ACLF

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

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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

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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.

GENFIT Announces Solid Revenues and Cash Position as of December 31, 2021

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월요일, 2월 28, 2022
LabCorp, U.S. Securities and Exchange Commission, Partnership, Omicron, Growth, SEC, AMF, Annual report, Chronic liver disease, VAT, COVID-19, Industry, Comprehensive annual financial report, Company, Clinical trial, United Kingdom, IFRS, Private Securities Litigation Reform Act, Safety, Sale, PBC, Review, Acquisition, Liver disease, Biomarker, Chapter Two, Cholangiocarcinoma, Nasdaq, Cirrhosis, Patient, NASH, COVID, CRO, History, Research, Program, Infection, CEO, Primary biliary cholangitis, Security (finance), Animal, Cryptocurrency, Pharmaceutical industry, Property management, Euronext, Ipsen, ACLF

As of December 31, 2021, the Companys cash and cash equivalents amounted to 258.8 million compared with 171.0 million, as of December 31, 2020.

Key Points: 
  • As of December 31, 2021, the Companys cash and cash equivalents amounted to 258.8 million compared with 171.0 million, as of December 31, 2020.
  • This amount includes:
    A 120 million non-refundable upfront payment from Ipsen received in December 2021, as well as 24 million in VAT collected on that amount
    As of June 30, 2021, cash and cash equivalents amounted to 104.4 million.
  • Pascal Prigent, CEO of GENFIT, commented: This breakthrough strategic partnership with Ipsen marks the beginning of a new chapter for GENFIT.
  • Revenues for 2021 were 80.06 million compared to 0.76 million for 2020.

GENFIT: 2022 Financial Calendar

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월요일, 1월 24, 2022
Calendar, U.S. Securities and Exchange Commission, Biomarker, Patient, Research, Cholangiocarcinoma, Private Securities Litigation Reform Act, SEC, AMF, Safety, LabCorp, Chapter Two, Nasdaq, Review, NASH, History, Industry, United Kingdom, PBC, Company, Chronic liver disease, Cirrhosis, Liver disease, Primary biliary cholangitis, Annual report, Acquisition, Pharmaceutical industry, Euronext, ACLF

Publication of revenue and cash position at September 30, 2022

Key Points: 
  • Publication of revenue and cash position at September 30, 2022
    This calendar is subject to change.
  • GENFIT is a pioneer in liver disease research and development with a rich history and strong scientific heritage spanning more than two decades.
  • Its R&D is focused on three franchises: cholestatic diseases, Acute on Chronic Liver Failure (ACLF) and NASH diagnostics.
  • In ACLF, a Phase 1 clinical program with nitazoxanide has been initiated with data expected as early as the third quarter 2022.

On heels of global strategic partnership announced today, GENFIT acquires rights to novel asset

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금요일, 12월 17, 2021
Standard of care, Institute of Liver and Biliary Sciences, Primary biliary cholangitis, Acquisition, Primary sclerosing cholangitis, Autoimmunity, Review, Nasdaq, Probability, Heel, PBC, Disease, Autophagy, Bile, Growth, Biomarker, United Kingdom, Safety, AMF, GMT, Infection, U.S. Securities and Exchange Commission, Partnership, KOL, Lysosome, COVID-19, Cancer, SEC, Chronic liver disease, CEO, Research, Hepatolithiasis, Palmitoyl(protein) hydrolase, Liver cancer, Company, History, Private Securities Litigation Reform Act, Industry, Annual report, Risk, Ipsen, Patient, Mortality, Cirrhosis, Chapter Two, Pharmaceutical industry, Fine chemical, Euronext, Cholangiocarcinoma, Cholangiocarcinoma, ACLF, Squamous cell carcinoma

This announcement comes on the heels of todays other announcement on our global strategic pharma partnership.

Key Points: 
  • This announcement comes on the heels of todays other announcement on our global strategic pharma partnership.
  • GENFIT is also committed to take a 3 million equity stake in Genoscience Pharma through the subscription of new ordinary shares.
  • Pascal Prigent, CEO of GENFIT, stated: This licensing agreement with Genoscience Pharma comes as an immediate follow-up to the global strategic partnership announced today.
  • Proceeds from this strategic agreement will strengthen the trajectory of our long-term growth and pipeline expansion, which is exemplified by the acquisition of GNS561s rights in cholangiocarcinoma.

