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Home  /   Forum   /   Galapagos   /   GALAPAGOS SEPTEMBER

Aandeel Galapagos AEX:GLPG.NL, BE0003818359

Laatste koers (eur) Verschil Volume
25,920   +0,160   (+0,62%) Dagrange 25,840 - 26,160 30.781   Gem. (3M) 87,1K

GALAPAGOS SEPTEMBER

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5.070 Posts
Pagina: «« 1 ... 131 132 133 134 135 ... 254 »» | Laatste | Omlaag ↓
  1. twinkletown 25 september 2015 16:51
    Published: 16:44 CEST 25-09-2015 /GlobeNewswire /Source: Galapagos NV / : GLPG /ISIN: BE0003818359
    Galapagos to advance filgotinib to Phase 3 in rheumatoid arthritis

    Galapagos regains all unencumbered rights to filgotinib
    Filgotinib is the most selective JAK1 inhibitor
    Best-in-class efficacy and safety in RA in 24-week Phase 2B studies in 877 patients
    Phase 3 start in RA expected in early 2016

  8. forum rang 10 voda 25 september 2015 16:54
    PERSBERICHT: Galapagos to advance filgotinib to Phase 3 in rheumatoid arthritis


    -- Galapagos regains all unencumbered rights to filgotinib

    -- Filgotinib is the most selective JAK1 inhibitor

    -- Best-in-class efficacy and safety in RA in 24-week Phase 2B studies in
    877 patients

    -- Phase 3 start in RA expected in early 2016

    Galapagos to hold a conference call open to the public today at 17.15
    CET/11:15 AM EDT

    CODE: 830162




    UK: +44 330 336 6025
    USA: +1 719 325 2556
    Belgium: +32 2400 6966
    NL: +31 207 940454
    France: +33 176 7722 61


    Mechelen, Belgium; 25 September 2015: Galapagos NV (Euronext & NASDAQ:
    GLPG) announced today that the Company will be moving filgotinib, its
    highly selective JAK1 inhibitor, into Phase 3 in rheumatoid arthritis by
    early 2016. Filgotinib has shown best-in-class efficacy and safety in
    the DARWIN Phase 2B studies in rheumatoid arthritis and is now fully
    owned by Galapagos.

    Galapagos has demonstrated that high selectivity for JAK1 results in
    excellent efficacy and safety in rheumatoid arthritis patients. Based
    on our own human whole blood assays comparing ABT-494 to filgotinib,
    filgotinib is three-fold more JAK1 selective than ABT-494. Galapagos
    reported best-in-class efficacy and safety in 24-week Phase 2B studies
    in 877 patients with filgotinib. Furthermore, Galapagos has more than
    700 patient-years of treatment experience with filgotinib in RA patients,
    of which more than 500 years at the highest 200 mg dose, all with a
    clean safety profile consistent with JAK1 inhitbition: filgotinib showed
    a clear dose dependent increase in hemoglobin concentration without any
    impact on NK cells and lymphocyte counts.

    "We see a rapid path forward in development for filgotinib, which we
    will be taking into Phase 3. Galapagos is currently in advanced
    discussions with a substantial number of large pharma companies to
    partner filgotinib. We anticipate starting Phase 3 in rheumatoid
    arthritis with filgotinib early in 2016 and we are expecting data from
    our Phase 2B FITZROY study with filgotinib in Crohn's disease by
    yearend,"said Onno van de Stolpe, CEO of Galapagos.

    On efficacy, Galapagos consistently has reported ACR scores using the
    most conservative NRI approach. The table below shows the ACR scores
    for the DARWIN 1 study at 24-weeks on the LOCF basis, for comparison
    purposes :




    DARWIN1 (MTX-IR) ACR20 ACR50 ACR70
    50mg, once-daily 61(*) 35(**) 22(*)
    100mg, once-daily 74(***) 54(***) 38(***)
    200mg, once-daily 78(***) 55(***) 31(**)
    25mg, twice-daily 62(*) 38(**) 22(*)
    50mg, twice-daily 66(*) 38(**) 25(*)
    100mg, twice-daily 87(***) 62(***) 43(***)
    placebo 45 16 9


    * p< 0.05 vs. placebo; ** p<0.01 vs. placebo; *** p<0.001 vs. placebo;
    ACR scores based on LOCF analysis



    AbbVie notified Galapagos today of termination of the agreement on
    filgotinib.

    Conference call and webcast presentation

    Galapagos will conduct a conference call open to the public today (25
    September 2015) at 17:15 CET/11:15 AM EDT. To participate in the
    conference call, please call one of the following numbers ten minutes
    prior to commencement:

    CODE: 830162




    UK: +44 330 336 6025
    USA: +1 719 325 2556
    Belgium: +32 2400 6966
    NL: +31 207 940454
    France: +33 176 7722 61

