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Genfit - 2023

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  8. forum rang 10 DeZwarteRidder 30 mei 2024 10:53

    • DeZwarteRidder

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    quote:

    Vileine schreef op 30 mei 2024 10:45:

    Verklaar je nader DZW,
    Een misbruiker van voorkennis wil niet opvallen, want dan gaat hij regelrecht naar de gevangenis.
  10. forum rang 10 DeZwarteRidder 30 mei 2024 11:05

    • DeZwarteRidder

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    quote:

    Vileine schreef op 30 mei 2024 10:59:

    Heb je dan een andere verklaring voor deze stijging van het aandeel Genfit?
    Ja, een grote koper, die denkt dat Genfit een goede koop is.
  13. Vileine 30 mei 2024 12:40

    • Vileine

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    Volgens het forum van Boursorama:
    Kortom: Genfit heeft een theoretische waardering van €1 miljard, oftewel een koersdoel van €20.
    ?Verwachte gebeurtenissen: FDA MA (10 juni) + EMA MA (??) + positieve ACLF P2 resultaten die volgende week op het EASL-congres zullen worden gepresenteerd
  15. Vileine 30 mei 2024 13:19

    • Vileine

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    Op hety Franse forum Boursorama wordt dat door sommige forumleden wel verwacht, omdat Ipsen al 8% van Genfit in zijn bezit heeft.
  16. forum rang 10 DeZwarteRidder 30 mei 2024 14:50

    • DeZwarteRidder

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    About GENFIT

    We are a late-stage biopharmaceutical Company dedicated to improving the lives of patients with rare and life-threatening liver diseases characterized by high unmet medical needs.

    We are a pioneer in the discovery and development of drugs targeting liver diseases, with a longstanding history and strong scientific heritage spanning more than two decades. Thanks to our expertise in bringing early-stage assets with high potential to late-stage development and to our strong track record to develop long term collaboration and partnerships, today we boast a growing and diversified pipeline of innovative therapeutic and diagnostic solutions.

    We are a world leader in Acute-on-Chronic Liver Failure (ACLF) and its associated medical complications, with five assets in development based on differentiated mechanisms of action leveraging complementary pathways.

    Given the high unmet medical need in this indication, some of these programs may qualify for some of the expedited regulatory pathways provided by health authorities

    www.genfit.com/
  20. forum rang 10 DeZwarteRidder 11 juni 2024 07:28

    • DeZwarteRidder

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    GENFIT: Historic Milestone Achieved with U.S. FDA Accelerated Approval of Ipsen’s Iqirvo® for Primary Biliary Cholangitis
    June 10, 2024
    PDF Version

    Ipsen’s Iqirvo® (elafibranor) 80 mg tablets receives U.S. FDA accelerated approval as a first-in-class treatment for Primary Biliary Cholangitis (PBC)
    First-ever drug developed in-house by GENFIT to achieve U.S. FDA’s approval
    GENFIT is eligible to receive a €48.7 million milestone payment from Ipsen upon the first commercial sale of Iqirvo in the U.S., as well as tiered double-digit royalties of up to 20%

    Lille (France), Cambridge (Massachusetts, United States), Zurich (Switzerland), June 10, 2024 - 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 the achievement of a historic corporate milestone: the U.S. Food and Drug Administration (FDA) accelerated approval of Iqirvo1 (elafibranor)2 80 mg tablets – as unveiled today by Ipsen (Euronext: IPN; ADR: IPSEY) – as a first-in-class treatment for PBC in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA, or as monotherapy in patients unable to tolerate UDCA.

    Elafibranor will be marketed and commercialized by Ipsen under the trademark Iqirvo and may be prescribed immediately in the U.S. for eligible patients.

    This indication is approved under accelerated approval based on reduction of alkaline phosphatase (ALP). Improvement in survival or prevention of liver decompensation events have not been demonstrated. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s). Iqirvo is not recommended for people who have or who develop decompensated cirrhosis (e.g., ascites, variceal bleeding, hepatic encephalopathy).

    Pascal Prigent, CEO of GENFIT, commented: “This approval is a source of pride for all GENFIT employees. We took elafibranor (Iqirvo) all the way from drug discovery to the end of Phase 3 and now, thanks to our partnership with Ipsen, it will be made available to healthcare providers in the US and ultimately provide patients with a valuable therapeutic alternative. The upcoming launch is both a major achievement and the beginning of a new chapter, as we expect that the revenues derived from the commercialization of elafibranor will now finance the development of a new and exciting portfolio of programs focused on ACLF.”

    In 2024, as previously communicated, GENFIT expects to receive total milestone payments from Ipsen of approximately €89 million, including €48.7 million upon the first commercial sale of Iqirvo in the U.S., and a €13.3 million milestone payment which was invoiced in December 2023, and received in February 2024.

    These revenues present GENFIT with new financial opportunities and will help to finance our strategic pivot towards Acute on-Chronic Liver Failure (ACLF) and other liver diseases.
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