Elafibranor

GENFIT Announces Revenues and Cash Position as of December 31, 2023

Retrieved on: 
Thursday, February 29, 2024
Marketing, EMA, New Drug Application, MAA, Annual report, FDA, Food, Part, PDUFA, NTZ, PBC, Primary biliary cholangitis, Collaboration, European Medicines Agency, Patient, Elafibranor, NDA, Research, Priority review, Pharmaceutical industry

As of December 31, 2023, the Company’s cash and cash equivalents amounted to €77.8 million compared with €140.2 million as of December 31, 2022.

Key Points: 
  • As of December 31, 2023, the Company’s cash and cash equivalents amounted to €77.8 million compared with €140.2 million as of December 31, 2022.
  • As of September 30, 2023, cash and cash equivalents totaled €93.9 million.
  • Revenues for 2023 amounted to €28.6 million compared to €20.2 million for the same period in 2022.
  • The 2023 Universal Registration Document, the 2023 Annual Financial Report (included in the 2023 Universal Registration Document), and the Annual Report on Form 20-F will be published by the end of April 2024.

Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC

Retrieved on: 
Thursday, December 7, 2023
Liver, Ascending cholangitis, Ipsen, Food, Itch, Health care, Woman, FDA, EMA, MAA, PDUFA, Primary biliary cholangitis, Bile, Fatigue, NDA, Elafibranor, MHRA, ADR, New Drug Application, European Medicines Agency, Common, IPN, PPAR, Liver failure, Patient, Medicine, EVP, PBC, CHMP, Pharmaceutical industry

New Drug Application granted priority review with PDUFA date set for June 10, 2024

Key Points: 
  • New Drug Application granted priority review with PDUFA date set for June 10, 2024
    Investigational elafibranor is the first novel second-line treatment for primary biliary cholangitis (PBC) to be filed in E.U.
  • An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.
  • The target FDA PDUFA date under priority review is June 10, 2024.
  • “This is a condition where many patients are living with worsening disease and debilitating symptoms despite being on treatment.

Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBC

Retrieved on: 
Thursday, December 7, 2023
Liver, UDCA, Chapter Two, Woman, FDA, MAA, Fatigue, Nausea, Primary biliary cholangitis, Inflammation, ADR, Patent, Liver disease, Diagnosis, AMF, CHMP, Ascending cholangitis, UCD, Business, ACLF, PDUFA, Itch, Risk, New Drug Application, OA, Common, EASL, MASH, Liver failure, Safety, Ammonia, Elafibranor, Therapy, Epidemiology, History, Patient, Cholangiocarcinoma, Food, Health care, EMA, Ursodeoxycholic acid, MHRA, Cirrhosis, Medicine, NTZ, EVP, Cholestasis, NASH, Research, Diarrhea, Bile, NDA, PBC, Abdominal pain, Clinical trial, European Medicines Agency, IPN, PPAR, P10, CCA, Fibrosis, Pharmaceutical industry

An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.

Key Points: 
  • An oral, once-daily dual peroxisome activated receptor alpha/delta (PPAR α,δ) agonist, investigational elafibranor could potentially be the first novel second-line treatment for the rare, cholestatic liver disease, PBC, in nearly a decade.
  • The trial enrolled 161 patients who were randomized 2:1 to receive either elafibranor 80mg once daily or placebo.
  • ELATIVE also investigated the effect of treatment with elafibranor on pruritus (severe itch), a significant symptom burden amongst people living with PBC.
  • Findings from the secondary endpoint using the PBC Worst Itch NRS score, showed a reduction in pruritis for elafibranor, which was not statistically significant.

GENFIT Highlights ACLF Development Strategy at “ACLF Day” during AASLD The Liver Meeting® 2023

Retrieved on: 
Thursday, November 16, 2023
Multiple organ dysfunction syndrome, Primary biliary cholangitis, Permeability (electromagnetism), Hepatic encephalopathy, PBC, AASLD, IND, Disease, Mortality, Cirrhosis, Elafibranor, UCSF, Patient, Heart, Liver, ASK1, Caregiver, NTZ, Chronic liver disease, Cell death, MBA, MD, University, Transplant, Doctor of Philosophy, Microbiota, Fibrosis, Ipsen, University of California, European Foundation, Human, Inflammation, Pharmaceutical industry, ACLF, Hyperammonemia, Boston, Euronext

GENFIT is now mainly focused on the development of therapies for ACLF which is an area of very high unmet medical need.

