FSGS

American Kidney Fund’s New APOL1-Mediated Kidney Disease Campaign Aims to Educate and Increase Awareness About APOL1 Gene Mutations

Retrieved on: 
Tuesday, September 27, 2022
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People diagnosed with focal segmental glomerulosclerosis (FSGS)a rare kidney disease that causes scarring on the kidneys filtersare 17 times more likely to have APOL1 mutations.

Key Points: 
  • People diagnosed with focal segmental glomerulosclerosis (FSGS)a rare kidney disease that causes scarring on the kidneys filtersare 17 times more likely to have APOL1 mutations.
  • This new campaign will boost awareness and education about the connection between APOL1 and kidney disease and the need for increased genetic testing.
  • People who have kidney disease and APOL1 gene mutations may see their disease progress more quickly than other causes of kidney disease and turn into kidney failure.
  • The American Kidney Fund (AKF) fights kidney disease on all fronts as the nations leading kidney nonprofit.

Despite Amplified Use of SGLT2 Inhibitors for Glomerular Diseases, EU and US Nephrologists Express a Continued Strong Desire for New Treatment Options for FSGS Patients, Spherix Reports

Retrieved on: 
Wednesday, September 21, 2022
Proteinuria, Gaps, Jay Traver, Vifor Pharma, Pulse, Steroid, ESRD, Nephrology, Vertex, Growth, Empagliflozin, Patient, Physician, AstraZeneca, Genetic testing, ACE, Diagnosis, IgA nephropathy, SGLT2, Focal segmental glomerulosclerosis, Research, Awareness, FSGS, ARB, Immunoglobulin A, Nephrotic syndrome, Pharmaceutical industry, EU

EXTON, PA., Sept. 21, 2022 /PRNewswire/ -- Focal segmental glomerulosclerosis (FSGS) is one of the leading causes of nephrotic syndrome across the world and is considered the most common glomerular cause of end-stage renal disease (ESRD).1 Spherix has been tracking the evolution of the FSGS market since 2018 to keep a pulse on how nephrologists are treating patients and the perceived potential for products as they make their way through development.

Key Points: 
  • Over the past few months, Spherix has released two reports revealing insights from both US-based and EU5-based nephrologists as a part of its Market Dynamix: Focal Segmental Glomerulosclerosis (FSGS) research services.
  • Of note, Spherix experts found that while most FSGS patients are still confirmed via kidney biopsies, nephrologists are becoming increasingly likely to use genetic testing for diagnosis.
  • In fact, reported use of SGLT2 inhibitors in primary FSGS patients more than doubled year-over-year in both regions captured in these studies, with expectations for continued growth.
  • To gauge pipeline product potential, Spherix assessed awareness, familiarity, desire to have approved, likelihood to prescribe, and estimated patient candidacy for the following assets:

CSL Vifor and Travere Therapeutics announce EMA has accepted for review the Conditional Marketing Authorization application for sparsentan for the treatment of IgA Nephropathy

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Monday, August 22, 2022
Biotechnology, Pharmaceutical, Health, Clinical Trials, COVID-19, Jay Traver, Safety, Swelling, Heart Protection Study, Dialysis, CSL, U.S. Securities and Exchange Commission, Medicine, Company, ESKD, Risk, Patient, EMA, Fresenius Medical Care, Chronic kidney disease, Caregiver, Immunoglobulin A, Kidney, EGFR, Private Securities Litigation Reform Act, Proteinuria, Nephrology, Hematuria, Security (finance), NDA, Form 10-K, Therapy, NASDAQ, DUET, Irbesartan, Disease, Blood, Multimedia, Patent, ASX, Review, Marketing, ARB, File, Focal segmental glomerulosclerosis, CMA, Union, Edema, Urine, Life, Conditional, Pharmaceutical industry, EU, FSGS, IgA nephropathy

The EMA will review the application under the centralized marketing authorization procedure and a review decision on a potential approval is expected in the second half of 2023.

Key Points: 
  • The EMA will review the application under the centralized marketing authorization procedure and a review decision on a potential approval is expected in the second half of 2023.
  • We look forward to continuing to collaborate with our partners at CSL Vifor and with the EMA throughout the review process.
  • Headquartered in St. Gallen, Switzerland, CSL Vifor also includes the joint company Vifor Fresenius Medical Care Renal Pharma (with Fresenius Medical Care).
  • There is no guarantee that the EMA will grant conditional marketing authorization of sparsentan for IgAN or that sparsentan will be approved at all.

Travere Therapeutics and CSL Vifor Announce EMA has Accepted for Review the Conditional Marketing Authorization Application for Sparsentan for the Treatment of IgA Nephropathy

Retrieved on: 
Monday, August 22, 2022
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SAN DIEGO and ST. GALLEN, Switzerland, Aug. 22, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) and CSL Vifor today announced that the EMA has accepted for review the Conditional Marketing Authorization (CMA) application for sparsentan for the treatment of IgAN, a rare kidney disorder and leading cause of end-stage kidney disease (ESKD). The EMA will review the application under the centralized marketing authorization procedure and a review decision on a potential approval is expected in the second half of 2023.

