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Galapagos maart 2019

8.357 Posts
Pagina: «« 1 ... 238 239 240 241 242 ... 418 »» | Laatste | Omlaag ↓
  1. [verwijderd] 25 maart 2019 21:01
    Ik begrijp eerlijk gezegd niets van de complottheorieën hier. Mdxhealth (-5%), Biocartis (-5%), Asit (-6,5%), Mithra (-4%).... Allemaal voorkennis van Finch 1/3 of allemaal massaal gedrukt volgens jullie dan of? Gewoon een kutdag voor (Belgische) biotech. Niets meer en niets minder. Glpg is een gouden bedrijf, heb gewoon wat geduld.
  2. forum rang 6 wiegveld 25 maart 2019 21:04
    Cortellisrapport over UPA:

    Rheumatoid arthritis is a chronic, progressive and
    debilitating autoimmune condition in which the immune
    system attacks joint linings, resulting in pain, swelling and
    stiffness. Damage can also occur in the heart, lungs, skin,
    eyes, kidneys and blood vessels. More general symptoms
    include fatigue, loss of appetite and weight loss. The
    triggers of the disease are unclear and there is no cure.
    However, treatments can reduce symptoms and prolong
    time between flare-ups. Rheumatoid arthritis affects
    between 0.3% and 1% of the worldwide population.1,2,3
    Upadacitinib
    AbbVie’s upadacitinib is an orally dosed inhibitor of an intracellular
    target called JAK1. Dysfunction in the regulation of the JAK
    family of molecules is implicated in the aberrant production of
    pro-inflammatory mediators that are involved in the pathogenesis
    of rheumatoid arthritis, and inhibition of JAK proteins is an
    established method of controlling the symptoms of this disease.3
    Upadacitinib was filed for approval in the U.S. and EU in
    December 2018, and accepted for U.S. Priority Review
    in February 2019.4 Cortellis forecasts a 95% probability
    of approval in each region, with U.S. approval forecast
    for August 2019 and EU approval in October 2019. Sales
    forecasts for upadacitinib for 2023 are $2.20 billion.
    The filings for upadacitinib were based on data from the phase 3
    SELECT trial program.4 The SELECT trials produced significant
    efficacy in moderate to severe rheumatoid arthritis in different
    patient cohorts, highlights of which are noted below.
    • SELECT-NEXT: In patients not responding adequately
    to conventional synthetic disease-modifying anti-rheumatic
    drugs (DMARDs)5
    • SELECT-BEYOND: In patients not adequately
    responding to or intolerant of biologic DMARDs6
    • SELECT-MONOTHERAPY: In patients switching from
    methotrexate monotherapy after inadequate responses7
    • SELECT-COMPARE: In combination with methotrexate in
    patients with inadequate responses. Superiority to AbbVie’s
    long-established rheumatoid arthritis drug Humira
    (adalimumab) was shown8
    • SELECT-EARLY: In methotrexate-naive patients9
    Phase 3 trials of upadacitinib are also underway in ulcerative
    colitis, psoriatic arthritis, Crohn's disease and atopic dermatitis.
    Phase 2 development is ongoing in ankylosing spondylitis and
    a registration-enabling trial is planned for giant cell arteritis
  3. forum rang 6 wiegveld 25 maart 2019 21:04
    The rheumatoid
    arthritis market
    Launch of upadacitinib is anticipated in
    2019, assuming approval is granted, but
    the drug would be a late entrant into a
    crowded market dominated by biological
    agents – many of which are recommended
    for use ahead of newer agents.10
    The biologicals include ones that inhibit
    the pro-inflammatory mediator tumor
    necrosis factor (TNF), such as Humira,
    Enbrel (etanercept; Amgen/Pfizer/
    Takeda), Simponi (golimumab) and
    Remicade (infliximab; both Johnson &
    Johnson/Merck & Co/Mitsubishi Tanabe),
    and Cimzia (certolizumab pegol; UCB/
    Astellas). The American College of
    Rheumatology guidelines on rheumatoid
    arthritis treatment recommend these
    drugs as second-line therapy options after
    DMARDs.10 Biosimilar versions of Humira
    (2017 sales of $18.77 billion) entered the EU
    market in 2018 and are set to launch in the
    U.S. in 2023 – creating additional pressures
    in this already complex market.11,12,13
    Also recommended ahead of newer
    agents are the non-TNF biologicals
    such as Actemra (tocilizumab; Roche/
    Chugai), Orencia (abatacept; Bristol-Myers
    Squibb/Ono) and Rituxan (rituximab;
    Roche/Biogen), which are positioned
    as alternatives to the TNF biologicals or
    after TNF inhibitor therapy failure.10
    Upadacitinib will also face direct
    competition from other JAK inhibitors.
    First-in-class Xeljanz (tofacitinib; Pfizer)
    is a broad-spectrum JAK family inhibitor
    that has shown comparable efficacy
    to Humira. The American College of
    Rheumatology recommends it in the event
    of biological therapy failure.14,15 Xeljanz sales
    in 2017 were $1.35 billion, with forecast
    sales rising to $3.31 billion in 2023.
    Eli Lilly and Incyte’s Olumiant (baricitinib),
    which is selective for JAK1/JAK2 and
    has shown superior efficacy to Humira,
    entered the EU and Japanese markets
    in 2017 and the U.S. in 2018.16 Sales of
    Olumiant were $46 million in 2017, with
    sales of $977 million forecast for 2023 –
    approximately half those of upadacitinib.
    Olumiant faces a number of challenges:
    for example, it has a black-box warning on
    its label more extensive than the Xeljanz
    one. Additionally, although Olumiant is
    available in the EU and elsewhere as 2-mg
    and 4-mg doses (the 4-mg dose is the most
    commonly used, outside the U.S.), the FDA
    has only approved the 2-mg dose. This
    decision was based on safety concerns
    with the 4-mg dose.17,18,19,20,21 However, it was
    the 4-mg dose that showed superiority
    to Humira in the RA-BEAM trial, and thus
    the FDA’s refusal to approve that dose is
    a significant blow to Olumiant, but also a
    potential opportunity for upadacitinib.22
  4. forum rang 5 Endless 25 maart 2019 21:07
    quote:

