Van beleggers
voor beleggers
Uitgebreid zoeken

Beurscodes, betekenis en hulp bij zoeken

Europa

AEX
Euronext Amsterdam
BRU
Euronext Brussels
PSE
Euronext Paris
LIS
Euronext Lissabon
CHX
CBOE Europe, grote(re) EU aandelen
NAV
Investment Funds (NAV)

Noord-Amerika

NYS
New York Stock Exchange
OTC
CBOE BZX Exchange (US)
TSE
Toronto Stock Exchange

Kunt u een instrument niet vinden?

Zoek dan via de zogenaamde ISIN code. Elk instrument, aandeel etc. heeft een unieke code.

Kies vervolgens - wanneer er meerdere resultaten zijn - de notering op de beurs van uw keuze.

Waar vind ik die ISIN code?

Google de naam van het instrument, aandeel etc. met de toevoeging 'ISIN'.

Als zoeken op ISIN code geen resultaten oplevert hebben wij het instrument of aandeel niet in onze koersendatabase.

desktop iconMarkt Monitor
  • Word abonnee
  • Inloggen

    Inloggen

    • Geen account? Registreren

    Wachtwoord vergeten?
Home  /  Forum  /  Genfit  /  Genfit 2020

Ontvang nu dagelijks onze kooptips!

word abonnee

Aandeel Genfit PSE:GNFT.FR, FR0004163111

  • 3,235 23 apr 2024 09:00
  • 0,000 (0,00%) Dagrange 3,235 - 3,235
  • 1.437 Gem. (3M) 144,7K

Genfit 2020

53 Posts
Pagina: «« 1 2 3 »» | Laatste | Omlaag ↓
  1. forum rang 10 DeZwarteRidder 12 mei 2020 11:12
    GENFIT: Announces Results from Interim Analysis of RESOLVE-IT Phase 3 Trial of Elafibranor in Adults with NASH and Fibrosis
    May 11, 2020
    Elafibranor did not demonstrate a statistically significant effect on the primary endpoint of NASH resolution without worsening of fibrosis

    GENFIT will engage with regulatory authorities to determine next steps regarding the extension phase evaluating the effect of elafibranor on clinical outcomes

    Safety and tolerability of elafibranor was consistent with previously conducted studies

    GENFIT to host investor calls in English on May 11, 2020 at 4:30pm EDT / 10:30pm CEST, and in French on May 12, 2020 at 1:30am EDT / 7:30am CEST

    Lille (France), Cambridge (Massachusetts, United States), May 11, 2020 – GENFIT (Nasdaq and Euronext: GNFT), a late-stage biopharmaceutical company dedicated to improving the lives of patients with metabolic and liver diseases, today announced results from an interim analysis of the RESOLVE-IT Phase 3 trial evaluating once-daily, 120mg of elafibranor in adults with non-alcoholic steatohepatitis (NASH).

    The trial did not meet the predefined primary endpoint of NASH resolution without worsening of fibrosis in the ITT population of 1,070 patients. The response rate in the 717 patients enrolled on study drug was 19.2% for patients who received elafibranor 120mg compared to 14.7% for patients in the placebo arm. On the fibrosis key secondary endpoint, 24.5% of patients who received elafibranor 120mg achieved fibrosis improvement of at least one stage compared to 22.4% in the placebo arm. The other key secondary endpoint related to metabolic parameters did not achieve statistical significance.

    Pascal Prigent, CEO of GENFIT, stated: “These results are highly disappointing, not only for the GENFIT team, but also for patients and healthcare providers as there continues to be considerable unmet medical need in the NASH space. The GENFIT team is actively reviewing the full interim dataset and will be conducting additional analyses, to gain a clearer understanding of the higher than anticipated response rates in the placebo arm. We plan to share these detailed findings with the regulatory authorities in the coming months and with their guidance, determine a final decision regarding the continuation of the RESOLVE-IT trial. In parallel, we continue as planned with our NIS4TM and Phase 3 PBC (primary biliary cholangitis) programs, which are independent of our NASH program with elafibranor. We will provide updated guidance on our global corporate strategy later in the year, once we have more clarity on the regulatory implications of the RESOLVE-IT interim readout, as well as more visibility on the evolution of the impact of the worldwide pandemic on our ongoing studies.”

