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[verwijderd] 18 oktober 2018 19:00

0

Waarom ook alweer Galapagos 200 euro per aandeel waard is.

Galapagos (GLPG)

As we said, a pipeline is everything when it comes to biotech stocks. Luckily for clinical-stage firm Galapagos (NASDAQ:GLPG), its pipeline is very robust indeed.

GLPG has multiple late-stage programs as well as 25 different drugs in discovery/early trial stages. That alone is worth the price of admission given its recent price drop. But what is really is exciting is its highly selective JAK1 inhibitor — Filgotinib — as well as its Cystic fibrosis programs.

Partnering with giant Gilead (NASDAQ:GILD), GLPG’s Filgotinib is quickly becoming a monster and recently unveiled insanely impressive phase-3 data for rheumatoid arthritis. With that, GILD and GLPG have moved closer to marketing the drug for RA. With a better safety profile and injectability, the drug could significantly chip away at AbbVie’s (NASDAQ:ABBV) leading RA drug Humira. Ironically, ABBV pulled the plug on its partnership with GLPG for Filgotnib just before the results came out.

The second win for Galapagos comes from Cystic fibrosis. Right now, there aren’t many CF drugs available and they don’t all work for everyone. GLPG recently started enrolling initial trials for its CF program and results from these programs should start coming in over the next few months.

With these catalysts, Galapagos could be a great clinical-stage biotech to buy after the recent rout. GLPG stocks future still looks very rosy.

[verwijderd] 21 oktober 2018 13:50

2

Groen licht voor koersstijging Galapagos naar 200 euro niveau.

www.analist.be/corporatenieuws/175759...

[verwijderd] 22 oktober 2018 19:00

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En de winnaar is ?

FILGOTINIB

The GSK3196165 result compares unfavorably to clinical data on rival drugs, too. Last month, Gilead and Galapagos reported 30.6% of patients in a phase 3 trial of JAK1 inhibitor filgotinib achieved DAS28(CRP) < 2.6 at week 24. AbbVie has generated similar data on its JAK1 inhibitor upadacitinib.

GlaxoSmithKline’s rheumatoid arthritis prospect misses phase 2 endpoint
by Nick Paul Taylor | Oct 22, 2018 9:10am

www.fiercebiotech.com/biotech/glaxosm...

[verwijderd] 22 oktober 2018 19:22

1

POSITIVE TRIAL RESULTS WITH FILGOTINIB IN PSORIATIC ARTHRITIS AND ANKYLOSING SPONDYLITIS BOTH PUBLISHED IN THE LANCET

www.globenewswire.com/news-release/20...

[verwijderd] 22 oktober 2018 20:50

2

www.thelancet.com/journals/lancet/art...

[verwijderd] 23 oktober 2018 18:24

3

Goednieuwsshow:

Pronkt Galapagos met anderhalf miljard op de rekening?

23 oktober 201816:34

www.tijd.be/markten-live/nieuws/aande...

[verwijderd] 23 oktober 2018 22:42

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Galapagos

Annual R&D Update & Q3 Results

PR Q3 Results: 24 Oct 22.01 CET Webcast & teleconference: 25 Oct 16.15 CET

[verwijderd] 24 oktober 2018 16:39

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Toledo is geboren.

Het preklinisch programma GLPG3312 (ziekte van Crohn) is het volgens laboresultaten het beste ooit gezien in auto-immuunziekten.

[verwijderd] 24 oktober 2018 19:04

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quote:
inspirator schreef op 24 oktober 2018 16:39:
Toledo is geboren.

Het preklinisch programma GLPG3312 (ziekte van Crohn) is het volgens laboresultaten het beste ooit gezien in auto-immuunziekten.

Bron?

[verwijderd] 24 oktober 2018 22:16

0

quote:
inspirator schreef op 24 oktober 2018 16:39:
Toledo is geboren.

Het preklinisch programma GLPG3312 (ziekte van Crohn) is het volgens laboresultaten het beste ooit gezien in auto-immuunziekten.

Outlook 2018
In Q4, we expect to present more detailed findings from the EQUATOR, TORTUGA, and FINCH 2 trials with filgotinib, including at our R&D Update tomorrow 25 October. We will also present first data and our development strategy with regard to Toledo, our new program in inflammatory indications. We expect to start dosing in the ISABELA (Ph3 IPF '1690) and PINTA (Ph2 IPF '1205) patient trials. As a result of the recently announced revision of the AbbVie collaboration agreement in CF, we are reducing our expected operational cash burn from the last guided €180-200 million, as mentioned in our H1 2018 report, to €140-160 million in 2018.

