CKD

XPHOZAH® (tenapanor) Granted Orphan Drug Designation by U.S. FDA for the Treatment of Pediatric Hyperphosphatemia

Retrieved on: 
Wednesday, November 15, 2023
Chronic kidney disease, Hyperphosphatemia, China Biologic Products, Orphan, Patient, Dialysis, Food, CKD, FDA, Pharmaceutical industry

WALTHAM, Mass., Nov. 15, 2023 (GLOBE NEWSWIRE) -- 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 U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia.

Key Points: 
  • WALTHAM, Mass., Nov. 15, 2023 (GLOBE NEWSWIRE) -- 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 U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to XPHOZAH® (tenapanor) for the treatment of pediatric hyperphosphatemia.
  • XPHOZAH is a single tablet taken twice daily that offers a first-in-class mechanism of action that blocks phosphate absorption through its primary pathway.
  • “We are pleased that the FDA has recognized the important need among pediatric patients with hyperphosphatemia for treatment options,” said Mike Raab, president and chief executive officer of Ardelyx.
  • In October, XPHOZAH was approved by the FDA to reduce serum phosphorus in adults with chronic kidney disease (CKD) on dialysis as add-on therapy in patients who have an inadequate response to phosphate binders or who are intolerant of any dose of phosphate binder therapy.

ProKidney Reports Third Quarter Financial Results

Retrieved on: 
Tuesday, November 14, 2023
Chronic kidney disease, Webcast, Research, D, International, Biostatistics, Patient, Clinical trial, CKD, Conference, REACT, Pharmaceutical industry, Cryptocurrency

WINSTON-SALEM, N.C., Nov. 14, 2023 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced financial results for the third quarter ended September 30, 2023.

Key Points: 
  • WINSTON-SALEM, N.C., Nov. 14, 2023 (GLOBE NEWSWIRE) -- ProKidney Corp. (Nasdaq: PROK) (“ProKidney”), a leading late clinical-stage cellular therapeutics company focused on chronic kidney disease (CKD), today announced financial results for the third quarter ended September 30, 2023.
  • Further, you may listen to the presentation by dialing 1-877-407-0784 (US) or 1-201-689-8560 (International) and entering the Conference ID: 13742672.
  • Following the completion of the presentation, a replay of the webcast will also be accessible on the investor relations section of ProKidney website here .
  • Shares outstanding: Class A and Class B ordinary shares outstanding at September 30, 2023 totaled 235,434,630.

Galera Reports Third Quarter 2023 Financial Results and Recent Corporate Updates

Retrieved on: 
Tuesday, November 14, 2023
NDA, Cisplatin, Disclosure, Galera, Chronic kidney disease, Annual general meeting, Superoxide dismutase, ASN, ASTRO, Food, Type, SBRT, Head, Incidence, Investment, New Drug Application, Clinical trial, American Society of Nephrology, Insurance, Patient, Workforce, Research, Radiation therapy, Death, FDA, CKD, Neoplasm, LAPC, Therapy, Manganese, Enterocyte, GRECO, Cancer, CRL, Symantec Endpoint Protection, Combination, Superoxide dismutase mimetics, Layoff, Society, HNC, Poster, Pharmaceutical industry

MALVERN, Pa., Nov. 14, 2023 (GLOBE NEWSWIRE) -- Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced financial results for the third quarter ended September 30, 2023 and provided recent corporate updates.

Key Points: 
  • The Company is exploring potential strategic alternatives, as it is not feasible to conduct an additional trial with the Company’s current resources.
  • Research and development expenses were $6.1 million in the third quarter of 2023, compared to $8.1 million for the same period in 2022.
  • General and administrative expenses were $5.0 million in the third quarter of 2023, compared to $4.9 million for the same period in 2022.
  • As of September 30, 2023, Galera had cash, cash equivalents and short-term investments of $28.4 million.

ProKidney Announces Positive Interim Data from RMCL-002 Phase 2 Clinical Trial of Renal Autologous Cell Therapy (REACT®) for Diabetic CKD and Provides Corporate Updates

Retrieved on: 
Monday, November 13, 2023
Chronic kidney disease, Webcast, QP, Renal replacement therapy, GMP, Specialization, International, Physician, Kidney failure, Kidney disease, CVS Health, Risk, Surgeon, Glomerular filtration rate, Data, Patient, Framingham Heart Study, Dialysis, CKD, Boston University, Internal medicine, Baxter International, Albuminuria, Documentation, Health, Nephrology, Business administration, Conference, REACT, Trial of the century, EGFR, Quality of life, Memorial University of Newfoundland, Kellogg School of Management, Commercialization, Medical device, Pharmaceutical industry, Cryptocurrency

Positive interim Phase 2 data demonstrate the potential of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients.

