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Home  /   Forum   /   Galapagos   /   inhoudelijk LIGHT

Aandeel Galapagos AEX:GLPG.NL, BE0003818359

Laatste koers (eur) Verschil Volume
26,360   +0,120   (+0,46%) Dagrange 25,800 - 26,380 17.134   Gem. (3M) 104,5K

inhoudelijk LIGHT

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4.141 Posts
Pagina: «« 1 ... 166 167 168 169 170 ... 208 »» | Laatste | Omlaag ↓
  1. forum rang 4 Wall Street Trader 31 oktober 2020 10:58
    quote:

    Bosebox schreef op 30 oktober 2020 16:56:

    Analisten, investors en media hebben het nergens anders meer over dan dat 200mg essentieel is voor launch. Maar wie zegt eigenlijk dat dat zo is? De reumamarkt daar kan ik (deels) in meekomen, maar geldt hetzelfde voor de AS, PsA en Uveitis deelmarkten? Naar mijn weten (correct me if i’m wrong) wordt Rinvoq niet onderzocht in Uveitis (redelijk kleine markt ook trouwens). Daar zou je met alleen 100mg toch een verschil kunnen maken tegenover Humira?
    ......

    Only green light for the low 100mg dose is a black scenario, Van de Stolpe confirms.
    In that case, Gilead will likely decide not to introduce filgotinib in the US at all.

    Van de Stolpe acknowledged that in the event that only the 100mg filgotinib dose receives FDA approval for RA, Gilead could choose not to launch in the US for this indication and under this scenario Galapagos would not take on US commercialisation for this indication themselves.

    Partner Gilead doesn’t see a commercial benefit of launching with just the 100mg dose in RA. Should only the 100mg dose receive FDA approval and, under this scenario, should Gilead decide not to go forward in RA in the US, Van de Stolpe doesn’t see a scenario where Galapagos takes on full US RA rights themselves.

    That being said, he doesn’t believe Gilead will withdraw from filgotinib entirely should the 200mg dose not get FDA approved in the US for RA.
    In the competitive battle on the American market, the high dosage is of great importance, if not crucial.

    Van de Stolpe highlighted that the Type A FDA meeting is important with respect to the future of development for PsA (Psoriasis arthritis) and AS (Ankylosing Spondylitis).

    Gilead already in the meantime are pausing screening and enrollment for ongoing trials in psoriatic arthritis, ankylosing spondylitis and uveitis as they believe the FDA meeting will inform the broader filgotinib development program.

    Ulcerative Colitis was positive in the 200mg dose only, meaning that potential sales will not only be delayed until at least 2022, but FDA concerns will need to be alleviated to allow success in this indication.

    Van de Stolpe confirmed that filing for UC in Europe and Japan will be done in 4Q’20 and early-21, respectively, with approval in Europe on track for 2H’21, while the US filing is waiting for the MANTA and MANTA-Ray safety trials to read out in 1H’21.

    Regarding scenarios after the Type A meeting, Gilead said that there were many scenarios and that the markets would be informed once they know more.

    The human resources, finance and legal departments at Galapagos were already fully prepared for American sales. "Then you also have to take a good look at your organization," says Van de Stolpe. “We now appear not to be the company that will immediately receive a lot of income from the sale of this drug in America. But of course our costs will continue, and all the research we do. It really is a wake-up call for us. ”

    More concretely, for Galapagos this means a 'mark-up in terms of workforce'. This does not apply to the commercial department, a branch that has to grow because of the sale of Jyseleca in European countries. “But other departments, such as research and development and support services, will be paused,” says Van de Stolpe. “They will shrink a little when contracts expire, or temporary positions are not filled again. That should be clear. ”

    Among other things, the FDA is concerned about possible effects of Jyseleca on fertility in men. Animal experiments showed a decrease in sperm production. Galapagos and the European regulator were satisfied when no decrease in men's testosterone levels was measured in patients, but the American regulator did not.

