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Genfit 2019

117 Posts
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  1. forum rang 10 DeZwarteRidder 30 maart 2019 10:37
    quote:

    Dr. Bob schreef op 30 maart 2019 10:35:

    [...]Als de prijs van dit aandeel 100% stijgt, is het weer terug op het prijsniveau van 6 maanden geleden.
    Tjonge, Dr Bob, blijkbaar heb je ook nog rekenen geleerd op school.....!!!
  2. [verwijderd] 30 maart 2019 21:32
    quote:

    DeZwarteRidder schreef op 30 maart 2019 10:39:

    En als Genfit met 200% stijgt dan staan ze weer op het nivo van ca 4 jaar geleden........
    En hebben de mensen die na de top van 4 jaar geleden zijn ingestapt 200% winst........

    Echt een top opmerking weer van de zwarte kneus........
  3. Wil Helmus 31 maart 2019 15:05
    quote:

    DeZwarteRidder schreef op 30 maart 2019 08:33:

    ELAFIBRANOR werkt niet of nauwelijks tegen NASH.
    Fase 3 wordt dus niks.
    The paediatric trial builds on findings from a prior Phase II trial conducted in adults with NASH.

    Results showed that the drug achieved efficacy on the FDA-recommended endpoint of NASH resolution without worsening of fibrosis. Elafibranor also demonstrated beneficial cardiovascular profile, without any safety and tolerability concerns.

    www.drugdevelopment-technology.com/ne...

  4. forum rang 10 DeZwarteRidder 31 maart 2019 15:29
    quote:

    Wil Helmus schreef op 31 maart 2019 15:05:

    [...]The paediatric trial builds on findings from a prior Phase II trial conducted in adults with NASH.

    Results showed that the drug achieved efficacy on the FDA-recommended endpoint of NASH resolution without worsening of fibrosis. Elafibranor also demonstrated beneficial cardiovascular profile, without any safety and tolerability concerns.

    www.drugdevelopment-technology.com/ne...
    Het positieve effect op NASH was nauwelijks meetbaar en wie zit er te wachten op een peperduur middel dat nauwelijks werkzaam is, terwijl minder en gezonder eten veel meer effect heeft en zelfs geld oplevert....???

    Dit is een BUST....!!
  5. forum rang 10 DeZwarteRidder 31 maart 2019 17:24
    quote:

    Dr. Bob schreef op 31 maart 2019 16:32:

    Bijgaand de link naar de Genfit bedrijfspresentatie van januari jl.

    De resultaten van de fase 2 studie spreken m.i. voor zich.

    www.genfit.com/wp-content/uploads/201...
    Het verschil met het placebo is niet de moeite waard.
  6. forum rang 10 DeZwarteRidder 31 maart 2019 17:33
    www.fool.com/investing/general/2015/1...

    No. 3: Doubts emerge for NASH treatment
    Nonalcoholic steatohepatitis (NASH) is a fast-growing cause of liver failure that is estimated to occur in 5% of patients and it could become the leading cause of liver transplant by 2020. In a bid to keep that from happening, Intercept Pharmaceuticals (NASDAQ:ICPT) is developing obeticholic acid.

    Last year, positive mid-stage findings resulted in Intercept Pharmaceuticals kicking off a phase 3 study in the U.S. with a scheduled interim look in 2017, but enthusiasm for NASH therapy has faded since competitor Genfit reported in March that its NASH drug failed in phase 2 studies and Intercept Pharmaceuticals reported in October that a phase 2 study of obeticholic acid in Japan failed to improve patient's liver disease by two points on a standard liver disease measure.

    Because these trial failures raise concern that obeticholic acid may not be as effective as previously thought, shares in Intercept Pharmaceuticals have fallen to less than $150 from a peak of $480 earlier this year.