[verwijderd] 24 oktober 2018 22:42

0

Koers Galapagos 200 euro nadert snel.

BinnenlandBuitenlandArchief
*Galapagos publiceert tussentijdse resultaten van FALCON-studie naar taaislijmziekte
woensdag 24 oktober 2018 22:34
(END) Dow Jones Newswires October 24, 2018 16:34 ET (20:34 GMT) Copyright (c) 2018 ABM Financial News. All rights reserved....

*Galapagos draagt alle programma's in taaislijmziekte (cystic fibrosis) over aan partner AbbVie
woensdag 24 oktober 2018 22:33
(END) Dow Jones Newswires October 24, 2018 16:33 ET (20:33 GMT) Copyright (c) 2018 ABM Financial News. All rights reserved....

*Galapagos ontvangt 45 miljoen euro van AbbVie; plus 200 miljoen euro aan mogelijk mijlpaalbetalingen en evt royalties
woensdag 24 oktober 2018 22:33
(END) Dow Jones Newswires October 24, 2018 16:33 ET (20:33 GMT) Copyright (c) 2018 ABM Financial News. All rights reserved....

*Galapagos kaspositie verbetert in eerste negen maanden met 192 miljoen euro tot 1,34 miljard euro
woensdag 24 oktober 2018 22:30
(END) Dow Jones Newswires October 24, 2018 16:30 ET (20:30 GMT) Copyright (c) 2018 ABM Financial News. All rights reserved....

*Galapagos verlaagt verwachting voor de cash burn in 2018 van 180-200 miljoen naar 140-160 miljoen euro
woensdag 24 oktober 2018 22:30
(END) Dow Jones Newswires October 24, 2018 16:30 ET (20:30 GMT) Copyright (c) 2018 ABM Financial News. All rights reserved....

*Galapagos operationele cash burn in eerste negen maanden was 101 miljoen euro, tegen 89 miljoen in 2017
woensdag 24 oktober 2018 22:30
(END) Dow Jones Newswires October 24, 2018 16:30 ET (20:30 GMT) Copyright (c) 2018 ABM Financial News. All rights reserved....

*Galapagos omzet derde kwartaal stijgt van 27 miljoen naar 95 miljoen euro
woensdag 24 oktober 2018 22:27
(END) Dow Jones Newswires October 24, 2018 16:27 ET (20:27 GMT) Copyright (c) 2018 ABM Financial News. All rights reserved....

*Galapagos boekt nettowinst van 15 miljoen euro in derde kwartaal 2018
woensdag 24 oktober 2018 22:27
(END) Dow Jones Newswires October 24, 2018 16:27 ET (20:27 GMT) Copyright (c) 2018 ABM Financial News. All rights reserved....

Galapagos en AbbVie wijzigen samenwerking
woensdag 24 oktober 2018 22:25
MECHELEN (AFN) - Galapagos heeft de samenwerkingsovereenkomst met farmaceut AbbVie in het onderzoek naar taaislijmziekte geherstructureerd. Dat werd woensdag bekendgemaakt bij de presentatie van de derdekwartaalcijfers van de biotechnoloog. AbbVie neemt alle cystic fibrosis-programma's over en gaat door met de ontwikkeling van een drievoudige combinatietherapie. AbbVie verkrijgt exclusieve wereldwijde rechten op de huidige portefeuille van medicijnkandidaten die door de twee bedrijven in de samenwerking ontwikkeld werden. AbbVie zal verantwoordelijk zijn voor alle toekomstige activiteiten en zal voortaan alle kosten van deze portefeuille dragen. Galapagos krijgt nu een betaling van 45 miljoen dollar van AbbVie en kan daarnaast maximaal 200 miljoen dollar aan mijlpaalbetalingen ontvangen bij het behalen van bepaalde mijlpalen. Ook zijn zogeheten royalties afgesproken. Galapagos behoudt exclusieve wereldwijde commerciële rechten om...

[verwijderd] 24 oktober 2018 22:49

0

quote:
inspirator schreef op 24 oktober 2018 22:16:
[...]

