Cirrhosis

Madrigal Pharmaceuticals Announces U.S. Availability of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic NASH with Moderate to Advanced Liver Fibrosis

Retrieved on: 
Tuesday, April 9, 2024
Diagnosis, Biopsy, Fatty liver disease, Cirrhosis, Exercise, F2, Patient, Prescription, MD, Diet, Fibrosis, Pharmacy, NASH, Therapy, FDA, THR, JD

I can finally tell my appropriate patients with moderate to advanced fibrosis that we have an approved treatment to help improve fibrosis and resolve NASH.

Key Points: 
  • I can finally tell my appropriate patients with moderate to advanced fibrosis that we have an approved treatment to help improve fibrosis and resolve NASH.
  • Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program.
  • This program is designed to help patients navigate insurance and affordability challenges and provide co-pay support for eligible patients.
  • Madrigal has also established a patient assistance program (PAP) to help patients with no insurance access Rezdiffra.

Galectin Therapeutics Reports the Positive Outcome of the Fifth Data and Safety Monitoring Board Meeting for NAVIGATE Phase 2b/3 Study of Belapectin in Patients with Cirrhotic Portal Hypertension Caused by Metabolic Dysfunction-Associated SteatoHepatitis

Retrieved on: 
Tuesday, April 9, 2024
Data monitoring committee, Cirrhosis, Metabolism, Disease, Risk, Patient, Hope, MASH, Final Analysis, Therapy, GALT, Safety, DSMB, Interim, Plasma protein binding, Esophageal varices, Liver, Pharmaceutical industry

The objective of this fifth DSMB meeting was to further review the emerging tolerance and safety profiles of belapectin.

Key Points: 
  • The objective of this fifth DSMB meeting was to further review the emerging tolerance and safety profiles of belapectin.
  • Based on its deliberation, which included an unblinded review of the data collected thus far, the DSMB concluded that NAVIGATE can continue as designed, without modifications.
  • The Phase 2b/3 NAVIGATE study is a global, seamless, adaptive, randomized, placebo-controlled, double-blind trial.
  • Enrolled patients have been randomized to receive every two weeks a blinded infusion of belapectin at 2 mg/kg/LBM or 4 mg/kg/LBM or placebo.

EnteroBiotix Completes £27m Financing Round to Advance Clinical Trials

Retrieved on: 
Thursday, April 4, 2024
Cirrhosis, Scottish Enterprise, Partnership, Patient, Irritable bowel syndrome, Bank, Standard of care, Therapy, Hepatic encephalopathy, Scottish National Investment Bank

GLASGOW, United Kingdom, April 04, 2024 (GLOBE NEWSWIRE) -- EnteroBiotix Limited, a clinical-stage biotechnology company focussed on developing best-in-class full-spectrum microbiome therapeutics, today announced that the Company has completed its £27m ($34m USD) funding round, supported by new and existing investors.

Key Points: 
  • GLASGOW, United Kingdom, April 04, 2024 (GLOBE NEWSWIRE) -- EnteroBiotix Limited, a clinical-stage biotechnology company focussed on developing best-in-class full-spectrum microbiome therapeutics, today announced that the Company has completed its £27m ($34m USD) funding round, supported by new and existing investors.
  • Existing investors including Scottish Enterprise and many of the Company’s private investors also participated.
  • Dr James McIlroy, CEO of EnteroBiotix, said: “This significant new investment helps enable our vision of transforming the standard of care for patients suffering from serious conditions linked to the gut microbiome.
  • It will help accelerate the development of our innovative product pipeline and propels us towards our goal of bringing these innovative treatments to market.

Galectin Therapeutics Reports 2023 Financial Results and Provides Business Update

Retrieved on: 
Friday, March 29, 2024
Research, Data monitoring committee, Cirrhosis, Disease, Metabolism, AASLD, Safety, Patient, Food and Drug Administration, Liver, Mortality, Liver transplantation, Hope, Hepatology, Fibrosis, Clinical trial, Annual report, Therapy, GALT, Pharmacokinetics, Data, DSMB, NASH, Food, Esophageal varices

NORCROSS, Ga., March 29, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2023.

