Immunoglobulin A

VitaGraft Kidney Expands Utility in Recurrent Primary Disease Patients

Retrieved on: 
Tuesday, July 25, 2023
DNA, OCX, CSO, Microalbuminuria, Acute kidney injury, EGFR, Liver, Immunoglobulin A, Biomarker, DSA, Doctor of Philosophy, Medicare, IgA nephropathy, Nephrology, Kidney, MD, Patient, Physician, Kidney transplantation, Health, Pharmaceutical industry, Palmetto

IRVINE, Calif., July 25, 2023 (GLOBE NEWSWIRE) -- Oncocyte Corporation (Nasdaq: OCX), a precision diagnostics company, today announced the publication of new data demonstrating VitaGraft Kidney’s novel ability to help physicians treat kidney transplant patients more precisely, quickly, and effectively. The test was able to distinguish between two prevalent causes of premature graft failure: biopsy-proven antibody-mediated rejection (ABMR) and recurrent IgA nephropathy (IgAN). This is the first publication investigating this application of VitaGraft’s donor-derived cell-free DNA (dd-cfDNA) diagnostic technology for kidney transplant patients. The data was published as a paper in the peer-reviewed journal Kidney International Reports.

Key Points: 
  • This is the first publication investigating this application of VitaGraft’s donor-derived cell-free DNA (dd-cfDNA) diagnostic technology for kidney transplant patients.
  • This ongoing prospective, observational trial evaluated VitaGraft Kidney’s dd-cfDNA diagnostic technology as a tool to discriminate between recurrent IgAN and ABMR.
  • In the study, VitaGraft Kidney demonstrated higher sensitivity and specificity for detection of ABMR over routine tests (eGFR, uACR, DSA).
  • Oncocyte has submitted its dd-cfDNA tests VitaGraft Kidney and Liver for Medicare reimbursement and expects its next feedback from Palmetto, which administers the MolDx Program, within 30 days.

Mirum Pharmaceuticals Enters Agreement to Acquire Bile Acid Product Portfolio for the Treatment of Rare Liver Diseases from Travere Therapeutics

Retrieved on: 
Monday, July 17, 2023
Biotechnology, Pharmaceutical, Health, Morgan Stanley, CTX, Spiroplasma mirum, Event, Gallbladder, Hepatology, Liver disease, Gibson Dunn, Research, Immunoglobulin A, Sale, Medication, Cooley, IgA nephropathy, Acquisition, DSM-IV codes, Patient, Latham & Watkins, Cholic acid, Webcast, Rare, Therapy, Pharmaceutical industry, Jay Traver, FSGS, Evercore

Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) and Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that they have entered into a definitive agreement for the sale of Travere’s bile acid product portfolio that includes Cholbam® (cholic acid) and Chenodal® (chenodiol), two medications addressing rare diseases in high-need settings.

Key Points: 
  • Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) and Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that they have entered into a definitive agreement for the sale of Travere’s bile acid product portfolio that includes Cholbam® (cholic acid) and Chenodal® (chenodiol), two medications addressing rare diseases in high-need settings.
  • Under the terms of the definitive agreement, Mirum will purchase Travere’s bile acid product portfolio for $445 million, consisting of $210 million upfront and $235 million in potential sales-based milestone payments.
  • Concurrent with entering into the definitive agreement to acquire Travere’s bile acid portfolio, Mirum has also entered into a definitive agreement for the sale of common stock in a private placement.
  • The proceeds from the private placement are intended to fund the up-front payment for the acquisition of Travere’s bile acid portfolio.

Travere Therapeutics Enters Agreement to Sell its Bile Acid Product Portfolio for the Treatment of Rare Liver Diseases to Mirum Pharmaceuticals

Retrieved on: 
Monday, July 17, 2023
CTX, Spiroplasma mirum, Gallbladder, Hepatology, Liver disease, Gibson Dunn, Research, Immunoglobulin A, Sale, Cooley, IgA nephropathy, Acquisition, DSM-IV codes, Patient, SAN, Cholic acid, Rare, Therapy, Pharmaceutical industry, Jay Traver, FSGS

SAN DIEGO and FOSTER CITY, Calif., July 17, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) and Mirum Pharmaceuticals, Inc. (NASDAQ: MIRM) today announced that they have entered into a definitive agreement for the sale of Travere’s bile acid product portfolio that includes Cholbam® (cholic acid) and Chenodal® (chenodiol), two medications addressing rare diseases in high-need settings.