Key Points: 
  • Positive interim Phase 2 data demonstrate the potential of REACT® to preserve kidney function in moderate and high-risk diabetic CKD patients.
  • Updated interim REACT RMCL-002 study data support continued investigation of REACT’s potential to benefit patients with moderate and high-risk diabetic CKD.
  • The ongoing Phase 2 clinical study assessed adverse events and changes in kidney function as measured by estimated glomerular filtration rate (eGFR), as primary study endpoints.
  • Further, you may listen to the presentation by dialing 1-877-407-0784 (US) or 1-201-689-8560 (International) and entering the Conference ID: 13742672.

Cara Therapeutics Reports Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
Prospective payment system, Sale, CSL, ESRD, Safety, Therapy, Conference call, Investment, Clinical trial, Administration, Patient, Research, Dialysis, Notalgia paresthetica, CKD, Marketing, CSL Vifor, G&A, Atopic dermatitis, Conference, CMS, EST, KICK, Research and development, Kidney, Medicare, R, Itch, Pharmaceutical industry, Cryptocurrency, Music, Nursing, Life insurance

– Conference call today at 4:30 p.m. EST –

Key Points: 
  • – Conference call today at 4:30 p.m. EST –
    STAMFORD, Conn., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Cara Therapeutics, Inc. (Nasdaq: CARA), a commercial-stage biopharmaceutical company leading a new treatment paradigm to improve the lives of patients suffering from pruritus, today announced financial results and operational highlights for the third quarter ended September 30, 2023.
  • “We are pleased to have closed our non-dilutive financing transaction with HealthCare Royalty, which extends our cash runway into 2025,” said Christopher Posner, President and Chief Executive Officer of Cara Therapeutics.
  • Wholesalers shipped 90,828 vials to dialysis centers during the third quarter of 2023.
  • Revenues: Total revenue was $4.9 million and $10.8 million for the three months ended September 30, 2023 and 2022, respectively.

Mineralys Therapeutics Further Defines Endotype-Specific, Targeted Approach to Treatment of Uncontrolled or Resistant Hypertension with Lorundrostat Data at AHA Scientific Sessions 2023

Retrieved on: 
Saturday, November 11, 2023
Chronic kidney disease, Blood pressure, Hypertension, Therapy, AHA, BP, Patient, CKD, Obesity, American Heart Association, Aldosterone, Leptin, BMI, Risk, Poster, Target, Pharmaceutical industry

RADNOR, Pa., Nov. 11, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today presented data from the Target-HTN Phase 2 trial that further defines an endotype-specific targeted approach for treating uncontrolled or resistant hypertension with lorundrostat, a highly selective aldosterone synthase inhibitor. The data were presented in a poster at the American Heart Association (AHA) Scientific Sessions 2023, which is being held in Philadelphia from November 11th –13th.

Key Points: 
  • The data were presented in a poster at the American Heart Association (AHA) Scientific Sessions 2023, which is being held in Philadelphia from November 11th –13th.
  • Data previously presented from Target-HTN showed that elevated body mass index (BMI) was predictive of an enhanced reduction in systolic blood pressure (BP) from lorundrostat treatment.
  • Target-HTN trial results support the transition to late-stage development of lorundrostat as a treatment for uncontrolled or resistant hypertension.
  • The poster at AHA Scientific Sessions 2023 titled, “Lorundrostat for Treatment of Obesity-Related, Aldosterone-Dependent Hypertension - An Endotype-Specific, Targeted Approach to the Treatment of Uncontrolled Hypertension,” can be accessed on the publications page of the Mineralys corporate website.

Mineralys Therapeutics to Participate in Three Upcoming Conferences

Retrieved on: 
Thursday, November 9, 2023
Chronic kidney disease, Evercore, Hypertension, Conference, Therapy, CKD, Pharmaceutical industry

RADNOR, Pa., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced that members of the senior management will be participating in the Stifel Healthcare Conference being held in New York on November 14-15, the Jefferies London Healthcare Conference being held in London on November 14-16, and the Evercore ISI 6th Annual HealthCONx Conference being held in Miami on November 28-30.

