ARDX Ardelyx Inc.

0.89
-0.03  -3%
Previous Close 0.92
Open 0.9
52 Week Low 0.9001
52 Week High 9.23
Market Cap $100,623,492
Shares 112,743,408
Float 97,861,622
Enterprise Value $28,127,555
Volume 1,693,527
Av. Daily Volume 3,269,184
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Drug Pipeline

Drug Stage Notes
Tenapanor
Serum phosphorus - chronic kidney disease (CKD) on dialysis
CRL
CRL
FDA issued CRL on July 29 2021. The FDA held a Type A meeting with Ardelyx, but it did not provide enough clarity on what constitutes "clinical relevance of the magnitude of treatment effect" and continues to await additional information regarding the path forward for the company's NDA, noted October 13, 2021. Company to issue a formal dispute resolution request (FDRR), noted November 4, 2021.
Tenapanor - AMPLIFY
Hyperphosphatemia - adjunctive therapy to phosphate binders
Phase 3
Phase 3
Phase 3 trial met primary endpoint.
Tenapanor (T3MPO-1)
Constipation-predominant irritable bowel syndrome (IBS-C)
Phase 3
Phase 3
Phase 3 data released May 12, 2017. Primary endpoint met - however, competitive concerns raised.
RDX013
Hyperkalemia
Phase 2
Phase 2
Phase 2 trial planned for 2021.
Tenapanor (T3MPO-2)
Constipation-predominant irritable bowel syndrome (IBS-C)
Approved
Approved
FDA approval announced September 12, 2019.

Latest News

  1. FREMONT, Calif. and WALTHAM, Mass., Nov. 12, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today reported business events and financial results for the third quarter ended September 30, 2021.

    Recent Business Events

    • The company presented four posters at the American Society of Nephrology Kidney Week 2021 (ASN Kidney Week), which took place virtually on November 4November 7, 2021, highlighting additional positive clinical observations with tenapanor, a first-in-class phosphate absorption inhibitor which has completed three successful Phase 3 clinical trials for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The company also shared important data focusing on the patient experience with tenapanor from the Phase 4 OPTIMIZE trial, which is designed to optimize the treatment of hyperphosphatemia in patients with CKD on dialysis.
    • On November 4, 2021, the company announced that it expects to submit a Formal Dispute Resolution Request (FDRR) by the end of the fourth quarter 2021 to appeal the issuance of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis.
    • On October 13, 2021, the company announced the results of an End of Review Type A meeting with FDA's Division of Cardiology and Nephrology, noting that the meeting did not provide clarity regarding a reasonable path forward for the resubmission of the company's NDA for tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis.
    • On October 12, 2021, the company announced that it began implementing a restructuring plan to reduce operating costs and better align the company's workforce with the needs of its business following the receipt of the CRL from the FDA on July 28, 2021, and the outcome of the End of Review Type A meeting. The restructuring plan is expected to be completed in December 2021.
    • On September 3, 2021, the company announced the publication of the company's long term 52-week Phase 3 PHREEDOM trial in the American Society of Nephrology Journal, Kidney 360. The publication highlights a clinically meaningful reduction in mean serum phosphorus from 7.7 mg/dL to 5.1 mg/dL at the end of the 26-week treatment period in the efficacy analysis set.