Key Points: 
  • The EMA will review the application under the centralized marketing authorization procedure and a review decision on a potential approval is expected in the second half of 2023.
  • We look forward to continuing to collaborate with our partners at CSL Vifor and with the EMA throughout the review process.
  • If approved, sparsentan would receive CMA in all member states of the European Union, as well as in Iceland, Liechtenstein and Norway.
  • There is no guarantee that the EMA will grant conditional marketing authorization of sparsentan for IgAN or that sparsentan will be approved at all.

Angion Provides Corporate Update and Reports Second Quarter 2022 Financial Results

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Monday, August 15, 2022
U.S. Securities and Exchange Commission, Disclosure, Patient safety, IgA nephropathy, Oppenheimer, GLOBE, Private Securities Litigation Reform Act, Sale, Focal segmental glomerulosclerosis, Security (finance), Income, Patient, Mission statement, FSGS, Therapy, NASDAQ, Research, Pharmaceutical industry, Video game, Tutoring

Contract revenue for the quarter ended June30, 2022 was $0.7 million compared with $0.5 million in the second quarter of 2021.

Key Points: 
  • Contract revenue for the quarter ended June30, 2022 was $0.7 million compared with $0.5 million in the second quarter of 2021.
  • Research and development expenses for the quarter ended June30, 2022 were $6.1 million compared with $14.4 million in the second quarter of 2021.
  • General and administrative expenses for the quarter ended June30, 2022 were $3.6 million compared with $4.3 million in the second quarter of 2021.
  • Other income (expense) for the quarter ended June30, 2022 was $(0.1) million compared with $1.2 million in the second quarter of 2021.

Chinook Therapeutics Provides Business Update and Reports Second Quarter 2022 Financial Results

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Monday, August 8, 2022
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SEATTLE, Aug. 08, 2022 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today provided a business update and reported financial results for the quarter and six months ended June 30, 2022.

Key Points: 
  • SEATTLE, Aug. 08, 2022 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today provided a business update and reported financial results for the quarter and six months ended June 30, 2022.
  • During the second quarter of 2022, we executed well on advancing our pipeline of clinical and preclinical programs for rare, severe chronic kidney diseases.
  • Chinook plans to report additional data from the AFFINITY trial in the second half of 2022, as well as during 2023.
  • We paid this milestone, net of taxes and expenses, to the CVR holders in the second quarter of 2022.

Travere Therapeutics Provides Regulatory Updates on its Development Programs

Retrieved on: 
Wednesday, August 3, 2022
Chronic kidney disease, Fast Track, Focal segmental glomerulosclerosis, Glomerulosclerosis, HIV disease progression rates, CMA, Food, Patient, Company, Review, Kidney, Jay Traver, NDA, II, Safety, FDA, Maintenance, Program, HCU, Research, Heart Protection Study, Prescription Drug User Fee Act, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Irbesartan, EGFR, GLOBE, Vifor Pharma, New Drug Application, Breakthrough, Breakthrough therapy, Therapy, ETAR, Podocyte, Immunoglobulin A, Proteinuria, NASDAQ, Doctor of Philosophy, Renewable energy, Pharmaceutical industry, PDUFA, FSGS, IgA nephropathy

ET

Key Points: 
  • ET
    SAN DIEGO, Aug. 03, 2022 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today provided regulatory updates for its sparsentan programs in IgA nephropathy (IgAN) and focal segmental glomerulosclerosis (FSGS), as well as its pegtibatinase program for classical homocystinuria (HCU).
  • The Company and its partner Vifor Pharma are submitting a Conditional Marketing Authorisation (CMA) application for sparsentan for the treatment of IgAN in Europe.
  • As a result, they are living at high risk of developing long-term, serious complications from disease progression, said Bill Rote, Ph.D., senior vice president of research and development at Travere Therapeutics.
  • At Travere Therapeutics, we are in rare for life.