Key Points: 
  • RADNOR, Pa., Nov. 09, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced that members of the senior management will be participating in the Stifel Healthcare Conference being held in New York on November 14-15, the Jefferies London Healthcare Conference being held in London on November 14-16, and the Evercore ISI 6th Annual HealthCONx Conference being held in Miami on November 28-30.

Can-Fite Reports Third Quarter 2023 Financial Results and Clinical Update

Retrieved on: 
Thursday, November 30, 2023
Technology, Research, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Artificial Intelligence, Oncology, Ras, Pancreatic cancer, NYSE, Policy, CANF, CFO, Exercise, Ascites, Artificial intelligence, Psoriasis, Conquer, RAS, Patient, Inflammation, ASCO, Growth, CKD, Machine learning, Intellectual, DSM-IV codes, Conference, University, Trial of the century, Survival, Phase, Cancer, HCC, AI, Quality of life, Society, TASE, NASH, AACR, Pharmaceutical industry, Medical device, Cryptocurrency, Life insurance, Genetics, Medicine, Oculocerebrorenal syndrome

(NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results for the nine months ended September 30, 2023.

Key Points: 
  • (NYSE American: CANF) (TASE: CANF), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address oncological and inflammatory diseases, today announced financial results for the nine months ended September 30, 2023.
  • Financial income, net for the nine months ended September 30, 2023 was $0.38 million compared to financial expense, net of $0.14 million for the same period in 2022.
  • The decrease in financial expense, net was mainly due to revaluation of our short-term investment and increase in interest income from deposits in 2023.
  • The Company's consolidated financial results for the nine months ended September 30, 2023 are presented in accordance with US GAAP Reporting Standards.

New Study Finds Significant Impact of Plant-Based Diets on Chronic Kidney Disease Patients

Retrieved on: 
Friday, December 15, 2023
Diet, Chronic kidney disease, Disease, National Kidney Foundation, Research, NKF, AJKD, MHS, Risk, Mortality, Vegetable, Patient, Plant, CKD, Kidney, MPH, Survival, Phosphorus, Public health, Quality of life, Soft drink, Dietary supplement, Pharmaceutical industry, MD, Doctor of Philosophy

NKF's AJKD study reveals that a healthy plant-based diet will reduce the risk of all-cause mortality in CKD patients.

Key Points: 
  • NKF's AJKD study reveals that a healthy plant-based diet will reduce the risk of all-cause mortality in CKD patients.
  • This study suggests that plant-based diets can be a viable and beneficial dietary option for CKD patients.
  • It also emphasizes the importance of dietary quality by distinguishing between overall plant-based diets, healthy plant-based diets, and unhealthy plant-based diets.
  • The study, which involved 2,539 participants with CKD from the Chronic Renal Insufficiency Cohort (CRIC) study, conducted between 2003 and 2008, sheds light on the impact of dietary choices in CKD patients.

Kidneylink Announces Program Growth in Value-Based Kidney Care

Retrieved on: 
Wednesday, December 13, 2023
NPS, Chronic kidney disease, Kidney disease, Associate, ESKD, Pharmacist, Risk, RNS, Patient, Nephrology, USRC, Dialysis, CKD, Kidney transplantation, MD, Partnership, Social, Growth, Physician, FASN, Quality of life, Hospital, HIV disease progression rates, Pharmaceutical industry, Nursing

PLANO, Texas, Dec. 13, 2023 /PRNewswire/ -- Kidneylink – a national, value-based kidney care company founded by U.S. Renal Care, is pleased to announce significant growth and success on behalf of its patients and providers – expanding its network to more than 600 nephrologists across 20 U.S. based markets and caring for more than 16,000 people living with kidney disease, both Chronic Kidney Disease (CKD) and End Stage Kidney Disease (ESKD). Since its inception in 2021, Kidneylink has improved clinical outcomes for patients resulting in double-digit percentage reductions in hospitalizations and medical costs.

Key Points: 
  • PLANO, Texas, Dec. 13, 2023 /PRNewswire/ -- Kidneylink – a national, value-based kidney care company founded by U.S. Renal Care , is pleased to announce significant growth and success on behalf of its patients and providers – expanding its network to more than 600 nephrologists across 20 U.S. based markets and caring for more than 16,000 people living with kidney disease, both Chronic Kidney Disease (CKD) and End Stage Kidney Disease (ESKD).
  • Kidneylink is also not limited to U.S. Renal Care dialysis centers—more than 50% of Kidneylink ESKD patients are treated outside of USRC's facilities.
  • Many value-based kidney organizations rely on virtual care management teams that work around the nephrologist.
  • The future of kidney care is value-based care.