Hyperphosphatemia

Unicycive Therapeutics Announces Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, March 28, 2024
ODD, Research, Hyperphosphatemia, DGF, CRRT, ERA, Administration, Congress, Conference, OLC, CKD, Patient, AKI, National Kidney Foundation, Mitochondrion, NDA, Kidney transplantation, Insurance, Kidney disease, Critical care, Acute kidney injury, Clinical trial, Therapy, Drug development, Safety, Chronic kidney disease, Dialysis, LOS, Research and development, SAD, FDA, KATP, Food, Pharmaceutical industry

LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., March 28, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY) (the “Company” or “Unicycive”), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the year ended December 31, 2023, and provided a business update.
  • Completed a private placement with new and existing healthcare institutional investors that generated $50 million in gross proceeds to Unicycive.
  • Cash Position: As of December 31, 2023, cash and cash equivalents totaled $9.7 million.
  • Subsequent to year end, in March 2024, Unicycive completed a private placement of preferred stock which generated $50 million in gross proceeds.

American Kidney Fund Launches Phosphorus Management Education and Awareness Campaign

Retrieved on: 
Tuesday, March 19, 2024
Phosphorus, Hyperphosphatemia, American Kidney Fund, Disease, Education, Patient, Cramp, Kidney failure, Kidney disease, Diet, AKF, Skin, Dialysis, Blood

ROCKVILLE, Md., March 19, 2024 (GLOBE NEWSWIRE) -- The American Kidney Fund (AKF) today announced a new patient-focused educational awareness campaign on managing high phosphorus, also known as hyperphosphatemia.

Key Points: 
  • ROCKVILLE, Md., March 19, 2024 (GLOBE NEWSWIRE) -- The American Kidney Fund (AKF) today announced a new patient-focused educational awareness campaign on managing high phosphorus, also known as hyperphosphatemia.
  • AKF’s phosphorus management education campaign will work to raise awareness among dialysis patients about why phosphorus levels matter, ways to manage phosphorus intake with low phosphorus foods and fluids, and information about existing and new phosphate lowering medications, including phosphate blockers.
  • The campaign will provide people with a host of resources, including a patient-facing education page on AKF’s website; a page on AKF’s nutrition website, Kidney Kitchen ®; downloadable guides on talking to your doctor about phosphorus and low phosphorus foods; and a patient-facing session on hyperphosphatemia management at Kidney Action Week 2024 .
  • We hope that this campaign provides much-needed information to patients and families and can make an impact on their disease management.”

Kidney Patients Raise National Health Alert on Phosphorus

Retrieved on: 
Thursday, April 4, 2024
Hyperphosphatemia, Transplant, Nutrient, Hyperkalemia, Congress, Patient, Stroke, Social media, Investment, United States Senate, Phosphorus, Representative, Ways and means committee, Research, Education, Itch, Risk, ESRD, Policy, FMLA, CMS, Senate, Food, Federation, Kidney failure, Prospective payment system, Death, House, Executive (government), Louisiana House of Representatives, Graduate diploma, Dialysis, FDA, Government, Seizure, CKD, Mortality, Kidney disease, Medicare, Physician, Pharmaceutical industry

WASHINGTON, April 4, 2024 /PRNewswire/ -- The American Association of Kidney Patients (AAKP), the oldest and largest independent kidney patient consumer organization in the U.S., is raising public awareness on April 5, National Phosphorus Awareness Day, about the devastating impacts of unmanaged phosphorus levels in individuals with advanced chronic kidney disease (CKD).

Key Points: 
  • Kidney patients are at an increased risk for high phosphorus (termed hyperphosphatemia) due to their decreased kidney function and an inability to excrete excess nutrients, including phosphorus.
  • Kidney patients are medically complex and typically manage multiple co-related health conditions including hyperphosphatemia , hyperkalemia , CKD associated pruritis (CKD-aP) , and more .
  • Kidney patients and all people of goodwill involved in the fight to improve kidney health are making their voices heard by contacting their U.S.
  • Since 1969, The American Association of Kidney Patients has been a patient-led organization driving policy discussions on kidney patient care choice and medical innovation.

