Galapagos BE0003818359

Analyst reports 2020

1. avantiavanti 16 oktober 2020 08:13

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   Raymond James 15 oktober 2020
   
   ROCCELLA Update, Endpoint Not Met
   On Thursday, after market close, Galapagos NV and partner Servier announced that the
   Phase 2 ROCCELLA trial of GLPG1972/SR01086 for knee osteoarthritis (OA) did not meet the
   primary endpoint of reducing cartilage loss of central medial tibiofemoral compartment
   of the target knee. The primary endpoint did not show efficacy compared to placebo, as
   the change from baseline to week 52 in cartilage thickness, in mm (SD) was -0.116 (0.27) for
   the placebo group and -0.068 (0.20), -0.097 (0.27), and -0.085 (0.22), for the low, medium, and
   high doses of GLPG1972, respectively. Galapagos reported that statistically significant difference
   versus placebo was not reached for the primary or secondary endpoints, for any of the treated
   groups. GLPG1972 was generally well-tolerated by patients in the trial. Galapagos is conducting
   additional analyses of the results, and will present them at upcoming medical conferences. We had not incorporated GLPG1972 into our model, and thus make no changes to our estimates.

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2. avantiavanti 16 oktober 2020 08:18

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   Stifel 15 oktober 2020
   
   ROCCELLA Fail Likely To Raise More Questions About GLPG's R&D Engine; We're Sticking To The Sidelines
   
   Summary
   We are reiterating our Hold rating on GLPG shares after the company reported that
   its Phase 2b ROCCELLA study evaluating GLPG1972, an ADAMTS5 inhibitor, in knee
   osteoarthritis failed. While we thought the risk/reward was pretty balanced into the
   readout +5-10%/-5-10%, we think the outright failure will raise questions about the
   company's R&D engine which represents the bull thesis. The company is expected to
   unveil its Toledo program later this month (Oct. 27) which has long been talked about, but the
   mechanism of action is not validated/known, and they just brought it into Phase 2 trials. For
   now, we remain on the sidelines and think buying shares here one must truly believe GLPG can
   deliver on its pipeline and that filgotinib will be competitive in the US - neither of which we have
   much clarity or confidence in at this point. Our target price moves to $138 on the news.

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3. avantiavanti 16 oktober 2020 08:22

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   De Groof Petercam 15 oktober 2020
   
   ROCCELLA Phase 2b failed meeting its primary endpoint
   • The company today announced the failure of the ROCCELLA Ph2b trial
   • Today’s news has an impact on valuation
   
   Facts:
   • The ROCCELLA trial is a global, double-blind, placebo-controlled, dose ranging
   trial evaluating the efficacy and safety of three different once-daily oral doses
   of ADAMTS-5 inhibitor GLPG1972 in 932 patients with knee osteoarthritis (OA)
   over 52 weeks of treatment.
   • The primary objective of the trial was to demonstrate a significant reduction in
   cartilage loss versus placebo. The trial failed to meet this objective. The change
   from baseline to week 52 in cartilage thickness, in mm (SD) was -0.116 (0.27) for
   the placebo group and -0.068 (0.20), -0.097 (0.27) and -0.085 (0.22), for the low,
   medium and high dose, respectively. Statistically significant difference versus
   placebo was not reached in any of the treated groups.
   • There was also no significant difference compared to placebo observed on
   secondary endpoints, including clinical outcomes.
   • GLPG1972 was generally well-tolerated by patients.
   
   Our View:
   • Today’s announcement is an unfortunate setback, given the high unmet need
   and substantial market opportunity for novel, disease-modifying drug
   candidates in OA.
   • Prior to today’s news, we attributed a 26% success rate to the GLPG1972
   program and projected potential peak sales of EUR 2bn. This contributed EUR
   292m or EUR 5 per share to our SOTP.
   
