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Galapagos oktober 2020

4.802 Posts
Pagina: «« 1 ... 225 226 227 228 229 ... 241 »» | Laatste | Omlaag ↓
  1. [verwijderd] 29 oktober 2020 21:44
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  2. forum rang 6 Raasgier 29 oktober 2020 21:44
    quote:

    Endless schreef op 29 oktober 2020 21:36:

    [...]
    Zit ik net op filgotinib draadje te lezen lijkt inderdaad zelfde informatie .
    Dit zou zomaar de grote koersval vandaag verklaren. Thx dat je me op de eerder bekend informatie wijst, werd er alweer nerveus van thx
    Ok, dan geloof ik dat ik aan alle plussen en minnen op dat draadje meer gewicht ga geven dan aan dit artikel :)
  3. forum rang 6 Goudmijn64 29 oktober 2020 21:44
    quote:

    Endless schreef op 29 oktober 2020 21:20:

    Gilead stops 3 filgotinib trials pending FDA feedback on faltering JAK1 inhibitor
    Ach ja .... weer een deukje in het vertrouwen.
  4. Wiema 29 oktober 2020 21:48
    quote:

    moneymaker_BX schreef op 29 oktober 2020 21:44:

    Investing Quotes ADRs GLPG Overview
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    Goed gezien, met volume van 10 stuks moneymaker! Snel kopen!
  5. forum rang 6 Goudmijn64 29 oktober 2020 21:50
    quote:

    W-0803 schreef op 29 oktober 2020 21:48:

    [...]
    Goed gezien, met volume van 10 stuks moneymaker! Snel kopen!
    Is Walid aan het inslaan??
  6. forum rang 4 Lingus 29 oktober 2020 21:51
    quote:

    Goudmijn64 schreef op 29 oktober 2020 21:22:

    After hours trading Gala + 8,71% (helaas op een omzet van 346 stuks)
    www.marketwatch.com/investing/stock/glpg
    Op het filgotinib draadje heeft Lama een nieuwe trial gemeld: Filgotinib 200 mg in fase 1 in een combotherapie, gesponsord door Gilead.

    clinicaltrials.gov/ct2/show/NCT04608344

    346 stuks. Draai 346 eens om... GLPG0643 = filgotinib.

    Met enige fantasie kan je er een signaal in zien...

    Disclaimer: ik heb heel veel fantasie.
  7. forum rang 6 Raasgier 29 oktober 2020 21:55
    quote:

    Goudmijn64 schreef op 29 oktober 2020 21:44:

    [...]

    Ach ja .... weer een deukje in het vertrouwen.

    Lees vooral in dingen die je erin wilt lezen hoor. Maar als je even net een paar posts meer terugleest, zou je op het idee kunnen komen om even naar het Filgotinib-draadje te gaan om daar wat meer nuances op dit nieuws toe te passen. Nee het is niet supergoed nieuws, maar ook niet zo simpelweg slecht als deze schrijver suggereert.
  8. Camul 29 oktober 2020 21:57
    quote:

    Lingus schreef op 29 oktober 2020 21:51:

    [...]
    Op het filgotinib draadje heeft Lama een nieuwe trial gemeld: Filgotinib 200 mg in fase 1 in een combotherapie, gesponsord door Gilead.

    Dan heeft Gilead in ieder geval nog veel vertrouwen in de 200mg....Of zie ik dat verkeerd ?
  9. forum rang 4 Sentiment 29 oktober 2020 22:07
    After Hours Time (ET) After Hours Price After Hours Share Volume
    16:41:49 $126.98 10
    16:41:49 $126.98 10
    16:29:06 $117.00 2
    16:15:03 $126.98 10
    16:03:54 $116.81 12
    16:00:07 $116.81 106
    16:00:07 $116.81 50

    Ach, 30 stuks, waar hebben we het over?
  10. [verwijderd] 29 oktober 2020 22:16
    Over de PINTA studie gesproken, die resultaten laten wel heel lang op zich wachten. Met maar 60 deelnemers, lijkt me dat ze die al wel moeten hebben. Morgan Stanley lijkt toch beter op de hoogte te worden gehouden (zie vroege rapport over scenario’s Type A meeting) en recentelijk een scenario rapport over ‘1205, waarin hun base case toch positief is. Het zal mij niet verbazen áls ‘1205 inderdaad redelijk tot goede resultaten laat zien in IPF, Gilead meteen een opt-in doet voor het molecuul ter waarde van $150 mil. Dan doorstomen naar phase 2b/3 en combinatiestudie opstarten na futility analysis ‘1690?
  11. Insider 29 oktober 2020 22:31
    www.evaluate.com/vantage/articles/new...

