up to one year.

    The primary efficacy endpoint of the study was the difference in change in serum phosphorus between the pooled tenapanor-treated patients and placebo-treated patients in the efficacy analysis set from the end of the 26-week treatment period to the endpoint visit of the 12-week randomized withdrawal period. The efficacy analysis set (n=131), which was accepted by the U.S. Food and Drug Administration as the primary analysis set, included patients who completed the 26-week treatment period and achieved a 1.2 mg/dL decrease in serum phosphorus in the same period.

    About Tenapanor for Hyperphosphatemia

    Tenapanor, discovered and developed by Ardelyx, is a first-in-class, proprietary, minimally absorbed, oral, medicine in late-stage clinical development for the control of serum phosphorus in 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 the tightening of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate, the primary pathway of phosphate absorption. In addition to the positive results of the PHREEDOM trial, the company previously reported results from its first Phase 3 monotherapy study with tenapanor in patients with CKD on dialysis, reporting that the primary endpoint was met (p=0.01).

    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 and especially those 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).

    Conference Call Information
    The company will host a conference call today, December 3, 2019 at 8:00 AM ET to discuss the PHREEDOM findings. To participate in the conference call, please call (855) 296-9612 (toll-free) or (920) 663-6277 (toll) and reference call ID number 8065608. A webcast of the call and accompanying slides can also be accessed by visiting the Investor page of the company's website www.ardelyx.com and will be available on the website for 60 days following the call.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes tenapanor, a treatment of hyperphosphatemia in people with chronic kidney diseases (CKD) who are on dialysis, 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 has received approval of IBSRELA® (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com and connect with us on Twitter @Ardelyx.

    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 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 binders for the treatment of hyperphosphatemia, the potential for tenapanor with binders to achieve serum phosphorus levels of less than 5.5 mg/dL and less than 4.6 mg/dL, and Ardelyx's expected timing for an NDA submission for tenapanor for hyperphosphatemia. 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 inherent in the clinical development process, including the regulatory approval 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 November 6, 2019, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

     

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  28. FREMONT, Calif., Dec. 2, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, announced that it will hold a conference call tomorrow, December 3, at 8:00 am Eastern Time to review the results from the pivotal Phase 3 PHREEDOM study evaluating tenapanor in chronic kidney disease (CKD) patients on dialysis. Tenapanor is Ardelyx's investigational, first-in-class, small molecule, non-binder, phosphate absorption inhibitor.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    To participate in the conference call, please dial (855) 296-9612 (domestic) or (920) 663-6277 (international) and refer to conference ID 8065608. Live audio of the conference call and…

    FREMONT, Calif., Dec. 2, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, announced that it will hold a conference call tomorrow, December 3, at 8:00 am Eastern Time to review the results from the pivotal Phase 3 PHREEDOM study evaluating tenapanor in chronic kidney disease (CKD) patients on dialysis. Tenapanor is Ardelyx's investigational, first-in-class, small molecule, non-binder, phosphate absorption inhibitor.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    To participate in the conference call, please dial (855) 296-9612 (domestic) or (920) 663-6277 (international) and refer to conference ID 8065608. Live audio of the conference call and accompanying slides will be simultaneously webcast and will be available under the Investors section of the company's website at www.ardelyx.com. The webcast will be archived and available for replay for 60 days following the call.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes tenapanor, a treatment of hyperphosphatemia in people with end-stage renal disease (ESRD) who are on dialysis, 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 has received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com and connect with us on Twitter @Ardelyx.

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  29. FREMONT, Calif., Nov. 26, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced that Mike Raab, president and chief executive officer of Ardelyx, will participate in a fireside chat at the Piper Jaffray 31st Annual Healthcare Conference on Tuesday, December 3, 2019 at 2:00 p.m. ET in New York City.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    To access the live webcast of Ardelyx's presentation please visit the Events & Presentations page within the Investor section of the Ardelyx website at ir.ardelyx.com. A replay of the webcast will be available on the Ardelyx website for 90 days following the conference.

    About Ardelyx, Inc.

    FREMONT, Calif., Nov. 26, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced that Mike Raab, president and chief executive officer of Ardelyx, will participate in a fireside chat at the Piper Jaffray 31st Annual Healthcare Conference on Tuesday, December 3, 2019 at 2:00 p.m. ET in New York City.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    To access the live webcast of Ardelyx's presentation please visit the Events & Presentations page within the Investor section of the Ardelyx website at ir.ardelyx.com. A replay of the webcast will be available on the Ardelyx website for 90 days following the conference.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease (ESRD) who are on dialysis, 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 has received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com and connect with us on Twitter @Ardelyx.

     

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  30. FREMONT, Calif. and TOKYO, Nov. 25, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases and Kyowa Kirin Co., Ltd., (TSE:4151, President and CEO: Masashi Miyamoto, Kyowa Kirin), a Japan-based Global Specialty Pharmaceutical Company, today announced the expansion of their partnership with two new agreements.

    In the first agreement, the companies have established a two-year research collaboration, whereby Ardelyx will execute a research plan, in which Kyowa Kirin will also join, to advance two of Ardelyx's ongoing research programs focused on the identification and design of compounds to two undisclosed…

    FREMONT, Calif. and TOKYO, Nov. 25, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases and Kyowa Kirin Co., Ltd., (TSE:4151, President and CEO: Masashi Miyamoto, Kyowa Kirin), a Japan-based Global Specialty Pharmaceutical Company, today announced the expansion of their partnership with two new agreements.

