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Home  /   Forum   /   Genfit   /   Koers Genfit 2016

Aandeel Genfit PSE:GNFT.FR, FR0004163111

Laatste koers (eur) Verschil Volume
4,060   +0,040   (+1,00%) Dagrange 3,945 - 4,110 137.854   Gem. (3M) 312,7K

Koers Genfit 2016

Volgen
159 Posts
Pagina: 1 2 3 4 5 6 ... 8 »» | Laatste | Omlaag ↓
  2. [verwijderd] 4 januari 2016 19:30
    seekingalpha.com/article/3782506-2016...

    Although Intercept has been considered one of the leaders, I remain very skeptical that OCA will ever get approved for the NASH indication. Furthermore, I have some issues with the phase 2 trial design of Genfit's (OTCPK:GNFTF) Elafibranor that could impact ultimate approval. However, even if either of these drugs is approved, the market is large and there are multiple targets. I note that ICPT's and GNFTF's market capitalizations are $3.7 billion and $835 million, respectively.
  3. [verwijderd] 6 januari 2016 11:48
    seekingalpha.com/article/3788956-inte...

    Once a darling of the biotech space, Intercept Pharmaceuticals (NASDAQ:ICPT) has seen investors flee from the shares in droves, pushing it down close to 50% from my last article on the company and leading to a significant underperformance to its primary NASH-driven comparable Genfit (GNFT.PA) (OTCPK:GNFTF), which has fallen almost 20% over the same time period.

    Investors have had a lot to mull over since the beginning of summer. Both Intercept and Genfit have produced mixed clinical trial results that have required further explanations from management, and both are subject to the questions and risks over pricing for drugs that could be given to millions of patients. More specific to Intercept, there are valid concerns now about safety, efficacy, competition, and market potential for its lead drug, and investors aren't happy about the uncertainty.

    I still believe that Intercept's lead drug OCA is active and safe in primary biliary cirrhosis (PBC) and likely to demonstrate approval safety and efficacy in nonalcoholic steatohepatitis (NASH). I also believe, though, that there are meaningful questions about true market potential and that Genfit could be a more significant competitor (albeit not necessarily on an apples-to-apples basis).

    A Japanese Study Muddies The Water

    The late October release of data from a Phase II study of OCA in Japanese NASH patients conducted by Intercept's partner Sumitomo Dainippon Pharma did not help the investment case for Intercept. This relatively small study (200 pts versus 283 pts in the U.S. FLINT study) was meant as a dose-ranging study and not powered to show improvement in fibrosis, but the results were nevertheless lacking.
    On the primary endpoint of a 2-point improvement in NAS score with no worsening of fibrosis, the study missed statistical significance. It was a close miss (p = 0.053), but only one of the three dose groups (40mg) made the cut, with an 18% improvement over placebo (38% versus 20%). Looking at the completers instead of intent-to-treat, there was an even bigger improvement at the 40mg dose (51% vs. 22%).

    There was no statistical evidence of fibrosis improvement (and this was true for the full data release as well), but the company noted improvements in "ballooning," which is often tied to fibrosis. It's also important to note that half of the 40mg patients experienced pruritus (persistent itchiness), with 10% of the intent-to-treat patients at this dose dropping out.

    The bearish view is pretty straightforward. Even with the more forgiving post-hoc analysis, only one of the three treatment groups achieved the endpoint, and the impact on fibrosis was not statistically significant. What's more, the drug only worked at a dose that is well above the highest dose in the U.S. Phase III study... and even then it caused significant pruritus.

    The bullish view is, at best, nuanced. First, it was a smaller study that was not powered to show a stat-sig benefit to fibrosis. Second, as more and more papers are published on NASH, it is becoming clearer that NASH is a heterogeneous disease. With that, it's worth noting that Japanese NASH patients aren't like their Western counterparts (lower BMIs, higher dyslipidemia, less diabetes) and those differences limit the transferability/applicability of these results to the future of OCA in the U.S. and European NASH markets. In the bull view, then, this is more likely just an uninspiring read on the future of OCA in treating NASH in Japanese patients.
    Meanwhile, Safety And Tolerability Are In Play

    One of the other concerns that has grown around OCA in both PBC and NASH is its impact on cholesterol. There were concerns in the past after data from the Phase II FLINT study showed elevation of bad cholesterol and some cardiovascular adverse outcomes. Intercept is running a Phase II study to evaluate the impact of OCA on lipid levels in NASH patients, but the results won't be available for a while.

    In the meantime, cholesterol/cardio may emerge as a marketable advantage for Genfit. The GOLDEN study showed a statistically significant benefit to lipids (lower LDL and higher HDL) and a lower-than-expected drop-out rate from Genfit's drug elafibranor (or GFT-505). While elafibranor hasn't shown the same level of efficacy in reducing fibrosis (possibly due to shorter trial periods), Genfit may well be able to focus the benefits of its drug around the better lipid/cardiovascular outcomes.

