IgA nephropathy

Omeros Corporation Reports Second Quarter 2023 Financial Results

Retrieved on: 
Wednesday, August 9, 2023
Neurology, Biotechnology, Pharmaceutical, Oncology, Health, FDA, Clinical Trials, Other Health, DSM-IV codes, Survival, Tardive dyskinesia, Bangladesh Technical Education Board, Data analysis, Patent, Investment, Patient, Congress, BLA, Inflammation, Emory University, Therapy, Paroxysmal nocturnal hemoglobinuria, European Hematology Association, Research, Emory, Government, Proteinuria, Kidney International, CUD, Glomerulus, Manuscript, L-DOPA, Hematuria, Safety, Omeros, COVID-19, Inflammation Research, Immunoglobulin A, Fibrosis, PIN, Cancer, PNH, National Institute on Drug Abuse, LID, PDE7, Hemolysis, Complement, Clinical trial, Mannan-binding lectin, Sale, Trial of the century, IgA nephropathy, Corporation, NIDA, Society, C5, Pharmaceutical industry, Reinsurance, Music, Security (finance), Vaccine, Video game, Frontiers, Hematology, Immunology, Agency

“Our team continued building significant shareholder value throughout the second quarter of 2023,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer.

Key Points: 
  • “Our team continued building significant shareholder value throughout the second quarter of 2023,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer.
  • Total costs and expenses for the second quarter of 2023 were $40.9 million compared to $37.4 million for the second quarter of 2022.
  • Interest expense during the second quarter of 2023 was $7.9 million compared to $4.9 million during the prior year quarter.
  • During the second quarter of 2023, we earned $4.5 million in interest and other income compared to $0.7 million in the prior year quarter.

Chinook Therapeutics Announces First Patient Enrolled in Pivotal Phase 3 BEYOND Study of Zigakibart (BION-1301) for Patients with IgA Nephropathy

Retrieved on: 
Friday, July 28, 2023
University, MBBS, Galactose, University of New South Wales, Medicine, Immunoglobulin A, Doctor of Philosophy, Dialysis, Kidney disease, Proteinuria, Patient, Kidney, FASN, Health, Therapy, Safety, Disease, Pharmaceutical industry, FRACP, IgA nephropathy, Chinook

SEATTLE, July 28, 2023 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today announced that the first patient with IgA nephropathy (IgAN) has been enrolled in the BEYOND study, a pivotal phase 3 clinical trial evaluating the safety and efficacy of zigakibart (BION-1301), a potentially disease-modifying anti-APRIL monoclonal antibody.

Key Points: 
  • SEATTLE, July 28, 2023 (GLOBE NEWSWIRE) -- Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, today announced that the first patient with IgA nephropathy (IgAN) has been enrolled in the BEYOND study, a pivotal phase 3 clinical trial evaluating the safety and efficacy of zigakibart (BION-1301), a potentially disease-modifying anti-APRIL monoclonal antibody.
  • “Initiation of the phase 3 BEYOND study is an important step towards our goal of providing an innovative treatment option for patients with IgAN, a disease with high unmet need and limited treatment options,” said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics.
  • “IgAN is the most common primary glomerular disease worldwide with limited treatment options currently available, causing many patients to progress to end-stage kidney disease, requiring dialysis or kidney transplant.
  • With the potential to be disease-modifying based on the encouraging results observed in the phase 1/2 study, I believe zigakibart could be an important new therapeutic treatment option for patients with IgAN.”

Everest Medicines Announces Commercial Launch and First Prescription for XERAVA® in China

Retrieved on: 
Thursday, July 27, 2023
Vaccine, Neutropenia, VRE, Fungal infection, Eravacycline, Infection, Fever, New Drug Application, MRSA, Gram-negative bacteria, NDA, Urinary tract infection, First Affiliated Hospital of Xinjiang Medical University, Hematopoietic stem cell transplantation, Soochow University, Incidence, MDR, Radiation, HKEX, Patient, National Medical Products Administration, Huashan Hospital, Fudan University, IgA nephropathy, CRE, NMPA, Pharmaceutical industry, Mount Everest

SHANGHAI, July 26, 2023 /PRNewswire/ -- Everest Medicines (HKEX 1952.HK, "Everest", or the "Company"), a biopharmaceutical company focused on the development, manufacturing and commercialization of innovative medicines and vaccines, announced today XERAVA® (eravacycline) has been successfully launched in China with its first prescription issued at Huashan Hospital affiliated to Fudan University. The commercialization of XERAVA® in China marks Everest's transformation into a commercial-stage innovative biopharmaceutical company.

Key Points: 
  • "The commercialization of XERAVA® in China is a significant milestone for Everest as a company, as this marks the beginning of Everest as a commercial-stage biopharma company.
  • I want to thank everyone involved in bringing XERAVA® to a successful launch," said Rogers Yongqing Luo, Chief Executive Officer of Everest Medicines.
  • "After the commercial launch, we will accelerate patient access to XERAVA® with a lean commercial team, following a highly efficient commercial strategy.
  • The launch of eravacycline in China will help doctors tackle the challenges of clinical drug resistance."

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.

Unicycive Therapeutics to Participate in the H.C. Wainwright 2nd Annual Kidney Conference

Retrieved on: 
Thursday, July 20, 2023
IgA nephropathy, Webcast, LOS, Therapy, Patient, Conference, Kidney disease, Tip, Pharmaceutical industry, Broadcasting

LOS ALTOS, Calif., July 20, 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 that Shalabh Gupta, M.D., Chief Executive Officer will participate in a fireside chat at the H.C. Wainwright 2nd Annual Kidney Conference “Glomerular Disease: IgAN Is Just the Tip of the Iceberg” on Tuesday, July 25, 2023 at 11:00 a.m.

Key Points: 
  • LOS ALTOS, Calif., July 20, 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 that Shalabh Gupta, M.D., Chief Executive Officer will participate in a fireside chat at the H.C. Wainwright 2nd Annual Kidney Conference “Glomerular Disease: IgAN Is Just the Tip of the Iceberg” on Tuesday, July 25, 2023 at 11:00 a.m.
  • ET.
  • A link to the live and archived webcast may be accessed on the Unicycive website under the Investors section: Events and Presentations .
  • An archive of the webcast will be available for three months.

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.