ACLF

GENFIT Announces Signature of the Share Purchase Agreement and the Completion of its Acquisition of Versantis

Retrieved on: 
목요일, 9월 29, 2022
Nasdaq, Safety, COVID-19, Primary biliary cholangitis, Loos, Cholangiocarcinoma, Biomarker, Institute of Liver and Biliary Sciences, FRANCE, NASH, U.S. Securities and Exchange Commission, Liver disease, Company, Acquisition, Review, Private Securities Litigation Reform Act, Industry, Business, Patient, History, United Kingdom, Chronic liver disease, Annual report, Financial assistance (share purchase), Professor, LabCorp, Doctor of Philosophy, Board, ETH Zurich, Chapter Two, AMF, Cirrhosis, PBC, Research, SEC, Medical imaging, Pharmaceutical industry, ACLF, Euronext

GENFIT will also further expand its pipeline in other liver diseases characterized by high unmet medical needs with additional product candidates developed by Versantis.

Key Points: 
  • GENFIT will also further expand its pipeline in other liver diseases characterized by high unmet medical needs with additional product candidates developed by Versantis.
  • GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases characterized by high unmet medical needs.
  • GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanning more than two decades.
  • The company is headquartered in Zurich, Switzerland, with an established wholly-owned U.S. subsidiary, Versantis, Inc. For additional information, visit: www.versantis.com.

Mallinckrodt Receives U.S. FDA Approval for Terlivaz® (terlipressin) for injection for the Treatment of Hepatorenal Syndrome (HRS)

Retrieved on: 
목요일, 9월 15, 2022
Hospital, Terlipressin, Dialysis, Therapy, Safety, Trial of the century, Liver support system, Hypoxia, Hepatorenal syndrome, American College, AASLD, Risk, FDA, Food, Breathe Me, Diarrhea, American Association for the Study of Liver Diseases, American Association, ACG, Verified, Renal replacement therapy, Survival, Oxygen saturation (medicine), Patient, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Severe cutaneous adverse reactions, The New England Journal of Medicine, Physician, 2021 Essex County Council election, Terminology, Use, American College of Gastroenterology, Volume overload, Caregiver, Boxed warning, Kidney failure, SCR, Abdominal pain, Association, Nausea, Mortality, Kidney, ACLF, HRS, Institute of Liver and Biliary Sciences, Pharmaceutical industry, Mallinckrodt

DUBLIN, Sept. 14, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz® (terlipressin) for injection. Terlivaz is the first and only FDA-approved product indicated to improve kidney function in adults with hepatorenal syndrome (HRS) with rapid reduction in kidney function,1 an acute and life-threatening condition requiring hospitalization.2 

Key Points: 
  • DUBLIN, Sept. 14, 2022 /PRNewswire/ -- Mallinckrodt plc (OTCMKTS: MNKPF), a global specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) approved Terlivaz (terlipressin) for injection.
  • The CONFIRM trial was completed prior to the updated diagnostic criteria and terminology published in the 2021 AASLD guidance on hepatorenal syndrome.
  • * Note, Terlivaz was not evaluated in comparison to other treatment options in a head-to-head clinical study.
  • Monitor patients for hypoxia using continuous pulse oximetry during treatment and discontinue TERLIVAZ if SpO2 decreases below 90%.

FDA Grants GENFIT’s GNS561 Orphan Drug Designation for the Treatment of Cholangiocarcinoma

Retrieved on: 
화요일, 9월 13, 2022
Nasdaq, Safety, Industry, Patient, U.S. Securities and Exchange Commission, United Kingdom, Research, Disease, Palmitoyl(protein) hydrolase, Probability, COVID-19, Food, Company, Acquisition, History, Primary sclerosing cholangitis, Annual report, Chapter Two, Associate, AMF, SEC, Mortality, FDA, Loos, NASH, Hope, Liver disease, Review, Lysosome, Cirrhosis, Hepatolithiasis, Johns Hopkins University, Autophagy, Primary biliary cholangitis, Biomarker, FRANCE, Private Securities Litigation Reform Act, Bile, Regulation of food and dietary supplements by the U.S. Food and Drug Administration, Risk, Cancer, Chronic liver disease, LabCorp, PBC, Pharmaceutical industry, Medical imaging, ACLF, Cholangiocarcinoma, Oncology, Euronext

GNS561 has completed pre-clinical studies and a Phase 1b trial confirming the rationale for targeting cholangiocarcinoma.

Key Points: 
  • GNS561 has completed pre-clinical studies and a Phase 1b trial confirming the rationale for targeting cholangiocarcinoma.
  • Dr Mark Yarchoan, Associate Professor of Oncology at John Hopkins Medicine (Baltimore, MD) commented: Cholangiocarcinoma is a rare cancer with a high mortality rate.
  • This is why new therapies are urgently needed and is one of the reasons that GNS561 was granted Orphan Drug Designation by the FDA.
  • There is a real path forward for new options for second line treatment in cholangiocarcinoma, and GNS561 represents a strong second-line therapy candidate and hope to patients.