    About Galapagos

    Galapagos www.glpg.com/ (Euronext & NASDAQ: GLPG) is a
    clinical-stage biotechnology company specialized in the discovery and
    development of small molecule medicines with novel modes of action, with
    a pipeline comprising three Phase 2 programs, two Phase 1 trials, five
    pre-clinical studies, and 20 discovery small-molecule and antibody
    programs in cystic fibrosis, inflammation, and other indications.
    Filgotinib is an orally-available, selective inhibitor of JAK1 for the
    treatment of rheumatoid arthritis and potentially other inflammatory
    diseases, currently in Phase 2B studies in RA and in Phase 2 in Crohn's
    disease. Galapagos reported good activity and a favorable safety profile
    in both the DARWIN 1 and 2 trials in RA. In the field of cystic
    fibrosis, AbbVie and Galapagos signed a collaboration agreement to
    develop and commercialize molecules that address mutations in the CFTR
    gene. Potentiator GLPG1837 is currently in a Phase 1 trial, and
    corrector GLPG2222 is at the pre-clinical candidate stage. GLPG1205, a
    first-in-class inhibitor of GPR84 and fully-owned by Galapagos, is
    currently being tested in a Phase 2 proof-of-concept trial in ulcerative
    colitis patients. GLPG1690, a fully proprietary, first-in-class
    inhibitor of autotaxin, has shown favorable safety in a Phase 1 trial
    and is expected to enter Phase 2 in idiopathic pulmonary fibrosis. The
    Galapagos Group, including fee-for-service subsidiary Fidelta, has
    approximately 400 employees, operating from its Mechelen, Belgium
    headquarters and facilities in The Netherlands, France, and Croatia.
    More info at www.glpg.com

    CONTACT

    Galapagos NV

    Elizabeth Goodwin, Head of Corporate Communications & IR

    Tel: +31 6 2291 6240

    ir@glpg.com

    Galapagos forward-looking statements
  9. forum rang 10 voda 25 september 2015 16:55
    Galapagos forward-looking statements

    This release may contain forward-looking statements, including without
    limitation statements regarding the possibility and timing of the
    initiation of Phase 3 activities in rheumatoid arthritis with filgotinib,
    the possibility of partnering filgotinib with a third partyand
    filgotinib's safety and/or efficacy profile. Galapagos cautions the
    reader that forward-looking statements are not guarantees of future
    performance. Forward-looking statements involve known and unknown risks,
    uncertainties and other factors which might cause the actual results,
    financial condition and liquidity, performance or achievements of
    Galapagos, or industry results, to be materially different from any
    historic or future results, financial conditions and liquidity,
    performance or achievements expressed or implied by such forward-looking
    statements. In addition, even if Galapagos' results, performance,
    financial condition and liquidity, and the development of the industry
    in which it operates are consistent with such forward-looking statements,
    they may not be predictive of results or developments in future periods.
    Among the factors that may result in differences are the inherent
    uncertainties associated with competitive developments, clinical trial
    and product development activities and regulatory approval requirements
    (including that data from Galapagos' ongoing DARWIN and FITZROY programs
    with filgotinib may not support registration or further development of
    filgotinib due to safety, efficacy or other reasons), Galapagos'
    reliance on collaborations with third parties, and estimating the
    commercial potential of Galapagos' product candidates. A further list
    and description of these risks, uncertainties and other risks can be
    found in Galapagos' Securities and Exchange Commission filing and
    reports, including in Galapagos' prospectus filed with the SEC on May
    14, 2015 and future filings and reports by Galapagos. Given these
    uncertainties, the reader is advised not to place any undue reliance on
    such forward-looking statements. These forward-looking statements speak
    only as of the date of publication of this document. Galapagos
    expressly disclaims any obligation to update any such forward-looking
    statements in this document to reflect any change in its expectations
    with regard thereto or any change in events, conditions or circumstances
    on which any such statement is based or that may affect the likelihood
    that actual results will differ from those set forth in the
    forward-looking statements, unless specifically required by law or
    regulation.

    This announcement is distributed by NASDAQ OMX Corporate Solutions on
    behalf of NASDAQ OMX Corporate Solutions clients.

    The issuer of this announcement warrants that they are solely
    responsible for the content, accuracy and originality of the information
    contained therein.

    Source: Galapagos NV via Globenewswire

    HUG#1954668


    www.glpg.com
  12. [verwijderd] 25 september 2015 16:56
    Als ik het forum moet geloven......
    Onno tevreden nu de deal niet doorgaat? Wie gelooft dat?
    Hij heeft de afgelopen tijd al gesprekken gehad met andere bedrijven, waarom weten wij dat niet?
    Terwijl nagenoeg iedereen op het forum dacht dat Abviee de licensie zou nemen of er een overname zou volgen, blijkt nu opeens dat al bekend was dat dit waarschijnlijk niet zou gebeuren (lees ik in persbericht).
    Volgen mij allemaal flauwekul om de pijn te verzachten.
    Er komen kosten bij, uitstel van product op de markt brengen, meer concurrentie, zie nog wel eens emissie of een andere manier om geld in het laatje te krijgen volgen.
    Enfin, ik ben eruit, veel kopers zijn vandaag ook weer verkopers met (natuurlijk) winst door lage inkopen en hogere verkopenprijs.
    Zo blijkt maar weer dat bijna niemand verlies heeft vandaag.
  20. forum rang 10 voda 25 september 2015 17:00

    Fonds: aand. Galapagos
    Beurs: Euronext Amsterdam

    Laatste 43,07 91 16:59:35
    Verschil -12,00 -21,7904 %
    Bied 43,085 260 16:59:36
    Laat 43,09 635 16:59:37
    Hoogste 56,34 09:01:12
    Laagste 33,42 13:30:01
    Cum. volume --- 2.939.952 16:59:35
    Indicatieve opening ---
    Open 56,34 09:00:00
    Vorig slot 55,07 24-09-2015
    Gemiddelde dagomzet --- 322.629
5.070 Posts
Pagina: «« 1 ... 131 132 133 134 135 ... 254 »» | Laatste |Omhoog ↑

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