    An additional study into the effects of Jyseleca on fertility in men was already underway.
    The results are expected in the first half of next year. Partner Gilead hopes that this will still convince the regulator.

    European and Japanese regulators are also interested in these results, Van de Stolpe confirms. “Of course, we still assume that those data do not show a negative effect of Jyseleca, and that will hopefully alleviate concerns that the drug has an impact on sperm production.
    In the unlikely event that there is a different outcome, we have another problem. Medicines are re-evaluated whenever new data or long-term data become available.
    Then a warning can be added to the drug, or it can even be withdrawn from the market. ”

    In my opinion if Gilead unfortunately are only going forward with the IBD indications and Gilead decides not to file RA in the US this will have a potential negative outcome for the stock price.
  2. forum rang 4 Wall Street Trader 5 november 2020 22:21
    Dear shareholders,

    This quarter has been one of mixed fortunes for Galapagos.

    September 25 was a historic day with the approval of filgotinib, under the brand name Jyseleca®, for the treatment of moderate to severe rheumatoid arthritis (RA) patients by both the Japanese and European authorities. This is a major achievement, and a great recognition of the tireless work by so many at Galapagos. Both authorities approved Jyseleca’s 100 mg and 200 mg dose, as monotherapy or in combination with methotrexate (MTX). Our commercial teams are in the process of bringing our first product to patients in the Benelux and EU5, together with our co-commercialization partner Gilead.

    Unfortunately we also had less good news this quarter, as Gilead received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for the New Drug Application (NDA) for filgotinib in the U.S. for the treatment of adults with moderate to severe RA. This was a very disappointing result. In order to finalize its review of the application, the FDA requests the results of the MANTA and MANTA-RAy studies. In addition, the FDA expressed concerns about the overall risk-benefit profile of the filgotinib 200 mg dose.

    Although this is a significant setback, we, together with our collaboration partner Gilead, continue to believe in the risk-benefit profile of filgotinib.

    The potential of filgotinib was further confirmed with positive results from the SELECTION Phase 2b/3 study of filgotinib in patients with ulcerative colitis (UC), a chronic disorder that, despite existing therapies, has a huge impact on the quality of the lives of more than 2 million people worldwide. This is the first Phase 2b/3 study for filgotinib in inflammatory bowel diseases (IBD). The SELECTION results, which were presented to the scientific and healthcare community at the International United European Gastroenterology Week (UEGW), demonstrated that filgotinib 200 mg, orally administered, versus placebo reduced bleeding and stool frequency, while also achieving remission across a range of measures, such as endoscopy and histology. Gilead submitted an application for approval in UC in Europe, and a filing for UC in Japan is expected in the first half of 2021. In the U.S., Gilead is expected to provide timelines on the filing for UC once the MANTA and MANTA-RAy results are in.

    Another disappointment was the result of the ROCCELLA Phase 2 study of GLPG1972 in patients with osteoarthritis. Galapagos and collaboration partner Servier executed this study in 932 patients over 52 weeks of treatment, but the study did not meet its primary and secondary objective. With that result, the development of GLPG1972 for OA is halted.

    Moving to fibrosis, we and partner Gilead announced positive topline results for the NOVESA Phase 2a study with ziritaxestat (GLPG1690) in patients with diffuse cutaneous systemic sclerosis (dcSSc). SSc is a difficult indication, and there currently are no drugs approved for overall disease treatment. The fact that ziritaxestat reached statistical significance for the primary endpoint in this difficult to treat patient population is an additional validation of the anti-fibrotic activity of ziritaxestat, which was already observed in the FLORA study in patients with idiopathic pulmonary fibrosis (IPF).

    In addition, ziritaxestat obtained Fast Track status from the FDA in the lead indication of IPF. There is a high need for new treatment options for patients with this rare and progressive disease. The worldwide ISABELA Phase 3 study with ziritaxestat in IPF patients is currently ongoing and we still expect to announce the results of the futility analysis of ISABELA in the first half of 2021.