Versantis Presents New VS-01 Data at The International Liver CongressTM 2022

Retrieved on: 
금요일, 6월 24, 2022
Biotechnology, Hospitals, Pharmaceutical, Health, Department, FDA, Patient, ETH Zurich, Liver, Brain, 2021 Essex County Council election, Fatty liver disease, Blood, ExCeL London, Industry, Section, Mortality, OF, Prevalence, EMA, U.S. FDA, Cirrhosis, Internal, Health, Chronic liver disease, Level 1, Incidence, Board, Multiple organ dysfunction syndrome, Liposome, MD, ODD, Urea, ACLF, Institute of Liver and Biliary Sciences, Pharmaceutical industry, Medical device, EU

The data will be presented in two posters on Saturday June 25 at the International Liver Congress 2022.

Key Points: 
  • The data will be presented in two posters on Saturday June 25 at the International Liver Congress 2022.
  • The abstract entitled Metabolomic analysis of organ failure marker compounds in blood samples of patients with decompensated liver cirrhosis after administration of the novel drug VS-01 was also selected for inclusion in the Best of International Liver CongressTM 2022.
  • We are proud and honored to have had one of our abstracts chosen for inclusion in the Best of International Liver CongressTM 2022, said Mark Fitzpatrick, Chief Executive Officer of Versantis.
  • Versantis is a clinical stage biotechnology company focused on addressing the growing, unmet medical need in liver diseases.

GENFIT: May 25, 2022 Combined Shareholders Meeting results

Retrieved on: 
수요일, 5월 25, 2022
U.S. Securities and Exchange Commission, Roger W. Jones Award for Executive Leadership, Company, History, Private Securities Litigation Reform Act, NASH, FRANCE, Nasdaq, Doctor of Philosophy, Director, Patient, AMF, PBC, Review, Chapter Two, Research, United Kingdom, Cholangiocarcinoma, Industry, Partnership, Liver disease, Primary biliary cholangitis, Board, Safety, Biomarker, Board of directors, Loos, Cirrhosis, LabCorp, SEC, Acquisition, Chronic liver disease, Annual report, Management, Pharmaceutical industry, Euronext, Pharmacovigilance, ACLF, Ipsen

The quorum on first convening amounted to 25.16% and shareholders approved all of the resolutions submitted by the Board of Directors.

Key Points: 
  • The quorum on first convening amounted to 25.16% and shareholders approved all of the resolutions submitted by the Board of Directors.
  • Jean-Franois Mouney, Chairman of GENFITs Board of Directors, commented: I would like to thank all of our shareholders who participated in this Combined Shareholders Meeting.
  • This appointment is in keeping with the long-term strategic partnership agreement signed with Ipsen at the end of 2021.
  • In ACLF, a Phase 1 clinical program with nitazoxanide has been initiated with data expected as early as the third quarter 2022.

GENFIT Reports First Quarter 2022 Financial Information (Unaudited financial information under IFRS)

Retrieved on: 
수요일, 5월 11, 2022
Company, History, Private Securities Litigation Reform Act, U.S. Securities and Exchange Commission, NASH, FRANCE, Nasdaq, Patient, AMF, PBC, Review, Chapter Two, Research, United Kingdom, Cholangiocarcinoma, Industry, Partnership, Liver disease, Primary biliary cholangitis, Safety, Biomarker, Loos, IFRS, Cirrhosis, LabCorp, SEC, Acquisition, Chronic liver disease, Annual report, Online gambling, Cryptocurrency, Security (finance), Pharmaceutical industry, Euronext, VAT, ACLF, Ipsen

Furthermore, to underscore the long-term commitment represented by this partnership, Ipsen purchased newly issued GENFIT equity representing 8% post-issuance through a 28.0 million investment in GENFIT.

Key Points: 
  • Furthermore, to underscore the long-term commitment represented by this partnership, Ipsen purchased newly issued GENFIT equity representing 8% post-issuance through a 28.0 million investment in GENFIT.
  • Revenues for the first three months of 2022 amounted to 3.895 million compared to 1 thousand for the same period in 2021.
  • Revenues for the first three months of 2022 mainly came from the partial recognition of this amount corresponding to this period.
  • In ACLF, a Phase 1 clinical program with nitazoxanide has been initiated with data expected as early as the third quarter 2022.

GENFIT Announces Publication of the 2021 Universal Registration Document; the 2021 Annual Report on Form 20-F and Availability of Preparatory Documents for the Annual Combined Shareholders Meeting on May 25, 2022

Retrieved on: 
금요일, 4월 29, 2022
U.S. Securities and Exchange Commission, AMF, FRANCE, Statute, Patient, Nasdaq, Chapter Two, PBC, Liver disease, Investor, The Annual, Cirrhosis, Private Securities Litigation Reform Act, Chronic liver disease, Loos, United Kingdom, History, LabCorp, Biomarker, Company, Mission statement, Acquisition, Annual report, Research, Statutory auditor, Board, NASH, Industry, SEC, Review, Primary biliary cholangitis, Cholangiocarcinoma, Safety, Online gambling, Pharmaceutical industry, Euronext, ACLF

The 2021 Registration Document is also available on the AMFs website: www.amf-france.org and the Annual Report on Form 20-F is available on the website of the SEC ( www.sec.gov ).