Unicycive Therapeutics Completes Enrollment in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC)

Retrieved on: 
Thursday, March 7, 2024
Chronic kidney disease, LOS, MD, Physician, FDA, Dialysis, Food, CKD, Hyperphosphatemia, Safety, Therapy, Pharmacokinetics, Patient, Clinical trial, Kidney disease, NDA, Pharmaceutical industry

LOS ALTOS, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).

Key Points: 
  • LOS ALTOS, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced enrollment has been completed in the open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).
  • OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
  • “The completion of enrollment in our pivotal OLC clinical trial is a critical achievement for Unicycive as we strive to bring an improved therapy to chronic kidney disease patients struggling with hyperphosphatemia,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • “Positive results from the trial will provide the basis to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA).

Ardelyx Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Thursday, February 22, 2024
Fosun Pharma, Kyowa Kirin, Research, New Drug Application, Investment, Dialysis, Growth, Sale, Death, Diarrhea, Webcast, Abdominal distension, Orphan, XBR, Chronic kidney disease, Incidence, Peritoneal dialysis, Rat, Record, Calendar, ESG, CKD, Hyperphosphatemia, Safety, Human, Nephrology, IBS-C, Master of Science, Gastroenterology, FDA, Food, Social, Emeritus, Dehydration, Risk, Constipation, Society, Patient, Pharmaceutical industry

WALTHAM, Mass., Feb. 22, 2024 (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 reported financial results for the fourth quarter and full year ended December 31, 2023 and provided a business update.

Key Points: 
  • During the fourth quarter of 2023, IBSRELA U.S. net product sales revenue was $28.1 million, reflecting 26% growth compared to the third quarter of 2023.
  • Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.
  • U.S. net product sales revenue in the fourth quarter of 2023 were $2.5 million.
  • U.S. net product sales revenue in 2023 for XPHOZAH was $2.5 million following its commercial launch in November 2023.

Unicycive Therapeutics Issues Shareholder Letter to Highlight Corporate Progress and Key Upcoming Milestones

Retrieved on: 
Tuesday, January 23, 2024
CMC, LOS, Dialysis, Patient, Therapy, International Society of Nephrology, NKF, National Kidney Foundation, ATP, Agency, Hyperphosphatemia, American Journal, Acute kidney injury, Nephrology, Clutch (eggs), ISN, Trial of the century, Society, Kidney disease, Chronic kidney disease, Water, NDA, European Renal Association, HIV/AIDS, CKD, Conditional sentence, Heart, FDA, Tablet, ERA, Letter, Patent, International Society, Mitochondrial disease, Diabetes, Physician, Pharmaceutical industry

LOS ALTOS, Calif., Jan. 23, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today issued a letter to shareholders.

Key Points: 
  • As I sit down to write this letter, I am filled with a profound sense of gratitude and excitement, energized for the year ahead.
  • In this letter, I am pleased to recap for you another year of great accomplishments.
  • We’ve made significant advancements in our clinical programs which will propel us to new heights in 2024.
  • I would like to express my deep appreciation to the physician investigators, study participants, and especially to our dedicated Unicycive employees.

U.S. Food and Drug Administration Grants Full Approval for BALVERSA® to Treat Locally Advanced or Metastatic Bladder Cancer with Select Genetic Alterations

Retrieved on: 
Friday, January 19, 2024
Potassium, Death, Xerostomia, Patient, State, Overalls, Hyperphosphatemia, Shanda, OS, Bladder cancer, Stomatitis, PD-1, MUC, Survival, Fatigue, Sodium, Calcium, Cohort, Risk, FGFR, PD-L1, Xeroderma, Food, Constipation, Disease, Nail, Creatinine, Johnson & Johnson, Erdafitinib, Neoplasm, FDA, Confidence interval, Diarrhea, New Drug Application, FGFR3, Drug, Appetite, Pharmaceutical industry

RARITAN, N.J., Jan. 19, 2024 /PRNewswire/ -- Johnson & Johnson announced today that the U.S. Food and Drug Administration (FDA) approved a supplemental New Drug Application (sNDA) for BALVERSA® (erdafitinib) for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study. BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.

