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Home  /  Forum  /  Genfit  /  Genfit 2018

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Aandeel Genfit PSE:GNFT.FR, FR0004163111

  • 3,160 19 apr 2024 17:35
  • -0,025 (-0,78%) Dagrange 3,130 - 3,190
  • 60.592 Gem. (3M) 154K

Genfit 2018

82 Posts
Pagina: «« 1 2 3 4 5 »» | Laatste | Omlaag ↓
  1. forum rang 4 Lingus 31 augustus 2018 12:06
    quote:

    DeZwarteRidder schreef op 28 augustus 2018 08:39:

    [...]
    Waar blijft het geneesmiddel tegen NASH...???

    Zijn ze er stiekem mee gestopt ofzo...???
    Among those milestones, three programs (GENFIT, GILEAD and INTERCEPT PHARMACEUTICALS) have achieved full patient enrollment (Subpart H) for their on-going phase 3 trial in NASH, and should announce top-line results as early as next year that could lead to the first FDA- and EMAapproved drugs in the NASH space.
    Of these most advanced molecules, GENFIT’s elafibranor is the only drug-candidate that has been able to show in a Phase 2b trial (Ratziu et al., Gastroenterology, 2016) a combination of:
    - Efficacy on “NASH resolution without worsening of fibrosis” (26% vs 5%; p-value 0,02): o biopsy-based regulatory approved endpoint for phase 3 clinical trials o based on a strong rationale, as reducing hepatocellular ballooning and inflammation is known to be correlated with fibrosis improvement - Beneficial cardiovascular profile (LDL, TG, HDL, insulin resistance) - Clean safety and tolerability
  2. forum rang 10 DeZwarteRidder 19 september 2018 16:06
    Viking Therapeutics stock up after promising results for fatty liver drug
    By Cristin Flanagan Sep. 18, 2018
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    Shares of Viking Therapeutics soared 87 percent Tuesday to close at $19.46 after the company said initial results for an experimental therapy for fatty liver disease exceeded investors’ expectations.

    Viking’s medicine, VK2809, cut the bad cholesterol, or low-density lipoprotein, as well as liver fat more than the placebo, the study showed. Ten milligrams of the therapy was shown by MRI to cut liver fat by 57 percent when taken every other day and by 60 percent when taken once a day. Results from the 12-week study of both doses showed liver fat was cut by roughly 30 percent or more in roughly 83 percent of patients, compared with 18 percent with the placebo.

    Shares of the San Diego company have soared in the past 12 months, climbing more than 750 percent as data from Madrigal Pharmaceuticals spurred the rally. Both companies are developing similar drugs belonging to the same class of liver-directed thyroid hormone receptor agonists.

    While Viking’s results were in non-alcoholic fatty liver disease, the company plans to move VK2809 forward in a more severe form of the disease known as non-alcoholic steatohepatitis, where there is also inflammation and liver damage, in addition to built-up fat in the liver, Chief Executive Officer Brian Lian said.

    The severe form of the disease, which is occurring more with ever-increasing rates of obesity, is expected to be a multibillion-dollar market, and drug companies are racing to find new treatments for the disease. Viking still needs to make a final report of the study results before talking to the Food and Drug Administration, which Lian expects to happen in the first half of 2019.

    The next step for Viking after clearing a plan with the agency will be a combined mid- to late-stage study where patients get liver biopsies at the beginning and end of the study.

    “Madrigal and others have shown that liver fat reductions seem to be similar across disease severity,” Lian said. He believes a study solely in non-alcoholic steatohepatitis patients will produce results similar to the current data.

    Meanwhile, comparisons to Madrigal’s results are already being made. Viking’s drug looks “best in class,” William Blair analyst Andy Hsieh wrote in a note to clients. While acknowledging the caveats of comparing across trials, he said VK2809 appears to be “numerically better” when compared with the up to 42 percent cut in liver fat from a separate mid-stage study of Madrigal’s drug. Madrigal shares dropped 9 percent to $207.30.

    Viking’s results have been submitted to the American Association for the Study of Liver Diseases, which will meet in San Francisco Nov. 9-13.
  9. [verwijderd] 6 december 2018 10:11

    Impressive results this morning from Genfit's PBC clinical trials. See below some memorable comments from the experts:

    Dr. Velimir A. Luketic, MD, Division of Gastroenterology, Hepatology and Nutrition Virginia Commonwealth University School of Medicine, Richmond, VA (USA), commented: “The data emerging from this clinical trial are very impressive, particularly the substantial reduction in ALP in just 12 weeks”

    Dr. Jörn Schattenberg, MD, Division of Gastroenterology and Hepatology, University Medical Center, Mainz (Germany) further added: “The study data are impressive and support the rationale for elafibranor’s PPAR alpha/delta approach in PBC. Not only does elafibranor greatly reduce ALP, which is arguably the most important prognostic marker for PBC patients, but it also improves many other biochemical parameters and may reduce pruritus. With these benefits, elafibranor has the potential to offer patients significant advantages over existing treatments.”