    Dr. Stephen Harrison, MD, Hepatologist, Medical Director of Pinnacle Clinical Research, San Antonio, TX, (USA) commented: “NASH is a complicated, heterogeneous disease, and the results of the RESOLVE-IT Phase 3 study of elafibranor in NASH demonstrate this significant hurdle. Placebo response was higher compared to some other late phase trials, and it will be important for the field to understand variations across all trials.”

    INTERIM RESULTS

    The RESOLVE-IT Phase 3 trial evaluated the effect of elafibranor compared to placebo in 1,070 patients (ITT population) with biopsy proven NASH as defined by NAS greater than or equal to 4, fibrosis stage 2 or 3. Patients were randomized 2:1 to receive elafibranor 120mg or placebo once daily, with a follow-up liver biopsy at week 72 to evaluate histologic endpoints (resolution of NASH without worsening of fibrosis or fibrosis improvement of at least one stage). Patients with no biopsy results at week 72 were considered as non-responders in the efficacy analysis.
  9. forum rang 10 DeZwarteRidder 30 juni 2020 08:03
    Intercept Shares Tumble on NASH Disappointment

    By Josh Nathan-Kazis
    June 29, 2020 4:05 pm ET

    NASH was once the next big thing for big pharma; a newly defined disorder requiring chronic treatment afflicting millions of people in developed countries. Scores of companies are developing drugs for the disease, which can cause deadly conditions like decompensated cirrhosis or liver cancer.

    But the quest for the first big NASH drug has hit some stumbling blocks. In May, a French company called Genfit (ticker: GNFT), which had one of the most advanced NASH programs, announced that a Phase 3 trial of its NASH drug Elafinbranor had failed to achieve its primary endpoint.

    Now, another setback is tanking shares of Intercept Pharmaceuticals (ICPT), which analysts had expected to introduce the first NASH drug sometime this year. Intercept had submitted an application for accelerated approval with the Food and Drug Administration for its drug obeticholic acid as a treatment for NASH. On Monday, the company said that the FDA had sent it a letter saying that the expected benefit of the drug “does not sufficiently outweigh the potential risks.”

    The company said that the agency had asked for additional analyses from an ongoing study. Shares of Intercept fell 39% on Monday. On an investor call Monday morning, Intercept CEO Mark Pruzanski called the FDA’s action “completely unexpected and disappointing.”

    “At no point during review did the FDA communicate that OCA was not approvable on an accelerated basis,” Pruzanski said.

    Questions about NASH drugs have been emerging for months. In December, Barron’s highlighted those concerns, arguing that investors should be skeptical of the field.

    Intercept’s application for OCA was based on interim data from a study that found that liver scarring improved, and other NASH parameters did not worsen, in 23.1% of patients who received a higher dose of the drug, compared with 11.9% of patients in the placebo arm of the study.

    In an interview in December, Pruzanski told Barron’s that the most important metric was the stabilization of fibrosis, and that 40% of the patients in the high dose group improved by a full stage of fibrosis.

    The drug also raises levels of so-called bad cholesterol, which could be a concern given that the patients likely to take the drug to treat NASH are also prone to heart disease. In the December interview, an Intercept executive told Barron’s that the risk could be managed with other dugs.

    Shares of Intercept are down 61.8% so far this year.
  10. forum rang 10 DeZwarteRidder 30 juni 2020 08:18
    On Monday, the company said that the FDA had sent it a letter saying that the expected benefit of the drug “does not sufficiently outweigh the potential risks.”

    The company said that the agency had asked for additional analyses from an ongoing study. Shares of Intercept fell 39% on Monday. On an investor call Monday morning, Intercept CEO Mark Pruzanski called the FDA’s action “completely unexpected and disappointing.”

    “At no point during review did the FDA communicate that OCA was not approvable on an accelerated basis,” Pruzanski said.
  11. Ferdinand 62 5 augustus 2020 09:10
    Het lijkt er op dat er toch weer leven in Genfit zit. Een mooi bericht wat de koers goed zal doen.