    Our most innovative program in inflammatory diseases and fibrosis, Toledo, continues to advance rapidly. The first patients with psoriasis were dosed with GLPG3970, our most advanced Toledo compound in a new target category with dual action in inflammatory diseases and fibrosis. Several proof-of-concept patient studies have been initiated to evaluate GLPG3970 in various autoimmune diseases: the CALOSOMA Phase 1 study in psoriasis, SEA TURTLE Phase 2 study in UC, and LADYBUG Phase 2 study in RA. We also expect to initiate two additional Phase 2 studies with GLPG3970 early next year. We recently revealed that the Toledo target family are salt-inducible kinase inhibitors, and presented the preclinical and clinical data which confirm the dual mode of action of lead compound GLPG3970.

    Our balance sheet in the third quarter remains strong with a cash position of €5.3 billion, enabling us to deliver on our growth plan, further expand our pipeline, attract new talent, and support the commercialization of our first medicine. For the full fiscal year 2020, we retain our previous cash burn guidance of between €490 and €520 million.

    Outlook 2020

    Our collaboration partner Gilead is in direct dialogue with the FDA on filgotinib’s NDA following receipt of the CRL for filgotinib in RA in the U.S., and we expect more clarity on next steps in the coming months. With the MANTA and MANTA-RAy studies fully recruited, we expect to have key results available in the first half of 2021.

    In the fourth quarter of this year we expect to report topline data from the PINTA Phase 2 study with GLPG1205 in IPF. Furthermore there have been over 1,200 patients recruited in our global landmark ISABELA Phase 3 program with ziritaxestat in IPF. We remain on track to announce the futility analysis in the first half of 2021.

    In order to evaluate the broad potential of our most advanced Toledo compound, the SIK2/3 inhibitor GLPG3970, in inflammatory diseases, we anticipate first dosing in the LADYBUG (RA) and SEA TURTLE (UC) proof-of-concept studies.

    We retain our operational cash burn guidance of €490 to €520 million for full year 2020.

    As we head into the last months of 2020, we continue to execute on our strategy to develop novel mechanism of action drugs aimed at addressing unmet need in inflammation, fibrosis, and other diseases. We have a strong cash position, expert teams, and excellent science to achieve this.

    Onno van de Stolpe

    CEO

    Q3 Report 2020

    Dutch

    reports.glpg.com/2020/q3/nl/servicepa...

    English

    reports.glpg.com/2020/q3/en/servicepa...
  3. forum rang 4 Wall Street Trader 5 november 2020 22:23
    OncoArendi and Galapagos enter into exclusive collaboration on chitinase
    inhibitors in fibrosis

    Mechelen, Belgium and Warsaw, Poland, 5 November 2020, 22.15 CET –
    Galapagos NV (Euronext & NASDAQ: GLPG) and OncoArendi Therapeutics SA
    (WSE: OAT), announced that they have signed an exclusive collaboration and
    license agreement for the global development and commercialization of
    OncoArendi’s OATD-01. OATD-01 is a Phase 2-ready chitotriosidase/acidic
    mammalian chitinase (CHIT1/AMCase) inhibitor for the treatment of idiopathic
    pulmonary fibrosis (IPF) and other diseases with a fibrotic component.

    More information about OATD-01

    oncoarendi.com/en/oncoarendi-therapeu...

    Dutch

    ml-eu.globenewswire.com/Resource/Down...

    English

    ml-eu.globenewswire.com/Resource/Down...
  5. Lama Daila 5 november 2020 23:38
    oncoarendi.com/en/oncoarendi-therapeu...

    OncoArendi Therapeutics broadens its collaboration with VIB, a leading life science research institute in Europe, to investigate the role of chitinase family of proteins as potential therapeutic targets in COVID-19 patients

    September 11, 2020

    OncoArendi Therapeutics SA today signed an agreement with VIB, one of the world leading life science research institutes. The scope of this research collaboration focuses on the role of chitinase and chitinase-like-proteins (CLPs) in COVID-19 and subsequent complication. This collaboration can lead to identification of new drug candidates that can alleviate COVID-19 complications, such as lung fibrosis.

