Nephrology

American Kidney Fund Hosts Fourth National Summit on Unknown Causes of Kidney Disease

Retrieved on: 
Tuesday, December 5, 2023
Nephrology, Cardiology, Public policy, Genetic counseling, Food, Risk, Division, Research, Kidney disease, Vertex Pharmaceuticals, Health, Education, Legislation, Therapy, Columbia University, Focal segmental glomerulosclerosis, Kidney, COVID-19, Patient, Diagnosis, AKF, American Kidney Fund, Pharmaceutical industry

ROCKVILLE, Md., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Today, the American Kidney Fund (AKF) will convene more than 100 medical leaders, patient advocates and academic and industry leaders for the fourth national summit of its Unknown Causes of Kidney Disease (UCKD) Project, which seeks to improve understanding of how undiagnosed or misdiagnosed causes of kidney disease directly impact patient care and outcomes.

Key Points: 
  • ROCKVILLE, Md., Dec. 05, 2023 (GLOBE NEWSWIRE) -- Today, the American Kidney Fund (AKF) will convene more than 100 medical leaders, patient advocates and academic and industry leaders for the fourth national summit of its Unknown Causes of Kidney Disease (UCKD) Project, which seeks to improve understanding of how undiagnosed or misdiagnosed causes of kidney disease directly impact patient care and outcomes.
  • This will be the first in-person summit after three years of virtual summits due to the pandemic.
  • This week’s summit, which will be held in Arlington, Virginia, will further explore how the kidney community can drive innovation in research, diagnosis and treatment of the underlying causes of kidney disease.
  • “Finding out the root cause of one’s kidney disease can bring crucial clinical insights to providers and have life-saving implications for individuals.

Travere Completes Successful pre-NDA Meeting for FILSPARI in IgAN; Provides Regulatory Updates for both IgAN and FSGS

Retrieved on: 
Monday, December 4, 2023
Workforce, Depreciation, Food, Nephrology, Immunoglobulin A, Shanda, FDA, SAN, Therapy, Focal segmental glomerulosclerosis, New Drug Application, Proteinuria, HCU, EGFR, Pharmaceutical industry

SAN DIEGO, Dec. 04, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (Nasdaq: TVTX) today announced the completion of a successful pre-NDA meeting with the U.S. Food and Drug Administration (FDA) for FILSPARI® (sparsentan) in IgA nephropathy (IgAN). The Company will submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for conversion of the existing U.S. accelerated approval of FILSPARI to full approval. The Company also completed regulatory engagement on focal segmental glomerulosclerosis (FSGS) in which the FDA communicated that the Phase 3 DUPLEX Study results alone are not sufficient to support an sNDA submission for an FSGS indication for sparsentan. As a result, the Company will be conducting additional analyses of FSGS data with plans to re-engage FDA in 2024, and is implementing a strategic reorganization in Q4 2023 to focus near-term resources on the ongoing FILSPARI launch in IgAN and the advancement of pegtibatinase in classical homocystinuria (HCU).

Key Points: 
  • The Company will submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 for conversion of the existing U.S. accelerated approval of FILSPARI to full approval.
  • “Following a successful pre-NDA meeting, we are pleased to be moving forward with our planned sNDA submission for full approval of FILSPARI in IgA nephropathy.
  • “Unfortunately, there is uncertainty around a regulatory path forward for FSGS.
  • Together with $634.6 million in cash and cash equivalents as of September 30, 2023, the Company expects to have a cash runway into 2028.

American Kidney Fund Renews Calls for Early Diagnosis and Treatment of Chronic Kidney Disease in New Report

Retrieved on: 
Thursday, November 30, 2023
Food, Nephrology, Treatment, Novartis, Caregiver, Chronic kidney disease, Diagnosis, FDA, Kidney disease, PAI, Disease, Caregiver burden, Therapy, Risk, Medicare, CSL Vifor, Patient, AKF, American Kidney Fund, Pharmaceutical industry

Advocates urge the U.S. Preventive Services Task Force to make recommendations on screening for chronic kidney disease, and strongly support legislative action for direct Medicare reimbursement to genetic counselors.

Key Points: 
  • Advocates urge the U.S. Preventive Services Task Force to make recommendations on screening for chronic kidney disease, and strongly support legislative action for direct Medicare reimbursement to genetic counselors.
  • Educating health care providers and patients about kidney disease and treatment options: Patient advocates have identified patient education and navigation as major challenges.
  • Many people at high risk aren’t aware of their risk factors and don’t know when to ask for screening for kidney disease.
  • The report also recommends identifying opportunities for advocates and policymakers to weigh in on policies that impact chronic kidney disease care.

