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NASH - bedrijven

65 Posts
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  6. Wil Helmus 19 november 2018 14:39

    • Wil Helmus

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    Viking Therapeutics upgraded to Strong Buy at Raymond James

    As previously reported, Raymond James upgraded Viking Therapeutics (VKTX) to Strong Buy from Outperform with a $43 price target. Following AASLD, Analyst Steven Seedhouse thinks TR-B remains one of the most promising mechanisms with proof-of-concept in NASH based on VK2809 and MGL-3196 data presented and conversations with physicians. The analyst expects increased comfort with Viking's path to market as we approach several catalysts including a long-term animal toxicology study completion, IND filing/acceptance, and Phase 2b start. Seedhouse also expects the M&A premium in Madrigal Pharmaceuticals (MDGL) to shift to Viking, which has a more attractive valuation if there is a rush on NASH assets.

    Read more at:
    thefly.com/landingPageNews.php?id=282...
  9. forum rang 4 Lingus 19 november 2018 17:00

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    quote:

    DeZwarteRidder schreef op 19 november 2018 14:57:

    [...]
    Genfit is een misfit.
    Boeiend verhaal. Lekker kort ook.
  10. MVo_ 18 januari 2019 12:42

    • MVo_

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    2019 wordt een belangrijk jaar voor de Nash bedrijven. Intercept zal Q1 als eerste zijn fase 3 resultaten presenteren, de koers is al flink opgelopen de laatste maanden (evenals de shorts overigens).

    Daarnaast wordt verwacht dat Gilead stappen zal ondernemen om zijn programma uit te breiden, hun eigen onderzoek heeft niet echt tot goede kandidaten geleid die de markt kunnen overvallen.

    Mijn geld staat op Intercept en Viking, ookal loopt Viking ze ietsje achter op Madrigal en Intercept. Tot op heden lijkt hun product 'best in class' te worden en zijn ze nog relatief goed geprijsd. Ik ben benieuwd hoe het ervoor staat als Gilead zich gaat bewegen op de markt en als er meer resultaten binnen komen.
  12. MVo_ 12 februari 2019 14:42

    • MVo_

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    Zoals verwacht, vannacht het persbericht van Gilead:
    www.investors.com/news/technology/gil...

    Gild faalt hard in onderzoek naar een potentiële kandidaat tegen NASH. Viking, Madrigal en Intercept stijgen voorbeurs goed door. Nu is de vraag; wat gaat Gilead doen. Slaan ze toe via een overname? Zo ja; wie van de 3? Of verlaten ze het NASH speelveld en lijven ze wellicht Galapagos in..

    Gilead zal iets moeten doen om de aandeelhouders tevreden te houden, bijna ieder zelf ontwikkeld medicijn is geflopt na hun grootste kaskraker tegen HIV.
  13. Wil Helmus 15 februari 2019 10:45

    • Wil Helmus

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    Hoe denken jullie over Inventiva? Kleine speler op NASH gebied. Hun middel Lanifibranor bevind zich momenteel in fase 2. Het aandeel is de afgelopen dagen flink gestegen
  16. sp1946 11 april 2019 14:52

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    News Release Issued: Apr 11, 2019 (7:02am EDT)

    SAN DIEGO, April 11, 2019 /PRNewswire/ -- Viking Therapeutics, Inc. (Viking) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced the presentation of new results from the company's 12-week Phase 2 study of VK2809, its novel liver-selective thyroid receptor beta agonist, in patients with non-alcoholic fatty liver disease (NAFLD) and elevated low-density lipoprotein cholesterol (LDL-C) at the International Liver Congress™ 2019. The study results were presented in the late-breaker poster session of the annual meeting of the European Association for the Study of the Liver (EASL), being held April 10-14 in Vienna, Austria.