    Third Quarter 2021 Financial Results

    • Cash Position: As of September 30, 2021, Ardelyx had total cash, cash equivalents and short-term investments of $141.7 million, as compared to total cash, cash equivalents and investments of $188.6 million as of December 31, 2020.
    • Revenue: The company generated $1.2 million in revenue for the three months ended September 30, 2021, which primarily represents collaborative development revenue from the 2019 Research Collaboration and Option Agreement between the company and Kyowa Kirin Co., Ltd.
    • R&D Expenses: Research and development expenses were $23.7 million for the three months ended September 30, 2021, an increase of $11.5 million, or 94 percent, compared to $12.2 million for the three months ended September 30, 2020. The increase was due primarily to clinical study costs from the advancement of the company's OPTIMIZE study which were partially offset by lower costs for the PHREEDOM clinical study, as well as higher employee-related expenses for the research and development workforce. Research and development employee-related expenses included $1.2 million in severance payments and other employee-related costs associated with a restructuring implemented in August 2021.
    • G&A Expenses: General and administrative expenses were $19.7 million for the three months ended September 30, 2021, an increase of $12.1 million, or 158 percent, compared to $7.6 million for the three months ended September 30, 2020. The increase in general and administrative expenses was primarily due to an increase in costs associated with building and staffing the company's commercial infrastructure as it prepared for the potential regulatory approval and U.S. launch of tenapanor for the control of serum phosphorus in adult patients with CKD on dialysis. General and administrative employee-related expenses included $2.4 million in severance payments and other employee-related costs associated with a restructuring implemented in August 2021.
    • Net Loss: Net loss for the quarter ended September 30, 2021, was $43.6 million, compared to $18.1 million for the quarter ended September 30, 2020.

    About Ardelyx, Inc.

    Ardelyx is focused on discovering, developing and commercializing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiorenal diseases. Ardelyx is developing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. 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 their 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 Ardelyx's expectation to submit a Formal Dispute Resolution Request to appeal the FDA's issuance of a CRL for its NDA for tenapanor for the control of serum phosphorus in CKD patients on dialysis, and the expected timing thereof, and Ardelyx's expectations regarding the timing of the completion of the restructuring that it began implementing in October 2021. 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, uncertainties associated with the NDA process, and the Formal Dispute Resolution process, as well as uncertainties associated with restructuring efforts. 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. 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 12, 2021, 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, 2021



    December 31, 2020



    (Unaudited)



    (1)

    Assets







    Cash and cash equivalents

    $

    75,288



    $

    91,032

    Investments

    66,363



    97,566

    Accounts receivable

    287



    Property and equipment, net

    2,651



    1,936

    Right-of-use assets

    13,580



    2,274

    Prepaid and other assets

    12,679



    8,754

    Total assets

    $

    170,848



    $

    201,562









    Liabilities and stockholders' equity







    Accounts payable

    $

    4,263



    $

    5,626

    Accrued compensation and benefits

    4,770



    5,672

    Current portion of operating lease liability

    3,391



    2,117

    Loan payable, current portion

    44,444



    4,167

    Deferred revenue

    3,474



    4,177

    Accrued expenses and other liabilities

    11,373



    6,657

    Operating lease liability, net of current portion

    10,669



    413

    Loan payable, net of current portion

    7,032



    46,621

    Stockholders' equity

    81,432



    126,112

    Total liabilities and stockholders' equity

    $

    170,848



    $

    201,562





    (1)

    Derived from the audited financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2020.



     

    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,



    2021



    2020



    2021



    2020

    Revenues:















    Collaborative development revenue

    $

    886



    $

    1,356



    $

    3,650



    $

    3,656

    Product supply revenue

    285



    1,357



    411



    1,400

    Licensing revenue

    2





    5,007



    706

    Total revenues

    1,173



    2,713



    9,068



    5,762

    Operating expenses:















    Cost of revenue





    1,000



    141

    Research and development

    23,695



    12,240



    70,172



    46,948

    General and administrative

    19,714



    7,634



    56,969



    21,810

    Total operating expenses

    43,409



    19,874



    128,141



    68,899

    Loss from operations

    (42,236)



    (17,161)



    (119,073)



    (63,137)

    Interest expense

    (1,216)



    (1,202)



    (3,518)



    (3,785)

    Other (expense) income, net

    (134)



    255



    664



    1,485

    Loss before provision for income taxes

    (43,586)



    (18,108)



    $

    (121,927)



    $

    (65,437)

    Provision for income taxes

    1





    4



    Net loss

    $

    (43,587)



