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Koers Genfit 2016

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  2. [verwijderd] 11 februari 2016 19:51

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    Hieronder de reden voor het koerhupje van vandaag?!

    Data from Phase 2b trial of GENFIT’s Elafibranor published in Gastroenterology

    The peer-review publication highlights the resolution of NASH without fibrosis worsening with 120mg Elafibranor

    This result is confirmed both in intention-to-treat population as well as in subgroups of moderate/severe NASH patients, based on the recommended definition of “NASH resolution” now used for clinical trials

    In addition, the publication confirms that Elafibranor significantly improved the cardiometabolic risk profile and was safe, well-tolerated

    Lille (France), Cambridge (Massachusetts, United States), February 11, 2016 – GENFIT (Euronext: GNFT - ISIN: FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases, that notably affect the liver or the gastrointestinal system, today announces that detailed results from the Phase 2b clinical trial evaluating GFT505 in NASH, the company’s investigational once-daily oral drug (first-in-class), have been published online in Gastroenterology, in advance of appearing in print in the May isssue. Key elements of context and content below :

    The GOLDEN-505 clinical trial was the first international trial on NASH, conducted in 56 centers spread across 9 countries, with the ambition to address the NASH burden using “resolution of NASH without worsening of fibrosis” as primary endpoint.

    The detailed results of the GOLDEN-505 trial represent an essential contribution to the global effort to address this disease related to the obesity and diabetes epidemics (and for this reason considered a priority by the regulatory agencies, as confirmed by the fast-track designation granted to Elafibranor, as well as by the Subpart H process applied to its Phase 3 trial).

    In the Phase 2b trial, GFT505/Elafibranor or a placebo was administered to patients with a histological diagnosis of NASH. The treatment was taken for 52 weeks. The inclusion and end-of-treatment biopsies were all read centrally in a blinded manner. At end of study, all slides (baseline and end-of-study) were read in scrambled order.

    The conclusions of the scientific publication take into account the new recommended definition of “NASH resolution”, which focuses on the necroinflammation, considered as the key driver of disease activity and progressive fibrosis towards cirrhosis (necroinflammation is defined as the combination of two important lesions in the liver : hepatocellular ballooning, and lobular inflammation).

    A key conclusion of the work carried out by the large team of worldwide specialists in the field of hepatology is that 120mg Elafibranor achieved resolution of NASH without fibrosis

    2

    worsening, in both intention-to-treat population and subgroups of moderate/severe NASH patients, based on the recommended definition of “NASH resolution” now used for clinical trials.

    Key results can be summarized as follows :

    120mg Elafibranor significantly increased resolution of NASH without fibrosis worsening (19% vs. 12%, OR=2.31, 95% CI [1.02,5.24], p=0.045) on the whole study population, in an analysis based on the new recommended definition for

    “NASH resolution”. In a subgroup of NAS=4 patients (N=234), 120mg Elafibranor performed better than placebo, regardless of the definition used for “NASH resolution” (20% vs. 11%, OR=3.16, 95% CI [1.22-8.13], p=0.018 ; and 19% vs. 9%, OR=3.52, 95% CI [1.32-9.40], p=0.013; for the predefined protocol definition and for the new recommended definition, respectively). o Patients with NASH resolution on 120mg Elafibranor improved liver fibrosis (mean reduction of the fibrosis score [b]-0.65±0.61 in responders vs. increase 0.10±0.98 for non-responders[/b], p<0.001). o In the 120mg Elafibranor group, liver enzymes and inflammatory markers have been reduced significantly; lipid and glucose profiles have also been improved.

    Elafibranor was well tolerated, without weight gain, without cardiac events, and with a mild and reversible increase in serum creatinine.

    The online version is available here :

    Elafibranor, an Agonist of the Peroxisome Proliferator-activated Receptor-a and -d, Induces Resolution of Nonalcoholic Steatohepatitis Without Fibrosis Worsening

    www.gastrojournal.org/article/S0016-5...