   Investment conclusion:
   We cut our TP from EUR 120 per share to EUR 115 per share following the exclusion
   of the GLPG1972 program from our SOTP. We value Galapagos using an rNPV
   model (WACC: 12%; Exhibit 1). The main contributors are the strong cash position
   and the filgotinib programs. With relatively light newsflow expected near-term, we
   recommend Holding the stock and await US regulatory feedback on filgotinib and
   readouts of more advanced programs, such as the Phase 3 of ziritaxestat in
   idiopathic pulmonary fibrosis (IPF), expected in 2022.

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4. avantiavanti 20 oktober 2020 06:38

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   Morgan Stanley extract uit update 19/10
   
   Galapagos NV (GLPG.O)
   Catalyst Driven Idea: US Filgotinib Outcomes
   
   North America
   Stock Rating Equal-weight
   Price Target $159.00
   
   Matthew Harrison, Connor Meehan, Thomas F Lavery, J.D.
   October 19, 2020
   
   A potential decision on the commercial path forward for filgotinib in the US specifically for RA or potentially even more broadly could be made after a meeting with the FDA in late October or November. With a variety of outcomes, GLPG could move +/-15-20%.
   
   What and when is the catalyst? Filgotinib US commercialization decision potentially in coming weeks: Galapagos has previously licensed rights to JAK inhibitor filgotinib to Gilead. While management received approval in the lead indication for Rheumatoid Arthritis in both the EU and Japan, the US FDA issued a complete response letter requesting more data on male toxicity and questioning the relative safety profile of the 200mg dose versus the 100mg dose (see our prior note here). While we had originally expected data from the male toxicity study in 1Q21 and a potential refiling with the FDA subsequently, Gilead management is conducting a Type A meeting with FDA in the near-term and has indicated that if it believes approval of the 200mg dose is unlikely to have a path forward after that meeting, it may adjust its commercial stance in the US related to the marketing of filgotinib. Such actions could include a full return of US commercial rights, a decision to not pursue the RA indication, but continue to pursue the IBD indications or a decision to move ahead based on a positive outcome related to 200mg.
   
   What are the potential outcomes for this event? Scenario 1: Gilead returns US commercial rights to Galapagos. In this scenario we would expect some additional consideration such as a renegotiation of European rights where Galapagos may take over commercialization in the EU. Scenario 2: Gilead decides not to file RA in the US, but continues with the IBD indications. Scenario 3: The Type A meeting suggests 200mg is potentially approvable and there is no change to the commercialization agreement.
   
   What are the potential stock implications from these outcomes? Scenario 1: Removing US filgotinib from our model decreases our Galapagos valuation by ~20%. We would expect some offset if Galapagos regains European rights and see GLPG down 10-15% Scenario 2: Removing US filgotinib in RA from our model decreases our Galapagos valuation by ~10%. However, we would expect some investor relief if Gilead reaffirms its commitment to the US IBD indications and see GLPG down 5-7% Scenario 3: We expect broad investor relief and see GLPG up 10-20%.
   
   What is our base case expectation for this event? Our base case expectation is Scenario 2, where we believe a filing in RA will not proceed in the US, but development will continue with the IBD indications. We base this on the fact that other JAK inhibitors have been approved at higher doses in IBD compared to RA and that management is unlikely to gain clarity on the acceptability of the 200mg dose in RA at the Type A meeting.
   
   
5. avantiavanti 20 oktober 2020 15:06

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   quote:

   avantiavanti schreef op 20 oktober 2020 06:38:

   Morgan Stanley extract uit update 19/10
   
   Galapagos NV (GLPG.O)
   Catalyst Driven Idea: US Filgotinib Outcomes
   
   North America
   Stock Rating Equal-weight
   Price Target $159.00
   
   Matthew Harrison, Connor Meehan, Thomas F Lavery, J.D.
   October 19, 2020
   
   

   Volledige update MS waarvan vanochtend extract geplaatst.