    For full news report:
    www.genfit.com/wp-content/uploads/201...

  14. forum rang 10 DeZwarteRidder 18 mei 2019 20:44
    quote:

    MZ schreef op 18 mei 2019 20:12:

    Wat is het stil hier bij het Genfit forum. Lijkt mij toch een ruwe diamant met een giganitsch koerspotentieel als hun NASH middel op de markt komt. De resultaten zien er in ieder geval goed uit.
    Hun NASH-middel zal nooit op de markt komen; hun andere geneesmiddel misschien wel.
  15. forum rang 4 Lingus 23 mei 2019 17:15
    Ik twijfel over Genfit, gezien de laatste publicaties van analisten op SeekingAlpha, de koers die maar niet boven de €24 wil komen en de tijd tot de eerstvolgende NASH resultaten, komt pas over een half jaar. Ik heb de twijfels omgezet in daden en GNFT verkocht, eergisteren. Hopelijk voor de zittenblijvers krijg ik ongelijk, maar ik kan het vrijgekomen geld beter in iets veelbelovender stoppen, al ben ik er nog niet uit waarin, verschillende opties staan open.
  17. forum rang 10 DeZwarteRidder 25 mei 2019 13:05
    quote:

    MZ schreef op 18 mei 2019 20:12:

    Wat is het stil hier bij het Genfit forum. Lijkt mij toch een ruwe diamant met een giganitsch koerspotentieel als hun NASH middel op de markt komt. De resultaten zien er in ieder geval goed uit.
    Je weet toch dat hun NASH-middel bijna net zo goed werkzaam was als het placebo....???
  18. [verwijderd] 27 mei 2019 08:59
    GENFIT Launches a Combination Therapy Clinical Program in NASH

    GENFIT has identified multiple therapeutic compounds synergistic with its lead asset, elafibranor (PPAR alpha/delta), for the treatment of NASH

    Combined metabolic mechanisms could offer optimal benefits by addressing the underlying drivers of NASH disease progression and its downstream consequence, fibrosis, through complementary pathways

    A proof of concept study will initiate in 2H19 to evaluate safety, tolerability and exploratory markers of efficacy of a GLP-1 receptor agonist or an SGLT2 inhibitor in combination with elafibranor as backbone therapy

    This program will leverage non-invasive diagnostic tools, including GENFIT’s NIS4, an innovative diagnostic blood test for NASH identification and monitoring

    www.globenewswire.com/news-release/20...
  19. forum rang 10 DeZwarteRidder 27 mei 2019 10:53
    quote:

    Brouya schreef op 27 mei 2019 08:59:

    GENFIT Launches a Combination Therapy Clinical Program in NASH

    GENFIT has identified multiple therapeutic compounds synergistic with its lead asset, elafibranor (PPAR alpha/delta), for the treatment of NASH

    Combined metabolic mechanisms could offer optimal benefits by addressing the underlying drivers of NASH disease progression and its downstream consequence, fibrosis, through complementary pathways

    A proof of concept study will initiate in 2H19 to evaluate safety, tolerability and exploratory markers of efficacy of a GLP-1 receptor agonist or an SGLT2 inhibitor in combination with elafibranor as backbone therapy

    This program will leverage non-invasive diagnostic tools, including GENFIT’s NIS4, an innovative diagnostic blood test for NASH identification and monitoring
    www.globenewswire.com/news-release/20...
    Genfit geeft dus nu officieel toe dat hun NASH-middel alleen werkt in combinatie met andere middelen.
  20. [verwijderd] 5 juni 2019 08:19
    Genfit: GENFIT Launches a Phase 2 Trial Evaluating Elafibranor on Hepatic Lipid Composition for NAFL

    Elafibranor, a PPAR alpha/delta agonist, is currently the only late-stage, Phase 3 (RESOLVE-IT) therapy undergoing investigation for “NASH resolution without the worsening of fibrosis” (approved regulatory endpoint for Phase 3 trials), and could be the first therapy able to eliminate the underlying cause of NASH disease progression. The results from the P2b GOLDEN trial showed elafibranor’s unique ability to address NASH resolution, and beneficial effects on cardiometabolic lipids (LDL decrease, HDL increase, and TG decrease), glucose metabolism (HbA1c, HOMA-IR, FPG, FFA, C-peptide), in addition to a favorable safety and tolerability profile. Therefore, elafibranor’s superior, pluripotent mechanism of a PPAR alpha and delta, could be beneficial by improving quantity and quality of fat in the liver, specifically targeting the more harmful, lipotoxic fat subtypes that buildup in NAFLD and drive progression to NASH

    www.globenewswire.com/news-release/20...
82 Posts
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