    In the first agreement, the companies have established a two-year research collaboration, whereby Ardelyx will execute a research plan, in which Kyowa Kirin will also join, to advance two of Ardelyx's ongoing research programs focused on the identification and design of compounds to two undisclosed targets. In return, Kyowa Kirin will pay Ardelyx $10 million ($5 million a year for two years) to support the ongoing research. Following the end of the research period, Kyowa Kirin will have the option to license any candidates nominated by the companies for further development and commercialization in certain specified territories, with additional commitments payable to Ardelyx of up to $10.5 million in upfronts and up to $500 million in development and sales milestones. The research collaboration will be governed by a joint research committee. Additional terms were not disclosed.

    Under the second agreement, Kyowa Kirin has made a $20 million equity investment in Ardelyx at $6.96 for 2,873,563 shares.

    "Kyowa Kirin is a leader in the development and commercialization of medicines for patients with cardiorenal disease and an important and highly collaborative partner for Ardelyx and we're thrilled to expand our relationship with them," said Mike Raab, president and chief executive officer of Ardelyx.  "The research collaboration will leverage our successful drug discovery platform, which includes tools and techniques for selectively modulating the exposure of drug leads, our human stem cell-based translational technology, and our extensive experience in developing disease models, expertise that has proven successful in our development and approval of tenapanor. Funding from this agreement and the equity investment serve as an important source of capital as we prepare for the potential launch and commercialization of tenapanor in hyperphosphatemia."

    Takeyoshi Yamashita, Ph.D., Executive officer, Director of Corporate Strategy & Planning Department of Kyowa Kirin added, "We view Ardelyx's ability selectively targeting key molecule to be well validated with the successful discovery and development of tenapanor, a novel, ground-breaking inhibitor of the sodium hydrogen exchanger 3 (NHE3).  Through our newly established research and equity agreements, we look forward to a deeper, expanded collaboration with the Ardelyx team."   

    Ardelyx and Kyowa Kirin initially established a collaboration partnership in November 2017 through a license agreement that provided Kyowa Kirin with exclusive rights to develop and commercialize Ardelyx's lead investigational product, tenapanor, for the treatment of cardiorenal diseases, including hyperphosphatemia, in Japan. Kyowa Kirin will have the exclusive rights to develop, market and commercialize tenapanor for cardiorenal diseases and conditions associated with them, including hyperphosphatemia, in Japan.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease (ESRD) who are on dialysis, 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 has received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com and connect with us on Twitter @Ardelyx.

    About Kyowa Kirin
    Kyowa Kirin commits to innovative drug discovery driven by state-of-the-art technologies. The company focuses on creating new values in the four therapeutic areas: nephrology, oncology, immunology/allergy and neurology. Under the Kyowa Kirin brand, the employees from 36 group companies across North America, EMEA and Asia/Oceania unite to champion the interests of patients and their caregivers in discovering solutions wherever there are unmet medical needs.

    You can learn more about the business of Kyowa Kirin at www.kyowakirin.com 

    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 Kyowa Kirin to exercise one or more of the options granted under the research collaboration agreement with Ardelyx, and the potential for Ardelyx to receive upfront or sales or development milestone payments from Kyowa Kirin should Kyowa Kirin exercise one or more of the options arising from the research collaboration.  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 inherent in research, and the clinical development process, including the regulatory approval 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 November 6, 2019, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

    Ardelyx logo (PRNewsFoto/Ardelyx)

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  31. FREMONT, Calif., Nov. 6, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced a late-breaking oral presentation of its recently announced AMPLIFY Phase 3 clinical data will be presented at Kidney Week 2019, the American Society of Nephrology's Annual Meeting, to be held November 5-10, 2019, in Washington D.C.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    The late-breaking presentation will include data from AMPLIFY, the pivotal Phase 3 study of tenapanor in combination with phosphate binders in patients with chronic kidney disease (CKD) on dialysis whose hyperphosphatemia was not previously controlled with binders alone. 

    Details…

    FREMONT, Calif., Nov. 6, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced a late-breaking oral presentation of its recently announced AMPLIFY Phase 3 clinical data will be presented at Kidney Week 2019, the American Society of Nephrology's Annual Meeting, to be held November 5-10, 2019, in Washington D.C.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    The late-breaking presentation will include data from AMPLIFY, the pivotal Phase 3 study of tenapanor in combination with phosphate binders in patients with chronic kidney disease (CKD) on dialysis whose hyperphosphatemia was not previously controlled with binders alone. 

    Details for the presentation are as follows:

    Late-Breaking Oral Presentation:
    Title: Efficacy of tenapanor in combination with phosphate binders in patients with CKD on dialysis with uncontrolled hyperphosphatemia on phosphate binders alone.
    Abstract Number: TH-PO1187
    Date / Time: Thursday, November 7, 10:00am-12:00pm ET
    Presenters: Pablo E. Pergola, Renal Associates, P.A., San Antonio, TX, USA, David P. Rosenbaum, Ardelyx, Inc., Fremont, CA, USA, Yang Yang, Ardelyx, Inc., Fremont, CA, USA, and Glenn Chertow,  Division of Nephrology, Stanford University School of Medicine, Stanford, CA, USA

    For more information about Kidney Week 2019, visit https://www.asn-online.org/education/kidneyweek/.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease (ESRD) who are on dialysis, 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 has received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com and connect with us on Twitter @Ardelyx.