Key Points: 
  • GENFIT is now mainly focused on the development of therapies for ACLF which is an area of very high unmet medical need.
  • ACLF is a potentially deadly, but reversible, condition in patients with chronic liver diseases, which is associated with multi-organ failure and high short-term mortality.
  • Pascal Prigent, CEO of GENFIT, commented: “During AASLD we were excited to further discuss our development strategy around our new pipeline focused on ACLF, where we believe multiple programs have the potential to transform the treatment paradigm for these patients.
  • As part of the “ACLF Day” event during AASLD, the critical need for treatment has been highlighted by leading experts in ACLF.

Results from Ipsen’s ELATIVE® pivotal Phase III trial of elafibranor in PBC presented as late breaking data at AASLD congress and published in New England Journal of Medicine

Retrieved on: 
Monday, November 13, 2023
Primary biliary cholangitis, ALP, Safety, IPN, NEJM, PBC, AASLD, PPAR, Patient, Abstract, Liver disease, Alkaline phosphatase, Elafibranor, Biomarker, Ipsen, ADR, Itch, HIV disease progression rates, Medical device, Euronext

ELATIVE® Phase III trial confirms potential for investigational elafibranor as a novel, first-in-class, dual PPAR α,δ agonist for patients with primary biliary cholangitis.

Key Points: 
  • ELATIVE® Phase III trial confirms potential for investigational elafibranor as a novel, first-in-class, dual PPAR α,δ agonist for patients with primary biliary cholangitis.
  • “When managing PBC our first goal is to effectively control the disease progression which can lead to liver failure.
  • Data from ELATIVE demonstrated the possibility of improved pruritus for patients taking elafibranor compared with those on placebo.
  • Data from ELATIVE are being used to support submissions for elafibranor as a treatment for PBC with regulatory authorities worldwide.

GENFIT: Results from Ipsen’s ELATIVE® pivotal Phase III trial of elafibranor in PBC presented as late breaking data at AASLD congress and published in New England Journal of Medicine

Retrieved on: 
Monday, November 13, 2023
Hepatology, ALP, Safety, IPN, NEJM, PBC, AASLD, PPAR, Patient, Abstract, Alkaline phosphatase, Elafibranor, Biomarker, Ipsen, ADR, Primary biliary cholangitis, Itch, HIV disease progression rates, Medical device, Euronext

ELATIVE® Phase III trial confirms potential for investigational elafibranor as a novel, first-in-class, dual PPAR α,δ agonist for patients with Primary Biliary Cholangitis.

Key Points: 
  • ELATIVE® Phase III trial confirms potential for investigational elafibranor as a novel, first-in-class, dual PPAR α,δ agonist for patients with Primary Biliary Cholangitis.
  • Data from ELATIVE® demonstrated the possibility of improved pruritus for patients taking elafibranor compared with those on placebo.
  • Adverse events occurring in >10% of patients and more frequently on elafibranor versus placebo included abdominal pain, diarrhea, nausea, and vomiting.
  • Data from ELATIVE® are being used to support submissions for elafibranor as a treatment for PBC with regulatory authorities worldwide.

GENFIT Reports Full-Year 2022 Financial Results and Provides Corporate Update

Retrieved on: 
Thursday, April 13, 2023
KRAS, US Foods, Hepatic encephalopathy, Safety, MEK, Journal, Acquisition, Patient, Disease, NASH, PBC, Drug discovery, UCD, Methylmalonic acidemia, Pharmacokinetics, HE, American Association for the Study of Liver Diseases, Primary biliary cholangitis, Orphan drug, Ascites, Diagnosis, FDA, Cirrhosis, IND, Conference, Cholangiocarcinoma, Conference call, CCA, SOC, Liver, OA, Standard of care, English, Metabolism, Hepatology, Bank statement, NTZ, Elafibranor, Liver support system, Kidney, Itch, Chronic liver disease, Poster, Food, Pharmaceutical industry, Rare-earth element, Ipsen, ACLF, Euronext

Throughout 2022 GENFIT and Ipsen stepped up their collaboration in order to minimize the time to filing as well as prepare for the commercial launch next year, if approved.