New Real-World Data Highlight the Clinical Benefits of Ultrafiltration Therapy with Hematocrit Monitoring for Pediatric Patients

Retrieved on: 
Tuesday, November 28, 2023
Patient, Nephrology, Trust, Diuretic, Hypervolemia, FDA, Mortality, Blood volume, Blood, Overload, MD, Research, Ultrafiltration, Pharmaceutical industry

The publication, “ Using Aquapheresis with Continuous Hematocrit Monitoring to Guide Ultrafiltration ,” was featured in Pediatric Nephrology.

Key Points: 
  • The publication, “ Using Aquapheresis with Continuous Hematocrit Monitoring to Guide Ultrafiltration ,” was featured in Pediatric Nephrology.
  • 1
    The publication is a single-center case study review of pediatric patients with hypoalbuminemia and severe fluid overload.
  • Patients were treated with Nuwellis’ Aquadex® ultrafiltration therapy with continuous hematocrit monitoring to guide isotonic fluid removal.
  • “The continuous hematocrit monitoring function within the Aquadex provides unique and proprietary therapeutic direction, as demonstrated in this important publication.”
    Effectively managing fluid overload for pediatric patients is critical.

The Barth Syndrome Foundation Delivers Petition to FDA Advocating for a Fair, Equitable and Appropriate Review of the Only Potential Treatment for Barth Syndrome

Retrieved on: 
Thursday, December 21, 2023
Patient, Elamipretide, Nephrology, Food, Genetic disorder, State, Division, Death, Infection, Friends, United States Congress, FDA, Hope, Fatigue, Disease, Exercise, NDA, Incidence, Muscle weakness, Congress, BSF, Education, Heart, Clinical trial, Life expectancy, Natural history, New Drug Application, Mutation, Barth syndrome, Military personnel, Medicine, Heart failure, DSM-IV codes, Child, Life, Pharmaceutical industry

BOSTON, Dec. 21, 2023 /PRNewswire/ -- The Barth Syndrome Foundation (BSF), the only patient advocacy organization dedicated to Barth syndrome and saving lives around the world through education, advances in treatment and finding a cure, today announced that it is petitioning the U.S. Food and Drug Administration (FDA) to review the New Drug Application (NDA) for elamipretide, the only potential treatment for Barth syndrome, in a fair, equitable and appropriate manner. Despite compelling evidence that elamipretide has been well-tolerated and has demonstrated clinical benefit in Barth syndrome, and despite ongoing efforts by the Barth Syndrome Foundation and other advocates to engage with regulators, the FDA has refused to review an NDA to date. The petition ran from mid-September to mid-November, and in just two months, garnered nearly 20,000 signatures from individuals across all 50 U.S. states, plus Washington, DC, Puerto Rico, the U.S. Virgin Islands and deployed military personnel.

Key Points: 
  • There are currently no FDA-approved treatments for Barth syndrome, and there are no other potential therapies in clinical development.
  • The Barth Syndrome Foundation and leading scientific thought leaders lobbied for the development of elamipretide for Barth syndrome beginning in 2014.
  • There simply aren't enough people with Barth syndrome, though, to meet the impossible statistical requirements of the FDA to give elamipretide a full drug review.
  • Barth syndrome is a rare, X-linked genetic disorder with an estimated incidence of only 1 in 1 million live births.

DaVita Giving Foundation Invests $1 Million in Western Governors University to Support Nursing Students

Retrieved on: 
Tuesday, December 19, 2023
Workforce, Nephrology, LSH, University, Student, IA Financial Group, City, Health, Retirement, Start Early, Education, Love, DaVita Inc., WGU, Curriculum, Nursing

DENVER, Dec. 19, 2023 /PRNewswire/ -- The DaVita Giving Foundation has awarded Western Governors University's (WGU) Michael O. Leavitt School of Health (LSH) a $1 million grant over the next three years to support more than 1,500 nursing students in Start Early, a program co-created by DaVita Inc. and WGU to help increase nursing degree completion at the university nationwide.

Key Points: 
  • DENVER, Dec. 19, 2023 /PRNewswire/ -- The DaVita Giving Foundation has awarded Western Governors University's (WGU) Michael O. Leavitt School of Health (LSH) a $1 million grant over the next three years to support more than 1,500 nursing students in Start Early , a program co-created by DaVita Inc. and WGU to help increase nursing degree completion at the university nationwide.
  • The WGU Start Early program will provide resources for nursing students who demonstrate financial barriers to their education and will support their efforts to complete their nursing degree.
  • Additionally, through the funding from the DaVita Giving Foundation, up to 80 students annually will receive critical, need-based scholarships to help them afford their education.
  • Underserved student populations include students of color, students with comparatively lower incomes, students in geographically remote areas and/or students who are the first in their families to attend a university.