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  32. FREMONT, Calif., Nov. 6, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment choices for people with cardiorenal diseases, today reported business highlights and financial results for the third quarter ended September 30, 2019.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    "The third quarter was particularly exciting with two transformational milestones occurring in rapid succession and serving as major catalysts for growth and momentum at Ardelyx," said Mike Raab, president and chief executive officer of Ardelyx. "First, we were pleased to report successful results from our Phase 3 AMPLIFY study for tenapanor in hyperphosphatemia, positioning us one step closer to submitting our…

    FREMONT, Calif., Nov. 6, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment choices for people with cardiorenal diseases, today reported business highlights and financial results for the third quarter ended September 30, 2019.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    "The third quarter was particularly exciting with two transformational milestones occurring in rapid succession and serving as major catalysts for growth and momentum at Ardelyx," said Mike Raab, president and chief executive officer of Ardelyx. "First, we were pleased to report successful results from our Phase 3 AMPLIFY study for tenapanor in hyperphosphatemia, positioning us one step closer to submitting our New Drug Application to the FDA and potentially providing our drug broadly to patients in need. On the heels of that milestone, we announced the approval of IBSRELA. This approval marked a momentous achievement for Ardelyx as our first ever product approved and represented the culmination of more than a decade of diligent execution and commitment by our talented team. Importantly, these milestones propel us toward fulfilling our mission to bring innovative first-in-class medicines to improve treatments for patients in need." 

    Business and Pipeline Updates

    • In October 2019, Ardelyx hosted Analyst Day, the second of an anticipated annual event. The event featured Myles Wolf, M.D., chief of nephrology at Duke University, and the company's new team of sales and marketing leaders. The event focused on the significant need to improve hyperphosphatemia management in patients on dialysis, challenges with today's treatment options that are limited to phosphate binders, and the commercial strategy to bring tenapanor to market, if and when approved. A replay of the event is available on the Events and Presentations page under the investor relations section of Ardelyx's website at www.ardelyx.com.
    • In September 2019, Ardelyx announced positive results from the pivotal Phase 3 AMPLIFY study evaluating tenapanor in dialysis patients who have uncontrolled hyperphosphatemia despite phosphate binder treatment. The AMPLIFY study met the primary and all key secondary endpoints, including demonstrating a statistically significant (p=0.0004) reduction in serum phosphorus levels for patients treated with tenapanor and phosphate binders compared to phosphate binders alone. Approximately two times more patients achieved the established serum phosphorus treatment goal of less than 5.5mg/dL in the tenapanor arm compared to binders alone (p -values≤0.0097) for each week of treatment.
    • In September 2019, Ardelyx received FDA approval for IBSRELA® (tenapanor). The company continues discussions with potential strategic partners to market IBSRELA in the United States.

    Upcoming Milestones

    The company currently expects to announce results in the fourth quarter of 2019 from the PHREEDOM clinical trial, the company's second Phase 3 clinical trial evaluating tenapanor as a monotherapy treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) who are on dialysis.

    Third Quarter 2019 Financial Results

    • Cash Position: As of September 30, 2019, Ardelyx had total capital resources including cash, cash equivalents and short-term investments of $103.5 million compared to total capital resources including cash, cash equivalents and short-term investments of $168.1 million as of December 31, 2018.
    • R&D Expenses: Research and development expenses were $17.5 million for the three months ended September 30, 2019, a decrease of $0.4 million, or 2 percent, compared to $17.9 million for the three months ended September 30, 2018. The decrease in expense was primarily related to reduction in the company's manufacturing expense of tenapanor, a reduction in costs associated with the continued clinical development of tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis and a decrease in professional services, partially offset by an increase in expenses in the company's hyperkalemia program, RDX013, an increase in headcount and related personnel costs and an increase in stock-based compensation expenses.
    • G&A Expenses: General and administrative expenses were $6.9 million for the three months ended September 30, 2019, an increase of $0.9 million, or 16 percent, compared to $6.0 million for the three months ended September 30, 2018. The increase was primarily related to an increase in stock-based compensation costs and an increase in professional services, partially offset by a decrease in personnel costs related to a one-time severance payment during the three months ended September 30, 2018.
    • Net Loss: Net loss for the three months ended September 30, 2019 was $23.5 million, or $0.37 per share, compared to a net loss of $24.1 million, or $0.39 per share, for the three months ended September 30, 2018.

    Financial Guidance

    Ardelyx maintains its expectation that its cash, cash equivalents and short-term investments are sufficient to fund the company's operations until at least early 2021 based on its current operating plans.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the way people with cardiorenal diseases are treated by developing first-in-class medicines. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with end-stage renal disease (ESRD) who are on dialysis, 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 has received approval of IBSRELA (tenapanor). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin (formerly known as Kyowa Hakko Kirin) in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com and connect with us on Twitter @Ardelyx.

    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 Ardelyx's products and product candidates in treating the diseases and conditions for which they are approved and being developed, the potential for the use of tenapanor as monotherapy and in combination with phosphate binders for the treatment of hyperphosphatemia, Ardelyx's expected timing for receipt and announcement of data from its ongoing PHREEDOM Phase 3 clinical trial of tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis, the potential to submit a New Drug Application to the FDA for tenapanor for the treatment of hyperphosphatemia in CKD patients on dialysis and the potential for the FDA approval of tenapanor in such indication, and Ardelyx's expectation regarding the exhaustion of its current capital resources. Such forward-looking statements involve substantial risks and uncertainties that could cause the development and commercialization of Ardelyx's products and 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 inherent in research and the clinical development process; the uncertainties associated with the regulatory approval process; and the 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 November 6, 2019, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

     

    Ardelyx, Inc.

