NHE3

Ardelyx Announces FDA Advisory Committee Votes that the Benefits of XPHOZAH® (tenapanor) Outweigh its Risks for the Control of Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dialysis

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Wednesday, November 16, 2022
OND, Kyowa Hakko Kirin, Indiana University School of Medicine, Adult, Human, Hyperphosphatemia, Conference, NHE3, U.S. Securities and Exchange Commission, Security (finance), Knight Therapeutics, Diarrhea, PAI, Fosun Pharma, Chronic kidney disease, CKD, Hyperkalemia, Metabolic acidosis, Nephrology, Physician, Conference call, Safety, Center for Drug Evaluation and Research, Research, Phosphorus, FDA, ID, View, Center, Therapy, Advisory Committee, Multimedia, Hypertension, Regulation of tobacco by the U.S. Food and Drug Administration, Patient, Blood, Kidney, BID, Dialysis, Food, Endpoint security, Pharmaceutical industry, Facebook

WALTHAM, Mass., Nov. 16, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced the vote of the U.S. Food and Drug Administration's (FDA) Cardiovascular and Renal Drugs Advisory Committee (CRDAC) meeting for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis. The CRDAC voted nine to four that the benefits of treatment with XPHOZAH outweigh its risks for the control of serum phosphorus in adults with CKD on dialysis when administered as a monotherapy and voted ten to two, with one abstention, that the benefits of treatment with XPHOZAH in combination with phosphate binder treatment outweigh its risks.

Key Points: 
  • "We are confident that the data from three Phase 3 clinical trials involving more than 1,200 patients support the approval of XPHOZAH in the U.S. for the control of serum phosphorus in adult patients with CKD on dialysis.
  • We want to thank the patients, physicians and the advocacy community who shared their valuable insights today and throughout the development program.
  • The nephrology community is enthusiastic to have access to this therapy with its novel mechanism of action to help our patients."
  • Ardelyx is developing XPHOZAH (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 Presents New Data Analyses at Kidney Week 2022, Further Supporting the Clinical Relevance of XPHOZAH® (tenapanor), an Investigational, Phosphate Absorption Inhibitor to Control Serum Phosphorus in Adult Patients with Chronic Kidney Disease on Dia

Retrieved on: 
Thursday, November 3, 2022
Chronic kidney disease, Phosphate, U.S. Securities and Exchange Commission, Adult, Society, HD, Safety, American Society of Nephrology, Randomness, Knight Therapeutics, Dialysis, Kidney, PAI, NHE3, Diarrhea, Poster, Security (finance), ASN, MD, ESRD, Fosun Pharma, Treatment, CKD, Multimedia, Nasdaq, Blood, Metabolic acidosis, View, Phosphorus, Hyperkalemia, Therapy, Pharmaceutical industry, Medical device, Patient, Hyperphosphatemia, Kyowa Hakko Kirin

WALTHAM, Mass., Nov. 3, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced that new analyses of data from its three Phase 3 trials supporting the clinical utility of XPHOZAH (tenapanor) will be presented at the American Society of Nephrology (ASN) Kidney Week 2022, taking place in Orlando, Florida from November 3-6, 2022. XPHOZAH is an investigational first-in-class phosphate absorption inhibitor (PAI) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

Key Points: 
  • XPHOZAH is an investigational first-in-class phosphate absorption inhibitor (PAI) for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
  • "These data continue to support the benefit that novel-mechanism XPHOZAH could have for patients on dialysis with hyperphosphatemia," said David Rosenbaum, Ph.D., chief development officer for Ardelyx.
  • This information could help guide treatment decisions that maximize the potential therapeutic benefit of XPHOZAH for these patients.
  • At week 4, the mean pre-HD weight decreased in patients whose treatment included XPHOZAH, while it increased in patients who received phosphate binders alone.

Ardelyx Announces Poster Presentations on XPHOZAH® (tenapanor) at ASN's Kidney Week 2022

Retrieved on: 
Thursday, October 20, 2022
PAI, ASN, ESRD, Dialysis, Therapy, Patient, Diarrhea, NHE3, Multimedia, Knight Therapeutics, Fosun Pharma, Kidney, Kyowa Hakko Kirin, Metabolic acidosis, MD, Hyperphosphatemia, Blood, Phosphorus, Adult, Hyperkalemia, CKD, View, Pharmaceutical industry

In addition to the poster presentations during ASN, Ardelyx is sponsoring an Exhibitor Spotlight titled: The Phosphorus Management Puzzle and Need for New Pieces: the Patient and Physician Perspective, on Saturday November 5, 2022, from 12:30-1:15pm ET.