Outlook 2018
In Q4, we expect to present more detailed findings from the EQUATOR, TORTUGA, and FINCH 2 trials with filgotinib, including at our R&D Update tomorrow 25 October. We will also present first data and our development strategy with regard to Toledo, our new program in inflammatory indications. We expect to start dosing in the ISABELA (Ph3 IPF '1690) and PINTA (Ph2 IPF '1205) patient trials. As a result of the recently announced revision of the AbbVie collaboration agreement in CF, we are reducing our expected operational cash burn from the last guided €180-200 million, as mentioned in our H1 2018 report, to €140-160 million in 2018.

Toledo en Filgotinib zijn multi-blockbustermedicijnen.

Fantastische resultaten en vooruitzichten bij Galapagos.

[verwijderd] 25 oktober 2018 20:04

0

quote:
inspirator schreef op 24 oktober 2018 22:16:
[...]

Outlook 2018
In Q4, we expect to present more detailed findings from the EQUATOR, TORTUGA, and FINCH 2 trials with filgotinib, including at our R&D Update tomorrow 25 October. We will also present first data and our development strategy with regard to Toledo, our new program in inflammatory indications. We expect to start dosing in the ISABELA (Ph3 IPF '1690) and PINTA (Ph2 IPF '1205) patient trials. As a result of the recently announced revision of the AbbVie collaboration agreement in CF, we are reducing our expected operational cash burn from the last guided €180-200 million, as mentioned in our H1 2018 report, to €140-160 million in 2018.

Gouden deal van Onno geeft duidelijkheid.

AbbVie will assume full development and commercialization responsibilities for all cystic fibrosis (CF) programs partnered with Galapagos, under a restructuring of the companies’ five-year-old collaboration that could generate more than $245 million for the Belgian biotech.

Under the restructuring, AbbVie will continue development of a CF therapy combining three Galapagos candidates—as well as oversee several clinical and preclinical compounds originally discovered and developed jointly by AbbVie and Galapagos.

The triple combination—Galapagos’ C2 corrector GLPG2737, C1 corrector GLPG2222, and potentiator GLPG2451— are intended to collectively increase the activity of the mutated copies of the cystic fibrosis transmembrane conductance regulator (CFTR) protein that causes CF.

The triple combination showed no additional enhancement of CFTR activity over a dual combination of GLPG2222 and GLPG2451 following two weeks of treatment, according to topline interim results of Part 1 of the Phase I FALCON trial (NCT03540524) announced by Galapagos.

And after a previous two-week period, treatment with the dual combination resulted in a mean increase in percent predicted FEV1 of just approximately 3%, and mean decrease from baseline in sweat chloride concentration of approximately 25 mmol/L.

The triple combination candidates are three of five clinical-phase CFTR modulators identified by Galapagos in a June 7 investor presentation; the other two were potentiator GLPG3067, and C1 corrector GLPG2851. Also identified was a preclinical candidate, the C2 corrector GLPG3748.

‘Promising Candidates’
“Our previous work with Galapagos has identified a number of promising candidates and we thank them for their contribution to our partnership,” Michael Severino, M.D., AbbVie EVP of R&D and CSO, said yesterday in a company statement. “We have a proven track record working with challenging molecular targets across a wide range of life-threatening illnesses and will harness this expertise to progress the next-generation of CF treatment.”

AbbVie agreed to pay Galapagos $45 million upfront, and up to $200 million tied to achieving development, regulatory, and commercial milestones. Upon receiving regulatory approval and attaining commercial sales in CF, AbbVie has agreed to pay Galapagos royalties ranging from the single digit to low teen percentages.

Galapagos said it retains exclusive global commercial rights to develop GLPG2737 in all indications outside of CF. Should GLPG2737 or other candidates be approved for indications other than CF, Galapagos has agreed to pay AbbVie future milestone payments and tiered single digit royalties on future global commercial sales.

“We are very pleased with the outcome of our discussions with AbbVie regarding the future of the CF portfolio,” stated Galapagos CEO Onno van de Stolpe. “We believe that AbbVie is well-equipped to further develop this CF portfolio and to come up with a competitive triple combination product for CF patients.”

Galapagos and AbbVie launched their collaboration in September 2013, focused on treating CF by discovering, developing, and commercializing potentiator and corrector molecules. At the time, AbbVie paid Galapagos $45 million upfront and agreed to pay up to $405 million.