Versantis Appoints Mark Fitzpatrick, Seasoned Biotech Executive, as its New CEO

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월요일, 12월 20, 2021
Science, Biotechnology, Research, Pharmaceutical, Human Resources, Health, Professional Services, Clinical Trials, Mark (given name), Institute of Liver and Biliary Sciences, FDA, ACLF, ETH Zurich, Senior living, Board, Proteon Therapeutics, Growth, Â, Brain, Industry, Vincent, EMA, NASDAQ, Chronic liver disease, ODD, Liver, Arthur Andersen, CEO, Patient, CFO, Leadership, Liposome, Urea, Multimedia, Cirrhosis, U.S. FDA, Management, Pharmaceutical industry, Chiasm

He joins Versantis with more than 25 years of experience in the biopharma industry, primarily in senior executive roles, and will be based in the U.S. following the establishment of Versantis, Inc.

Key Points: 
  • He joins Versantis with more than 25 years of experience in the biopharma industry, primarily in senior executive roles, and will be based in the U.S. following the establishment of Versantis, Inc.
  • Mr. Fitzpatrick joined Versantis from Chiasma, Inc. a publicly traded, commercial-stage company recently acquired by Amryt PLC, where he held positions of increasing responsibility, including CFO, President and CEO.
  • Versantis is a clinical stage biotechnology company focused on addressing the growing, un-met medical need in liver diseases.
  • Versantis lead program, VS-01, is in clinical development as a first-line therapy for the timely reversal of acute-on-chronic liver failure (ACLF).

Versantis to Present Positive Phase 1b Data at AASLD for VS-01 in Patients with Decompensated Cirrhosis

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월요일, 11월 15, 2021
Health, Clinical Trials, Research, Pharmaceutical, Science, Biotechnology, American Association, Hepatic encephalopathy, Industry, American Association for the Study of Liver Diseases, Ascites, Cirrhosis, Safety, Institute of Liver and Biliary Sciences, Mark (given name), Goethe University Frankfurt, Non-alcoholic fatty liver disease, Prevalence, Urea, Mortality, PK, Section, Trial of the century, Standard of care, Research, Association, Internal, FDA, Brain, Ammonia, Public, PD, Health, CEO, ETH Zurich, Department, Liver, AASLD, Peritoneum, Drainage, Abstract, Pharmacokinetics, Obesity, Liposome, Peritoneal cavity, ODD, Part, U.S. FDA, EMA, Coma, Paracentesis, Board, Incidence, ACLF, Death, Diabetes, Chronic liver disease, Pharmaceutical industry, Medical imaging, Acute-on-Chronic Liver Failure (ACLF), Versantis, ACUTE-ON-CHRONIC LIVER FAILURE (ACLF), VERSANTIS

The data show that VS-01 was safe and well tolerated in these patients, and demonstrated promising early indications of efficacy in this clinical study.

Key Points: 
  • The data show that VS-01 was safe and well tolerated in these patients, and demonstrated promising early indications of efficacy in this clinical study.
  • The data show that VS-01 is safe and well tolerated in cirrhotic patients with ascites and covert (mild) hepatic encephalopathy, so very promising.
  • VS-01 represents a promising new therapeutic for the potential treatment of patients with ascites and acute complications of cirrhosis.
  • We are now preparing to initiate a multi-center Phase 2a study in patients with ACLF, a seriously underserved and under-resourced indication.

GENFIT: Third Quarter 2021 Financial Information

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월요일, 11월 8, 2021
Safety, Loos, Biomarker, Industry, Private Securities Litigation Reform Act, Chapter Two, IVD, U.S. Securities and Exchange Commission, Nasdaq, COVID-19, Research, AMF, Annual report, PSC, Institute of Liver and Biliary Sciences, Cirrhosis, PBC, Chronic liver disease, Company, NASH, ACLF, LabCorp, History, FRANCE, SEC, Primary sclerosing cholangitis, Review, Patient, Primary biliary cholangitis, Cryptocurrency, Pharmaceutical industry, Animal

As of September 30, 2021, the Companys cash and cash equivalents amounted to 91.5 million compared with 199.3 million a year earlier.