Key Points: 
  • In addition to the poster presentations during ASN, Ardelyx is sponsoring an Exhibitor Spotlight titled: The Phosphorus Management Puzzle and Need for New Pieces: the Patient and Physician Perspective, on Saturday November 5, 2022, from 12:30-1:15pm ET.
  • XPHOZAH (tenapanor), discovered and developed byArdelyx, is an investigational first-in-class phosphate absorption inhibitor (PAI).
  • 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.
  • Ardelyx is developing XPHOZAH (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 Announces FDA Advisory Committee Meeting to Review XPHOZAH® NDA Tentatively Scheduled for November 16, 2022

Retrieved on: 
Tuesday, June 21, 2022
Hyperkalemia, Chronic kidney disease, Security (finance), FDA, NDA, Metabolic acidosis, NHE3, Regulation of tobacco by the U.S. Food and Drug Administration, Kidney, View, Endpoint security, Tobacco Products Scientific Advisory Committee, Circulatory system, Advisory, U.S. Securities and Exchange Commission, Fosun Pharma, Kyowa Hakko Kirin, New Drug Application, OND, CKD, Diarrhea, Calendar, PAI, Dialysis, Adult, Advisory Committee, Food, Patient, Knight Therapeutics, Multimedia, Therapy, Pharmaceutical industry

The Advisory Committee will discuss the company's New Drug Application (NDA) for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

Key Points: 
  • The Advisory Committee will discuss the company's New Drug Application (NDA) for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
  • A response from the OND to Ardelyx's appeal is expected within thirty calendar days after the conclusion of the Advisory Committee meeting.
  • XPHOZAH (tenapanor), discovered and developed by Ardelyx, in an investigational first-in-class phosphate absorption inhibitor (PAI).
  • Ardelyx was founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs.

Spherix Global Insights Identifies Significant Unmet Need and Strong Opportunity for a Newly Launched Mechanism of Action in IBS-C Market

Retrieved on: 
Thursday, May 12, 2022
Physician, IBS, Constipation, EOE, Patient, Nephrology, PBC, IBS-C, NHE3, Depression, FDA, Dynamix, Gastroenterology, Eosinophilic esophagitis, CED, Anxiety, Diet, Primary biliary cholangitis, Degenerative disease, Diagnosis, PCP, Pharmaceutical industry

EXTON, Pa., May 12, 2022 /PRNewswire/ -- Spherix recently surveyed 102 gastroenterologists and 100 primary care physicians (PCPs), including eight qualitative interviews with gastroenterologists, to gain perspective on the current and future management of irritable bowel syndrome with constipation (IBS-C). Data captured in Spherix's Market Dynamix™: IBS-C (US) service also specifically examined the treatment and diagnosis trends for this indication.

Key Points: 
  • Data captured in Spherix's Market Dynamix: IBS-C (US) service also specifically examined the treatment and diagnosis trends for this indication.
  • Indeed, the majority of surveyed physicians indicate a desire for therapies with a novel mechanism of action in IBS-C.
  • Insights highlight market size, current treatment approaches, unmet needs, and expert opinions on the likely disruption introduced by pipeline agents.
  • Spherix Global Insights is a hyper-focused market intelligence firm that leverages our own independent data and expertise to provide strategic guidance, so biopharma stakeholders make decisions with confidence.

Ardelyx Announces FDA Plan to Convene Advisory Committee for XPHOZAH® (tenapanor)

Retrieved on: 
Monday, April 25, 2022
Center for Drug Evaluation and Research, NDA, Advisory Committee, Kidney, Circulatory system, Chronic kidney disease, U.S. Securities and Exchange Commission, PAI, Adult, Security (finance), Regulation of tobacco by the U.S. Food and Drug Administration, Metabolic acidosis, Annual report, CDER, Center, Hyperphosphatemia, Food, Hyperkalemia, Endpoint security, Cardiology, Patient, Nephrology, Dialysis, Fosun Pharma, CRL, Therapy, OND, Knight Therapeutics, CKD, Kyowa Hakko Kirin, Division, NHE3, Multimedia, FDA, Diarrhea, View, Pharmaceutical industry, Research

WALTHAM, Mass., April 25, 2022 /PRNewswire/ -- Ardelyx, Inc. (Nasdaq: ARDX), a biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs, today announced that the Office of New Drugs (OND), Center for Drug Evaluation and Research (CDER) of the U.S. Food and Drug Administration (FDA), has provided an interim response to Ardelyx's second level of appeal of the Complete Response Letter (CRL) received on July 28, 2021, for XPHOZAH. The OND noted that additional input from the Cardiovascular and Renal Drug Advisory Committee in general, and specifically, from experts, including expert clinicians, would be valuable in further considering the clinical meaningfulness of the phosphate lowering effect observed in Ardelyx's phase 3 clinical program for XPHOZAH. Accordingly, the OND intends to direct the Division of Cardiology and Nephrology to bring the XPHOZAH New Drug Application (NDA) to the Cardiovascular and Renal Drugs Advisory Committee, and to provide a response to Ardelyx's appeal within thirty (30) days after the conclusion of the Advisory Committee meeting. Ardelyx is seeking approval for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.

Key Points: 
  • Ardelyx is seeking approval for XPHOZAH for the control of serum phosphorus in adult patients with chronic kidney disease (CKD) on dialysis.
  • While we await direction from the OND on the timing of this meeting, we look forward to the opportunity to further discuss XPHOZAH with the Cardiovascular and Renal Drugs Advisory Committee."
  • XPHOZAH (tenapanor), discovered and developed by Ardelyx, in an investigational first-in-class phosphate absorption inhibitor (PAI).
  • Ardelyx was founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs.