    $

    (18,108)



    $

    (121,931)



    $

    (65,437)

    Net loss per common share, basic and diluted

    $

    (0.42)



    $

    (0.20)



    $

    (1.21)



    $

    (0.73)

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

    104,144,606



    89,365,798



    100,480,156



    89,109,772

































     

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  2. FREMONT, Calif. and WALTHAM, Mass., Nov. 11, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that Mike Raab, president and chief executive officer of Ardelyx, will participate in a fireside chat at the Jefferies London Healthcare Conference, which is taking place virtually and in-person on November 16 – 19, 2021. The fireside chat will be available to all registered participants on-demand between 3:00 a.m. ET on November 18, 2021 and 12:00 p.m. ET on November 19, 2021.

    FREMONT, Calif. and WALTHAM, Mass., Nov. 11, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that Mike Raab, president and chief executive officer of Ardelyx, will participate in a fireside chat at the Jefferies London Healthcare Conference, which is taking place virtually and in-person on November 16 – 19, 2021. The fireside chat will be available to all registered participants on-demand between 3:00 a.m. ET on November 18, 2021 and 12:00 p.m. ET on November 19, 2021.

    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 30 days following the presentation.

    About Ardelyx, Inc.

    Ardelyx is focused on discovering, developing, and commercializing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiorenal diseases. Ardelyx is developing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. In addition, tenapanor has already received FDA approval for the treatment of irritable bowel syndrome with constipation (IBS-C) under the tradename IBSRELA®. 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 their respective territories.

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  3. FREMONT, Calif. and WALTHAM, Mass., Nov. 5, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced multiple presentations covering additional positive clinical observations with tenapanor at the American Society of Nephrology Kidney Week 2021 (ASN Kidney Week), which is taking place virtually November 4 - November 7, 2021. Ardelyx has completed three successful Phase 3 pivotal trials, and an additional clinical trial (OPTIMIZE) for tenapanor, an investigational, first-in-class phosphate absorption inhibitor for the control of serum phosphorus…

    FREMONT, Calif. and WALTHAM, Mass., Nov. 5, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced multiple presentations covering additional positive clinical observations with tenapanor at the American Society of Nephrology Kidney Week 2021 (ASN Kidney Week), which is taking place virtually November 4 - November 7, 2021. Ardelyx has completed three successful Phase 3 pivotal trials, and an additional clinical trial (OPTIMIZE) for tenapanor, an investigational, first-in-class phosphate absorption inhibitor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. Tenapanor was discovered and developed by Ardelyx.

    "These data provide additional perspective on the potential benefits of tenapanor and further support its utility in the management of serum phosphorus," said Laura Williams, M.D., MPH, chief medical officer for Ardelyx. "We continue to pursue approval of this first-in-class, novel therapy which we believe represents an important innovation for the nephrology community."

    "As a person living with kidney disease who has struggled with managing phosphorus, it gives me great hope to see the patient perspective and patient priorities being incorporated into clinical studies," said Derek Forfang, chair, NKF Kidney Patient Advocacy Committee and co-chair, Forum of ESRD Networks' Kidney Patient Advisory Council. "The OPTIMIZE results suggest that tenapanor could have an enormous positive impact on the health and quality of life of many patients on dialysis through its novel mechanism that blocks, not binds, phosphorus. Tenapanor has the potential to help more patients achieve target phosphorus levels and reduce the treatment burden associated with currently available hyperphosphatemia therapies. The incorporation of the patient voice into the clinical trial design and evaluation of tenapanor is a huge step forward for patients."

    Pablo E. Pergola, M.D., Ph.D., director, Clinical Advancement Center, Renal Associates PA, San Antonio, Texas, added, "These data for tenapanor reported at ASN reveal new important observations, including its efficacy in both peritoneal dialysis and hemodialysis, its ability to lower PTH and FGF23 levels, and its lowering of serum phosphorus without affecting other electrolytes. In addition, the new data reported from the OPTIMIZE trial provides a first glimpse into the real-world use of tenapanor, showing its ability not only to help more patients achieve target phosphorus levels, but also its ability to improve the patient experience regarding the management of hyperphosphatemia."  