    The collaboration involves the research group of Prof. Bart Lambrecht at the VIB-UGent Center for Inflammation Research, currently also involved in several COVID-19 clinical trials at the University Hospital Ghent. The aim of this collaboration is to investigate the role of two proteins from the chitinase family – CHIT1 and YKL-40, for which OncoArendi is currently developing small molecule inhibitors. A better understanding of their role in lung diseases, in particular in patients after a SARS-CoV-2 infection, may contribute to developing these drug candidates for treatment of post COVID-19 complications.

    PB Galapagos:

    Additionally, under the terms of the agreement, Galapagos will pay OncoArendi €2 million for the right of first negotiation on all other earlier stage programs on its chitinase platform. OncoArendi remains responsible for all research activity until preclinical candidate selection, after which Galapagos can exercise the option to initiate negotiations to obtain development or commercialization rights for the selected molecules. Any such transaction will be subject to a separate set of payments.
  9. Loureiro 7 november 2020 10:48
    quote:

    Lama Daila schreef op 7 november 2020 09:13:

    Galapagos NV (GLPG) CEO Onno van de Stolpe on Q3 2020 Results - Earnings Call Transcript

    seekingalpha.com/article/4386233-gala...

    Thx Lama Daila.
    Heb alles eens gelezen en wat mij betreft staat er niks negatiefs in.
    Ik ben zelfs wat optimistischer geworden wat betreft filgotinib voor de VS.
    Zelfs toelating 200mg voor RA met vertraging zou het vertrouwen in GLPG volledig herstellen.
    Ik begrijp nog steeds niet de grote daling van de koers gisteren op basis van de kwartaalresultaten.
    Ben ook benieuwd naar de reactie van onze kenners hier op het forum zoals Wic32, Reykus, Barbet ea.

  10. Lama Daila 7 november 2020 12:12
    quote:

    abelheira schreef op 7 november 2020 10:48:

    [...]
    Ik begrijp nog steeds niet de grote daling van de koers gisteren op basis van de kwartaalresultaten.
    Ben ook benieuwd naar de reactie van onze kenners hier op het forum zoals Wic32, Reykus, Barbet ea.

    Ik dacht hier en daar gelezen te hebben dat de daling zou kunnen te maken hebben met het feit dat de type A meeting verder in de toekomst ligt dan verwacht. Sommigen hadden gedacht dat die meeting al achter de rug was en we snel iets gingen vernemen, maar nu is duidelijk dat die meeting nog moet doorgaan. Het is dus zeker nog een tijdje wachten op de feedback van Gilead. En beleggers wachten niet graag ...
  12. ZyppBe 7 november 2020 15:32
    quote:

    abelheira schreef op 7 november 2020 13:49:

    Als ik het juist heb, zijn er onlangs nog onderzoeken gestart in fase 1 voor filgotinib met uitslagen in december.
    Zou dit op vraag van de FDA geweest zijn?
    Daarom meeting A voor eind dit jaar?
    Die bedenking heb ik ook gemaakt, ik neem aan dat je deze studie bedoeld:

    clinicaltrials.gov/ct2/show/NCT046083...

    Disease: RA en enkel de 200 mg w/ onderzocht.

    Kunnen de (safety) resultaten van de Phase 2b/3 SELECTION (filgo 200 mg UC) eigenlijk ook voorgelegd worden op de Type A?
  13. forum rang 10 voda 7 november 2020 17:03
    Galapagos NV (GLPG) CEO Onno van de Stolpe on Q3 2020 Results - Earnings Call Transcript
    Nov. 6, 2020 9:21 PM ET | About: Galapagos NV (GLPG), GLPGF

    Subscribers Only
    Earning Call Audio
    Galapagos NV (NASDAQ:GLPG) Q3 2020 Results Conference Call November 6, 2020 8:00 AM ET