    Condensed Balance Sheets

    (In thousands)




    September 30,
    2019


    December 31,
    2018



    (Unaudited)


    (1)

    Assets







    Cash and cash equivalents


    $

    92,673


    $

    78,768

    Short-term investments



    10,870



    89,321

    Accounts receivable



    2,699



    85

    Unbilled license revenue





    5,000

    Property and equipment, net



    3,943



    5,611

    Right-of-use assets



    4,453



    Prepaid and other assets



    4,772



    4,547

    Total assets


    $

    119,410


    $

    183,332








    Liabilities and stockholders' equity







    Accounts payable and other current liabilities


    $

    15,175


    $

    16,728

    Uncharged license fees





    1,000

    Current portion of operating lease liability



    2,504



    Operating lease liability, net of current portion



    2,770



    Loan payable, long term



    49,803



    49,209

    Other long-term liabilities





    582

    Stockholders' equity



    49,158



    115,813

    Total liabilities and stockholders' equity


    $

    119,410


    $

    183,332



    (1) Derived from the audited consolidated financial statements included on Form 10-K for the year ended December 31, 2018.

     

    Ardelyx, Inc.

    Condensed Consolidated Statements of Operations

    (In thousands, except share and per share amounts)




    Three Months Ended September 30,


    Nine Months Ended September 30,




    2019


    2018


    2019


    2018




    (Unaudited)


    (Unaudited)


    (Unaudited)


    (Unaudited)


    Revenue:














    Licensing revenue


    $

    3,000


    $


    $

    3,000


    $

    2,320


    Other revenue



    13



    172



    31



    202


    Total revenues



    3,013



    172



    3,031



    2,522


    Cost of revenue



    600



    2



    600



    466


    Gross Profit



    2,413



    170



    2,431



    2,056


    Operating expenses:














    Research and development


    $

    17,580


    $

    17,941


    $

    57,436


    $

    47,337


    General and administrative



    6,922



    5,961



    17,410



    18,290


    Total operating expenses



    24,502



    23,902



    74,846



    65,627


    Loss from operations



    (22,089)



    (23,732)



    (72,415)



    (63,571)


    Interest Expense



    (1,443)



    (1,404)



    (4,328)



    (2,096)


    Other income (expense), net



    294



    1,010



    1,896



    2,237


    Provision for income taxes



    (301)





    (303)



    (6)


    Net loss


    $

    (23,539)


    $

    (24,126)


    $

    (75,150)


    $

    (63,436)


    Net loss per common share, basic & diluted


    $

    (0.37)


    $

    (0.39)


    $

    (1.20)


    $

    (1.17)


    Shares used in computing net loss per share, basic and diluted



    62,828,513



    62,071,397



    62,676,591



    54,204,907


     

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  33. FREMONT, Calif., Oct. 10, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), today announced that it will hold an Analyst Day on Thursday, Oct. 17, 2019, from 7:30 a.m. to 11:00 a.m. ET in New York City. This year's event will focus on a review of late stage clinical development and commercial potential in hyperphosphatemia, pipeline program in hyperkalemia and the recent approval of the Company's New Drug Application for tenapanor for the treatment of IBS-C. Leading nephrologist, Myles Wolf, M.D., Chief of Nephrology, Duke University, will offer a clinician's perspective on the challenges of treating hyperphosphatemia in patients with CKD on dialysis.  

    Ardelyx logo (PRNewsFoto/Ardelyx)

    A live webcast of the event will be available for 30 days on the Events and Presentations…

    FREMONT, Calif., Oct. 10, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), today announced that it will hold an Analyst Day on Thursday, Oct. 17, 2019, from 7:30 a.m. to 11:00 a.m. ET in New York City. This year's event will focus on a review of late stage clinical development and commercial potential in hyperphosphatemia, pipeline program in hyperkalemia and the recent approval of the Company's New Drug Application for tenapanor for the treatment of IBS-C. Leading nephrologist, Myles Wolf, M.D., Chief of Nephrology, Duke University, will offer a clinician's perspective on the challenges of treating hyperphosphatemia in patients with CKD on dialysis.  

    Ardelyx logo (PRNewsFoto/Ardelyx)

    A live webcast of the event will be available for 30 days on the Events and Presentations page under the investor relations section of Ardelyx's website at www.ardelyx.com.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the lives of people with cardiorenal diseases by developing first-in-class medicines that matter. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with CKD on dialysis, 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. On September 3, 2019, the company reported positive data from AMPLIFY, a pivotal Phase 3 study investigating tenapanor in combination with phosphate binders in patients with chronic kidney disease on dialysis whose hyperphosphatemia was not previously controlled with binders alone. The study successfully met the primary endpoint and all key secondary endpoints, including demonstrating a statistically significant mean reduction in serum phosphorus from baseline to the end of the treatment period. On September 12, 2019, Ardelyx received approval of IBSRELA (tenapanor) for the treatment of irritable bowel syndrome with constipation (IBS-C). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for IBSRELA for IBS-C and tenapanor for hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin Company Limited in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com and connect with us on Twitter @Ardelyx.

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  34. FREMONT, Calif., Sept. 17, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced that Mike Raab, president and chief executive officer of Ardelyx, will present a company overview at the Ladenburg Thalmann Conference on Tuesday, September 24, 2019 at 9:00 a.m. ET in New York City.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    To access the live webcast of Ardelyx's presentation please visit the Events & Presentations page within the Investor section of the Ardelyx website at ir.ardelyx.com. A replay of the webcast will be available on the Ardelyx website for 60 days following the conference.