    New clinical observations presented at ASN:

    • ePoster # PO1733 titled "Patient-Reported Experience with Tenapanor in the OPTIMIZE Trial" presents the first data generated from the randomized, open-label OPTIMIZE trial designed to evaluate ways to integrate tenapanor into clinical practice to optimize phosphorus management in patients with CKD on dialysis. Patients who were being treated with phosphate binders were equally divided into two groups: one (n=123) that was switched from binders to tenapanor (straight switch arm), and another (n=123) that reduced their binder dose by 50% upon starting tenapanor 30 mg twice daily (50% binder dose reduction arm). 82.1% of patients in the straight switch arm and 85.4% of patients in the 50% binder dose reduction arm reported an improvement in their overall experience managing phosphorus with tenapanor compared to their previous experience managing phosphorus, primarily due to an improved medication regimen.  Approximately 30% of patients reported improved frequency of bowel movements as the top reason for the improved treatment experience with tenapanor.
    • ePoster # PO0544 titled "Impact of Tenapanor in Peritoneal Dialysis," based on a post-hoc analysis from the PHREEDOM study, demonstrates similar safety and efficacy in serum phosphorus reduction among patients on peritoneal dialysis (PD) (n=42) and patients on hemodialysis (HD) (n=365) treated with tenapanor. The mean change from baseline to week 26 was -1.70 mg/dL in the PD group vs. -1.33 in the HD group, and the safety profile of tenapanor was also similar between the groups.
    • ePoster # TH-OR18 titled "Tenapanor Controls Serum Phosphorus and Reduces PTH and FGF-23 in Patients on Dialysis with Severe Secondary Hyperparathyroidism" evaluates tenapanor's effect on serum phosphorus (sP), parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23) levels in patients with severe secondary hyperparathyroidism (iPTH>600 pg/mL). In this post-hoc analysis from PHREEDOM, patients treated with tenapanor had ~22%, 34% and 41% reductions in sP, PTH and FGF23, respectively. PTH is a common co-morbidity and elevated levels of FGF23 have been linked to greater risks of LVH (left ventricular hypertrophy) and mortality in patients with CKD.
    • ePoster # PO1732 titled "Long-Term Safety of Tenapanor for the Control of Serum Phosphorus in Patients with CKD on Dialysis: Serum Electrolytes and Albumin" evaluates the effects of tenapanor on serum electrolytes and albumin, based on a post-hoc analysis from the three tenapanor pivotal trials, all of which met their primary and key secondary endpoints, and shows that tenapanor decreases serum phosphorus selectively by inhibiting paracellular absorption of phosphate without affecting other serum electrolytes (sodium, bicarbonate, chloride, potassium, calcium, magnesium) or serum albumin.

    About OPTIMIZE

    OPTIMIZE is a randomized, open label study, which included 330 patients with chronic kidney disease (CKD) on dialysis with hyperphosphatemia. The study was designed to evaluate different methods of initiating tenapanor to optimize phosphorus management in both binder-naïve and binder-treated patients. The objective was to evaluate the ability of tenapanor, with its novel blocking mechanism, administered as core therapy for the treatment of hyperphosphatemia in adult patients with chronic kidney disease (CKD) on dialysis, alone or in combination with phosphate binders, to achieve target serum phosphorus (s-P) levels ≤5.5 mg/dL. Patients with s-P >5.5 and ≤10.0 mg/dL during stable phosphate binder treatment were randomized in a 1:1 ratio to two different treatment cohorts: Cohort 1, a straight switch approach where current phosphate binder treatment was discontinued and patients were switched to tenapanor 30 mg twice daily (BID) or Cohort 2, where current phosphate binder dose was reduced by at least 50% and tenapanor therapy was initiated at 30 mg BID. After week 2, investigators could adjust phosphate binder dose to achieve a phosphorus level of ≤5.5 mg/dL with tenapanor as the core therapy and binders as adjunctive. A third cohort comprised of phosphate binder naïve patients with s-P >4.5 and ≤10.0 mg/dL (Cohort 3) were enrolled and initiated on tenapanor 30 mg BID.