Key Points: 
  • The 2021 Registration Document is also available on the AMFs website: www.amf-france.org and the Annual Report on Form 20-F is available on the website of the SEC ( www.sec.gov ).
  • Documents for the Annual Combined Shareholders Meeting on May 25, 2022 are available to shareholders in accordance with existing regulations, and can be found on the Companys website, in the Investors and Media section ( https://ir.genfit.com/financial-information/shareholders-meeting ).
  • GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases characterized by high unmet medical needs.
  • In 2021, GENFIT signed an exclusive licensing agreement with IPSEN to develop, manufacture and commercialize elafibranor in PBC and other indications.

GENFIT Annual Combined General Meeting of May 25, 2022 — Availability of Preparatory Documents

Retrieved on: 
수요일, 4월 20, 2022
Nasdaq, Liver disease, Pharmacy, Internet, Cholangiocarcinoma, Primary biliary cholangitis, LabCorp, U.S. Securities and Exchange Commission, PARC, Documentation, Chapter Two, Research, Cirrhosis, Annual report, NASH, Faculty of Pharmaceutical Sciences, Chulalongkorn University, Private Securities Litigation Reform Act, Patient, Loos, Biomarker, Bulletin, PBC, Review, Company, United Kingdom, Chronic liver disease, FRANCE, SEC, Faculty, History, Investor, Safety, Industry, Acquisition, AMF, Pharmaceutical industry, ACLF, Euronext

For this 2022 Combined General Meeting, the Company will allow shareholders to send their voting instructions via Internet through the VOTACCESS platform.

Key Points: 
  • For this 2022 Combined General Meeting, the Company will allow shareholders to send their voting instructions via Internet through the VOTACCESS platform.
  • GENFIT is a late-stage biopharmaceutical company dedicated to improving the lives of patients with severe chronic liver diseases characterized by high unmet medical needs.
  • GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanning more than two decades.
  • In 2021, GENFIT signed an exclusive licensing agreement with IPSEN to develop, manufacture and commercialize elafibranor in PBC and other indications.

Versantis Awarded Innosuisse Grant of CHF475,000 to Develop Point of Care Device to Monitor Blood Ammonia in Liver Disease Patients

Retrieved on: 
수요일, 4월 13, 2022
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, EMA, Hepatic encephalopathy, ODD, CEO, Board, Urea, Liver disease, ACLF, Marketing, ETH, Ammonia, Cirrhosis, Caregiver, Brain, Death, Patient, IVD, Blood, CSO, Technology, Institute of Liver and Biliary Sciences, Scientific Reports, U.S. FDA, POC, ETH Zurich, Industry, FDA, Coma, Liver, Liposome, HE, Sensor, Pharmaceutical industry, Medical device, Medical imaging, Engineering

Increased blood ammonia levels are a common sign of chronic and acute liver diseases and lead to hepatic encephalopathy (HE), a serious and potentially fatal complication.

Key Points: 
  • Increased blood ammonia levels are a common sign of chronic and acute liver diseases and lead to hepatic encephalopathy (HE), a serious and potentially fatal complication.
  • To date, ammonia monitoring is a time-consuming process involving health care professionals, laboratory equipment, and burdensome hospital logistics.
  • The ZHAW School of Engineering will receive the grant funding to develop the optoelectronic component and engineer the biomedical instrumentation for the prototype device.
  • There is a great unmet medical need for an accurate and user-friendly device to monitor the levels of ammonia in patients with liver disease, said Dr. Vincent Forster, CSO and co-Founder of Versantis.

GENFIT Reports Full-Year 2021 Financial Results and Provides Corporate Update

Retrieved on: 
목요일, 4월 7, 2022
Kidney, Journal, Mission statement, Cholangiocarcinoma, Biomarker, Statutory auditor, Research, Elafibranor, Fibrosis, LabCorp, Data monitoring committee, Executive, Marketing, Diagnosis, Liver, Quality, Ursodeoxycholic acid, PBC, NASH, Omicron, Director, DSMB, NTZ, Board, Ownership, Primary biliary cholangitis, FNIH, National, Liver disease, COVID, VAT, Patient, Partnership, Company, CCA, CET, D, United Kingdom, ESG, CIR, Committee, Itch, COVID-19, United Nations Ocean Conference, Foundation, UDCA, Executive Committee, Animal, Pharmaceutical industry, Online gambling, Lithium, Ridesharing company, Cryptocurrency, Security (finance), Management, ACLF, Ipsen

Other revenue recognized in 2021 is related to licensing agreements with Labcorp for the deployment of NIS4 technology in NASH.

Key Points: 
  • Other revenue recognized in 2021 is related to licensing agreements with Labcorp for the deployment of NIS4 technology in NASH.
  • This decrease mainly reflected the effects of the reorganization and restructuring plan, which was initiated during the fourth quarter 2020 and throughout 2021.
  • In 2021, GENFIT generated a consolidated operating result of 31.8 million compared to an operating loss of 82.9 million in 2020.
  • 2021 resulted in a financial income of 37.7 million compared to a financial loss of 18.8 million in 2020.