    Company Participants

    Elizabeth Goodwin - Investor Relations

    Onno van de Stolpe - Chief Executive Officer

    Andre Hoekema - Chief Business Officer

    Bart Filius - Chief Operating and Financial Officer

    Walid Abi-Saab - Chief Medical Officer

    Piet Wigerinck - Chief Scientific Officer

    Michele Manto - Chief Commercial Officer

    Conference Call Participants

    Lenny Van Steenhuyse - KBC Securities

    Laura Sutcliffe - UBS

    Emily Field - Barclays

    Nick Nieland - Citi

    Peter Welford - Jefferies

    Rushee Jolly - Bernstein

    Evan Seigerman - Credit Suisse

    Brian Abrahams - RBC

    Matthew Harrison - Morgan Stanley

    Jason Gerberry - Bank of America

    Benoit Louage - Degroof Petercam

    Operator

    Ladies and gentlemen, thank you for standing by and welcome to the Q3 2020 Results Conference Call. I would now like to hand over the conference to your first speaker today. Elizabeth Goodwin. Please go ahead.

    Elizabeth Goodwin

    Hi. Thank you all for joining us today for third quarter results call. I'm Elizabeth Goodwin, Investor Relations, also representing our financial reporting to bring you this information today. This recorded webcast is accessible via the Galapagos website homepage and will be available for replay later on today.

    Sell-side analyst and profession investors are invited to post the question at the end of our call and can dial in at series of numbers in our press release from last night. Here is one for Belgium, that's 32-2793-3847, the code is 8542327, and I'll repeat that right before Q&A starts.

    I'd like to move now to our forward-looking statements and remind everyone that we will be making forward-looking statements during today's webcast. The statements include remarks concerning future developments of the pipeline, future financial results, growth of our company and possible changes in the industry and competitive environment.

    Because these forward-looking statements involve risks and uncertainties, Galapagos' actual results may differ materially from the results expressed or implied in these statements. Outside of filgotinib and rheumatoid arthritis in Europe and Japan, none of our drug candidates are approved by any regulatory authority.

    Today's call will be like our other quarterly calls, CEO, Onno van de Stolpe, will cover operational highlights for the third quarter; Chief Business Officer, Andre Hoekema, will present our deal with OncoArendi announced last night; and Chief Operating and Financial Officer, Bart Filius will highlight our financial results and close with the outlook for the coming months. During their presentation, you'll see the slides progress on screen and this will be followed by a Q&A session with the executives at the end.

    And at this point, I'd now like to hand over to Onno to talk about the third quarter operations. Go ahead.

    Onno van de Stolpe

    Thank you, Elizabeth, and welcome everybody. Good afternoon. Good morning. We would like to start with the operational highlights. Clearly, the highlight of the year for us is the approval of the Jyseleca so that filgotinib in new better trial is in the EU and Japan, which of course is a hallmark moment for Galapagos. This was overshadowed by the complete response letter we received from the FDA for the U.S. approval.

    In the CRL, they listed two reasons. One, the MANTA/MANTA-RAy results that they are awaiting before making a decision on the approval, which is the testicular tox study that we're executing with Gilead. And they express their concerns the risk benefits of the 200 milligrams, very disappointing CRL, very unexpected, but the reality we got to face with. And certainly for the Jyseleca, we were pleased lastly to announce the filing of the Jyseleca in the EU for osteoarthritis, the second indication for this work that we are going to go for.

    Voor meer, zie link:

    seekingalpha.com/article/4386233-gala...
  17. forum rang 4 Wall Street Trader 10 november 2020 11:30
    @Stultis

    see this post from 3 October:
    www.iex.nl/Forum/Post/12782220.aspx

    What's done is done, I still think this was information what should have been shared with the market.

    Believe me this was the reason the stock tumbled the weeks before the result from the FDA came in.

    There are always some individuals with foreknowledge thats why the stock tumbled.
    9 out of 10 times biotech shares rise before the run-up to an approval.
    The same thing happened with the Gilead/Galapagos deal last year, the stock kept rising and rising (28%) and then they both announced the deal.