    Genfit: wetenschappelijke publicatie over NIS4-technologie
    CERCLE FINANCE • 05/08/2020 om 08:42
    (CercleFinance.com) - Genfit kondigt aan dat gegevens die de afleiding en validatie van haar innovatieve niet-invasieve diagnostische technologie NIS4 beschrijven, zijn geaccepteerd voor publicatie in The Lancet Gastroenterology & Hepatology.

    Op basis van een bloedtest heeft de NIS4-technologie tot doel patiënten te identificeren met niet-alcoholische steatohepatitis (NASH) en significante fibrose (F> 2), gedefinieerd als NASH in het gepubliceerde artikel.

    Het biofarmaceutische bedrijf is van plan de exploitatierechten van NIS4 toe te kennen aan een belangrijke partner in diagnostiek voor de ontwikkeling en lancering van een klinische diagnostische test in de tweede helft van 2020.
  12. forum rang 10 DeZwarteRidder 21 augustus 2020 10:21
    De beurswaarde van Genfit is ca 180 miljoen, terwijl er nog ca 250 miljoen in de kas zit, dus Genfit op de huidige koers is tamelijk risicoloos, terwijl er wel opwaartse kansen zijn. Er kan binnenkort al nieuws uitkomen.
    Een verdubbeling is niet zo moeilijk voor dit soort aandelen.
  13. Ferdinand 62 27 augustus 2020 09:10
    En toch weer positief nieuws van Genfit.

    Genfit: twee presentaties gepland op het Liver Congress 2020
    CERCLE FINANCE • 27/08/2020 om 07:43 uur
    (CercleFinance.com) - Genfit kondigt twee mondelinge presentaties aan over nieuwe gegevens in NASH (niet-alcoholische steatohepatitis) op het Digital International Liver Congress 2020, de jaarlijkse bijeenkomst van de European Association for the Study of the Liver (EASL) gepland voor 27 tot 29 augustus.

    Een eerste zal de rol benadrukken van de miR-34a-biomarker - een van de essentiële componenten van NIS4-technologie - bij het uitsluiten van de diagnose van NAFLD en het vergemakkelijken van de identificatie van NAFLD-patiënten met risicofactoren voor NASH.

    Een tweede zal de positieve preklinische resultaten beschrijven die zijn verkregen door elafibranor - de meest geavanceerde verbinding van het biofarmaceutische bedrijf - in combinatie met semaglutide bij de vermindering van leverontsteking.
  14. forum rang 5 RW1963 19 september 2020 11:29
    quote:

    DeZwarteRidder schreef op 21 augustus 2020 10:21:

    De beurswaarde van Genfit is ca 180 miljoen, terwijl er nog ca 250 miljoen in de kas zit, dus Genfit op de huidige koers is tamelijk risicoloos, terwijl er wel opwaartse kansen zijn. Er kan binnenkort al nieuws uitkomen.
    Een verdubbeling is niet zo moeilijk voor dit soort aandelen.
    Een duikeling van ca. 10%. Moet ik mij nu zorgen maken of komt het volgens jou nog wel goed?
  16. forum rang 6 Hulskof 19 september 2020 14:07
    Wees eens concreet, Ridder, waarom dit afgeserveerd aandeel volgens jou kansrijk is. En kom met iets meer dan waardering is lager dan de kaspositie. Immers, die kas is zo leeg en als ze het uitgeven aan kansloze producten, gaat het met de koers enkel verder zuidwaarts. Dus, wat in de pijplijn is volgens jou de moeite waard en waarom? (Ik heb je hoog zitten, je bent normaal kritisch, dus het verbaast me dat je Genfit nu zo loopt te pumpen, ook in andere draadjes)
  17. forum rang 10 DeZwarteRidder 19 september 2020 14:45
    quote:

    Hulskof schreef op 19 september 2020 14:07:

    Wees eens concreet, Ridder, waarom dit afgeserveerd aandeel volgens jou kansrijk is. En kom met iets meer dan waardering is lager dan de kaspositie. Immers, die kas is zo leeg en als ze het uitgeven aan kansloze producten, gaat het met de koers enkel verder zuidwaarts. Dus, wat in de pijplijn is volgens jou de moeite waard en waarom? (Ik heb je hoog zitten, je bent normaal kritisch, dus het verbaast me dat je Genfit nu zo loopt te pumpen, ook in andere draadjes)
    Meestal hebben biotechs een zeer hoog risico, maar als je kunt kopen ver onder de intrinsieke waarde en het kassaldo, dan is het risico zeer beperkt.