    Gilead is to discuss with the FDA by the end of the year what might be done with Jyseleca in RA. If this suggests that it is a no-go, Mr Persay said two options were on the table: abandoning Jyseleca in RA but moving forward in Crohn’s disease and ulcerative colitis, or giving up any attempt to get the drug to the US market in any indication.

    The company is awaiting data from the Manta and Manta-Ray studies looking at the testicular safety of filgotinib in inflammatory bowel disease and various arthritic conditions respectively. It will decide once these are out at the start of next year.

    As for another programme that originated with Galapagos, Gilead said it would decide whether to opt in to the "Toledo" assets once they are “de-risked to the appropriate level”. Gilead has the option to buy ex-Europe rights to these candidates, now confirmed to target SIK1, 2 and 3 kinases, for $150m per programme plus royalties.

    “If you saw, hypothetically, a huge response in one indication that was really unexpected and blew it out of the water, we might opt in more early,” Mr Parsey said. Clinical successes on that scale are exactly what Gilead needs; time for investors to cross their fingers.
  12. [verwijderd] 29 oktober 2020 22:38
    quote:

    Insider schreef op 29 oktober 2020 22:31:

    www.evaluate.com/vantage/articles/new...

    Gilead is to discuss with the FDA by the end of the year what might be done with Jyseleca in RA. If this suggests that it is a no-go, Mr Persay said two options were on the table: abandoning Jyseleca in RA but moving forward in Crohn’s disease and ulcerative colitis, or giving up any attempt to get the drug to the US market in any indication.

    The company is awaiting data from the Manta and Manta-Ray studies looking at the testicular safety of filgotinib in inflammatory bowel disease and various arthritic conditions respectively. It will decide once these are out at the start of next year.

    As for another programme that originated with Galapagos, Gilead said it would decide whether to opt in to the "Toledo" assets once they are “de-risked to the appropriate level”. Gilead has the option to buy ex-Europe rights to these candidates, now confirmed to target SIK1, 2 and 3 kinases, for $150m per programme plus royalties.

    “If you saw, hypothetically, a huge response in one indication that was really unexpected and blew it out of the water, we might opt in more early,” Mr Parsey said. Clinical successes on that scale are exactly what Gilead needs; time for investors to cross their fingers.
    Wat is nou de kern van bovenstaande? Die 10 dollar hoger nabeurs zal toch niet zomaar gebeuren
  13. forum rang 5 Instapmoment 29 oktober 2020 22:51
    quote:

    moneymaker_BX schreef op 29 oktober 2020 22:38:

    [...]

    Wat is nou de kern van bovenstaande? Die 10 dollar hoger nabeurs zal toch niet zomaar gebeuren
    Staat los van de koers nabeurs. In het bericht hierboven staan geen feiten die we nog niet kennen.

    Verder lijkt het mij ook dat iemand een tikfout heeft gemaakt. Wie wil op dit moment de stukken hebben voor dat bedrag?! Vrees eerder voor een verdere daling
  14. toedenoedelie 30 oktober 2020 00:31
    quote:

    Raasgier schreef op 29 oktober 2020 21:28:

    [...]

    Mja de vraag is dus wie je precies met "men" bedoelt. Naar mijn inschatting dus alleen sommigen hier, dus zelfs de diagnose dat het "dan in de regel dus daalt" lijkt me wat overtrokken.
    Met 'men' bedoel ik die beleggers die zouden zijn ingestapt cq hun positie hadden uitgebreid bij TOLEDO nieuws dat ' Boven Verwachting' zou zijn geweest.
  15. [verwijderd] 30 oktober 2020 06:55
    Vind het toch maar bizar hoor. Langs de ene kant leggen ze trials stil tot ze hun gesprek gehad hebben met de FDA (wat het vertrouwen toch terug geen deugd doet), langs de andere kant starten ze een nieuwe trial op met geschatte einddatum december 2020, wat volgens mij toch ook in de periode ligt dat ze nog moeten spreken met de FDA.
    In plaats van ervoor te zorgen dat Filgotinib dan toch on track blijft voor toepassing in andere indicaties voor de landen waar het wel verkocht mag worden geven ze daar de concurrentie eventjes 1 à 2 maanden tijdsvoordeel, gratis en voor niets.

