NASH

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.

SHAREHOLDER ALERT: Pomerantz Law Firm Investigates Claims on Behalf of Investors of Akero Therapeutics, Inc. - AKRO

Retrieved on: 
Monday, April 8, 2024
Patient, EFX, LLP, News, Åkerö, Fibrosis, Pomerantz, NASH

NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Akero Therapeutics, Inc. (“Akero” or the “Company”) (NASDAQ: AKRO).

Key Points: 
  • NEW YORK, April 08, 2024 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Akero Therapeutics, Inc. (“Akero” or the “Company”) (NASDAQ: AKRO).
  • The investigation concerns whether Akero and certain of its officers and/or directors have engaged in securities fraud or other unlawful business practices.
  • In addition, Akero added that 12 patients, including 11 in EFX groups, discontinued the trial due to drug-related adverse events.
  • Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions.

US Gastroenterologists Project Swift Uptake of Madrigal Pharmaceuticals’ Rezdiffra (resmetirom) for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)

Retrieved on: 
Friday, April 5, 2024
Launch, Benchmarking, Liver, Patient, Gastroenterology, Weight loss, Market, Pulse, Fibrosis, NASH, FDA, Pharmaceutical industry

As anticipation builds for the launch of Rezdiffra, Spherix Global Insights recently conducted a pulse survey among gastroenterologists (n=81) to assess prescriber feedback and projected uptake of the brand post-launch.

Key Points: 
  • As anticipation builds for the launch of Rezdiffra, Spherix Global Insights recently conducted a pulse survey among gastroenterologists (n=81) to assess prescriber feedback and projected uptake of the brand post-launch.
  • Furthermore, 70% of gastroenterologists in the March 2024 pulse now report they are at least moderately familiar with Rezdiffra, a significant increase compared to April 2023.
  • When discussing the primary benefits of Rezdiffra, gastroenterologists highlight its distinction as the first indicated product for MASH, alongside its prospective efficacy in improving fibrosis.
  • Furthermore, gastroenterologists indicate that over one-third of MASH patients under their care would be suitable candidates for Rezdiffra, further bolstering the likelihood of swift uptake and utilization.

Madrigal Pharmaceuticals Reports Inducement Grants under Nasdaq Listing Rule 5635(c)(4)

Retrieved on: 
Wednesday, April 3, 2024
NASH, Therapy, Fatty liver disease, Employment, Pharmaceutical industry

The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

Key Points: 
  • The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).
  • The equity awards were granted as inducement material to employees’ acceptance of employment with the company.
  • All restricted stock units granted vest in a 25% increment on each of the first through fourth anniversaries of the grant date.
  • The vesting of all awards described above shall be subject to each such employee’s continued employment as of the vesting date.

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 .

Inventiva announces the nomination of Andre Turenne as Director

Retrieved on: 
Thursday, March 28, 2024
Business, Kalamazoo College, Tuck School of Business, Business development, Therapy, Fatty liver disease, Euronext Paris, NASH, Match point, Atlas Venture, Management

Frédéric Cren, Chairman, Chief Executive Officer, and cofounder of Inventiva: “We are extremely pleased that our Board of Directors has proposed the appointment of Andre.

Key Points: 
  • Frédéric Cren, Chairman, Chief Executive Officer, and cofounder of Inventiva: “We are extremely pleased that our Board of Directors has proposed the appointment of Andre.
  • We look forward to welcoming Andre as the newest member of our Board of Directors.”
    Mr. Turenne has more than 20 years of global experience in the pharmaceutical industry.
  • Prior to joining Matchpoint, Mr. Turenne served as President and Chief Executive Officer of Voyager Therapeutics.
  • Andre Turenne, non-executive director nominee: “I am delighted to have the opportunity to join the Board of Directors of Inventiva, which is at a pivotal stage in its clinical program in NASH.

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”).

Sagimet Biosciences Reports Full Year 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Monday, March 25, 2024
Research, FASN, Fatty liver disease, Congress, Exercise, Progression-free survival, F2, Patient, SAN, Food and Drug Administration, F3, G&A, IPO, Obesity, IND, Acne, Bevacizumab, Glioblastoma, Fibrosis, Clinical trial, NASH, FDA, Drug development, Pharmaceutical industry

SAN MATEO, Calif., March 25, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today reported financial results for the full year ended December 31, 2023, and provided corporate updates.

Key Points: 
  • In January 2024, Sagimet sold 9,000,000 shares of its Series A common stock in an underwritten public offering and received $104.7 million in net proceeds.
  • In November 2023, Sagimet presented preclinical data evaluating denifanstat alone or in combination with semaglutide in mouse models of MASH at the 7th Obesity and NASH Drug Development Summit.
  • In October 2023, Sagimet’s license partner for China, Ascletis Bioscience Co. Ltd. (Ascletis), presented Phase 2 topline results at the European Academy of Dermatology and Venereology (EADV) Congress 2023 in Berlin, Germany.
  • In July 2023, Sagimet closed an upsized IPO of Series A common stock, at a public offering price of $16.00 per share.

Inventiva announces the schedule of publication and presentation of its 2023 Full-Year Financial Results

Retrieved on: 
Friday, March 22, 2024
Q&A, MASH, Fatty liver disease, Euronext Paris, NASH, Audit

Inventiva’s 2023 full-year financial results will be published on Wednesday, March 27, 2024 at 4:00 pm (New York), 9:00 pm (Paris).

Key Points: 
  • Inventiva’s 2023 full-year financial results will be published on Wednesday, March 27, 2024 at 4:00 pm (New York), 9:00 pm (Paris).
  • The conference call and the slides of the presentation will be webcast live at: https://edge.media-server.com/mmc/p/eh78kegs and also available on Inventiva’s website in the “ Investors – Financial results ” section.
  • Participants will need to use the conference access information provided in the e-mail received at the point of registering (dial-in number and access code).
  • A replay of the conference call and the presentation will be available after the event at: http://inventivapharma.com/investors/financial-results-presentations/ .

SEQUANA MEDICAL SUCCESSFULLY RAISES EUR 11.5 MILLION IN AN EQUITY PLACEMENT

Retrieved on: 
Thursday, March 21, 2024
Cardiorenal syndrome, EUR, Partner, DSR, Offering, Liver disease, Ketel One, KBC, Patient, 2.0, Cancer, Quality management system, AMERICA, Prospectus, Heart failure, EQT, LSP, PMA, US FDA, NASH, Overload, THT, USD, FDA, Security (finance)

This is an exciting time for Sequana Medical as the US FDA's review of our alfapump® PMA filing progresses and we continue our preparations for US commercial launch.

Key Points: 
  • This is an exciting time for Sequana Medical as the US FDA's review of our alfapump® PMA filing progresses and we continue our preparations for US commercial launch.
  • We look forward to continuing our track record of meeting our corporate milestones and driving Sequana Medical forward."
  • (ii)   Finalizing the North American pivotal study in recurrent and refractory liver ascites (POSEIDON) towards secondary endpoint readout planned for Q2 2024.
  • As announced in February 2024, the Company entered into an unsecured and subordinated convertible loan agreement with Partners in Equity and Rosetta Capital for an aggregate principal amount of EUR 3.0 million.