    That's a lot of pain for investors to endure, but it's not all bleak for Intercept Pharmaceuticals. The company has already filed for approval of obeticholic acid in another much rarer form of liver disease and a decision from the FDA in that indication is expected in February. Additionally, there's still a chance that obeticholic acid posts better results in the larger ongoing U.S. phase 3 study than it did in this smaller Japanese phase 2 trial.
  7. forum rang 10 DeZwarteRidder 31 maart 2019 17:39

    Genfit's NASH drug flunks Phase II, but management sees a silver lining
    by Damian Garde | Mar 26, 2015 2:19pm

    Genfit's in-development drug for a pervasive liver disease failed to beat placebo in a midstage trial, but the company, undaunted, is setting sights on late-stage studies with eyes on what could be a blockbuster market.

    The drug, GFT505, is an oral treatment for nonalcoholic steatohepatitis (NASH), which is a liver-scarring disease that affects as many as 5% of Americans but has no approved therapies. In a one-year study on 274 patients, GFT505 failed to chart a statistically significant improvement in NASH symptoms--measured by liver fat reduction and fibrosis stabilization--compared with placebo.

    However, take out data from patients with early forms of the disease and the trial is a success, Genfit said, chalking up the overall failure to an enrollment error and the use of too many study sites. And management believes it has found a blueprint for further study, planning to design Phase III trials that focus on more severe NASH patients. Genfit says it plans to submit the Phase II data to global regulatory authorities in hopes of getting a late-stage program started as soon as possible.

    Investors seemed less optimistic, sending the biotech's shares down more than 30% on the Paris exchange.

    Genfit's most advanced competitor in NASH is Intercept Pharmaceuticals ($ICPT), whose obeticholic acid is on its way into Phase III after posting some promising midstage efficacy data, picking up the FDA's coveted breakthrough therapy designation. The news of GFT505's failure sent Intercept's shares up about 9%.

    The Phase II setback might throw some cold water on market chatter that Genfit was in line for a buyout, rumors that surfaced earlier this month when Bloomberg reported that Sanofi ($SNY), Novartis ($NVS) and Shire ($SHPG) were taking a look at the company.

    Elsewhere in NASH, Gilead Sciences ($GILD) splashed into the field this year with a $470 million deal to get its hands on a Phase II treatment for the disease, and the hepatitis C experts at Enanta Pharmaceuticals ($ENTA) are entering the space as well. Shire's $260 million acquisition of Lumena Pharmaceuticals gave it a Phase I NASH treatment, and Conatus Pharmaceuticals is plotting a Phase III effort for its emricasan.

    - read the results
  8. [verwijderd] 31 maart 2019 18:02
    quote:

    DeZwarteRidder schreef op 30 maart 2019 10:39:

    En als Genfit met 200% stijgt dan staan ze weer op het nivo van ca 4 jaar geleden........


    Uniqure zou volgens jou post uit 2014 ook naar 1 USD gaan, staan nu op bijna USD 60!!!

    DeZwarteRidder DeZwarteRidder 10 apr 2014 om 10:53 
    0

    De biotech-hype gaat gegarandeerd weer voorbij door talloze teleurstellingen, biotech-aandelen zullen dus nog harder omlaag gaan dan de gewone aandelen.
    Een koers van 1 usd voor UniQure binnen 5 jaar is helemaal niet onmogelijk.
  9. forum rang 10 DeZwarteRidder 31 maart 2019 19:17
    quote:

    Brouya schreef op 31 maart 2019 18:02:

    [...]
    Uniqure zou volgens jou post uit 2014 ook naar 1 USD gaan, staan nu op bijna USD 60!!!
    DeZwarteRidder DeZwarteRidder 10 apr 2014 om 10:53 
    0
    De biotech-hype gaat gegarandeerd weer voorbij door talloze teleurstellingen, biotech-aandelen zullen dus nog harder omlaag gaan dan de gewone aandelen.
    Een koers van 1 usd voor UniQure binnen 5 jaar is helemaal niet onmogelijk.
    Ik zat er niet ver naast: de koers van Uniqure is gedaald naar 5 dollar.

    En die 5 dollar kan gemakkelijk nogmaals bereikt worden, want QURE is een notoir slecht geleid bedrijf.
  10. forum rang 10 DeZwarteRidder 2 april 2019 15:10
    sharkinvesting.com/stock-of-the-week/

    Our Stock of the Week is Viking Therapeutics (VKTX). The company is developing a number of therapies for the treatment of metabolic and endocrine disorders, but what is of most immediate interest is its drug for the treatment of non-alcoholic steatohepatitis (NASH).