    About Ardelyx, Inc.
    Ardelyx…

    FREMONT, Calif., Sept. 17, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced that Mike Raab, president and chief executive officer of Ardelyx, will present a company overview at the Ladenburg Thalmann Conference on Tuesday, September 24, 2019 at 9:00 a.m. ET in New York City.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    To access the live webcast of Ardelyx's presentation please visit the Events & Presentations page within the Investor section of the Ardelyx website at ir.ardelyx.com. A replay of the webcast will be available on the Ardelyx website for 60 days following the conference.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the lives of people with cardiorenal diseases by developing first-in-class medicines that matter. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with CKD on dialysis, 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. On September 3, 2019, the company reported positive data from AMPLIFY, a pivotal Phase 3 study investigating tenapanor in a combination with phosphate binders in patients with chronic kidney disease on dialysis whose hyperphosphatemia was not previously controlled with binders alone. The study successfully met the primary endpoint and all key secondary endpoints, including demonstrating a statistically significant mean reduction in serum phosphorus from baseline to the end of the treatment period. On September 12, 2019, Ardelyx received approval of IBSRELA (tenapanor) for the treatment of irritable bowel syndrome with constipation (IBS-C). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for IBSRELA for IBS-C and tenapanor for hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin Company Limited in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com and connect with us on Twitter @Ardelyx.

     

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  35. FREMONT, Calif., Sept. 12, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced that the U.S. Food and Drug Administration has approved IBSRELA® (tenapanor), a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. IBSRELA is a minimally-absorbed small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    "IBSRELA has the potential to provide IBS-C patients and their…

    FREMONT, Calif., Sept. 12, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing innovative first-in-class medicines to improve treatment for people with cardiorenal diseases, today announced that the U.S. Food and Drug Administration has approved IBSRELA® (tenapanor), a 50 mg, twice daily oral pill for the treatment of irritable bowel syndrome with constipation (IBS-C) in adults. IBSRELA is a minimally-absorbed small molecule that acts locally in the gastrointestinal (GI) tract to inhibit the sodium-hydrogen exchanger NHE3, resulting in an increase in bowel movements and a decrease in abdominal pain for IBS-C patients.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    "IBSRELA has the potential to provide IBS-C patients and their doctors with a novel mechanism and an innovative approach to managing IBS-C, a highly burdensome and difficult-to-treat condition affecting more than 11 million people in the United States," commented Mike Raab, president and chief executive officer of Ardelyx.  "This approval is an extremely important and rewarding milestone for Ardelyx, and represents the culmination of years of dedication to advancing our discoveries and medicines in an effective and rigorous manner. We look forward to establishing a commercial collaboration with a partner that has the capabilities to drive the successful launch and marketing of IBSRELA in this large and underserved IBS-C patient population."

    Mr. Raab continued, "With the approval of IBSRELA for IBS-C, along with the successful completion of our AMPLIFY trial in hyperphosphatemia, we've delivered on two major corporate milestones in the last two weeks due to flawless execution by the remarkable and talented team at Ardelyx. With these milestones accomplished, and the PHREEDOM trial reading out in Q4, I have great confidence that we are well positioned to file our NDA for hyperphosphatemia next year with potential approval and launch in 2021. We are excited about this next chapter for Ardelyx as we begin the development of our playbook for launch and commercialization of tenapanor for hyperphosphatemia in chronic kidney disease patients on dialysis and are excited to begin sharing more of our vision in the coming months." 

    IBSRELA (tenapanor) Phase 3 IBS-C Program 

    Phase 3 Study Designs
    The Phase 3 IBS-C program included two randomized, double-blind, placebo-controlled trials. The trial designs were identical through the first 12 weeks of treatment, and thereafter differed in that Trial 1 (NCT02686138) continued for an additional 14 weeks of treatment (26 weeks double-blind treatment), whereas Trial 2 (NCT02621892) included a 4-week randomized withdrawal (RW) period (12 weeks double-blind treatment). Patients who were enrolled in these trials met the Rome III criteria for IBS-C, related to abdominal pain and bowel movement frequency. 

    Primary Endpoint
    The primary endpoint for both trials was the proportion of patients who were responders during the 12-week treatment period. A responder, as defined by the FDA, was a patient who experienced at least a 30% reduction in the weekly average abdominal pain score compared with baseline and an increase of at least 1 complete spontaneous bowel movement (CSBM) in weekly average from baseline, in the same week, for at least 6 of the first 12 treatment weeks.

    Results
    In both Phase 3 IBS-C trials, IBSRELA met the primary endpoint as compared with placebo (Trial 1: 37% versus 24%, IBSRELA versus placebo, respectively. Trial 2: 27% versus 19% IBSRELA versus placebo, respectively).

    In Trials 1 and 2, the proportion of responders for 9 out of the first 12 weeks, including at least 3 of the last 4 weeks, was greater in IBSRELA-treated patients compared to placebo-treated patients. In addition, in Trial 1, the proportion of responders for 13 out of 26 weeks was greater in IBSRELA‑treated patients compared to placebo-treated patients.  In both trials, improvements from baseline in average weekly CSBMs and abdominal pain were observed by Week 1, with improvement maintained through the end of treatment.

    In both studies, the most common adverse event was diarrhea (16% with IBSRELA vs 4% with placebo in Trial 1; and 15% with IBSRELA vs 2% with placebo in Trial 2), with severe diarrhea reported in 2.5% of IBSRELA-treated patients compared to 0.2% on placebo‑treated patients during the 26 weeks of Trial 1 and the 12 weeks of Trial 2. Overall discontinuation rates were low among patients treated with IBSRELA (7.6%) and placebo (0.8%) and the most common adverse reaction leading to discontinuation was diarrhea (6.5% of IBSRELA-treated patients compared to 0.7% of placebo-treated patients).