    To that end, I'd look at the Intercept study design for the Phase III REGENERATE study, which excludes patients with elevated LDL (despite treatment), certain types of cardiovascular disease, and less-controlled diabetes. I don't think Intercept's study design is unreasonable, but it may ultimately establish a differentiation between the two drugs that sees OCA directed more towards severe, later-stage patients and elafibranor directed more toward patients with less fibrosis and/or more concerns with cholesterol.

    The lipid/CV concern may well be relevant to the PBC indication as well. PBC is a strange disease in that patients typically have high overall cholesterol but also high good cholesterol (HDL). Unfortunately, OCA has been shown to lead to declines in HDL without any meaningful offsetting improvements to LDL.

    What that means, then, is that OCA is a drug that's known to cause itchiness (though this can be managed at least in part with dose titration and other practices) and may cause some cholesterol/CV problems. That could make it difficult to drive adoption beyond the 30,000 or so patients in the U.S. and EU with significant uncontrolled PBC (after or despite URSO treatment), and patient compliance could be an issue. The "good news" is that my modeling assumptions always included some patient drop-outs (25% to 40% of the addressable market).

  4. [verwijderd] 6 januari 2016 11:50
    Is Genfit Still In Play?

    The question of whether Intercept or Genfit has the better/best drug won't be answered until the Phase III results are in, and even then there is likely to be a lot of slicing, dicing, and recapitulating the data in an effort to show differences. Given the CV data on elafibranor and the company's Phase III design, I give at least a little more credit to Genfit now than I did before.

    Intercept designed its Phase III study around an interim analysis at 72 weeks of 1,400 patients on two co-primary endpoints. Although it is not required that every patient hit both endpoints, there needs to be a statistically significant improvement in the percentage of patients achieving a 1-stage improvement in fibrosis (with no worsening of NASH) and a stat-sig improvement in the percentage of patients achieving NASH resolution (with no worsening of fibrosis). That's a more rigorous standard than that used in the FLINT study, though REGENERATE will only be enrolling patients with stage 2 or stage 3 NASH, as well as high-risk stage 1. These design adjustments should address prior issues with healthier patients muddling the data and with the variability that goes with liver biopsies.

    Unlike Intercept, which is testing two doses of OCA, Genfit is testing one dose of elafibranor and the interim analysis will include 900 patients at 72 weeks. Unlike ICPT, which is looking to prove that OCA reduces fibrosis and resolves NASH, Genfit is using a single endpoint of NASH resolution with no worsening of fibrosis.

    That doesn't mean that this is an easy trial. Genfit previously counted "NASH resolution" as a zero score in one of three metrics (inflammation, steatosis, and ballooning) while Intercept's definition was a total NAS score of 3 or less (a more demanding standard).

    In this Genfit Phase III study, resolution will mean zero ballooning and a zero or one in inflammation, but can include higher levels of steatosis (zero to three). A post-hoc analysis from the Phase II GOLDEN study of the dose to be used in Genfit's Phase III RESOLVE study (120mg) did show efficacy versus the placebo (19% versus 12%) using this standard. That was in line with Intercept's post-hoc results, though Intercept's study showed a larger percentage of patients with a two-point or greater NAS improvement.

    All of that said, there is still no official FDA standard on NASH resolution (at least that I'm aware of), so there could eventually be some issues if/when it comes time for a panel meeting for approval and/or for marketing in the real world.

    The good news for Genfit is that this study design will reduce Intercept's prior lead, as both should have their interim results in the first half of 2018. The good news/bad news for Intercept is that hitting both the NASH resolution and fibrosis targets could be challenging. If ICPT can prove the fibrosis reduction, that will likely constitute a labeling advantage for OCA (at least in more serious cases), though Genfit's lipid/CV advantages could lead an edge among patients with cholesterol issues (not a small segment in NASH).

    What Will The Market Actually Look Like?

    I believe the NASH market could be one where it takes significant marketing and patient/doctor education efforts to build awareness and adoption. With that, first-to-market may not mean as much as it would with other drugs, as the initial competitors in the market will have to drive awareness, wrangle with payers over pricing, and so on. In other words, "have fun storming the castle." That may be more noteworthy with Genfit, as the company still needs to raise capital to fund its Phase III trial, let alone finance a commercialization effort (though clinical success would likely allow equity fundraising at a higher price down the line).

    With that, I'd note that there are numerous would-be rivals in the space. Gilead (NASDAQ:GILD), Galmed (NASDAQ:GLMD), Bristol-Myers (NYSE:BMY), Durect (NASDAQ:DRRX), Galectin (NASDAQ:GALT), and Conatus (NASDAQ:CNAT) are just some of the companies with their hats already thrown into the NASH ring. If NASH truly proves to be a multi-billion-dollar market, count on plenty of competition at some point.

    It may even prove to be the case that combo therapy becomes the norm here. Combo therapy is the standard of care in HIV and HCV and is heading quickly in that direction for many types of cancer. With various companies approaching NASH from metabolic, anti-inflammatory, and anti-fibrotic points of view, it may be the case that the best therapy is a combination of drugs, and that creates a whole new spectrum of possibilities for pricing, partnerships, and so on.