Key Points: 
  • Under the terms of the definitive agreement, Mirum will purchase Travere’s bile acid product portfolio for up to $445 million, consisting of $210 million upfront and $235 million in potential sales-based milestone payments.
  • “This agreement is an important step forward in Travere's strategy to deliver our pipeline of innovative medicines to patients living with rare diseases,” said Eric Dube Ph.D., president and chief executive officer of Travere Therapeutics.
  • “This synergistic acquisition of the bile acid portfolio along with the opportunity to sponsor the genetic testing program will help to reinforce our leadership position in pediatric hepatology.
  • For Mirum, Evercore is advising on the acquisition and Gibson, Dunn & Crutcher is acting as legal advisor.

IgA Nephropathy (IgAN) Epidemiology Forecast Report 2019-2023 & 2023-2032: Focus on 8 Major Markets - United States, Germany, Spain, Italy, France, United Kingdom, Japan, and China - ResearchAndMarkets.com

Retrieved on: 
Wednesday, June 28, 2023
Biotechnology, Pharmaceutical, Health, EU4, Kidney disease, Prevalence, Epidemiology, Immunoglobulin A, Biomarker, HIV disease progression rates, Patient, Autoimmune disease, Diagnosis, Growth, Biopsy, Medical imaging, Medical device, Nursing, IgA nephropathy

This report delivers an in-depth understanding of the IgA Nephropathy (IgAN), historical and forecasted epidemiology in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, Japan, and China.

Key Points: 
  • This report delivers an in-depth understanding of the IgA Nephropathy (IgAN), historical and forecasted epidemiology in the United States, EU4 (Germany, Spain, Italy, and France) and the United Kingdom, Japan, and China.
  • IgA Nephropathy (IgAN) is an autoimmune disease that attacks the kidneys and affects blood filtration in the small blood vessels of the kidneys.
  • According to the publisher estimates, in 2022, the highest number of prevalent cases of IgA Nephropathy (IgAN) were observed in the United States among the 7MM.
  • The IgA Nephropathy epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by prevalent cases of IgA Nephropathy, diagnosed prevalent cases of IgA, gender-specific cases of IgA Nephropathy, and age-specific cases of IgA Nephropathy in the 7MM and China covering the United States, EU4 countries (Germany, France, Italy, and Spain), United Kingdom, Japan, and China from 2019 to 2032.

Everest Medicines' Partner Calliditas Therapeutics Makes Data Presentations on Nefecon at European Renal Association - European Dialysis and Transplant Association Congress (ERA-EDTA )

Retrieved on: 
Wednesday, June 21, 2023
European Renal Association, EGFR, Mount Everest, Glomerular filtration rate, Immunoglobulin A, IgA nephropathy, HKEX, Patient, CALT, Pharmaceutical industry, Medical imaging

SHANGHAI, June 20, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company") announced today that its partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") made presentations on data from the NeflgArd Phase 3 Study at the European Renal Association – European Dialysis and Transplant Association Congress (ERA-EDTA), which was held in Milan, Italy, June 15-18.

Key Points: 
  • SHANGHAI, June 20, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company") announced today that its partner Calliditas Therapeutics AB (Nasdaq: CALT, Nasdaq Stockholm: CALTX) ("Calliditas") made presentations on data from the NeflgArd Phase 3 Study at the European Renal Association – European Dialysis and Transplant Association Congress (ERA-EDTA), which was held in Milan, Italy, June 15-18.
  • The presentations showed data and analyses from the NefIgArd Phase 3 clinical trial evaluating Nefecon in patients with IgA nephropathy (IgAN).
  • The key primary endpoint, eGFR over 2 years, was on average 5.05 mL/min/1.73 m2 higher with Nefecon compared to placebo (p
  • "Renal disease is a key focus area for Everest Medicines where we see significant unmet medical needs, particularly in Asia."

