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GALAPAGOS SEPTEMBER

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Omlaag ↓

[verwijderd] 25 september 2015 16:51

Had overigens al lang wat verwacht te horen van Onno...tot op heden nog niks...jammer...

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

Ruud Rubbers 25 september 2015 16:52

quote:
Stone13 schreef op 25 september 2015 16:50:
conference call om 17.15 uur

Heel goed nieuws, dan eindigen we nog in het groen! :)

de tuinman 25 september 2015 16:52

quote:
Stone13 schreef op 25 september 2015 16:50:
conference call om 17.15 uur

Waar kan ik die vinden?

[verwijderd] 25 september 2015 16:53

Wie wil er op 1 oktober nieuw draadje aanmaken om dit snel te vergeten ;-)

koetjeboe 25 september 2015 16:54

Ik heb bijgekocht en nu al een gedeelte van mijn verlies goed gemaakt.
Ik ga weekend houden.

Gegroet allemaal.

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

Ruud Rubbers 25 september 2015 16:54

quote:
Medion49 schreef op 25 september 2015 16:53:
Wie wil er op 1 oktober nieuw draadje aanmaken om dit snel te vergeten ;-)

Du?

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

B...K 25 september 2015 16:55

quote:
Stone13 schreef op 25 september 2015 16:50:
conference call om 17.15 uur

Dat wordt nog een heel heet kwartiertje voor de beurs sluit !!!

[verwijderd] 25 september 2015 16:56

*Galapagos: momenteel in gesprek met aantal grote farmabedrijven om samen te werken om filgotinib verder te ontwikkelen.

Wat gaat hier allemaal uitkomen is de vraag..!

[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.

voda 25 september 2015 16:56

quote:
Medion49 schreef op 25 september 2015 16:51:
[...]

Meer van dit Voda !
Zoals steeds is er vandaag een overreactie geweest.
Erg begrijpelijk wel...

Your wish, is my command. Zie hierboven! :-)

NielsjeB 25 september 2015 16:56

globenewswire.com/news-release/2015/0...

[verwijderd] 25 september 2015 16:56

om te lachen? ik heb ook alles ingezet en had never ever het gevoel dat dit zou plaatsvinden..les 1..wordt niet verliefd op aandelen..
les 2 hou de aandelen niet te lang meer, verkoop zodra je in de plus zit.al is het maar 3 of 4 %..

NielsjeB 25 september 2015 16:57

Based on our own human whole blood assays comparing ABT-494 to filgotinib, filgotinib is three-fold more JAK1 selective than ABT-494.

[verwijderd] 25 september 2015 16:58

Ja even op het laatste moment de koers omhoog lullen nog even en we staan weer op de slot koers
trap er niet in want vandaag het vrijdag en er zijn twijfels over de uitspraken van gala fala

FC Barcelona 25 september 2015 16:59

wie o wie kan mij uitleggen dat er as we speak duizenden aandelen van eigenaar verwisselen met een koers die ongeveer gelijk blijft ( tempo daarnet nog 100.000 aandelen in 10 minuten tijd !) ????

hoe kan dat ?

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

B...K 25 september 2015 17:00

globenewswire.com/news-release/2015/0...
Galapagos is momenteel in vergevorderde gesprekken met een groot aantal grote farmaceutische bedrijven om samen te werken met filgotinib - See more at: globenewswire.com/news-release/2015/0...

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