Key Points: 
  • As of September 30, 2021, the Companys cash and cash equivalents amounted to 91.5 million compared with 199.3 million a year earlier.
  • Revenues for the first nine months of 2021 amounted to 20 thousand compared to 350 thousand for the same period in 2020.
  • Patient enrolment is anticipated to be completed in the first quarter of 2022 and topline data is expected to be announced between the end of the first quarter and the end of the second quarter 2023.
  • Other than as required by applicable law, the Company does not undertake any obligation to update or revise any forward-looking information or statements, whether as a result of new information, future events or otherwise.

New Clinical Data on GENFIT’s Investigational Compound Elafibranor to be Presented at AASLD The Liver Meeting®

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화요일, 11월 2, 2021
Safety, AASLD, Research, FRANCE, Primary sclerosing cholangitis, PBC, Industry, Association, Institute of Liver and Biliary Sciences, Elafibranor, AMF, Chapter Two, Primary biliary cholangitis, History, Liver, Patient, Gastroenterology, American Association for the Study of Liver Diseases, Private Securities Litigation Reform Act, FDA, U.S. Securities and Exchange Commission, SEC, Review, Annual report, Liver disease, Nasdaq, Company, ACLF, Loos, Biomarker, COVID-19, Chronic liver disease, Cirrhosis, PSC, Pharmacokinetics, Cholestasis, American Association, Liver transplantation, NASH, IVD, Breakthrough therapy, The X Factor Digital Experience, Biliary tract, Pharmaceutical industry, Vaccine, Dietary supplement

Elafibranor was generally safe and well tolerated in this study, which is in keeping with previously conducted studies.

Key Points: 
  • Elafibranor was generally safe and well tolerated in this study, which is in keeping with previously conducted studies.
  • The pharmacokinetic data suggest that total drug exposure of elafibranor and its active metabolite are not significantly altered in hepatic impaired patients.
  • Data from a Phase 2 clinical trial demonstrated elafibranor has the potential to become an efficacious treatment in PBC, a rare liver disease.
  • Elafibranor is an investigational compound that has not been reviewed nor received approval by a regulatory authority.

Versantis Appoints Leading Hepatologist Prof Dr Katharina Staufer as Chief Medical Officer

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화요일, 10월 19, 2021
Health, Other Science, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, ODD, Cirrhosis, Center, Nature Reviews Gastroenterology & Hepatology, Liposome, Association, Internal medicine, Kidney, Institute of Liver and Biliary Sciences, EASL, Mark (given name), Medical school, EMA, ETH Zurich, American Association for the Study of Liver Diseases, Adult, Inselspital, Board, Professor, Center for Molecular Neurobiology Hamburg, AASLD, Molecular biology, Associate, FDA, CEO, Brain, Patient, University, Industry, University Medical Center, Gastroenterology, COO, University Medical Center Hamburg-Eppendorf, European Association for the Study of the Liver, U.S. FDA, ACLF, American Association, Medical University of Vienna, Therapy, University of Hamburg, Trial of the century, Medical imaging, Pharmaceutical industry

Versantis AG, a clinical-stage company developing novel therapies for rare liver diseases and rare pediatric diseases, today announced the appointment of Prof Dr Katharina Staufer as Chief Medical Officer.

Key Points: 
  • Versantis AG, a clinical-stage company developing novel therapies for rare liver diseases and rare pediatric diseases, today announced the appointment of Prof Dr Katharina Staufer as Chief Medical Officer.
  • Prof Staufer is a gastroenterologist and hepatologist with a strong clinical and scientific background in metabolic liver disease, liver cirrhosis and transplant hepatology, including orphan liver diseases.
  • We look forward to the contribution that Katharina will bring to unfold the full potential of VS-01 in our key adult and pediatric indications.
  • Versantis is a clinical stage company focused on addressing the growing, un-met medical need in liver diseases.