Fatty liver disease

Madrigal Pharmaceuticals Announces Pricing of Upsized $600 Million Public Offering

Retrieved on: 
Tuesday, March 19, 2024
Montgomery Street, Fatty liver disease, UBS, ECM, Madison Avenue, Goldman Sachs, Form, Telephone, Citizenship, Research, Sale, Public expenditure, Attention, Security (finance), Lexington Avenue, Prospectus, Suite, Jefferies, NASH, Therapy, Nicollet Mall, Equity capital markets, Jefferies Group, ATTN:, Evercore

The size of the offering was increased by $100 million subsequent to the initial announcement of the offering.

Key Points: 
  • The size of the offering was increased by $100 million subsequent to the initial announcement of the offering.
  • The gross proceeds to Madrigal from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $600 million.
  • Madrigal has granted the underwriters of the offering a 30-day option to purchase up to an additional 346,153 shares of common stock from the company at the public offering price, less underwriting discounts and commissions.
  • The offering is expected to close on or about March 21, 2024, subject to the satisfaction of customary closing conditions.

Madrigal Pharmaceuticals Announces Proposed Public Offering

Retrieved on: 
Monday, March 18, 2024
Montgomery Street, Fatty liver disease, UBS, ECM, Madison Avenue, Goldman Sachs, Form, Telephone, Citizenship, Research, Sale, Public expenditure, Attention, Security (finance), Lexington Avenue, Prospectus, Suite, Jefferies, NASH, Therapy, Nicollet Mall, Equity capital markets, Jefferies Group, ATTN:, Evercore

Madrigal also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions.

Key Points: 
  • Madrigal also intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of common stock offered in the public offering at the public offering price, less underwriting discounts and commissions.
  • All of the shares in the proposed offering are to be sold by Madrigal.
  • Goldman Sachs & Co. LLC, Jefferies, TD Cowen, Evercore ISI, Piper Sandler, UBS Investment Bank and Citizens JMP are acting as joint bookrunning managers of the proposed offering.
  • The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Inventiva announces positive results from the Phase II, LEGEND, Proof-of-Concept study combining lanifibranor with empagliflozin in patients with MASH/NASH and T2D

Retrieved on: 
Monday, March 18, 2024
Diagnosis, Glucose, Histology, Adipose tissue, Arm, Glycated hemoglobin, Type 2 diabetes, Disease, Connective tissue, Steatosis, Insulin, Weight gain, Diabetes, CT1, Patient, Inflammation, SGLT2, Adiponectin, Table, MASH, MD, Liver injury, Insulin resistance, LEGEND, Fibrosis, HDL, Fatty liver disease, Empagliflozin, Safety, Euronext Paris, Phase, NASH, Hepatitis, Lipid metabolism, Prediabetes, Liver disease

Patients treated with lanifibranor in combination with empagliflozin maintained a stable weight throughout the 24 weeks study, addressing the moderate, metabolically healthy, weight gain that has been observed in some patients treated with lanifibranor.

Key Points: 
  • Patients treated with lanifibranor in combination with empagliflozin maintained a stable weight throughout the 24 weeks study, addressing the moderate, metabolically healthy, weight gain that has been observed in some patients treated with lanifibranor.
  • The treatment with lanifibranor 800mg/once daily alone or in combination with empagliflozin for 24 weeks was well tolerated, with no safety concerns reported.
  • The trial is double-blind for the placebo arm and lanifibranor (800mg daily) arm, and open-label for the combination of lanifibranor (800mg daily) and empagliflozin (10 mg daily) arm.
  • More details on these results are expected to be presented in upcoming scientific conferences and submitted for publication.

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.