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6. Lama Daila 21 oktober 2020 07:35

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   Uit de Tijd:
   
   Galapagos krijgt eerste verkoopadvies
   
   Goedmorgen beste blogbezoekers! Opmerkelijk eerste nieuwtje voor bij de koffie: Galapagos GLPG0,00% heeft zijn eerste verkoopadvies te pakken. Goldman Sachs verlaagt zijn advies van 'houden' naar 'verkopen' en knipt zijn koersdoel van 108 naar 87 euro. Daarmee neemt het aantal barstjes in het aandeel verder toe. Die barstjes begonnen te ontstaan toen de Amerikaanse geneesmiddelenwaakhond FDA zijn bedenkingen plaatste bij filgotinib, het goudhaantje van Galapagos.
   Nog gisteren zei ook zakenbank Morgan Stanley in een update dat CEO Onno van de Stolpe rond Halloween - eind oktober, begin november - een cruciale vergadering tegemoed gaat. 'We hadden gedacht de data te krijgen in een studie in het eerste kwartaal van 2021 en een mogelijke nieuwe aanvraag bij de FDA. Maar partner Gilead plant een vergadering met de FDA en zegt dat als een goedkeuring onwaarschijnlijk is hij de commerciële afspraken rond de marketing van filgotinib gaat heroverwegen', zei Morgan Stanley.
   Volgens Morgan Stanley zijn er drie scenario's. 'Het eerste is dat Gilead de commerciële rechten voor de VS teruggeeft aan Galapagos. In dat geval is een heronderhandeling van de Amerikaanse rechten mogelijk, waarbij Galapagos de commercialisering op zich neemt. In het tweede scenario zal Gilead geen aanvraag indienen voor de behandeling tegen reumatoïde artritis, maar wel tegen colitis ulcerosa (dikkedarmontsteking). Een derde mogelijkheid is dat de bijeenkomst uitwijst dat filgotinib wel kans van slagen heeft, waarbij geen verandering van de afspraken rond de verkoop plaatsvindt.
7. voda 21 oktober 2020 07:37

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   Beursblik: Goldman zet Galapagos op de verkooplijst
   
   FONDS KOERS VERSCHIL VERSCHIL % BEURS
   Galapagos
   111,80 0,00 0,00 % Euronext Amsterdam
   
   (ABM FN-Dow Jones) Goldman Sachs heeft woensdag het advies voor Galapagos verlaagd van Neutraal naar Verkopen, terwijl het koersdoel werd verlaagd van 108,00 naar 87,00 euro.
   
   Het nieuwe koersdoel betekent een neerwaarts potentieel van ruim 20 procent, onderstreepten de analisten van Goldman.
   
   Centraal in het rapport van Goldman staan de timing en lancering van filgotinib in de VS en daarbuiten.
   
   In de VS voorzien de analisten een flinke vertraging nadat de FDA afgelopen zomer meer informatie opvroeg. Daarmee raakt filgotinib flink achter op concurrent AbbVie met Rinvoq.
   
   Daarnaast rekent Goldman nog op omzetbijdragen uit 5 indicaties, waar het eerder rekende op 10. Tot slot spraken de analisten ook van een "zwakkere marktpenetratie".
   
   Per saldo betekent dit dat de zakenbank de piekomzet voor filgotinib met bijna twee derde verlaagde naar 2,1 miljard dollar. Dat was voorheen meer dan 6 miljard.
   
   Door: ABM Financial News.
   info@abmfn.nl
   Redactie: +31(0)20 26 28 999
   
   © Copyright ABM Financial News B.V. All rights reserved.
8. avantiavanti 21 oktober 2020 08:59

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   Goldman Sachs 20 oktober 2020
   
   We lower our filgotinib outlook and see risk with the remaining pipeline
   
   Downgrade to Sell
   PT €87

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9. Endless 24 oktober 2020 04:40

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   email.seekingalpha.com/article/438112...
   
   Link geeft het hele rapport weer.
   
   Galapagos Is A Buy Despite Setback In The Conclusion
   
   Given how closely the two companies are tied together, one way to invest in Galapagos is to hold Gilead Science stock [which I do]. Gilead pays a dividend and has a large array of commercial therapies as well as an extensive pipeline. On the other hand, Gilead's stock price has been going mostly down for years. Since Galapagos will just begin to see commercial revenue this quarter, it is difficult to predict how filgotinib will fare in the competitive RA market. At the stock price of $123.68, Galapagos had a market capitalization of about $8.1 billion. Some revenue growth going forward is assumed in that market cap. I believe that would be justified if filgotinib eventually captures even 5% of the global RA market, which was near $58 billion in 2019, keeping in mind that Galapagos gets either royalties or a profit split.
   