    The company has had strong results but has been in a consistent downtrend since announcing results in September of last year. The stock has been languishing in the $7.00-8.50 range since December, but it has finally turned up following news that its drug worked effectively with a smaller dose. There have been concerns about safety, and this helped to ease the worries.

    In response to the news, analysts at Leerink upgraded the stock to outperform with a target of $21. The latest data is scheduled to be presented on April 11, which should help to provide support for the stock.

    The stock has been heavily shorted, but this shift in the technical conditions along with the positive data should push shorts to cover.

    As always, we would not chase the stock higher at the open on Monday but would look for entries either on lower volume pullbacks or sustained strength on high volume. There is support in the $9.25 area, which technicians will be watching.
  11. forum rang 10 DeZwarteRidder 4 april 2019 11:07
    Viking in particular caused something of a stir with data on VK2809, a thyroid hormone receptor beta agonist that counts as one of the sector’s most closely watched Nash projects.

    An abstract on a phase II trial contained the first data seen with a low 5mg dose of VK2809, suggesting that this could be as effective as 10mg, with obvious safety advantages. Leerink analysts wrote that should this be confirmed in larger studies, VK2809 could be a best-in-class compound.
  12. [verwijderd] 4 april 2019 11:21
    quote:

    DeZwarteRidder schreef op 4 april 2019 11:07:

    Viking in particular caused something of a stir with data on VK2809, a thyroid hormone receptor beta agonist that counts as one of the sector’s most closely watched Nash projects.

    An abstract on a phase II trial contained the first data seen with a low 5mg dose of VK2809, suggesting that this could be as effective as 10mg, with obvious safety advantages. Leerink analysts wrote that should this be confirmed in larger studies, VK2809 could be a best-in-class compound.
    Verder herinnert hij investeerders eraan dat Viking nog steeds "op zijn best" drie tot vier jaar achter Genfit en Madrigal staat. De VK2809-gegevens over de werkzaamheid zien er goed uit, maar door andere stoffen te vergelijken, worden appels vergeleken met sinaasappels, stelt Arce.
  13. [verwijderd] 4 april 2019 11:22
    H.C. Wainwright points out Viking is years behind Madrigal, Genfit

    In interpreting and reacting to Viking Therapeutics' (VKTX) Phase II VK2809 data yesterday, the market has gotten ahead of itself, especially relative to Madrigal Pharmaceuticals (MDGL) and Genfit (GNFTF), H.C. Wainwright analyst Ed Arce tells investors in a research note. The analyst sees "several significant limitations" of the Viking study, including a small sample size that he says limits the reliability of results, the non-alcoholic fatty liver disease patient population, which he notes is not the same as nonalcoholic steatohepatitis, its LDL reductions being similar to other agents, and the analyst's belief that safety questions remain. Further, he reminds investors that Viking is still, "at best," three-to-four years behind Genfit and Madrigal. The VK2809 efficacy data look strong, but evaluating it by other compounds is comparing apples to oranges, Arce contends. The analyst continues to believe that Genfit's market valuation is "substantially below" its intrinsic value.

    Read more at:
    thefly.com/landingPageNews.php?id=279...
  14. forum rang 10 DeZwarteRidder 4 april 2019 11:31
    Het middel van Genfit tegen NASH werkt net zo goed als een placebo, dus Genfit is heel slim bezig om de aandacht te verleggen naar een middel tegen PBC. Partners zijn in geen velden of wegen te zien.

    De uitkomst van fase 3 bij NASH zal een mislukking blijken te zijn.
  15. [verwijderd] 5 april 2019 07:35
    quote:

    DeZwarteRidder schreef op 4 april 2019 11:31:

    Het middel van Genfit tegen NASH werkt net zo goed als een placebo, dus Genfit is heel slim bezig om de aandacht te verleggen naar een middel tegen PBC. Partners zijn in geen velden of wegen te zien.

    De uitkomst van fase 3 bij NASH zal een mislukking blijken te zijn.
    Zoals door Brouya al gememoreerd, je wordt niet rijk door het vergelijken van appels en sinaasappels.
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