In April 2016, citing expansion of their CF portfolio, the companies expanded their CF collaboration by nearly doubling the size of AbbVie’s total potential payments to Galapagos tied to achieving Phase I and Phase II milestones.

[verwijderd] 26 oktober 2018 00:20

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Filgotinib Development Milestones
Rheumatoid Arthritis (RA)
• FINCH-2: Late-breaker poster at ACR 2018 meeting
– Phase 3 study achieved primary and secondary endpoints, including ACR20, ACR50, ACR70,
LDA and clinical remission at Weeks 12 and 24
– Safety profile consistent with previously reported studies of filgotinib

• FINCH-1 and FINCH-3: Phase 3 data expected in Q1 2019

• MANTA study: Ongoing
Psoriatic Arthritis (PA)
• EQUATOR: Phase 2 data presentation at ACR 2018 meeting and publication in The Lancet
– Achieved primary endpoint of improvement in signs and symptoms of PA at week 16
Ankylosing Spondylitis (AS)
• TORTUGA: Phase 2 data announced September 2018 and published in The Lancet
– Achieved primary and secondary endpoints, including improvement in AS Disease Activity Score (ASDAS) and ASAS20, at week 12. No new safety signals observed.

phx.corporate-ir.net/External.File?it...

[verwijderd] 26 oktober 2018 15:27

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John McHutchison -- Chief Scientific Officer and Head of Research and Development

Thank you, Laura. Welcome and thank you, everybody for joining us today. I'd like to start by talking about the progress we are making across our later-stage pipeline. As we enter the final quarter of the year and look ahead to 2019, we anticipate readouts from five Phase 3 studies over the next nine months. The American College of Rheumatology Meeting finished yesterday in Chicago. So I'll begin with some commentary about our work in the area of inflammation, starting with filgotinib, which as you know, is the selective JAK1 inhibitor.

Last month we announced positive results from FINCH 2, the first of three Phase 3 studies to readout in patients with rheumatoid arthritis. FINCH 2 compares filgotinib to placebo, each added to conventional disease-modifying anti-rheumatic drugs, or DMARDs in 423 patients who have previously not had an adequate response to biologic therapy. Filgotinib was generally well tolerated and met the study's primary endpoint in terms of the proportion of patients achieving an ACR20 at week 12.

In addition, key secondary endpoints, including ACR50 and ACR70 responses and the rates of low disease activity and remission were all higher with filgotinib compared to placebo. Importantly for these endpoints, we also noted a dose dependency as efficacy rates were numerically higher with the 200 milligram once daily dose of filgotinib, compared to the 100 milligram daily dose. The initial readout of the first Phase 3 data adds to our excitement about the potential of filgotinib, obviously.

We expect results from two other Phase 3 studies of filgotinib, FINCH 1 and FINCH 3, to be available in the first quarter of next year, and it's supported by the data to form the basis of our filings for regulatory approvals globally. As a reminder, FINCH 1 is a 52 week randomized study comparing both doses of filgotInib, plus methotrexate to adalimumab plus methotrexate and to methotrexate alone in patients who have previously had an inadequate response to methotrexate. FINCH 3 is a 52 week randomized study comparing filgotinib alone to methotrexate alone and to the combination of filgotinib plus methotrexate in methotrexate-naive patients.

Now our ability to file the NDA for filgotinib is dependent on data from the MANTA study. As you may recall, MANTA is a safety study in men with ulcerative colitis that was requested by the FDA and is designed to address non-clinical findings observed in preclinical animal studies. Because our Phase 3 FINCH trials have enrolled more rapidly than anticipated, enrollment in MANTA will likely be the rate limiting factor to filing an NDA in the United States. While we have been making every effort to expedite enrollment, the full impact of the efforts and their impact on the overall timeline are uncertain at this time.

Results from the EQUATOR study, a Phase 2 trial of filgotinib in 131 adults with active psoriatic arthritis were presented this week at ACR in a plenary session and concurrently published in The Lancet. The study also achieved its primary endpoint of improvement in the signs and symptoms of psoriatic arthritis at week 16. The study demonstrated an impressive ACR20 response of 80% to filgotinib 200 milligrams daily, versus 33% for placebo. The ACR50 and ACR70 responses were also significantly higher for filgotinib compared to placebo. Based upon the strength of these data, we are excited to be initiating plans for our Phase 3 program and are enthusiastic about what this may mean for people living with psoriatic arthritis and whose disease is not responded to prior treatments.