    Indications and Usage
    IBSRELA (tenapanor) is indicated for treatment of irritable bowel syndrome with constipation (IBS-C) in adults.

    IMPORTANT SAFETY INFORMATION

    WARNING:  RISK OF SERIOUS DEHYDRATION IN PEDIATRIC PATIENTS
    IBSRELA is contraindicated in patients less than 6 years of age; in young juvenile rats, tenapanor caused death presumed to be due to dehydration. Avoid use of IBSRELA in patients 6 years to less than 12 years of age.  The safety and effectiveness of IBSRELA have not been established in pediatric patients less than 18 years of age.

    Contraindications

    • IBSRELA is contraindicated in pediatric patients less than 6 years of age.
    • IBSRELA is contraindicated in patients with known or suspected mechanical gastrointestinal obstruction

    Warnings and Precautions

    Risk of Serious Dehydration in Pediatric Patients

    IBSRELA is contraindicated in patients below 6 years of age. The safety and effectiveness of IBSRELA in patients less than 18 years of age have not been established. In young juvenile rats (less than 1 week old; approximate human age equivalent of less than 2 years of age), decreased body weight and deaths occurred, presumed to be due to dehydration, following oral administration of tenapanor. There are no data available in older juvenile rats (human age equivalent 2 years to less than 12 years).

    Avoid the use of IBSRELA in patients 6 years to less than 12 years of age. Although there are no data in older juvenile rats, given the deaths in younger rats and the lack of clinical safety and efficacy data in pediatric patients, avoid the use of IBSRELA in patients 6 years to less than 12 years of age

    Diarrhea 

    Diarrhea was the most common adverse reaction in two randomized, double-blind, placebo-controlled trials of IBS-C. Severe diarrhea was reported in 2.5% of IBSRELA-treated patients. If severe diarrhea occurs, suspend dosing and rehydrate patient. 

    Adverse Reactions

    In the two IBS-C trials, the most common adverse reaction in IBSRELA-treated patients (incidence ≥2% and greater than in the placebo group) was diarrhea (Trial 1: 16% IBSRELA vs 4% placebo; Trial 2: 15% IBSRELA vs 2% placebo).

    Please also see the full Prescribing Information, including Box Warning, for additional risk information.

    About Irritable Bowel Syndrome with Constipation (IBS-C)
    Irritable bowel syndrome with constipation (IBS-C) is a GI disorder in which abdominal pain is associated with constipation, and significantly affects the health and quality of life of at least 11 million people in the US. A study published in the American Journal of Gastroenterology in 2015 showed that over 50 percent of IBS-C patients rated their pain, constipation and straining as being "extremely bothersome." In the same study, GI symptoms led to an average 4.9 days of "disrupted productivity" and 0.8 days of missed work per month.

    About IBSRELA for IBS-C
    IBSRELA (tenapanor) is a locally acting inhibitor of the sodium/hydrogen exchanger 3 (NHE3), an antiporter expressed on the apical surface of the small intestine and colon primarily responsible for the absorption of dietary sodium. In vitro and animal studies indicate its major metabolite, M1, is not active against NHE3. By inhibiting NHE3 on the apical surface of the enterocytes, tenapanor reduces absorption of sodium from the small intestine and colon, resulting in an increase in water secretion into the intestinal lumen, which accelerates intestinal transit time and results in a softer stool consistency.

    Tenapanor has also been shown to reduce abdominal pain by decreasing visceral hypersensitivity and by decreasing intestinal permeability in animal models. In rat model of colonic hypersensitivity, tenapanor reduced visceral hyperalgesia and normalized colonic sensory neuronal excitability.

    Conference Call Information
    The company will host a conference call today, September 12, 2019 at 4:30PM ET to discuss the approval of IBSRELA for the treatment of IBS-C. To participate in the conference call, please call (855) 296-9612 (toll-free) or (920) 663-6277 (toll) and reference call ID number 5897497. A webcast of the call can also be accessed by visiting the Investor page of the company's website www.ardelyx.com and will be available on the website for 60 days following the call.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the lives of people with cardiorenal diseases by developing first-in-class medicines that matter. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with CKD on dialysis, 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. On September 3, 2019, the company reported positive data from AMPLIFY, a pivotal Phase 3 study investigating tenapanor in a combination with phosphate binders in patients with chronic kidney disease on dialysis whose hyperphosphatemia was not previously controlled with binders alone. The study successfully met the primary endpoint and all key secondary endpoints, including demonstrating a statistically significant mean reduction in serum phosphorus from baseline to the end of the treatment period. On September 12, 2019, Ardelyx received approval of IBSRELA (tenapanor) for the treatment of irritable bowel syndrome with constipation (IBS-C). To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for IBSRELA for IBS-C and tenapanor for hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin Company Limited in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com and connect with us on Twitter @Ardelyx.

