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Home  /  Forum  /  Genfit  /  Genfit 2020

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Aandeel Genfit PSE:GNFT.FR, FR0004163111

  • 3,140 19 apr 2024 13:30
  • -0,045 (-1,41%) Dagrange 3,130 - 3,190
  • 44.534 Gem. (3M) 154,8K

Genfit 2020

53 Posts
Pagina: 1 2 3 »» | Laatste | Omlaag ↓
  1. forum rang 6 Hulskof 23 januari 2020 13:18

    JPM20: After a year of NASH collapses, all eyes on two biotechs
    SAN FRANCISCO – It’s not quite Dewey defeats Truman, but Goldman Sachs calling 2019 “The Year of NASH” may well go down in the annals of worst biotech predictions.

    Goldman Sachs slapped the label on weeks before 2019’s JP Morgan conference, projecting that long-discussed treatments for the obesity-driven condition suspected to lurk in millions of Americans would begin to bear fruit and investors would move accordingly. That did not quite happen.

    Pascal Prigent
    “If you look at 2019, it was just a string of disappointing news,” Pascal Prigent, CEO of NASH-focused biotech Genfit, told Endpoints News in an interview.

    The Year of NASH, or nonalcoholic steatohepatitis, became a year of NASH failures. Gilead failed two large Phase III trials. CymaBay went from a $1 billion company to a $100 million company after they found their drug appeared to be making patients worse. Cirius withdrew an $86 million IPO bid after a disastrous readout. Industry-wide, there were few acquisitions in a market often projected to be worth $35 billion.

    Gilead, after dominating the NASH discussion at the 2019 JPM, gave one quick mention to the program in their 2020 presentation before pivoting to other drugs.

    “As promising as some of the mechanisms looked in earlier stages, when push comes to shove in large study settings, they just haven’t proven out,” Mark Pruzanski, CEO of the NASH-focused biotech Intercept, told Endpoints in an interview.

    As biotech turns from 2019, the failures have refocused eyes away from Gilead and back toward two startups, both facing key events in the coming months: Intercept, which first alerted investors to NASH at JPM 2014, and the France-based Genfit.

    “It’s very, very busy, there’s a lot of different programs,” Prigent said. “But when you look at the products that will be on the market in a year-and-a-half, two years, it’s only ourselves and Intercept.”

    Two biotechs standing
    Intercept emerged early on as the lone winner from the Year of NASH.

    In February, they announced the first positive results from a Phase III NASH trial, showing their drug, obeticholic acid, could reduce liver scarring. The news was fitting; many investors were first clued in on NASH when the biotech announced a positive Phase II results six years ago, sending their stock up over 500%.

    Intercept hit on only one of two primary endpoints but it was enough to file for the first FDA-approved NASH drug. The advisory committee hearing will be in April and those who still believe in a NASH market – and that’s many – will be watching closely for how the FDA handles endpoints and diagnosis for a disease that is still less-than-perfectly understood.

    Rohan Palekar
    “This is the first time,” Rohan Palekar, CEO of the NASH biotech 89bio, told Endpoints in an interview. “For the NASH field that’s really important.”

    There will also be questions for the first commercial launch: Doctors and analysts have raised concerns that payers will treat NASH drugs like they did the cholesterol-regulating PCSK9 inhibitors and refuse to pay. They could require that patients undergo a biopsy — the standard for an FDA trial — to pay for the drug, a painful and risky procedure that would limit the number of patients who get treatment.

    But whether approved or rejected, Intercept’s drug won’t come close to treating the millions of potential patients that have attracted such buzz to the field. Their trial in advanced patients showed the drug improved fibrosis but not the fatty buildup itself. There’s debate in the field about which is more important and the FDA accepts both, but the results mean the drug will first be targeted toward around 500,000 people.

    “We’re very much looking at it as a specialty market,” Pruzanski said.

    Those looking for the next shot at a huge NASH drug will have to wait for Genfit; they won’t wait long. The French biotech is set to release Phase III results this quarter. They’re looking to resolve NASH and have a much broader patient population: 6-7 million Americans, Prigent estimated.

    Analysts are mixed on their view of the trial. In a December note, SVB Leerink’s Pasha Sarraf projected the trial to succeed, but called it “the most significant and volatile upcoming catalyst” they cover.

