GENFIT S.A. (GNFT) News
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GNFT News Highlights
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Latest GNFT News From Around the Web
Below are the latest news stories about GENFIT SA that investors may wish to consider to help them evaluate GNFT as an investment opportunity.
GENFIT Updates 2024 Outlook Following Acceptance of Elafibranor Filings in Primary Biliary Cholangitis (PBC)US Food and Drug Administration (FDA) has granted Priority Review for New Drug Application (NDA) for elafibranor in PBC, and European Medicine Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor.Acceptance triggers a first milestone payment. Further milestones are expected upon US and European launches which could now happen in 2Q24 in the US (FDA PDUFA1 action date: June 10, 2024) and 2H24 in Europe. These milestones total approximately 89M€. Launches i |
Ipsen confirms U.S. FDA grants priority review for New Drug Application for elafibranor for the treatment of rare cholestatic liver disease, PBCNew Drug Application granted priority review with PDUFA date set for June 10, 2024European Medicines Agency (EMA) has also validated the Marketing Authorization Application (MAA) for elafibranor Investigational elafibranor is the first novel second-line treatment for primary biliary cholangitis (PBC) to be filed in E.U. and U.S. in nearly a decade Paris (France), December 07, 2023 – Ipsen (Euronext: IPN; ADR: IPSEY) and GENFIT (Nasdaq and Euronext: GNFT) today announced that the U.S. Food and Dr |
GENFIT Announces Publication in the Journal of Hepatology on the Accurate Performance of NIS2+™ as a Screening Tool for the Enrollment of Patients in MASH Clinical TrialsThe paper published in Journal of Hepatology demonstrates that NIS2+™ technology could significantly reduce liver biopsy failure rate and maximizes accuracy of patient selection for MASH1 clinical trialsGrowing body of clinical evidence: this is the third paper on NIS2+™ that has been published in a leading medical journal in 2023 Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), December 6, 2023- GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical co |
GENFIT Highlights ACLF Development Strategy at “ACLF Day” during AASLD The Liver Meeting® 2023GENFIT highlighted new focus and development strategy in Acute On-Chronic Liver Failure (ACLF)ACLF is a very serious condition affecting ~294,0001 2 patients with chronic liver diseases in the USA and Europe every year and is associated with multi-organ failure and high short-term mortalityIt is an underserved medical condition with currently no approved treatment and few programs under development globallyGENFIT has developed a unique pipeline of 5 different drug candidates targeting key pathop |
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 MedicineELATIVE® 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.Elafibranor demonstrates significant improvements in biomarkers of disease progression versus placebo, including significant treatment benefit with improvement in biochemical response and alkaline phosphatase (ALP) normalization, along with patient-reported outcomes data suggesting a possible improvement in pruritus.Elafibrano |
GENFIT Reports Third Quarter 2023 Financial InformationCash and cash equivalents totaled €93.9 million as of September 30, 2023 Lille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); November 9, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and life-threatening liver diseases, today announced its cash position as of September 30, 2023 and revenue for the first nine months of 20231. Cash Position As of September 30, 2023, the Company’s |
GENFIT to Present Update on Scientific and Corporate Progress at The Liver Meeting® 2023GENFIT to lead 3 key events on ACLF during AASLD: ACLF Day for Investors/Analysts on November 11, 2023Patient Advocacy Council meeting on November 11, 2023ACLF Investigator event on November 12, 2023 Detailed interim data from the ELATIVE® Phase 3 results evaluating elafibranor in PBC to be presented by GENFIT’s partner Ipsen, in a late breaking oral session on November 13, 2023GENFIT to present new data on its NASH1 diagnostics technology Lille (France), Cambridge (Massachusetts, United States) |
GENFIT Announces Publication in Nature Medicine Confirming the Performance of its NASH Diagnostic TechnologyLille (France); Cambridge (Massachusetts, United States); Zurich (Switzerland); September 26, 2023 - GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with rare and severe liver diseases, today announced the publication of data demonstrating the effectiveness of its non-alcoholic steatohepatitis (NASH)1 diagnostic technology NIS4® by the FNIH’s2 NIMBLE3 project in the scientific journal, Nature Medicine4. NIMBLE, part of the F |
GENFIT S.A. Unsponsored ADR (GNFT) May Find a Bottom Soon, Here's Why You Should Buy the Stock NowAfter losing some value lately, a hammer chart pattern has been formed for GENFIT S.A. Unsponsored ADR (GNFT), indicating that the stock has found support. This, combined with an upward trend in earnings estimate revisions, could lead to a trend reversal for the stock in the near term. |
GENFIT Reports First Half-Year 2023 Financial Results and Provides Corporate UpdateCash, cash equivalents and current financial assets totaled €111.8 million as of June 30, 2023 Positive results in the pivotal Phase 3 ELATIVE® trial in June 2023, paving the way to: a potential submission to the health authorities by Ipsen, and a potential first milestone met before the end of 2023, and if approved, commercialization would trigger further milestone payments and royalty payments GENFIT’s leadership in ACLF is further strengthened, with now 5 complementary assets in development, |