Key Points: 
  • NORCROSS, Ga., March 29, 2024 (GLOBE NEWSWIRE) -- Galectin Therapeutics, Inc. (NASDAQ: GALT), the leading developer of therapeutics that target galectin proteins, today reported financial results and provided a business update for the year ended December 31, 2023.
  • Joel Lewis, Chief Executive Officer and President of Galectin Therapeutics, said “We have been focused on advancing our Metabolic Dysfunction-Associated Steatohepatitis (MASH, formerly known as NASH) cirrhosis program.
  • Dr. Jamil’s extensive experience in advanced liver disease, specifically for late-stage cirrhotic patients, is a tremendous asset to our program.
  • These results are included in the Company's Annual Report on Form 10-K, which has been filed with the U.S. Securities and Exchange Commission and is available at www.sec.gov .

Sequana Medical announces 2023 Full Year Results and 2024 Outlook

Retrieved on: 
Thursday, March 28, 2024
Cardiorenal syndrome, Cirrhosis, Partner, Congestion, American Medical Association, Ascites, DSR, Brussels Stock Exchange, Liver disease, RED, Patient, Peritoneal dialysis, 2.0, Mouse, Sheep, Cancer, Heart, Heart failure, PMA, US FDA, Safety, File, CPT9, Overload, Catheter, ISO, THT, FDA, Animal, Pharmaceutical industry

Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.

Key Points: 
  • Ian Crosbie, Chief Executive Officer of Sequana Medical, commented: “Securing PMA approval is a major value inflection point and the team is navigating through the approval process.
  • Furthermore, the alfapump can benefit from attractive pricing and leverage its FDA breakthrough device designation to enhance its reimbursement position.
  • Following this equity placement, the €3.0 million convertible loan agreement entered in February 2024 by Partners in Equity and Rosetta Capital will be mandatorily converted into new shares.
  • A day-100 meeting is scheduled with the FDA on April 9th 2024.

Altimmune Announces Positive Lean Mass Preservation Data for Pemvidutide and Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Wednesday, March 27, 2024
Research, Blood pressure, Body composition, LDL, Adipose tissue, Obesity, Development, Cirrhosis, Three Months, Exercise, Arrhythmia, Hepatitis B virus, Diabetes, Lipid, Patient, Heart rate, Fast Track, Weight loss, Sarcopenia, MASH, Woman, Diet, Investment, Fibrosis, Safety, Optimism, FDA, Triglyceride, IMPACT, Dietary supplement

“We are extremely pleased with the results of the body composition analysis from our recently completed MOMENTUM 48-week Phase 2 obesity trial of pemvidutide.

Key Points: 
  • “We are extremely pleased with the results of the body composition analysis from our recently completed MOMENTUM 48-week Phase 2 obesity trial of pemvidutide.
  • “There is a growing appreciation that the quality of weight loss is as important as the quantity of weight loss.
  • Achieved mean weight loss of 15.6% on 2.4 mg dose of pemvidutide at week 48, with weight loss continuing at the end of treatment.
  • Financial Results for the Three Months Ended December 31, 2023
    Altimmune had cash, cash equivalents and short-term investments totaling $198.0 million at December 31, 2023.

89bio Receives EMA PRIME Status for Pegozafermin in the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH) with Fibrosis and Compensated Cirrhosis

Retrieved on: 
Wednesday, March 27, 2024
MASH, Cirrhosis, Patient, SAN, European Medicines Agency, Marketing, FGF21, Liver, Fibrosis, PRIME, EMA, Pharmaceutical industry

SAN FRANCISCO, March 27, 2024 (GLOBE NEWSWIRE) -- 89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver and cardiometabolic diseases, today announced that the European Medicines Agency (EMA) has granted Priority Medicines (PRIME) status to pegozafermin in patients with MASH. The PRIME status was supported by positive data from the Phase 2b ENLIVEN trial of pegozafermin in patients with non-cirrhotic MASH with fibrosis (F2-F3) and MASH with compensated cirrhosis (F4).