    “The risk/reward is not for the faint of heart,” Sarraf wrote.

    Waves, combination and the rest
    Palekar, the 89bio CEO, said he’ll be watching the Genfit trial to see if it verifies the PPAR receptor approach. The metabolism-regulating proteins have captured much of the early work in the field but also led to the safety concerns in the CymaBay trial. (Genfit uses a different and less potent approach to PPAR).

    Palekar is also watching for an ongoing Bristol-Myers Squibb Phase II and other trials that target FGF21, the protein 89bio works on. Allergan has a Phase III in the works due out at year’s end, and Intercept has a Phase III underway for patients with compensated cirrhosis, a larger patient population. The Ionis program has a Phase II readout on their Pfizer-partnered compound coming this year, along with a Phase I readout on the AstraZeneca-partnered one.

    Ultimately, most in the field expect the drugs to one day be used in combination, with new drugs complementing each other.

    “We don’t necessarily see our two products as competitors,” Prigent said of Genfit and Intercept.

    At last year’s JP Morgan, when Gilead’s NASH program still held promise, the company’s R&D chief John McHutchison told investors there would be “waves of approvals,” first potent drugs for sicker patients and then safer ones for healthier patients yet to show significant symptoms.

    Pruzanski thinks those approvals will still come. It just might need a few more years of NASH.

    “This is clearly going to take a lot longer than we originally thought,” Pruzanski said.

    endpts.com/jpm20-after-year-of-nash-c...
  2. forum rang 6 Hulskof 23 januari 2020 14:23
    Is het niet zo dat de resultaten van Genfits fase 3 slechts iets beter of in lijn hoeven te zijn met die van Intercept? Genfits middel heeft naar het zich laat aanzien al een veel betere safety dan Intercept, dus al bij gelijke efficacy zal Genfit aan het langste eind trekken. Intercepts ADCOM in april zal volgens mij veel afhangen van Genfits fase 3 resultaten. Zijn die even goed of beter dan die van Intercept, dan zie ik het somber in voor Intercept. Zijn ze aanmerkelijk slechter (wat ik niet verwacht), dan spint Intercept daar garen bij en zal de eerste op de markt worden voor NASH.
    Qua efficacy scoort Intercept amper boven placebo en toch zal het middel mi worden goedgekeurd, tenzij Genfit betere resultaten laat zien. Wat denken jullie?
  5. Dr. Bob 30 maart 2020 22:12
    FDA meeting over Intercept's Ocaliva uitgesteld.
    www.fiercepharma.com/pharma/after-ear...

    Bryan Garnier schreef:
    "Genfit should have an answer from the FDA by 26th March regarding the addition of a new secondary endpoint to the phase III trial before any statistical analysis and readout can be completed. According to the company, no special message has been received from the FDA to alert over potential delays. The positive phase IIB clinical results published recently by Cymabay with seladelpar, a PPAR?, gave us more confidence that elafibranor should meet its primary endpoint of NASH resolution without worsening of fibrosis in the phase III study RESOLVE-IT. If the FDA is on time to give a green light regarding the addition of the new secondary endpoint, we believe the top-line interim results of RESOLVE-IT could be published in the first half of April. Finally, we estimate the gross cash position at EUR270m at the end of 2019."
  6. Dr. Bob 31 maart 2020 10:41
    In de guidance van 21 februari 2020 staat geschreven: today announced that unblinding of the Phase 3 RESOLVE-IT data will be delayed to incorporate the latest FDA insights expected by the end of March.

    Op 31 maart 2020 staat geschreven: The un-blinding of the study and subsequent announcement of interim results will take place after receipt and incorporation of insight from the FDA. We do not currently anticipate that the COVID-19 situation will significantly delay receipt of this feedback.

    Key lijkt mij de waarde die we aan het woord 'significant' mogen toedichten.

    ir.genfit.com/news-releases/news-rele...
  7. forum rang 10 DeZwarteRidder 31 maart 2020 10:56
    quote:

    Dr. Bob schreef op 31 maart 2020 10:41:

    In de guidance van 21 februari 2020 staat geschreven: today announced that unblinding of the Phase 3 RESOLVE-IT data will be delayed to incorporate the latest FDA insights expected by the end of March.