    Nu, futures amies staan ook weer donkerrood, dus het zal sowieso terug geen leuke dag worden vrees ik.
  16. forum rang 7 Just lucky 30 oktober 2020 07:14
    Zo gaat dat; de yanken liggen op een oor en de algo's zorgen ervoor dat de yanken bij het ontbijt weer goedkoop kunnen instappen. Hoe denk je anders dat partijen als GS die miljarden verdienen.
  17. forum rang 7 wiegveld 30 oktober 2020 07:14
    www.fool.com/earnings/call-transcript...

    And to close, a few words on Jyseleca, which is the brand name for filgotinib. Jyseleca has now launched in Germany, and launch planning is well under way across Europe, as well as Japan.And to close, a few words on Jyseleca, which is the brand name for filgotinib. Jyseleca has now launched in Germany, and launch planning is well under way across Europe, as well as Japan.

    Merdad Parsey: medical officer:

    Turning to filgotinib. We're excited about the launch of Jyseleca for rheumatoid arthritis in Europe. During the quarter, we shared data from the Phase IIb/III selection trial in ulcerative colitis showing filgotinib 200-milligram induced remission at week 10 and achieved endoscopic histologic and six-month corticosteroid free remission at week 58 with a consistent safety profile. We plan to file filgotinib for ulcerative colitis in Europe before the year-end and Japan early next year.

    As we previously shared, in August, the FDA issued a complete response letter for filgotinib in rheumatoid arthritis, requesting data from the MANTA and MANTA-RAy studies and expressing concerns regarding the benefit/risk profile of the 200-milligram dose. We met with the FDA for a Type C meeting to discuss MANTA, and we'll meet again for a Type A meeting in Q4 to further discuss the CRL. In the meantime, we're pausing screening and enrollment for ongoing trials in psoriatic arthritis, ankylosing spondylitis and uveitis as we believe the FDA meeting will inform the broader filgotinib development program. We continue to believe in the benefit/risk profile of filgotinib.

    I'd also like to highlight that we remain committed to inflammation into our long-term collaboration with Galapagos. Finally, I wanted to highlight that we are focused on ongoing strategic portfolio review and disciplined prioritization of our overall portfolio. We've shared a summary of important upcoming milestones across the pipeline in the materials we've provided. I'll turn over the call to Andy now.

    Matthew Harrison -- Morgan Stanley -- Analyst

    I guess on filgotinib, can you guys maybe just describe what you're thinking in terms of the potential outcomes here once you have that Type A meeting? Is this something where you could decide not to launch the drug in the U.S. at all? Or is this more a nuanced approach where maybe you won't move forward with RA but move forward with the IBD indication?

    Merdad Parsey -- Chief Medical Officer

    Matthew, it's Merdad. Yes, I think it's hard to predict what the outcomes are. I do think that both the options you suggested are possible. And I would sort of tend toward your latter approach, which is that if things aren't able to move forward with RA, we'd like to keep the door open for us to continue to move forward in IBD and continue those discussions, obviously, dependent on the MANTA and the MANTA-RAy data outcome.

    Evan Seigerman -- Credit Suisse -- Analyst

    Hi guys. Thank you so much for taking the question. I know it's a busy day. So with the recent review of Galapagos' Toledo program, Merdad, what do you really need to see from the proof-of-concept trials to opt in and be comfortable, potentially incorporating this into your portfolio given your focus on portfolio optimization? Thank you.

    Merdad Parsey -- Chief Medical Officer

    Yes. Thanks. Great question. They're doing a really great job of exploring the potential of that program in multiple indications.

    And they have a great approach of trying to get there quickly, looking for early signals of activity. On our end, obviously, we would like to see the programs de-risked to the appropriate level at the time that we opt in. That will vary based on the signals we see and the magnitude of the improvement that we see. So obviously, if you saw hypothetically a huge response in one indication that was really unexpected and blew it out of the water, we might opt in more early.