ZyVersa Therapeutics and University of Miami Awarded a Grant from The Michael J. Fox Foundation to Determine if Inhibition of Microglial Inflammasome Activation with IC 100 Blocks Neuroinflammation Driving Parkinson's Disease Pathology

Retrieved on: 
Wednesday, July 27, 2022
Goal, Inflammation, University, View, Phenotype, Multiple sclerosis, Kidney, Awareness, Center, Neurosurgery, Paralysis, ASC, Physiology, Traumatic brain injury, Twitter, Foundation, The Michael J. Fox Foundation, Parkinson's disease, Research, Government, FSGS, PFF, Associate, CNS, NIH Intramural Research Program, Therapy, Focal segmental glomerulosclerosis, Multimedia, DRS, Volunteering, Clinical trial, Fox Trial Finder, Ageing, Inflammasome, Cognitive neuroscience, Kidney disease, Miami, Patient, LinkedIn, Department, Stroke, Faculty, Microbiology, Alport syndrome, Invention, MJFF, Miami Project to Cure Paralysis, Pharmaceutical industry, Medicine, Immunology, Biophysics, Facebook

WESTON, Fla., July 27, 2022 /PRNewswire/ -- ZyVersa Therapeutics, Inc. (ZyVersa), a clinical-stage specialty biopharmaceutical company developing first-in-class drugs for treatment of inflammatory and renal diseases, is honored to receive a grant from The Michael J. Fox Foundation for Parkinson's Research (MJFF) to determine if IC 100 inhibition of inflammasomes and ASC specks blocks microglial-mediated inflammation in a PD model. The research will be conducted at the University of Miami Miller School of Medicine in the labs of IC 100 inventors, Drs. Robert W. Keane and Juan Pablo de Rivero Vaccari. Dr. Keane is Professor, Departments of Physiology and Biophysics, Neurological Surgery and Microbiology, Immunology, and The Miami Project to Cure Paralysis at the University of Miami Miller School of Medicine. Dr. de Rivero Vaccari is an Associate Professor in the Department of Neurological Surgery and The Miami Project to Cure Paralysis, and a Distinguished Faculty Member of the Center for Cognitive Neuroscience and Aging at the University of Miami Miller School of Medicine.

Key Points: 
  • Fox Foundation for Parkinson's Research (MJFF) to determine if IC 100 inhibition of inflammasomes and ASC specks blocks microglial-mediated inflammation in a PD model.
  • The research will be conducted at the University of Miami Miller School of Medicine in the labs of IC 100 inventors, Drs.
  • Dr. Keane is Professor, Departments of Physiology and Biophysics, Neurological Surgery and Microbiology, Immunology, and The Miami Project to Cure Paralysis at the University of Miami Miller School of Medicine.
  • Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today.

Goldfinch Bio Announces Publication in Science Advances on the Validation of Human Derived Organoids as a Predictable and Translatable Preclinical Model in Kidney Disease for the Evaluation of Therapeutic Drug Candidates

Retrieved on: 
Thursday, July 7, 2022
Research, Publishing, Genetics, Communications, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, FSGS, Kidney, Patient, Bio, Science, TRPC5, Precision medicine, IPSC, Tissue, Science Advances, UPCR, PD, Transience, Quality control, Quality of life, Animal, Kidney disease, Drug development, Perfusion, Organoid, Manuscript, Hope, Conference, Pharmaceutical industry, Goldfinch

The manuscript, titled Transplanted organoids empower human preclinical assessment of drug candidate for the clinic, is available online in the international peer-reviewed journal Science Advances at: https://www.science.org/doi/10.1126/sciadv.abj5633 .

Key Points: 
  • The manuscript, titled Transplanted organoids empower human preclinical assessment of drug candidate for the clinic, is available online in the international peer-reviewed journal Science Advances at: https://www.science.org/doi/10.1126/sciadv.abj5633 .
  • Since the start of Goldfinch Bio, we have been committed to using human organoids to improve the preclinical drug development process in kidney disease, which has lacked adequate and reliable tools to date.
  • To address this shortcoming, Goldfinch Bio scientists developed a novel, scalable approach for in vivo PD studies that leverages human tissue in the form of induced pluripotent stem cell (iPSC)-derived kidney organoids.
  • We have a robust pipeline of novel, precision medicine product candidates targeting kidney diseases with significant unmet need, including two clinical-stage assets.

High Unmet Needs Remain in Nephrology Despite Newly Approved Treatment Options According to Latest Research from Spherix Global Insights

Retrieved on: 
Thursday, June 30, 2022
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EXTON, Pa., June 30, 2022 /PRNewswire/ -- A survey of 124 US nephrologists, conducted just last week, identifies acute kidney injury (AKI), diabetic kidney disease (DKD), and polycystic kidney disease (PKD) as areas physicians would most like to see new products approved to treat patients under their care. New agents for glomerular diseases, including focal segmental glomerulonephritis (FSGS) and IgA nephropathy (IgAN) are also in high demand.

Key Points: 
  • New agents for glomerular diseases, including focal segmental glomerulonephritis (FSGS) and IgA nephropathy (IgAN) are also in high demand.
  • In prior Spherix research, following the receipt of these CRLs, many nephrologists expressed disappointment about the non-approval of the HIF-PH inhibitors, which are approved in countries outside the US, and tenapanor.
  • Korsuva, for CKD-associated pruritus in hemodialysis patients, is the newest approved renal product that Spherix is tracking.
  • Korsuva was originally approved in August of 2021; however, the product didn't officially launch until this past spring.