    About Tenapanor

    Tenapanor, discovered and developed by Ardelyx, is a first-in-class phosphate absorption inhibitor (PAI) that has a unique mechanism of action and acts locally in the gut to inhibit the sodium hydrogen exchanger 3 (NHE3), reducing phosphate absorption through the paracellular pathway, the primary pathway of phosphate absorption. This novel blocking mechanism enables a one 30mg tablet BID dosing regimen. The most common side effect with tenapanor in clinical trials was diarrhea.

    About Hyperphosphatemia

    Hyperphosphatemia is a serious condition resulting in an abnormally elevated level of phosphorus in the blood that is estimated to affect the vast majority of the 550,000 patients in the United States with CKD on dialysis. 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 with internationally recognized KDIGO treatment guidelines that recommend lowering elevated phosphate levels toward the normal range (2.5-4.5mg/dL).

    About Ardelyx, Inc.

    Ardelyx is focused on discovering, developing, and commercializing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiorenal diseases. Ardelyx is developing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. In addition, tenapanor has already received FDA approval for the treatment of irritable bowel syndrome with constipation (IBS-C) under the tradename IBSRELA®. 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 their respective territories.

     

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  4. FREMONT, Calif. and WALTHAM, Mass., Nov. 4, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced the company plans to submit a Formal Dispute Resolution Request (FDRR) to appeal the issuance of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. Formal Dispute Resolution is a pathway in the Center for Drug Evaluation and Research (CDER) by which NDA…

    FREMONT, Calif. and WALTHAM, Mass., Nov. 4, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced the company plans to submit a Formal Dispute Resolution Request (FDRR) to appeal the issuance of a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the company's New Drug Application (NDA) for tenapanor for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. Formal Dispute Resolution is a pathway in the Center for Drug Evaluation and Research (CDER) by which NDA applicants can seek to resolve scientific and/or medical disputes that cannot be resolved at the division level.

    "While we are disappointed that we could not come to a resolution with the Division of Cardiology and Nephrology during the End of Review meeting, the Formal Dispute Resolution process provides an opportunity to raise our scientific disagreement above the division level within CDER," said Mike Raab, president and chief executive officer of Ardelyx. "We believe that this represents the best approach to obtaining approval of tenapanor for the treatment of hyperphosphatemia and bringing this important medicine forward to patients and their treating physicians."

    "Phosphorus management is one of the most challenging aspects of caring for patients on dialysis," said Stuart Sprague, DO, FASN, FNKF, chief of the Division of Nephrology and Hypertension at Northshore University Health System, University of Chicago. "Despite our best efforts with currently available therapies, all of which act via the binding mechanism, nearly 80% of patients are unable to consistently achieve target phosphorus levels established by peer-reviewed global treatment guidelines, in spite of taking up to 10-12 pills per day. Thus, there is a strong need for a novel therapeutic approach, such as that of tenapanor, which blocks gastrointestinal phosphate absorption. The tenapanor clinical data package demonstrates that a significant proportion of patients respond to therapy with meaningful reductions in phosphorus with only 2 pills per day, and an acceptable safety and tolerability profile. The clinical relevance of tenapanor is clear. In addition, the meaningful impact tenapanor will have on the patient experience cannot be ignored. The delay in approval by the FDA is not in the best interest of patients. I applaud Ardelyx for their persistence in bringing this much-needed and innovative therapy to patients."