    Anders gezegd: de winst/risicoverhouding is zeer gunstig.

    De kans op een verdubbeling is bij Genfit veel groter dan bij b.v. Galapagos.

    Genfit heeft nog 4 kansrijke producten in de pijplijn en die krijg je er gratis bij.
  18. forum rang 10 DeZwarteRidder 19 september 2020 14:49
    There currently is no cure for primary biliary cholangitis (PBC). Although there are medications that work to slow its progression, there is still a significant medical need for new therapies, as current treatments either are ineffective for a large portion of PBC patients, cause significant side effects or include safety risks.
    Elafibranor: Significant effect on PBC hallmarks in a phase 2 study

    In December 2018, we announced positive preliminary results, including achievement of the primary endpoint and the composite endpoint, from our Phase 2 multi-center, double-blind, randomized, placebo-controlled clinical trial to evaluate the efficacy and safety of elafibranor after 12 weeks of treatment in patients with PBC and inadequate response to ursodexoycholic acid or UDCA. The trial was conducted at multiple clinical centers in the United States and in three European countries and enrolled a total of 45 patients. The patients were randomized into one of three treatment arms, receiving either elafibranor 80 mg, elafibranor 120 mg or placebo.

    The primary endpoint of “Change at week 12 in serum alkaline phosphatase (ALP) from baseline” was met. Both elafibranor doses demonstrated significant decrease in mean ALP: -48% for 80 mg -41% for 120 mg with +3% increase for placebo leading to highly significant treatment effect versus placebo: -52% for 80 mg (p<0.001) and -44% for 120 mg (p<0.001).

    Alongside substantial reductions in ALP, in both elafibranor-treated groups, patients showed improvement in other PBC markers such as gamma-glutamyl transferase and metabolic markers such as total cholesterol, LDL-C, and triglycerides. Improvement in pruritus was observed and will be confirmed in a study of longer duration.

    In April 2019, we presented detailed results from its positive Phase 2 clinical trial evaluating elafibranor in PBC during the European Association for the Study of the Liver (EASL) annual International Liver Congress™ (ILC). In a 12-week double-blind randomized placebo-controlled Phase 2 trial of non-cirrhotic patients with PBC and with inadequate response to UDCA, elafibranor showed a significant decrease of alkaline phosphatase (ALP) levels, resulting in significant treatment effects versus placebo on the primary endpoint, whilst also meeting the composite endpoint used for drug registration.

    In addition, patients on elafibranor showed improvements in other PBC markers, including gamma-glutamyl transferase (GGT), lipid markers (total cholesterol, LDL and triglycerides), and inflammatory markers (IgM, CRP, haptoglobin and fibrinogen) consistent with what was observed in our Phase 2 clinical trial in NASH. Treatment with both doses of elafibranor was generally well-tolerated.

    Based on these preliminary results, we plan to advance our PBC program into Phase 3 development in 2020.
53 Posts
Pagina: «« 1 2 3 »» | Laatste |Omhoog ↑

Meedoen aan de discussie?

Word nu gratis lid of log in met je emailadres en wachtwoord.

Direct naar Forum

Premium drie voorbeelden van IEX Premium: de exclusieve content op de site, de app op een smartphone en IEX Magazine.

Benieuwd naar onze analyses en kooptips?

Word nu abonnee van IEX en krijg onbeperkt toegang tot onze (koop)tips en succesvolle modelportefeuilles. Nu 3 maanden voor slechts €19,95! Profiteer van 58% korting!

Word abonnee

Lees verder op het IEX netwerk Let op: Artikelen linken naar andere sites

Gesponsorde links

Meld u aan voor de dagelijkse Beursupdate

Dagelijks een update van het laatste beursnieuws en beleggingskansen in uw mailbox!