    Op 31 maart 2020 staat geschreven: The un-blinding of the study and subsequent announcement of interim results will take place after receipt and incorporation of insight from the FDA. We do not currently anticipate that the COVID-19 situation will significantly delay receipt of this feedback.

    Key lijkt mij de waarde die we aan het woord 'significant' mogen toedichten.

    ir.genfit.com/news-releases/news-rele...
    'Significant' is het meest gebruikte woord in wasmiddelen-reclames.
  13. Noob nr1 20 april 2020 11:23
    PAR ANNE BARLOUTAUD | INVESTIR.FR | LE 20/04/20 À 08:00 @AnneBarloutaud
    La biotech annoncera dans moins de deux mois les résultats intermédiaires de la première partie de l'étude de phase III de son produit phare, dans la lutte contre la Nash. Le compte à rebours est lancé.
    GENFIT
    Résultats cliniques majeurs dans le traitement de la Nash fin mai | Crédits photo : Shutterstock
    L'analyse (Investir)
    La biotech, qui développe l'elafibranor, un médicament très avancé dans la lutte contre la Nash (maladie du foie gras), a certes affiché une perte de 65 millions en 2019, mais sa trésorerie s'élève à 277 millions. Elle provient de la levée de fonds réalisée en mars 2019, lors de sa cotation sur le Nasdaq et d'un paiement du partenaire Terns Pharmaceuticals, dans le cadre de l'accord de licence pour une commercialisation de l'elafibranor en Chine.

    Ainsi, Genfit ne sera pas en situation de fragilité dans le cadre de potentielles discussions de partenariat (européen et/ou américain) ou même de cession de la société, hypothèse évoquée de nombreuses fois par son fondateur, Jean-François Mouney. Aujourd'hui, la base de données correspondant à la première partie de l'étude de phase III de l'elafibranor, nommée « Resolve-It », a été verrouillée fin février, comme prévu, les 1.000 patients requis pour la demande d'approbation ayant effectué leur dernière visite.

    La biotech avait soumis en début d'année à l'autorité de santé américaine, qui l'avait acceptée, une demande de modification des paramètres d'analyse de son étude pour inclure notamment des paramètres cardio-métaboliques qui pourraient accroître l'intérêt thérapeutique de son médicament. Genfit avait également annoncé, il y a un mois, que « la levée d'aveugle des données de la phase III [serait] différée afin d'inclure les derniers commentaires de la FDA ».

    Désormais, à la suite de la réception de ces commentaires, fin mars, Genfit est en cours d'ajustement du plan d'analyse statistique de l'étude. Reste que l'impact de l'épidémie de Covid-19 touche aussi la biotech. « Dans le respect des recommandations des autorités réglementaires, et avec comme priorité la sécurité des participants aux essais cliniques, l'ensemble des autres essais en cours est suspendu », a indiqué la société.

    Elle a toutefois confirmé son étape cruciale : les résultats intermédiaires de Resolve-It sont attendus pour la fin du mois de mai. Initialement prévu en fin d'année, le dépôt du dossier d'enregistrement du produit vedette ne devrait pas intervenir avant le premier semestre 2021, si, bien entendu, les résultats de phase III sont convaincants.

    @AnneBarloutaud

    Le risque est binaire, mais l'enjeu est majeur au regard de la taille du futur marché de la Nash, estimé à plusieurs dizaines de milliards de dollars. Genfit reste l'acteur le plus avancé du secteur aux côtés de l'américain Intercept, valorisé 2,3 milliards de dollars (contre 615 millions d'euros pour Genfit).

    Le cours au moment du conseil : 16 €ACHAT SPÉCULATIF
    Objectif :30€
  14. forum rang 4 Opstapelen 11 mei 2020 22:28
    quote:

    Noob nr1 schreef op 14 april 2020 10:15:

    Genfit : Topline interim results from Phase 3 clinical trial are expected by the end of May 2020 and if successful Genfit expects to file the NDA for elafibranor in NASH in 1H21...
    Totale flop dus, voor wie ze nog heeft.
    Succes

    Edit, had hier zelf jaren geleden ook goede verwachtingen van..
53 Posts
Pagina: 1 2 3 »» | Laatste |Omhoog ↑

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