    Professor Vlad Ratziu, Principal Investigator of the GOLDEN-505 study, and Professor of Hepatology Hôpital Pitié Salpêtrière and Université Pierre et Marie Curie Paris, France, commented: “There is an urgent unmet medical need for a significant and increasing part of the population suffering from NASH, also known as nonalcoholic steatohepatitis. The large amount of data gathered in this first international trial has provided a breadth of information that the scientific community has already been able to use to discuss and define the future directions research should take in the field of NASH. The fact that these results get published today in Gastroenterology demonstrates how important this trial has been for the scientific and medical community, and how significant and positive Elafibranor’s activity could be for NASH patients.“

    COL (Dr.) Stephen Harrison, Hepatologist at Brooke Army Medical Center in San Antonio and Professor of Medicine, Uniformed Services University of the Health Sciences, commented: “Gastroenterology is a high impact journal and this publication represents a major milestone within the field of NASH. The data derived from this clinical trial showing improvement in both histopathology and cardiometabolic parameters, particularly in those patients with more advanced disease, have generated significant enthusiasm for an upcoming Phase 3 trial with Elafibranor. We are hopeful that NASH patients, who are already exposed to cardiometabolic risk,
  4. Terra2000 17 februari 2016 11:52

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    Seeking Alpha heeft weer eens een artikel geplaatst over Genfits NASH fase 2b.
    Mooi artikel het lezen zeker waard.
    seekingalpha.com/article/3899176-genf...

    Na al een aantal malen wat over Genfit gelezen te hebben, maar besloten ook in Genfit te stappen. 2016 moet tenslotte een belangrijk jaar worden voor ze worden.
    For all these reasons, we decided to launch the Phase III of Elafibranor in NASH at the end of 2015.
    2016 will therefore be a key year for its further development or co-development in this therapeutic
    indication.
    volgens Jean François Mouney, Chairman & CEO of GENFIT
    www.genfit.com/wp-content/uploads/201...
  6. [verwijderd] 29 februari 2016 10:03

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    quote:

    greenways schreef op 29 februari 2016 09:34:

    Open op 26, laag 25,70, nu in de mkt op bijna 29.
    Zie niets bij genfit zelf, iemand een idee?
    PRESS RELEASE
    1
    Not for publication or distribution in the United States, Canada, Australia
    or
    Japan.
    GENFIT
    RAISES EUR 49.6 MILLION IN PRIVATE PLACEMENT
    Lille (France), Boston (Massachusetts, United States), February 29, 2016
    –
    GENFIT (Euronext: GNFT ; ISIN : FR0004163111), a biopharmaceutical company at the forefront of developing therapeutic and diagnostic solutions in metabolic and inflammatory diseases that notably affect the liver or the gastrointestinal system, announces today that it has raised EUR 49.6 million in gross proceeds through a private placement to institutional investors, principally in the United States. Pursuant to the fifth resolution of the Shareholders General Meeting of February 24, 2015, GENFIT has placed 2,395,890 new shares at a price of EUR 20.70 per share. The offering represents 10% of the pre-transaction share capital and will bring the total number of shares after the issuance to 26,354,794, representing a dilution of 9.09% for the existing shareholders.The proceeds of this transaction will be used to:•continue the clinal development of Elafibranor/GFT505; •and for general corporate purposes.Jean-François Mouney, CEO, said: “We are very satisfied with the results of this private placement which shows that speciali
    zed healthcare investors appreciate the phase 2b results of Elafibranor in
    NASH, which has recently been accepted for publication in Gastroenterology, and fully recognize the potential of this drug. Our cash position is considerably strengthened and allows us to serenely
    advance with our strategy for development of the company.”The new shares will be fully fungible with GENFIT’s existing shares. Application has been made to list the new shares on Euronext Paris on the same line as GENFIT’s existing shares(ISIN Code FR0004163111). The settlement-delivery of the new shares is expected to take place on March 2, 2016. The capital increase was carried out without shareholders’ preferential subscription rights pursuant to Article L.225-136 of the French Commercial Code and the fourth and fifth resolutions of the Shareholders General Meeting of February 24, 2015. As the capital increase represents less than 10% of GENFIT’s outstanding share capital, no prospectus has been established for the purpose of the listing of the shares on Euronext Paris.

    You can find the above information at Genfit's website under press releases
  10. [verwijderd] 20 maart 2016 09:43

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    quote:

    greenways schreef op 16 maart 2016 14:16:

    [...]