    Highlights from the late-breaker poster include newly reported data demonstrating that all patients who received 5 mg of VK2809 dosed daily were considered responders, as defined by a relative reduction in liver fat of = 30% at Week 12. Patients in the VK2809 5 mg cohort also experienced a statistically significant median relative reduction in liver fat content of 53.8%. Consistent with the observations from the 10 mg cohorts in this study, VK2809 was shown to be safe and well tolerated when dosed at 5 mg daily, with no serious adverse events reported. Overall, a greater proportion of VK2809-treated patients completed the study compared with patients randomized to placebo.
  19. Wil Helmus 11 april 2019 19:32

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    Most developers of therapies to treat nonalcoholic steatohepatitis (NASH) are under modest pressure as investors remain unimpressed with the initial announcements from The International Liver Congress in Vienna.
  20. Wil Helmus 12 april 2019 22:45

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    EASL 2019 – Novo buys into Gilead’s Nash combo plan

    Today’s deal will see the companies take a triple combination into clinical trials.

    The diabetes specialist Novo Nordisk has already worked in Nash, so today’s clinical trial alliance with Gilead marks another baby step towards developing a treatment.

    The tie-up is noteworthy for other reasons, too, marking another buy-in to the theory that Nash needs to be treated with a combinatorial approach, and underlining its link with diabetes. But could this mean that existing diabetes drugs could be used for Nash? And what happens to the bull thesis that Gilead is on the lookout for acquisition targets in this liver disease?

    The buyout thesis has helped keep Nash enthusiasm going despite two late-stage setbacks this year, one of which involved Gilead's own selonsertib. However, Gilead striking small, clinical trial tie-ups suggests a far more cautious attitude from a company that many think needs to do M&A, though of course this does not entirely rule out future acquisitions.

    A little air escaped the Nash bubble yesterday, largely as a result of Intercept’s underwhelming data at the EASL conference, and even Viking, which presented a promising update for VK2809, ended the day down 2% (EASL 2019 – Viking to push the limits of its Nash contender, April 11, 2019).

    Three-way tie

    The Gilead/Novo tie-up will see the former’s cilofexor and firsocostat combined with the latter’s semaglutide, a GLP-1 analogue marketed for diabetes.

    Nash followers will be familiar with all three approaches. The Gilead compounds are already being combined, and a 20-subject proof-of-concept trial presented at EASLshowed that 74% had at least a 30% fall in liver fat, as measured by MRI-PDFF, from baseline after 12 weeks.

    Novo has an ongoing phase II trial of semaglutide monotherapy in Nash. And liraglutide, another Novo GLP-1 analogue diabetes drug, has already yielded impressive monotherapy results, showing Nash resolution in 39% subjects, versus 9% for placebo, in a small study.

    This is a threat to novel Nash projects. However, the fact that the Danish group has now seen the need to put semaglutide into a combo should give some comfort to those fearing the worst.

    It is thought that Nash, diabetes and obesity are related, but a developing school of thought holds that a combined approach is needed to affect fat metabolism and reduce fibrosis. Intercept, for instance, licensed Aralez’s PPAR agonist bezafibrate to combine with Ocaliva, though this was also driven by a need to broaden the latter’s therapeutic window.

    NN9499 FGF 21 analogue  Novo NordiskObesity project with Nash potential 

    It will not go unnoticed that PPAR agonism is also used to treat diabetes. Yet another player, Cymabay, is developing the PPAR delta agonist seladelpar for Nash, and one of its EASL presentations today concerned preclinical results of a combo with either Gilead's selonsertib, an Ask-1 inhibitor, or with liraglutide.

    Selonsertib appeared to show little additive effect on top of seladelpar, and notably the former was not part of today’s Novo deal with Gilead. But adding the GLP-1 to seladelpar caused a much greater reduction in liver fat than using either agent alone.

    “GLP-1 receptor agonists are increasingly being recognised as having significant potential for the treatment of Nash,” Charles McWherter, Cymabay’s chief scientific officer, told Vantage today at EASL. “When used in combination, they may represent an opportunity to take novel agents into Nash patients with earlier stages of fibrosis.”

    Pfizer, another GLP-1 player, agrees. “If we can induce significant weight loss we can have a positive impact on [Nash],” said Roberto Calle, a director in Pfizer’s internal medicine research unit. “And the GLP-1s have been proven to do that.”

    One consideration is that a monotherapy approval might be needed before any combination of the novel agents can hit the market. This, along with Gilead’s caution, could act as a further brake on the bull case for Nash.

    www.evaluate.com/node/14580/amp
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