Madrigal Pharmaceuticals Announces FDA Approval of Rezdiffra™ (resmetirom) for the Treatment of Patients with Noncirrhotic Nonalcoholic Steatohepatitis (NASH) with Moderate to Advanced Liver Fibrosis

Retrieved on: 
Thursday, March 14, 2024
Diagnosis, Fatty liver disease, Cirrhosis, Exercise, Entrepreneurship, Liver disease, Physician, F2, Patient, Research, Diet, Fibrosis, Drug development, NASH, Therapy, NAFLD, FDA, THR, Food, Pharmaceutical industry

Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.

Key Points: 
  • Continued approval for this indication may be contingent upon verification and description of clinical benefit in ongoing confirmatory trials.
  • Bill Sibold, Chief Executive Officer of Madrigal, stated, “NASH with moderate to advanced liver fibrosis is a serious and progressive liver disease that, until now, has not had an FDA-approved therapy.
  • Fibrosis improvement and NASH resolution were consistent regardless of age, gender, type 2 diabetes status, or fibrosis stage.
  • Madrigal is committed to helping appropriate patients who may benefit from Rezdiffra access the medication through the Madrigal Patient Support program.

89bio Initiates Phase 3 ENLIGHTEN-Fibrosis Trial of Pegozafermin in Non-Cirrhotic Metabolic Dysfunction-Associated Steatohepatitis (MASH) Patients with Fibrosis

Retrieved on: 
Tuesday, March 12, 2024
Fatty liver disease, FGF21, Cirrhosis, Patient, SAN, Hepatology, University, MASH, Fibrosis, Safety, Division, NASH, Liver, Pharmaceutical industry

SAN FRANCISCO, March 12, 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 the initiation of its Phase 3 ENLIGHTEN Program evaluating the efficacy and safety of pegozafermin in patients with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH). ENLIGHTEN-Fibrosis, the first of two Phase 3 trials in the program, has initiated and is evaluating non-cirrhotic MASH patients with fibrosis stage F2-F3.

Key Points: 
  • ENLIGHTEN-Fibrosis, the first of two Phase 3 trials in the program, has initiated and is evaluating non-cirrhotic MASH patients with fibrosis stage F2-F3.
  • “ENLIGHTEN-Fibrosis aims to enroll MASH patients, including those on background GLP-1-based therapies, where pegozafermin has demonstrated additional anti-fibrotic and metabolic effects.
  • The trial is designed to employ a three-panel consensus biopsy reading methodology, which was successfully utilized in the ENLIVEN trial.
  • Patients will self-administer pegozafermin using the planned commercial liquid formulation delivered as a single subcutaneous injection.

Can-Fite: Submits FDA with an IND Application to Conduct Phase IIb Clinical Trial of Namodenoson in MASH Patients

Retrieved on: 
Wednesday, April 3, 2024
Research, FDA, Diabetes, Clinical Trials, Biotechnology, Health, Pharmaceutical, Science, Oncology, Human, Obesity, Cirrhosis, CANF, Inflammation, Patient, MASH, Fibrosis, Fatty liver disease, Phase, NASH, Liver disease, Food, Pharmaceutical industry

Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and is seeking IND approval in order to include US patients in the ongoing study.

Key Points: 
  • Currently Can-Fite is enrolling patients for a Phase IIb clinical study in Europe and in Israel and is seeking IND approval in order to include US patients in the ongoing study.
  • The Phase IIb trial is a multicenter, randomized, double-blind, placebo-controlled study in subjects with biopsy-confirmed MASH.
  • The primary efficacy objective of the trial is to evaluate the efficacy of Namodenoson as compared to placebo in 140 subjects with MASH, as determined by a histological endpoint.
  • "We are eager to look at the therapeutic effect of Namodenoson in patients with MASH," said Motti Farbstein, chief executive officer of Can-Fite.

D&D Pharmatech Granted Fast Track Designation from US FDA for DD01 for the Treatment of NASH/MASH

Retrieved on: 
Tuesday, April 2, 2024
FDA, Health, Diabetes, Clinical Trials, Pharmaceutical, Biotechnology, Overweight, D&D, Obesity, Patient, Fatty liver disease, Fast Track, Weight loss, MASH, Fibrosis, Type 2 diabetes, T2D, Safety, MAFLD, NASH, Liver disease, Food, Dietary supplement

FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases.