Vera Therapeutics Announces Positive Week 36 Efficacy and Safety Results of Phase 2b ORIGIN Clinical Trial of Atacicept in IgAN in Late-Breaking Presentation at 60th European Renal Association (ERA) Congress

Retrieved on: 
Saturday, June 17, 2023
Enzyme inhibitor, ARB, B-cell activating factor, European Renal Association, Conference call, Clinical trial, EGFR, Immunoglobulin A, ERA, Proteinuria, Congress, IgA nephropathy, HIV disease progression rates, Patient, Therapy, ITT, Conference, Safety, Pharmaceutical industry

BRISBANE, Calif., June 17, 2023 (GLOBE NEWSWIRE) -- Vera Therapeutics, Inc. (Nasdaq: VERA), a late-stage biotechnology company focused on developing and commercializing transformative treatments for patients with serious immunological diseases, today announced the Phase 2b ORIGIN clinical trial of atacicept for the treatment of IgA nephropathy (IgAN) met its primary and key secondary endpoints, with statistically significant and clinically meaningful reductions in proteinuria and stabilization of eGFR through week 36. The week 36 results of ORIGIN were presented as a late-breaking presentation at the 60th European Renal Association (ERA) Congress, taking place June 15-18, 2023, in Milan, Italy and virtually.

Key Points: 
  • The week 36 results of ORIGIN were presented as a late-breaking presentation at the 60th European Renal Association (ERA) Congress, taking place June 15-18, 2023, in Milan, Italy and virtually.
  • Atacicept is the Company’s potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).
  • “The week 36 results of the Phase 2b ORIGIN clinical trial build on a growing body of data that demonstrates atacicept's potential to modify and delay disease progression in IgAN.
  • Longer term results, including the ongoing eGFR data, from the Phase 2b ORIGIN clinical trial are planned for presentation later in 2023 and 2024.

Vera Therapeutics to Host Presentation of Week 36 Data from Phase 2b ORIGIN Clinical Trial of Atacicept in IgAN

Retrieved on: 
Thursday, June 15, 2023
ERA, Stanford University Medical Center, Congress, IgA nephropathy, Therapy, B-cell activating factor, Patient, European Renal Association, Immunoglobulin A, Pharmaceutical industry

The event will feature Richard Lafayette, M.D., F.A.C.P.

Key Points: 
  • The event will feature Richard Lafayette, M.D., F.A.C.P.
  • (Stanford University Medical Center), discussing week 36 data from the Phase 2b ORIGIN clinical trial of atacicept for the treatment of IgA nephropathy (IgAN), which are initially being presented as a late-breaking clinical trial at the 60th European Renal Association (ERA) Congress on June 17, 2023.
  • Atacicept is a potential best-in-class, disease-modifying dual inhibitor of the cytokines B lymphocyte stimulator (BLyS) and a proliferation-inducing ligand (APRIL).
  • A live question and answer session will follow the formal presentation.

Chinook Therapeutics to Present Updated Data from Zigakibart (BION-1301) Phase 1/2 Trial in Patients with IgA Nephropathy (IgAN) at the 60th European Renal Association (ERA) Congress

Retrieved on: 
Monday, June 12, 2023
1991 World Sportscar Championship, PD, IV, ASSIST, Cohort, Pharmacokinetics, Research, Part, Immunoglobulin A, Biomarker, EDT, ERA, Congress, Proteinuria, Acquisition, HIV disease progression rates, Patient, CEST, Kidney, IgA nephropathy, Immunoglobulin G, Therapy, Chronic kidney disease-mineral and bone disorder, Kidney disease, Safety, Novartis, Pharmaceutical industry, Vaccine, Health insurance, Chinook

Blocking APRIL is a potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1).