    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 IBSRELA in treating IBS-C patients, the potential for Ardelyx's product candidates in treating the diseases and conditions for which they are being developed, Ardelyx's ability to establish additional collaborations, including a collaboration for the commercialization of IBSRELA, Ardelyx's expectations regarding the size of the patient populations for IBSRELA and for its product candidates, Ardelyx's expected timing of its NDA filing for tenapanor for hyperphosphatemia in CKD patients on dialysis, and Ardelyx's current expectations regarding the potential commercialization of tenapanor for hyperphosphatemia. 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 inherent in the clinical development process, 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 9, 2019, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

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  36. FREMONT, Calif., Sept. 3, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today reported positive results from AMPLIFY, a pivotal Phase 3 study of tenapanor in combination with phosphate binders in patients with chronic kidney disease (CKD) on dialysis whose hyperphosphatemia was not previously controlled with binders alone. The AMPLIFY study met the primary endpoint and all key secondary endpoints, including demonstrating a statistically significant (p=0.0004) reduction in serum phosphorus levels for patients treated with tenapanor and phosphate binders compared to phosphate binders alone. Tenapanor…

    FREMONT, Calif., Sept. 3, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, today reported positive results from AMPLIFY, a pivotal Phase 3 study of tenapanor in combination with phosphate binders in patients with chronic kidney disease (CKD) on dialysis whose hyperphosphatemia was not previously controlled with binders alone. The AMPLIFY study met the primary endpoint and all key secondary endpoints, including demonstrating a statistically significant (p=0.0004) reduction in serum phosphorus levels for patients treated with tenapanor and phosphate binders compared to phosphate binders alone. Tenapanor is an investigational, first-in-class, small molecule, non-binder, phosphate absorption inhibitor being developed to treat hyperphosphatemia in patients with CKD on dialysis.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    "I believe tenapanor has the potential to change the landscape of hyperphosphatemia treatment – finally, a novel agent that can lower serum phosphorus alone or in conjunction with binders," said Glenn Chertow, M.D., M.P.H., division chief of nephrology and professor of medicine at Stanford University. "Faced with an extremely high mortality rate of approximately 18% per year in dialysis patients, we are very focused on managing and treating elevated serum phosphorus. Elevated serum phosphorus is associated with mortality, cardiovascular events and bone fracture among patients receiving dialysis, and more than half of patients cannot achieve control of hyperphosphatemia despite taking a fist full of binders three times daily with meals. The AMPLIFY study results provide convincing evidence that controlling hyperphosphatemia will soon be within our reach."

    Mike Raab, president and chief executive officer of Ardelyx added, "We are thrilled with the positive results from the AMPLIFY study demonstrating that tenapanor can help significantly more patients achieve the established serum phosphorus treatment goal of less than 5.5 mg/dL. This result is striking as serum phosphorus levels above 5.5 mg/dL are associated with increased mortality. For too long, hyperphosphatemia management has been an enormous challenge for patients and clinicians. With tenapanor, patients may finally be able to achieve their treatment goal. We look forward to reporting results from our second Phase 3 monotherapy study, PHREEDOM, in the fourth quarter of this year. With additional positive results from that trial, we will complete our New Drug Application for tenapanor, encompassing two indications: monotherapy and combination therapy for the treatment of hyperphosphatemia. The promising results from AMPLIFY bring us one step closer to providing this important medicine to patients with CKD on dialysis."

    Key Study Results

    Efficacy
    For the primary endpoint, patients treated in the tenapanor arm (tenapanor in combination with phosphate binders, n=116) had a statistically significant (p=0.0004) mean reduction in serum phosphorus from baseline to the end of the four-week treatment period of 0.84 mg/dL, as compared to those treated in the binder arm (placebo in combination with phosphate binders, n=119) who had a mean reduction of 0.19 mg/dL. Patients in the tenapanor arm had statistically significant decreases in serum phosphorus during all four weeks ranging from 0.84 to 1.21 mg/dL (p-values<0.0004). During the treatment period, up to 49.1% of patients in the tenapanor arm achieved a serum phosphorus of <5.5 mg/dL which was statistically significant compared with up to 23.5% in the binder arm (p-values≤0.0097). There was a statistically significant 22% to 24% reduction (p-values≤0.0027) in FGF23 levels in the tenapanor arm as compared to the binder arm. Elevated levels of FGF23 are associated with an increased risk of major cardiovascular events.

    Safety
    Tenapanor was well tolerated. Only 4.3% of patients in the tenapanor arm discontinued treatment compared to 2.5% in the binder arm. The single adverse event with a placebo-adjusted rate greater than 3% was loose stools/diarrhea at 36%, where most incidents were reported within the first five days of treatment, were transient in nature and the median time to resolution was four days after onset. Notably, only 2.6% of patients in the tenapanor arm discontinued treatment due to loose stools/diarrhea, as compared to 0.8% in the binder arm. There were no serious adverse events related to tenapanor.

    About AMPLIFY
    AMPLIFY, a double-blind, placebo-controlled, randomized study, enrolled a total of 236 patients with CKD on dialysis, who despite a stable phosphate binder regimen, had a serum phosphorus level greater than or equal to 5.5 mg/dL and less than or equal to 10.0 mg/dL at screening. After a run-in of two to four weeks, patients were randomized 1:1 to receive tenapanor or placebo twice daily while continuing their established phosphate binder regimen. Baseline serum phosphorus at randomization was at a mean level of 6.8 mg/dL. Tenapanor was initiated at a starting dose of 30 mg twice daily with tenapanor dose adjustments allowed based on serum phosphorus level and gastrointestinal tolerability.

    The primary endpoint of the study was the comparison of the change from baseline in serum phosphorus levels at week four between the tenapanor and binder arms. The key secondary endpoints included a comparison of the proportion of patients achieving a serum phosphorus level below 5.5 mg/dL at week four and relative change from baseline in FGF23 levels between the tenapanor and binder arms at week four. (NCT 03824587)

    About Tenapanor for Hyperphosphatemia
    Tenapanor, discovered and developed by Ardelyx, is a first-in-class, proprietary, oral, medicine in late-stage clinical development for the control of serum phosphorus in 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 the tightening of the epithelial cell junctions, thereby significantly reducing paracellular uptake of phosphate, the primary pathway of phosphate absorption. In addition, if approved, tenapanor will be easier than phosphate binders for patients to take with a regimen of just one small pill, taken twice daily. The company previously reported results from its first Phase 3 monotherapy study with tenapanor in CKD patients on dialysis, reporting that the primary endpoint was met (p=0.01) and that 50% of patients (n=164) experienced a mean serum phosphorus reduction of 2.56 mg/dL.