Key Points: 
  • FDA Fast Track designation is intended to bring promising drugs to patients sooner by facilitating the development and expediting the review of drugs that fulfill unmet needs in serious diseases.
  • In animal models, DD01 treatment reduced hepatic steatosis, lobular inflammation, ballooning, and signs of fibrosis, all key diagnostic criteria MASH.
  • “We are pleased with the FDA’s decision to grant Fast Track designation for DD01 and look forward to initiating a Phase 2 study in biopsy-confirmed MASH patients,” said Seulki Lee, Ph.D., CEO of D&D.
  • DD01 provides rapid reductions in liver fat and beneficial effects on glucose control; thus, we anticipate further studying DD01 in biopsy-confirmed MASH patients after prolonged treatment in an upcoming Phase 2.”

Poxel to Report Its 2023 Annual Results by the End of April 2024

Retrieved on: 
Thursday, March 28, 2024
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, Imeglimin, NASH, DSM-IV codes, Fatty liver disease

POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, announces the publication at the end of April 2024 of its 2023 Annual Results, originally scheduled for April 9, 2024, given the expected completion of a transaction by the end of April.

Key Points: 
  • POXEL SA (Euronext: POXEL - FR0012432516), a clinical stage biopharmaceutical company developing innovative treatments for chronic serious diseases with metabolic pathophysiology, including non-alcoholic steatohepatitis (NASH) and rare metabolic disorders, announces the publication at the end of April 2024 of its 2023 Annual Results, originally scheduled for April 9, 2024, given the expected completion of a transaction by the end of April.
  • The Company, which has made significant progress in securing additional financing, is targeting to close, by the end of April, a transaction relating to the monetization of royalties from TWYMEEG® (Imeglimin) sales in Japan.
  • Poxel expects that its financial resources will be sufficient to maintain its operations until the finalization of this monetization transaction.
  • The Company will communicate its new financial calendar in April 2024 upon completion of this transaction.

American Liver Foundation Statement on FDA Approval of Resmetirom

Retrieved on: 
Thursday, March 14, 2024
HCC, Liver failure, American Liver Foundation, Fatty liver disease, Liver disease, Disease, Caregiver, Risk, Cirrhosis, Inflammation, Chairperson, Patient, Life, Liver transplantation, Hope, Doctor of Philosophy, MASH, MD, ALF, Pharmacotherapy, Fibrosis, NASH, Hepatology, Hepatocellular carcinoma, NAFLD, FDA, Liver, Food, Pharmaceutical industry

FAIRFIELD, N.J., March 14, 2024 /PRNewswire/ -- Today, the Food and Drug Administration (FDA) granted accelerated approval of a first of its kind drug therapy, resmetirom, for the treatment of nonalcoholic steatohepatitis (NASH) in patients who have progressed to fibrosis. NASH, now called metabolic dysfunction-associated steatohepatitis or MASH, is a dangerously progressive form of nonalcoholic fatty liver disease* (NAFLD) and causes inflammation in the liver and liver damage.

Key Points: 
  • NASH, now called metabolic dysfunction-associated steatohepatitis or MASH, is a dangerously progressive form of nonalcoholic fatty liver disease * (NAFLD) and causes inflammation in the liver and liver damage.
  • "American Liver Foundation applauds the FDA approval of the groundbreaking new drug therapy treatment, resmetirom, for patients with NASH who have progressed to fibrosis," said Lorraine Stiehl , Chief Executive Officer, American Liver Foundation.
  • American Liver Foundation offers many free resources to patients and families affected by liver disease.
  • *Note: The nomenclature for NAFLD and NASH recently changed to metabolic dysfunction-associated liver disease (MASLD) and metabolic dysfunction-associated steatohepatitis (MASH) respectively.