    Whereas if it's more nuanced in a small trial, we might want to flesh that out a little bit more before we opt in. Our contract allows us to continue to work with them as the program's already de-risked, and our desire is to opt in and move as quickly as possible once we have an appropriate level of risk.

    Michael Yee -- Jefferies -- Analyst

    Hey thanks for the question. I wanted to follow up a little more on filgotinib. Obviously, it's an important driver, and you said you'll have a Type A meeting, and you'll make some decisions. Can you just clarify what you would actually learn from a Type A? And if you were to, as you said, maybe keep IBD, isn't 200 milligrams really important, and so that would tie together with RA being approved at 200? So maybe just explain a little bit where these scenarios would evolve from.

    And could you just make tough decisions to not go forward at all? Thank you.

  18. forum rang 7 wiegveld 30 oktober 2020 07:14
    Merdad Parsey -- Chief Medical Officer

    Sure, Michael. Yes, couldn't agree more. Look, I think the conversation we'll have in the Type A meeting will center around really what level of evidence the FDA would be looking for on both of those issues, right, in terms of trying to get to a better benefit/risk understanding. And so that will depend -- so we need to find that out from the 200-milligram standpoint, and we need to find it out from the MANTA and MANTA-RAy standpoint.

    So those two things we will get guidance from the FDA at the Type A meeting. And then based on that outcome, we will make some decisions how to go forward, whether there's a clear path, whether we have to only go forward in IBD or whether 200 milligrams is not viable until MANTA reads out, MANTA-RAy readout. All those are possibilities, so it's hard to speculate what the outcome of that will be. We'll be transparent obviously as we have that discussion with how we'll proceed.

    Alethia Young -- Cantor Fitzgerald -- Analyst

    Hey guys. Thanks for taking my question. I just wanted to talk a little bit about kind of big picture immunology. So maybe depending on what you decide with filgotinib next year based on some of the conversations, like how are you thinking about the space? Are you still committed? Would you consider doing M&A? Or do you have an internal pipeline that continue to drive potential revenues there?

    Dan O'Day -- Chairman and Chief Executive Officer

    Thanks, Alethia. I'll start and then maybe Merdad can add as well. But first of all, I mean nothing has changed about our dedication to our three disease areas. As you know, I mean our strategy that we announced at the beginning of the year was based upon two really strong scientific disciplines that we have from a discovery perspective at Gilead and with our partners, and that is antivirals and immunomodulation.

    And we've been firmly focused on that strategy in terms of how it plays out in both antivirals, inflammation and fibrosis and then also oncology. So we think there's a lot of synergies associated with that science. Obviously, immunology, as you know, goes across so many disease states. Immunology plays in the antivirals, for instance, particularly when we look at some of our HBV cure programs.

    But clearly, in the field of inflammation, we've already spoken about where we stand with filgotinib. We have a variety of follow-on agents within our Gilead research, with our partners with Galapagos, and we'll maintain an external view on opportunities to continue to advance our inflammation portfolio in-house. And you can see, of course, what we've done in the oncology field, predominantly immuno-oncology over the past year, really building up our oncology base based upon -- largely based upon immuno-oncology. Trodelvy allows us to have a really strong footprint now into solid tumors in a pan-tumor way, which we think will be very complementary to our first-in-class, best-in-class immuno-oncology portfolio.

    Merdad, maybe you want to add as well your view on that question as well.

    Merdad Parsey -- Chief Medical Officer

    I think you hit all the key points, Dan. I think the only thing I'd add is I think we really have a great team here, and I think that team is going to be really great about charting our future in immunology. But as Dan said, we remain committed to that, and we'll continue to look at both near- and long-term opportunities there that makes sense for us in the portfolio.

    Dan O'Day -- Chairman and Chief Executive Officer

    I mean maybe, Merdad, it's just important to emphasize the unmet medical need in that area. It's still a very significant.

    Merdad Parsey -- Chief Medical Officer

    Yes. And maybe the only other thing I'd add is that we look at it through a fairly broad lens of what immunology means. There are a lot of indications with a lot of unmet need that persist in that space, and we'll be looking for that transformative profile.
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