Key Points: 
  • Blocking APRIL is a potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1).
  • Key highlights from the presentation include the following:
    Patients in Cohort 1 initially received a 450mg intravenous (IV) dose of zigakibart every two weeks.
  • Cohort 1 enrolled 10 patients, of which two patients withdrew from the study for reasons unrelated to study drug, and eight patients continued receiving treatment.
  • Of all 40 patients enrolled in both Cohorts 1 and 2:
    There were no anti-drug antibodies observed in any patients.

Chinook Therapeutics Enters into Agreement to be Acquired by Novartis AG

Retrieved on: 
Monday, June 12, 2023
Centerview Partners, Immunoglobulin A, Securities and Exchange Commission (Nigeria), Atrasentan, IgA nephropathy, Patient, CVR, Kidney, Hart–Scott–Rodino Antitrust Improvements Act, Security (finance), Therapy, News, Completion, Chronic kidney disease, Kidney disease, Pharmaceutical industry, Novartis, Chinook

“We believe this transaction is great news for kidney disease patients and the programs we have built at Chinook.

Key Points: 
  • “We believe this transaction is great news for kidney disease patients and the programs we have built at Chinook.
  • Centerview Partners LLC and MTS Health Partners, L.P. are serving as financial advisors, and Fenwick & West LLP is serving as legal counsel to Chinook.
  • Under the terms of the merger agreement, Novartis will acquire all of the outstanding shares of Chinook through a subsidiary for a price of $40 per share in cash at closing.
  • A copy of the merger agreement will be filed with the Securities and Exchange Commission (“SEC”) and will be publicly available.

Travere Therapeutics Announces Presentations of Abstracts at the 60th European Renal Association (ERA) Congress 2023

Retrieved on: 
Thursday, June 8, 2023
Abstract, Era, Kidney failure, Heart Protection Study, Urine, Impact, Sarah Travers, Session, FSGS, Immunoglobulin A, ERA, Proteinuria, Congress, Art, Natural history, SAN, Kidney, Patient, Therapy, Death, PROTECT, Pharmaceutical industry, IgA nephropathy

SAN DIEGO, June 08, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the Company and its collaborators will present nine abstracts, including the interim analysis from the ongoing Phase 3 PROTECT Study evaluating FILSPARI™ (sparsentan) versus an active comparator in IgA nephropathy (IgAN), at the 60th ERA Congress in Milan, Italy, June 15-18, 2023.

Key Points: 
  • SAN DIEGO, June 08, 2023 (GLOBE NEWSWIRE) -- Travere Therapeutics, Inc. (NASDAQ: TVTX) today announced that the Company and its collaborators will present nine abstracts, including the interim analysis from the ongoing Phase 3 PROTECT Study evaluating FILSPARI™ (sparsentan) versus an active comparator in IgA nephropathy (IgAN), at the 60th ERA Congress in Milan, Italy, June 15-18, 2023.
  • Also included in the presentations is a new analysis of the UK RaDaR Registry estimating the delay in time to kidney failure or death based on proteinuria reduction in IgAN, which has been designated among the 10 best-ranked abstracts of 2023 by ERA.
  • “We’re pleased to bring to the ERA Congress the strong interim results from our ongoing PROTECT Study which demonstrate that sparsentan significantly reduces proteinuria in IgA nephropathy,” said Jula Inrig, M.D., chief medical officer of Travere Therapeutics.
  • “We also look forward to sharing more data from the IgA nephropathy field showing the relationship between reducing proteinuria in IgA nephropathy and preservation of kidney function.”
    Session: The Art of Staring at Urine: Studies in IgA Nephropathy
    Session: The Art of Staring at Urine: Studies in IgA Nephropathy
    Alport Syndrome Natural History from the RaDaR Registry: Associations with Gene, Variant Type and Sex
    Humanistic Burden of Rare Kidney Diseases: Understanding the Impact of IgAN and FSGS on Patients & Care-Partners Study (HONUS): US IgAN Results Update