Ardelyx Announces US Launch of IBSRELA®, a New First-in-Class Treatment for IBS-C in Adults

Retrieved on: 
Monday, April 4, 2022
Beth Israel Deaconess Medical Center, Risk, Human, Diarrhea, RATS, NHE3, Adult, Abdominal distension, Defecation, Incidence, Medicine, Death, Week, Health, Dehydration, Safety, IBS-C, Bloating, Harvard Medical School, Constipation, FDA, Patient, Abdominal pain, Pharmaceutical industry, Health insurance, Birth control

"The commercialization of IBSRELA marks a significant milestone for Ardelyx and for adult patients with IBS-C and their healthcare providers," said Mike Raab, president and chief executive officer of Ardelyx.

Key Points: 
  • "The commercialization of IBSRELA marks a significant milestone for Ardelyx and for adult patients with IBS-C and their healthcare providers," said Mike Raab, president and chief executive officer of Ardelyx.
  • "It's hugely rewarding to see an idea born from our discovery research translate into a breakthrough medicine for patients.
  • IBSRELA (tenapanor) is indicated for the treatment of Irritable Bowel Syndrome with Constipation (IBS-C) in adults.
  • Ardelyx was founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs.

Goldfinch Bio Strengthens Leadership Team with Appointment of Jeff W. Jacobs, Ph.D. as Chief Scientific Officer

Retrieved on: 
Monday, December 6, 2021
Biotechnology, Diabetes, Health, Pharmaceutical, Clinical Trials, Patient, Kidney, Kidney disease, CSO, CMC, TRPC5, IBS-C, Biology, Chronic kidney disease, Health, Cancer, Precision medicine, Inflammation, Central nervous system, FSGS, Leadership, Facility, Therapy, CB1, DN, KGA, Gonzaga University, Hope, Research, Quality of life, Patent, Genetics, Constipation, FDA, Science, NHE3, Bio, Disease, Drug discovery, Growth, Pharmaceutical industry

Goldfinch Bio, a clinical stage biotechnology company focused on discovering and developing precision medicines for the treatment of kidney diseases, today announced the appointment of Jeff W. Jacobs, Ph.D. as Chief Scientific Officer (CSO).

Key Points: 
  • Goldfinch Bio, a clinical stage biotechnology company focused on discovering and developing precision medicines for the treatment of kidney diseases, today announced the appointment of Jeff W. Jacobs, Ph.D. as Chief Scientific Officer (CSO).
  • Were thrilled to welcome Jeff to the Goldfinch Bio team.
  • Dr. Jacobs commented, I am incredibly excited to take on the role of CSO at Goldfinch Bio, as we pioneer precision medicines for the severely underserved kidney disease patient population.
  • In 2020, Goldfinch Bio was named one of Fierce Biotechs Fierce 15 companies.

Ardelyx Launching IBSRELA® Second Quarter of 2022

Retrieved on: 
Tuesday, November 30, 2021
Patient, Adoption, Safety, Abdominal distension, Dehydration, IBS-C, Defecation, Diarrhea, Week, Human, University, Prescription, ID, RATS, Abdominal pain, Physician, Hyperphosphatemia, Death, Nasdaq, Research, Risk, Incidence, Constipation, FDA, NHE3, University of Michigan School of Social Work, IBS, Pharmaceutical industry, Health insurance, Birth control

This market is ripe for the entry of a novel therapeutic option like IBSRELA, as existing therapies do not adequately address all patient treatment needs.

Key Points: 
  • This market is ripe for the entry of a novel therapeutic option like IBSRELA, as existing therapies do not adequately address all patient treatment needs.
  • We will use the next few months to build commercial inventory and prepare the market for a second-quarter 2022 launch.
  • "The approval of IBSRELA was based on two successful Phase 3 trials involving over 1,200 patients with IBS-C.
  • Ardelyx received approval for IBSRELA (tenapanor) with plans to launch in the second quarter of 2022.

Ardelyx Reports Additional Positive Data Supporting Clinical Utility of Tenapanor at ASN's Kidney Week 2021

Retrieved on: 
Friday, November 5, 2021
Control, Society, MPH, LVH, PTH, Therapy, Calcium, Clinical trial, Constipation, Serum, ESRD, Magnesium, Mortality, Safety, HD, Left ventricular hypertrophy, Knight Therapeutics, Kidney, BID, Method, NHE3, Phosphorus, Blood, Nephrology, FDA, Metabolic acidosis, Adult, Quality of life, FGF23, View, Potassium, CKD, PD, Health, Multimedia, Chronic kidney disease, Hyperphosphatemia, Sodium, Hyperkalemia, Renal Association, PAI, Dialysis, Cohort, Kyowa Hakko Kirin, Electrolyte, Diarrhea, Kidney disease, Parathyroid hormone, Human, Defecation, Fosun Pharma, Serum albumin, ASN, IBS-C, Secondary hyperparathyroidism, Pharmaceutical industry

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.

Key Points: 
  • 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.
  • "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.
  • 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."