Last month we announced that filgotinib met its primary efficacy endpoint in the Phase 2 TORTUGA study in adults with moderately to severely active ankylosing spondylitis. Patients treated with filgotinib achieved significantly greater improvement in the ankylosing spondylitis disease activity score at week 12 compared to placebo. These results which were also published in The Lancet this week, compare favorably to those seen with other known DMARDs commonly known to treat ankylosing spondylitis patients. We'll determine the next steps for the program in the coming months.

Finally in the inflammation therapeutic area, I'm pleased to share that a Phase 2 study evaluating three investigational therapies, filgotinib; GS-9876, a Syk inhibitor; and tirabrutinib, a BTK inhibitor in patients with active Sjogren syndrome has fully enrolled 140 patients.

John McHutchison -- Chief Scientific Officer and Head of Research and Development

So I'll start first. So, after attending ACR this week and being at the meeting, it's clear that the efficacy that we are generating in multiple inflammatory diseases with filgotinib is as good or if not better than any other drug in the class, and equivalent to the biologics. And that holds true for FINCH 2 where we just saw the most difficult patients to treat, the biologic non-responders, inadequate responder patients where our ACR20 rates in people who had received three or more biologics previously was over 70%, just over 70%. So, I think efficacy wise, we are as good if not better than anything else out there in the class.

www.fool.com/earnings/call-transcript...

[verwijderd] 27 oktober 2018 18:46

1

J P Morgan koersdoel 125 euro Galapagos

www.iex.nl/Forum/Upload/2018/11181252...

[verwijderd] 27 oktober 2018 18:57

1

quote:
inspirator schreef op 27 oktober 2018 18:46:
J P Morgan koersdoel 125 euro Galapagos

www.iex.nl/Forum/Upload/2018/11181252...

www.trivano.com/aandeel/advies-jp-mor...

[verwijderd] 27 oktober 2018 22:45

0

Wederom een mooi bericht! Wat moet er nog MEER gebeuren om de koers te laten stijgen zou je zeggen. Het sentiment lijkt de grootste boosdoener; misschien volgende week een ommekeer. Bedankt voor je post inspirator; al het goede nieuws is welkom. AB-je!

[verwijderd] 28 oktober 2018 12:40

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Morphosys: Es wird noch einmal spannend.

MorphoSys collaborates with Galapagos with the aim to discover and develop antibody therapies based on novel modes of action in bone and joint disease, including rheumatoid arthritis, osteoporosis and osteoarthritis. The first joint development programme has recently advanced into preclinical development stage. The programme named MOR106 is an antibody made using MorphoSys's next-generation antibody library Ylanthia and will be developed in inflammatory diseases.

Welche Fortschritte konnten Sie bei MOR106 bereits erzielen und was sind die nächsten Etappen bei dem Projekt?

In unserer ersten klinischen Studie konnten wir bereits erste Anzeichen von Wirksamkeit zeigen. Inzwischen haben wir eine Phase-2-Studie gestartet, um verschiedene Dosierungen von MOR106 zu testen und weitere Erkenntnisse über die Wirksamkeit des Antikörpers zu erhalten. Außerdem wurde eine zusätzliche Phase-1-Studie gestartet, um den Einsatz von MOR106 in Form einer subkutanen Verabreichung vorzubereiten. Langfristig hoffen wir natürlich darauf, dass Novartis den Wirkstoff erfolgreich zur Zulassung bringt und vermarkten wird. Wir sehen bei Neurodermitis einen großen medizinischen Bedarf für neue Antikörper-basierte Therapien und ein enormes Marktpotenzial.

www.deraktionaer.de/aktie/morphosys--...

[verwijderd] 28 oktober 2018 12:46

0

Advies van InsingerGilissen over Galapagos
De analisten behouden hun koersdoel van 130,00 EUR.

www.trivano.com/aandeel/advies-insing...

Vertraagd	19 apr 2024 17:35
Koers	27,180
Verschil	-0,200 (-0,73%)
Hoog	27,280
Laag	26,860
Volume	62.640
Volume gemiddeld	80.149
Volume gisteren	135.801

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01 feb	Galapagos rondt Jyseleca-transactie af
04 jan	Galapagos in zee met Thermo Fisher

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