    The company expects to submit the FDRR to the FDA's Office of Cardiology, Hematology, Endocrinology and Nephrology (OCHEN) in the fourth quarter of 2021. The FDA's goal is to consider and decide on all FDRRs in thirty (30) days with some exceptions, including if a meeting is requested. A second appeal to the FDA's Office of New Drugs is possible if the company does not obtain a positive outcome from OCHEN.  

    About Ardelyx, Inc.

    Ardelyx is focused on discovering, developing, and commercializing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiorenal diseases. Ardelyx is developing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease, and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. In addition, tenapanor has already received FDA approval for the treatment of irritable bowel syndrome with constipation (IBS-C) under the tradename IBSRELA®. 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 their 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 Ardelyx's expectation to submit a FDRR in the fourth quarter of 2021 and Ardelyx's expectations regarding the timing of a decision regarding its FDRR. 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, uncertainties associated with the NDA process, the FDRR process, and appeal resolution with CDER. 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 13, 2021, and its future current and periodic reports to be filed with the Securities and Exchange Commission.

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  5. FREMONT, Calif. and WALTHAM, Mass., Oct. 29, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that four tenapanor abstracts have been accepted for presentation at the American Society of Nephrology Kidney Week 2021 (ASN Kidney Week), which is taking place virtually November 4 - November 7, 2021. The accepted abstracts present new observations for tenapanor, a first-in-class phosphate absorption inhibitor which has completed three successful Phase 3 clinical trials for the control of serum phosphorus in adult patients with chronic…

    FREMONT, Calif. and WALTHAM, Mass., Oct. 29, 2021 /PRNewswire/ -- Ardelyx, Inc. (NASDAQ:ARDX), a biopharmaceutical company focused on the discovery, development, and commercialization of innovative first-in-class medicines to improve treatment for people with kidney and cardiorenal diseases, today announced that four tenapanor abstracts have been accepted for presentation at the American Society of Nephrology Kidney Week 2021 (ASN Kidney Week), which is taking place virtually November 4 - November 7, 2021. The accepted abstracts present new observations for tenapanor, a first-in-class phosphate absorption inhibitor which has completed three successful Phase 3 clinical trials for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. Tenapanor was discovered and developed by Ardelyx.

    Information regarding ASN Kidney Week, including the abstracts listed below are available on the conference website at https://www.asn-online.org/education/kidneyweek/

    Ardelyx Poster Presentations:

    Title: Impact of Tenapanor in Peritoneal Dialysis

    Abstract Number: PO0544

    Date/Time: November 04, 2021, 10:00 AM-12:00 PM

    Title: Tenapanor Controls Serum Phosphorus and Reduces PTH and FGF-23 in Patients on Dialysis with Severe Secondary Hyperparathyroidism

    Abstract Number: TH-OR18

    Date/Time: November 04, 2021, 4:30 PM-6:30 PM

    Title: Long-Term Safety of Tenapanor for the Control of Serum Phosphorus in Patients with CKD on Dialysis: Serum Electrolytes and Albumin

    Abstract Number: PO1732

    Date/Time: November 04, 2021, 10:00 AM-12:00 PM

    Title: Patient-Reported Experience with Tenapanor in the OPTIMIZE Trial

    Abstract Number: PO1733

    Date/Time: November 04, 2021, 10:00 AM-12:00 PM

    About Ardelyx, Inc

    Ardelyx is focused on discovering, developing and commercializing innovative first-in-class medicines to enhance the lives of patients with kidney and cardiorenal diseases. Ardelyx is developing tenapanor, a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials. Ardelyx is also advancing RDX013, a potassium secretagogue, for the potential treatment of elevated serum potassium, or hyperkalemia, a problem among certain patients with kidney and/or heart disease and has an early-stage program in metabolic acidosis, a serious electrolyte disorder in patients with CKD. In addition, tenapanor has already received FDA approval for the treatment of irritable bowel syndrome with constipation (IBS-C) under the tradename IBSRELA®. 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 their respective territories.

     

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