    Tomwashier schreef op 25 maart 2019 21:01:

    Ik begrijp eerlijk gezegd niets van de complottheorieën hier. Mdxhealth (-5%), Biocartis (-5%), Asit (-6,5%), Mithra (-4%).... Allemaal voorkennis van Finch 1/3 of allemaal massaal gedrukt volgens jullie dan of? Gewoon een kutdag voor (Belgische) biotech. Niets meer en niets minder. Glpg is een gouden bedrijf, heb gewoon wat geduld.
    Zelf denk ik dat deze bedrijven in een EFT mandje zitten en deze gedumpt zijn na de mislukking van Biocen in de altzheimer onderzoek. Als je in een EFT zit wordt het hele mandje verkocht en niet individuele bedrijf.
  5. BLOO7 25 maart 2019 21:15
    Januari 2019
    Beste Forumleden,

    Allemaal een mooi 2019 gewenst, in goede gezondheid en met veel wijsheid voor jullie beleggingsstrategieën. Dit jaar gaat (wederom) erg belangrijk worden voor Galapagos. Veel filgotinib momenten: FINCH 1&3 resultaten, de filing voor RA in Europa en Amerika, fase 2 data in additionele indicaties, start fase 3’s in AS en PsA, rekrutering van ‘1690, ‘1972, ‘1205, start klinisch programma Toledo en nog veel meer.

    ...

    Blijf bij ons,
    Onno
  6. [verwijderd] 25 maart 2019 21:18
    quote:

    Endless schreef op 25 maart 2019 21:07:

    [...]
    Zelf denk ik dat deze bedrijven in een EFT mandje zitten en deze gedumpt zijn na de mislukking van Biocen in de altzheimer onderzoek. Als je in een EFT zit wordt het hele mandje verkocht en niet individuele bedrijf.
    Ik vind dit eerlijk gezegd redelijk kort door de bocht. Ik denk persoonlijk niet dat je het gefaalde onderzoek van Biogen in de verste verte kan vergelijken met bovenstaande bedrijven. Ook denk ik niet dat ETF-beheerders zich zo makkelijk laten verleiden tot een algehele biotech-dump.
8.357 Posts
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