    The communication from both company's could be a lot better. As I said earlier the market hates uncertainty.

    Look what happened yesterday and today with all the stocks impacted due to the COVID-19 pandemic. They were at all time lows and with much more potential return on your money and lesser risks and still keep rising and rising. Galapagos is still hanging around € 103 due to the uncertainty with Filgotinib in the US. I also think Gilead unfortunately are only going forward with the IBD indications and Gilead decides not to file RA in the US. This will have a (potential) negative outcome for the stock price.

    As you said before, don't expect the stock price to return to € 200 in a long time if ever.

    We are also still waiting for the PINTA studies results as where Piet said they would be disclosed at the end of October.

    More badnews, 2 Downgrades today:

    Galapagos: naar €110 van €112 en houden - Royal Bank of Canada
    Galapagos: naar €105 van €129 en houden - Credit Suisse

    Conclusion: Investors are disappointed (me included) and communication could and should be a lot better!
  18. Rekyus 10 november 2020 12:14
    Dat een collectief van víer journalisten nodig is voor één zo'n prutsartikel stemt mij droef. Eén centrale, volledig onbewezen stelling als fundament voor een compleet luchtkasteel van afgeleide vermoedens. Naïef vanwege aantoorbaar gebrek aan systeermkennis. Maar ook manipulatief: contextloze quootjes van deskundigen in reactie op geclausuleerde vragen om zo de beschuldigingen en vermoedens kracht bij te zetten....

    Even de centrale punten van het collectief op een rijtje:

    a) Gilead was al in een vroeg stadium op de hoogte van een formele wijziging in het beleid van de FDA, maar Gilead heeft niet aan zijn wettelijke informatieverplichting voldaan;
    b) Ook Galapagos heeft (na door Gilead te zijn geïnformeerd, omgaand of in een iets later stadium) niet voldaan aan zijn eigen, zelfstandige informatieverplichting;
    c) Bestuurders van beide ondernemingen hebben in weerwil van de ontstane voorwetenschap toegestaan dat derden aandelen hebben gekocht, wat die laatsten achterwege zouden hebben gelaten indien zij tijdig en volledig waren geïnformeerd en/of hebben zelf aandelentransacties verricht.

    De punten b en c komen pas aan de orde als onomstotelijk vaststaat dat het gestelde onder a) klopt. Van het gestelde onder a) is geen enkel bewijs te vinden in het artikel (of elders). Dat er sprake zou zijn geweest van een 'ijzige stemming' tijdens de FDA-meeting is geen reden om daarover melding te maken in een persbericht of publieke mededeling; slechts formele besluiten worden en moeten ook worden gecommuniceerd, niets meer, niets minder.

    Onderzoeksjournalistiek is een prachtig métier, met een grote maatschappelijke betekenis. Maar zo bedreven verdient het die naam niet.

    Meer woorden wil ik er niet aan kwijt.
  19. Lama Daila 10 november 2020 12:44
    @Rekyus,
    Het vermelde onderzoekscollectief Spit vraagt om hen te steunen:
    www.oc-spit.com/wiewijzijn

    Steun Spit
    Om meer onderzoeksjournalistiek mogelijk te maken, kunt u ons steunen door een bedrag te doneren

    Ze stellen voor om 10 EUR te storten, maar je mag het bedrag ook aanpassen :-)

  20. winx09 10 november 2020 13:20
    quote:

    Lama Daila schreef op 10 november 2020 12:44:

    @Rekyus,
    Het vermelde onderzoekscollectief Spit vraagt om hen te steunen:
    www.oc-spit.com/wiewijzijn

    Steun Spit
    Om meer onderzoeksjournalistiek mogelijk te maken, kunt u ons steunen door een bedrag te doneren

    Ze stellen voor om 10 EUR te storten, maar je mag het bedrag ook aanpassen :-)

    Ik ga ze een delfblauw tegeltje opsturen, voor boven het bureau.

    de tekst wordt waarschijnlijk:

    Niet door kennis geremd, blaat het ongetemd.

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