Key Points: 
  • Throughout 2022 GENFIT and Ipsen stepped up their collaboration in order to minimize the time to filing as well as prepare for the commercial launch next year, if approved.
  • In September 2022, GENFIT acquired clinical-stage biopharmaceutical company Versantis based in Zurich (Switzerland), significantly expanding its pipeline.
  • Two Pipeline Days were organized in October 2022 in Paris and New York, to present these programs in detail.
  • In October 2022, GENFIT announced the development of NIS2+TM, a next-generation technology for the diagnosis of at-risk NASH, and the presentation of results on NIS2TM+’s clinical performance in three poster presentations at The Liver Meeting® 2022 organized by the AASLD2.

The Worldwide Non-Alcoholic Steatohepatitis Industry is Projected to Reach $15 Billion by 2027 - ResearchAndMarkets.com

Retrieved on: 
Monday, January 9, 2023
Health, Other Health, ASK1, Elafibranor, Fatty liver disease, FDA, Vitamin E, Diagnosis, Application, Prevalence, Distribution, Pharmacy, Liver, Pioglitazone, Investment, NASH, Obesity, Pharmaceutical industry

Elafibranor non-alcoholic steatohepatitis market is the fastest growing segment of global non-alcoholic steatohepatitis market in the forecasted period of 2023-2027 owing to positive impact of elafibranor in NASH treatment during clinical trials and drug's capability to reduce fat substance of liver, improving the conditions caused by NASH.

Key Points: 
  • Elafibranor non-alcoholic steatohepatitis market is the fastest growing segment of global non-alcoholic steatohepatitis market in the forecasted period of 2023-2027 owing to positive impact of elafibranor in NASH treatment during clinical trials and drug's capability to reduce fat substance of liver, improving the conditions caused by NASH.
  • By Application Type: The report provides the bifurcation of the market into two segments based on application type: treatment and diagnosis.
  • By Region: The report provides insight into the non-alcoholic steatohepatitis (NASH) market based on the regions namely North America, Europe, Asia Pacific, Middle East & Africa, and Latin America.
  • The Asia Pacific non-alcoholic steatohepatitis market is further divided into six regions on the basis of geographical operations, namely, China, India, Japan, Australia, South Korea and Rest of Asia Pacific, where China non-alcoholic steatohepatitis market held the largest share in Asia Pacific non-alcoholic steatohepatitis market.

Global Non-Alcoholic Steatohepatitis Market Forecast to 2028 - Includes Performance Analyses of Leading Players Intercept Pharmaceuticals and Galmed Pharmaceuticals - ResearchAndMarkets.com

Retrieved on: 
Thursday, June 2, 2022
Health, Pharmaceutical, Hyperlipidemia, Chronic liver disease, Elafibranor, American Liver Foundation, Pharmacy, Liver cancer, Vitamin E, NASH, Obesity, NAFLD, Awareness, 25, American Association of Clinical Endocrinologists, American Association, Pioglitazone, Risk, Markov, COVID-19, Diagnosis, Cirrhosis, Prevalence, Association, Institute of Liver and Biliary Sciences, Fatty liver disease, Liver transplantation, CAGR, Pharmaceutical industry, Dietary supplement, Application

Major factors driving the non-alcoholic steatohepatitis (NASH) market growth include the rising prevalence of NASH and increasing initiatives for the awareness of NASH.

Key Points: 
  • Major factors driving the non-alcoholic steatohepatitis (NASH) market growth include the rising prevalence of NASH and increasing initiatives for the awareness of NASH.
  • The non-alcoholic steatohepatitis (NASH) market, by product, is segmented into vitamin E and pioglitazone, ocaliva, elafibranor, selonsertib & cenicriviroc, and others.
  • The selonsertib & cenicriviroc segment is expected to register the fastest CAGR in the non-alcoholic steatohepatitis (NASH) market during the forecast period.
  • Moreover, it is expected to register the highest CAGR in the non-alcoholic steatohepatitis (NASH) market during 2021-2028.

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

Retrieved on: 
Thursday, April 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.