Key Points: 
  • The PRIME status was supported by positive data from the Phase 2b ENLIVEN trial of pegozafermin in patients with non-cirrhotic MASH with fibrosis (F2-F3) and MASH with compensated cirrhosis (F4).
  • “The EMA PRIME status further supports pegozafermin’s positioning as a leading FGF21 analog for the treatment of MASH, which has demonstrated robust anti-fibrotic and metabolic benefits as seen in our Phase 2b ENLIVEN trial,” said Rohan Palekar, Chief Executive Officer of 89bio.
  • “This status recognizes the urgent need for effective treatment options for MASH patients with advanced fibrosis and underscores pegozafermin’s potential to address the targeted unmet medical need.
  • For more information on the PRIME status, please visit the EMA website at www.ema.europa.eu .

Gyre Therapeutics Reports Full Year 2023 Financial Results and Provides Business Update

Retrieved on: 
Tuesday, March 26, 2024
Hepatitis, KPMG, GNI, Cirrhosis, Patient, Chronic obstructive pulmonary disease, Sale, Coagulopathy, Ernst & Young, Idiopathic pulmonary fibrosis, Fibrosis, Therapy, COPD, Marketing, Partnership, Arthur Andersen, Audit committee, SAN, Safety, CVR, CHB, Fatty liver disease, Prevalence, Pharmacy, Hospital, Research, Acquisition, TGF, Pirfenidone, GAAP, Toxicity, Inflammation, Accounting, Entecavir, Loss, Orthostatic hypertension, IPF, Partner, NASH, Category 1, Pharmaceutical industry

Mr. Nussbaum brings nearly four decades of experience in accounting and financial reporting in the U.S. and Asia Pacific Region.

Key Points: 
  • Mr. Nussbaum brings nearly four decades of experience in accounting and financial reporting in the U.S. and Asia Pacific Region.
  • In October 2023, Gyre (formerly known as Catalyst Biosciences, Inc. (“Catalyst”)) completed the previously announced business combination with GNI Group Ltd. (“GNI”) and related entities.
  • In October 2023, Gyre Pharmaceuticals completed enrollment of its Phase 3 trial in patients with CHB-associated liver fibrosis in the PRC.
  • Use of Non-GAAP Financial Measures by Gyre Therapeutics, Inc.
    Gyre reports financial results in accordance with accounting principles generally accepted in the United States (“GAAP”).

Orphan designation: Florilglutamic acid (18F) Diagnosis of hepatocellular carcinoma, 21/03/2016 Withdrawn

Retrieved on: 
Tuesday, April 9, 2024
Eurostat, Diagnosis, Civil service commission, Radiation, MRI, Weakness, Cell, Hepatitis B, Disease, Infection, Magnetic resonance imaging, Cirrhosis, Patient, Committee, Weight loss, Knowledge, PET, Neoplasm, Abdomen, Tissue, Regulation, Cancer, EMA, IRIS, Hepatocellular carcinoma, Woman, Nausea, European, COMP, Sponsor, European Commission, Safety, Pain, Molecular imaging, Marketing, Swelling, Liver, Medicine, Pharmaceutical industry

Orphan designation: Florilglutamic acid (18F) Diagnosis of hepatocellular carcinoma, 21/03/2016 Withdrawn

Key Points: 


Orphan designation: Florilglutamic acid (18F) Diagnosis of hepatocellular carcinoma, 21/03/2016 Withdrawn

FDA’s Approval of Breakthrough NASH Treatment Opens Door for a Long-Neglected Patient Population

Retrieved on: 
Thursday, March 14, 2024
Organization, Obesity, Cirrhosis, Exercise, Cardiology, Partnership, F2, Risk, Patient, Fatty liver disease, Hope, Diet, NASH, Language, Liver disease, Liver cancer, Hypertension, FDA, Drug development, JD, Food, GLI

Developed by Madrigal Pharmaceuticals, Rezdiffra™ (resmetirom) was approved for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis, in conjunction with diet and exercise.

Key Points: 
  • Developed by Madrigal Pharmaceuticals, Rezdiffra™ (resmetirom) was approved for the treatment of adults with noncirrhotic NASH with moderate to advanced liver fibrosis, in conjunction with diet and exercise.
  • This breakthrough follows years of NASH patient-led, multi-stakeholder advocacy and partnership with researchers in both drug and diagnostic development.
  • “Today’s announcement represents the culmination of the work of the united NASH community.
  • It is particularly satisfying that we can mark Women’s History Month with a breakthrough from a female-founded company.