    Ardelyx believes that, if approved, tenapanor can become a foundational therapy for all CKD patients on dialysis who experience elevated serum phosphorus.

    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 common condition among people with CKD and especially those 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 over time (Spherix 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 dialysis patients (Block 2004), and common treatment goals are to manage serum phosphorus levels to <5.5mg/dL.

    About Fibroblast Growth Factor 23 (FGF23)
    FGF23 is a protein in humans that is responsible for phosphate and vitamin D metabolism. Prospective clinical studies have demonstrated a linear association between elevated levels of FGF23 and a greater risk of major cardiovascular events and mortality. FGF23 is independently associated with greater left ventricular mass and greater prevalence of left ventricular hypertrophy (Amaral 2012).

    Conference Call Information
    The company will host a conference call today, September 3, 2019 at 8:30AM ET to discuss the AMPLIFY findings. To participate in the conference call, please call (855) 296-9612 (toll-free) or (920) 663-6277 (toll) and reference call ID number 9789472. A webcast of the call can also be accessed by visiting the Investor page of the company's website www.ardelyx.com and will be available on the website for 60 days following the call.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the lives of people with cardiorenal diseases by developing first-in-class medicines that matter. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with CKD on dialysis, 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 has completed Phase 3 development of tenapanor for the treatment of irritable bowel syndrome with constipation (IBS-C) and submitted a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, for the treatment of patients with IBS-C which has been granted a target action date under the Prescription Drug User Fee Act (PDUFA) of September 12, 2019. To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin Co., Ltd. in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com and connect with us on Twitter @Ardelyx.

    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 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 in combination with phosphate binders for the treatment of hyperphosphatemia, the potential for tenapanor in combination with phosphate binders to achieve serum phosphorus levels of less than 5.5mg/dL, Ardelyx's expected timing for receipt of data from PHREEDOM, its ongoing Phase 3 clinical trial evaluating tenapanor as monotherapy for the treatment of hyperphosphatemia in CKD patients on dialysis, Ardelyx's expectations regarding its plans for the commercialization of tenapanor, Ardelyx's expectations regarding the size of the patient populations for its product candidates, and Ardelyx's expectations regarding the potential for tenapanor to become a foundational therapy for all patients on dialysis who experience elevated 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 inherent in the clinical development process, including the regulatory approval 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 9, 2019, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

     

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  37. FREMONT, Calif., Sept. 2, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, announced that it will hold a conference call tomorrow, September 3, at 8:30 am Eastern Time to review the results from the pivotal Phase 3 AMPLIFY study of tenapanor in combination with phosphate binders in patients with chronic kidney disease on dialysis whose hyperphosphatemia was not controlled with binders. Tenapanor is Ardelyx's investigational, first-in-class, small molecule, non-binder, phosphate absorption inhibitor.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    To participate in the conference call, please dial (855) 296-9612 (domestic) or (920) 663-6277 (international…

    FREMONT, Calif., Sept. 2, 2019 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a specialized biopharmaceutical company focused on developing first-in-class medicines to improve treatment for people with cardiorenal diseases, announced that it will hold a conference call tomorrow, September 3, at 8:30 am Eastern Time to review the results from the pivotal Phase 3 AMPLIFY study of tenapanor in combination with phosphate binders in patients with chronic kidney disease on dialysis whose hyperphosphatemia was not controlled with binders. Tenapanor is Ardelyx's investigational, first-in-class, small molecule, non-binder, phosphate absorption inhibitor.

    Ardelyx logo (PRNewsFoto/Ardelyx)

    To participate in the conference call, please dial (855) 296-9612 (domestic) or (920) 663-6277 (international) and refer to conference ID 9789472. Live audio of the conference call will be simultaneously webcast and will be available under the Investors section of the company's website at www.ardelyx.com. The webcast will be archived and available for replay for 60 days following the call.

    About Ardelyx, Inc.
    Ardelyx is focused on enhancing the lives of people with cardiorenal diseases by developing first-in-class medicines that matter. Ardelyx's cardiorenal pipeline includes the Phase 3 development of tenapanor for the treatment of hyperphosphatemia in people with CKD on dialysis, 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 has completed Phase 3 development of tenapanor for the treatment of irritable bowel syndrome with constipation (IBS-C) and submitted a new drug application, or NDA, to the U.S. Food and Drug Administration, or FDA, for the treatment of patients with IBS-C which has been granted a target action date under the Prescription Drug User Fee Act (PDUFA) of September 12, 2019. To efficiently bring its treatments to market, Ardelyx is pursuing strategic collaborations for tenapanor for IBS-C and hyperphosphatemia in certain territories. Ardelyx has established agreements with Kyowa Kirin Co., Ltd. in Japan, Fosun Pharma in China and Knight Therapeutics in Canada. For more information, please visit http://www.ardelyx.com and connect with us on Twitter @Ardelyx.

     

    Cision View original content to download multimedia:http://www.prnewswire.com/news-releases/ardelyx-to-host-conference-call-on-september-3-to-review-results-from-the-pivotal-phase-3-amplify-study-300910304.html

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