SeaStar Medical Reports Third Quarter 2023 Financial Results and Provides a Business Update

Retrieved on: 
Tuesday, November 14, 2023
Chronic kidney disease, Neutrophil, Acute respiratory distress syndrome, STEC-HUS, Cardiorenal syndrome, Safety, Food, Hepatorenal syndrome, University, AKI, HDE, Risk, ICU, Clinical trial, Monocyte, Mortality, CBER, Sepsis, Patient, Nephrology, Insurance, Research, Letter, Dialysis, Approvable letter, FDA, G&A, Child, Standard of care, Acute kidney injury, Partnership, Nephron, Clinical study design, R, Hospital, SCD, Physician, CKRT, Karger Publishers, PMA, HIV disease progression rates, Pharmaceutical industry, Nursing, Dietary supplement, Cryptocurrency

DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.

Key Points: 
  • DENVER, Nov. 14, 2023 (GLOBE NEWSWIRE) -- SeaStar Medical Holding Corporation (Nasdaq: ICU) (“SeaStar Medical” or the “Company”), a medical device company developing proprietary solutions to reduce the consequences of hyperinflammation on vital organs, reports financial results for the three and nine months ended September 30, 2023 and provides a business update.
  • “Recent clinical and regulatory successes have significantly improved and strengthened our company’s prospects,” said Eric Schlorff, SeaStar Medical CEO.
  • SeaStar Medical expects regulatory approval for the SCD-ADULT in the first half of 2025 and commercial launch in the second half of 2025.
  • The Company issued two convertible notes each for $0.5 million in August 2023 and a third convertible note for $0.5 million in September 2023.

Unicycive Announces Third Quarter 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, November 14, 2023
NDA, Chronic kidney disease, Hyperphosphatemia, Chemistry, Food, Therapy, Type, IND, Kidney disease, Clinical trial, Administration, Insurance, Patient, LOS, Agency, Research, Dialysis, FDA, Pharmacokinetics, Nephrology, Trial of the century, R, CMC, Research and development, Doctor of Philosophy, American Journal, Society, Travel, Drug development, Pharmaceutical industry, Management, OLC

LOS ALTOS, Calif., Nov. 14, 2023 (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 third quarter ended September 30, 2023, and provided a business update.

Key Points: 
  • LOS ALTOS, Calif., Nov. 14, 2023 (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 third quarter ended September 30, 2023, and provided a business update.
  • We also remain very active within the the medical community with a booth at Kidney Week and positive results published on the phosphate binding capacity for OLC,” concluded Dr. Gupta.
  • Unicycive believes that results from this pivotal trial will enhance the OLC data package from preclinical studies and our previously disclosed bioequivalence study.
  • Dr. Kenkare-Mitra brings Unicycive expertise spanning research, preclinical and clinical development, translational medicine, manufacturing, and regulatory.

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.

Annexon Reports Significant Progress with its Priority Programs and Third Quarter 2023 Financial Results

Retrieved on: 
Monday, November 13, 2023
Molecule, Ophthalmology, Visual acuity, Investment, HD, EMA, Research, Kidney, Autoimmune disease, Driver, C3, Conference, R, Facial muscles, Inflammation, Treatment, Meta-analysis, American Academy, American Society of Nephrology, G&A, Guillain, Society, Letter, Paratriathlon, European Medicines Agency, American Academy of Ophthalmology, Professional, C4, AAO, System, Nephrology, AMD, Immunoglobulin therapy, PACA, Plasma, Disease, Complement component 1q, Medicine, Complement system, FDA, Geographic atrophy, GBS, ARCHER, C5, HIV disease progression rates, Risk management, Pharmaceutical industry, Vaccine, Cryptocurrency, Patient, LN, ALS

EMA orphan drug designation requires that a novel rare disease therapeutic demonstrates the potential for significant benefit over available therapies.

Key Points: 
  • EMA orphan drug designation requires that a novel rare disease therapeutic demonstrates the potential for significant benefit over available therapies.
  • Importantly, Annexon also announced that it has achieved target enrollment of 225 patients in the randomized, double-blind, placebo-controlled Phase 3 trial of ANX005 in patients with GBS.
  • Research and development (R&D) expenses: R&D expenses were $27.9 million for the quarter ended September 30, 2023, reflecting the advancement of the company’s priority programs, including GBS, GA and ANX1502, compared to $27.9 million for the quarter ended September 30, 2022.
  • General and administrative (G&A) expenses: G&A expenses were $6.9 million for the quarter ended September 30, 2023, compared to $8.2 million for the quarter ended September 30, 2022.