    Reassessing The Value

    I've cut my fair value on Intercept's shares by almost $100/share, as I think I was too aggressive with my pricing assumptions for OCA and the failed Japanese study leads me to lower my assumed odds of approval in NASH. I estimate a little more than $50/share in value for the PBC indication of OCA, with pricing a key unknown as Intercept is likely to launch the drug at a higher price than it will be able to maintain once the NASH indication is approved. Key risks to PBC, in addition to a recent three-month delay in the PDUFA date, remain the question of whether ATP elevation is a good efficacy metric, whether there are enough "uncontrolled" patients with severe enough disease to create a large market for OCA, and whether those patients can/will tolerate the pruritus and cholesterol side-effects.

    I've cut about $75/share out of my NASH fair value (to $275) as I have lowered my long-term pricing assumptions (given the recent kerfuffles over drug pricing) and lowered my odds of approval (to 60%) given the mixed signals from the Japanese study. I'm assuming that OCA, at peak, gets about one-third of the severe NASH market (with Genfit getting around half of Intercept's share), but I would note that the relatively short patent protection for the drug (2027 with the Hatch-Waxman extension and maybe 2033 with other extensions) is a concern as it will make it more challenging for Intercept to recapture the benefits of all of the early market building that I believe will be required.

    The remaining valuation comes from Intercept's pipeline, including additional indications for OCA in areas like portal hypertension and primary sclerosing cholangitis.

    The Bottom Line

    Neither Intercept nor Genfit are sure-fire successes. I believe that Intercept will get approval in PBC this year, but this indication alone cannot support today's valuation. With a long wait before the 2018 interim results, I expect the Street to focus keenly on any incremental updates from Phase II studies, as well as the clinical updates of competitors and would-be competitors in the NASH space.

    There are a host of risks at Intercept, including a track record of less than pristine efficacy data, possible issues with lipid safety and tolerability, pricing concerns, and competition. The potential rewards are significant, though, and I think ICPT is worth a look from investors who can take well above-average risks in the pursuit of potentially well above-average returns.
  11. [verwijderd] 24 januari 2016 10:10
    quote:

    JOVRO schreef op 24 januari 2016 00:08:

    tweet syndicaat Sanofi:

    twitter.com/fo_sag/status/69094146104...

    Sanofi kan een spectaculaire overname gaan doen. Genfit of Adocia?

    Weet niet wat er van gaat komen, maar dit kan wel eens het einde van de belachelijk lage koers betekenen :-)
    Adocia heeft wel al een (belanrijke) samenwerking met Lilly



  14. @ out of the blue 26 januari 2016 13:41
    Ook vandaag vervolgt Genfit de stijging op geruchten van een een overname.

    Het volume is ook een stuk hoger dan gisteren. Nu maar hopen dat het straks geen gerucht blijkt te zijn, anders...

    BOURSE-Genfit poursuit sa hausse sur de nouvelles rumeurs de rachats
    Reuters le 26/01/2016 à 10:540

    PARIS, 26 janvier (Reuters) - L'action Genfit GNFT.PA
    poursuit sa progression mardi matin à la Bourse de Paris, où la
    société biopharmaceutique signe la plus forte hausse de l'indice
    SBF 120 .SBF120 dans des volumes nourris sur fond de nouvelles
    rumeurs d'un possible rachat de l'entreprise par un groupe
    pharmaceutique.
    A 10h51, le titre gagne 9,99% à 28,58 euros dans des volumes
    représentant 1,2 fois ceux réalisés en moyenne sur une séance
    complète au cours des trois derniers mois sur Euronext. Au même
    instant, le SBF 120 recule de 1,26% dans des volumes équivalents
    à 23% de leur moyenne journalière habituelle.
    "Il y a de nouvelles spéculations sur le marché à propos
    d'un rachat de la société. L'américain Gilead GILD.O et Sanofi
    SASY.PA pourraient être intéressés", indique l'un des traders
    interrogés par Reuters.
    Lundi, Genfit a bondi de 11,98% avec d'autres groupes
    biotechnologiques et biopharmaceutiques alors que des analystes
    jugent attractif le secteur après avoir fortement souffert
    depuis le début de l'année en Bourse.
    Joints par Reuters, Sanofi et Genfit n'ont fait aucun
    commentaire.
    La valeur fait régulièrement l'objet de rumeurs de rachat en
    Bourse.
    L'an dernier, le président du directoire de la société avait
    fait savoir que la société avait été approchée par des
    entreprises du secteur pharmaceutique en vue d'un possible
    partenariat et s'était même dit prêt à ouvrir ses livres de
    comptes en vue d'une ouverture de son capital.
  15. [verwijderd] 26 januari 2016 19:16
    We zullen moeten afwachten wat voor plannen er allemaal worden bedacht als je het adocia forum op bours leest lijkt het wel een copie van genfit veel gedachtes aannames en verwachtingen maar weinig feiten
    Het enigste wat wel duidelijk is dat genfit met de pet rond moet om fase3 te kunnen betalen en het word nu wel eens tijd om daar een begin mee te maken
159 Posts
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