    Helaas niet aan de koers te zien.
    Klopt de koersontwikkeling valt mij ook tegen wat de reden hiervan is blijft gissen
  11. @ out of the blue 31 maart 2016 14:09

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    NEW YORK, March 31 (Reuters) - French drugmaker Genfit SA GNFT.PA on Thursday said it would begin a midstage trial this year of its experimental drug elafibranor to treat primary biliary cholangitis, a chronic disease in which bile ducts in the liver are gradually destroyed.
    The company is already enrolling a 2,000-patient Phase III trial of elafibranor for the fast-growing fatty liver disease nonalcoholic steatohepatitis, or NASH, which is driven by obesity, diabetes and over-indulgent lifestyles and can lead to cirrhosis, liver failure and cancer.
    Genfit expects the late-stage trial for NASH to be completed by mid-2018 with possible approval a year later in a market some analysts have said could grow to as much as $40 billion, with effective drugs racking up annual sales of $10 billion each.
    "We think we can take 50 percent of the (NASH) market," Genfit Chief Executive Jean-Francois Mouney told Reuters.
    Mouney said Genfit decided to also go after the far smaller primary biliary cholangitis (PBC) market because it believes its drug offers advantages over treatments from likely competitors, such as Intercept Pharmaceuticals Inc ICPT.O, and because most patients are not helped by current treatments.
    The damage from PBC can inhibit the liver's ability to rid the body of toxins, and can lead to scarring of liver tissue known as cirrhosis.
    In earlier trials, the Genfit drug led to reductions in "bad" LDL cholesterol, triglycerides and blood sugar. Some potential rival drugs have caused LDL increases in clinical trials.
    A panel of advisers to the U.S. Food and Drug Administration is scheduled next week to decide whether to recommend approval of Intercept's drug for PBC.
    The Genfit PBC trial will test its one pill, once-a-day drug in patients who do not tolerate or do not respond sufficiently to the current standard treatment with ursodeoxycholic acid. That can be as many as 70 percent of PBC patients, Genfit said.
    After discussions with experts in the field, we have decided "that PBC is the next logical target in our development plan," Mouney said in a statement.
    The company made the announcement at a meeting in New York to discuss its research and development plans.
    Genfit said it will work with regulatory agencies to determine the study goals and design in the coming months, with the aim of beginning the trial before the end of the year.
  13. Terra2000 5 april 2016 11:40

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    Als het is omdat Gilead Nimbus Apollo heeft aangekocht voor zijn NASH programma die pas in fase 1 zit, lijkt mij deze koersreactie behoorlijk overtrokken.
  18. egeltjemetstekel 11 april 2016 01:14

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    quote:

    Brouya schreef op 10 april 2016 20:27:

    Koersverdiedubbeling voor 2019 is een optie:

    www.nashbiotechs.com/nash-biotech-ana...
    en als je naar de opticien gaat en vraagt of ie een bril voor je heeft waarmee je driedubbel scheel kunt zien heb je veel sneller een koersverdriedubbeling. ;-)
  19. Terra2000 2 mei 2016 21:05

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    Ik kom zo juist weer een artikel tegen van Logribel Biostocks in Seeking Alpha over NASH met daarin natuurlijk Genfit als een belangrijk medespeler op dit terrein met hun in de 3e fase verkerende onderzoek Elafibranor.
    Het is al een publicatie van 6 april, maar ik geloof niet dat deze hier al is geplaatst of besproken.
    Dus bij deze
    seekingalpha.com/article/3963505-nash...
  20. [verwijderd] 3 mei 2016 12:27

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    quote:

    Terra2000 schreef op 2 mei 2016 21:05:

    Ik kom zo juist weer een artikel tegen van Logribel Biostocks in Seeking Alpha over NASH met daarin natuurlijk Genfit als een belangrijk medespeler op dit terrein met hun in de 3e fase verkerende onderzoek Elafibranor.
    Het is al een publicatie van 6 april, maar ik geloof niet dat deze hier al is geplaatst of besproken.
    Dus bij deze
    seekingalpha.com/article/3963505-nash...
    Bedankt voor het plaatsten

    De shorters zijn nu toch geleidelijk hun posities aan het afbouwen
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