Key Points: 
  • BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
  • This FDA action converts the April 2019 accelerated approval of BALVERSA® to a full approval based on the clinical and overall survival benefit observed in the Phase 3 THOR study.
  • BALVERSA® is the first oral FGFR kinase inhibitor to be approved, and the first and only targeted treatment for patients with mUC and FGFR alterations.
  • This model is part of the Company's ongoing commitment to provide high-quality products, services, access, and support to healthcare professionals and patients.

Ardelyx Provides Update on Growing Commercial Momentum and 2024 Strategic Priorities

Retrieved on: 
Monday, January 8, 2024
Hyperphosphatemia, Food, Nephrology, Constipation, Risk, Death, Diarrhea, FDA, Master of Science, Incidence, Prescription, Bank statement, Rat, IBS-C, Calendar, Abdominal distension, Emeritus, Growth, Investment, Webcast, Patient, Human, Gastroenterology, Dehydration, Safety, Pharmaceutical industry

WALTHAM, Mass., Jan. 08, 2024 (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 provided an update on the company’s progress in 2023 and initial expectations for 2024.

Key Points: 
  • “2023 was a landmark year for Ardelyx, marking our first full year as a commercial entity and the approval and launch of our second first-in-class product.
  • XPHOZAH® joins IBSRELA in our portfolio of important treatment options for patients with unmet needs,” said Mike Raab, president and chief executive officer.
  • We are poised to continue with a growth trend in 2024.
  • Ardelyx currently expects full-year 2024 U.S. net product sales revenue for IBSRELA to be between $140.0 and $150.0 million.

Unicycive Therapeutics Announces Enrollment of First Patient in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC) in Patients with Chronic Kidney Disease on Dialysis

Retrieved on: 
Monday, December 18, 2023
Hyperphosphatemia, Quality of life, Physician, OLC, TID, Kidney disease, Trial of the century, NDA, MD, Therapy, Pharmacokinetics, Chronic kidney disease, LOS, Patient, Safety, Dialysis, CKD, Pharmaceutical industry

LOS ALTOS, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced the enrollment of the first patient in its open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).

Key Points: 
  • LOS ALTOS, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced the enrollment of the first patient in its open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC).
  • OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis.
  • “The initiation of patient enrollment in our OLC pivotal clinical trial is a critical milestone as we strive to reduce the pill burden and improve quality of life for individuals with chronic kidney disease on dialysis,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive.
  • Once titrated to a clinically effective dose, participants will then be treated for four weeks to evaluate serum phosphate levels.

Jemincare Announces 6 Approvals of Clinical Trials for its Innovative Drugs

Retrieved on: 
Tuesday, December 26, 2023
Hyperphosphatemia, Quality of life, Immunotherapy, Immune system, Klebsiella pneumoniae, FDA, PD-1, Renal cell carcinoma, Research, Bladder cancer, TKI, Cancer, Clinical trial, Pseudomonas aeruginosa, Acinetobacter baumannii, Chronic kidney disease, Phosphorus, Kidney disease, NMPA, BCG, Proteinuria, Escherichia coli, Kidney, Edema, National Medical Products Administration, Patient, Drug resistance, CKD, Dialysis, Gram-negative bacteria, Pharmaceutical industry

On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.

Key Points: 
  • On December 20, NMPA has approved a clinical trial for JMKX003801 to treat serious infection caused by Gram-negative bacteria.
  • Drug resistance of antibiotics, especially carbapenem resistance, in Escherichia coli, Klebsiella pneumoniae, Acinetobacter baumannii and Pseudomonas aeruginosa has risen year by year.
  • On December 12, NMPA has approved a clinical trial for JMKX003142 to treat renal edema.
  • On December 12, FDA has approved a clinical trial for JMKX000197 to treat BCG-unresponsive non-muscle-invasive bladder cancer, and earlier on October 19, NMPA has approved the clinical trial.