   The key for long-term investors is that filgotinib is just the start. In addition to the other potential drugs described in this article, Galapagos claims to be able to generate many more from its platform, and I find the claim credible. As always when enough clinical trials are involved, there will be some successes and failures, causing the stock price to dive or rise quickly at times. I have added Galapagos to the list of pharmaceutical companies I am considering buying, but it also has to compete with companies that are already in my portfolio that I think are undervalued and would like to own more of. Whether it is right for other investors depends on their individual investment strategies and assessments of the value of the pipeline.de
10. avantiavanti 27 oktober 2020 12:34

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    Morgan Stanley extract update 26 oktober 2020
    
    Stock Rating Equal-weight
    Price Target $159.00
    
    Matthew Harrison, Connor Meehan, Zhen Zeng, Ph.D.
    
    Catalyst Driven Idea: PhII IPF Data From PINTA Study
    
    PhII data for GLPG1205 in IPF is expected in the next few weeks. The drug is being evaluated on top of the SoC, and we will focus on the incremental benefit in forced vital capacity (FVC). Our base expectation (50% probability) is that '1205 will demonstrate a numerical reduction of ~25-50%+ in FVC.
    
    What and when is the catalyst?
    
    Data from the PhIIa PINTA trial is expected in coming weeks: Pipeline asset GLPG1205 is currently being evaluated in a PhIIa trial (PINTA) in patients with idiopathic pulmonary fibrosis (IPF). GLPG1205 is as an inhibitor of GPR84, which has been found to modulate fibrotic disease progression. PINTA is a randomized, double-blind trial that has enrolled a total of 69 patients. The primary endpoint is change from baseline in forced vital capacity (FVC) over 26 weeks versus placebo, which is a common measure of lung capacity. In addition to change in FVC, management plans to collect data on the drug's safety, tolerability, and other key factors, including functional respiratory imaging and a six minute walk test. The PINTA trial has been designed such that GLPG1205 is being evaluated as an add-on therapy to the standard of care (SoC). Management expects ~? patients on nintedanib (Ofev), ~? on pirfenidone (Esbiret), and ~ ? on a different local SoC. Patients will be randomized into GLPG1205+SoC or Placebo+SoC.
    
    Limited treatment options for IPF underscore the market opportunity for GLPG1205: IPF is an interstitial lung disease that causes scarring of the lungs. The disease is associated with significant morbidity and mortality, with a median lifespan of only a few years post diagnosis. Currently approved treatments for IPF include nintedanib and pirfenidone (marketed as Ofev and Esbriet, respectively), both of which have demonstrated only modest improvements in FVC decline, poor tolerability, and relatively high (~25%) rates of discontinuation.
    
    The incremental benefit GLPG1205 provides over the SoC will be in focus: Given the design, PINTA is underpowered for detecting any reduction in FVC decline. Therefore, we believe the p-value from the trial is less important as to interpreting the readouts and the numerical improvement in % reduction will be the focus. We have formulated the expected FVC change from baseline for the placebo arm based on the standard of care historical data, and provide different % reductions induced by the addition of GLPG1205, perceived as Bull, Base, and Bear. In key trials, Ofev and Esbiret demonstrated near-equivalent risk reductions for all-cause mortality, and similar % reductions in FVC change from baseline at week 26 (55-65%). Although the historical data revealed high variability in FVC change from baseline, we expect it will center around a reduction of 50 mL at week 26 in the Placebo+SoC arm. With a standard deviation of 200, derived from the Ofev studies, the bar for success with a 10% type I error rate is full reversal of decline plus an increase of 20-30 mL in FVC compared to baseline, which we believe defines a Bull case. Any reduction below 25% compared to the Placebo+SoC arm will be undesirable and defines a Bear case.
    
    Previous clinical data supports a tolerable safety profile: GLPG1205 has been previously investigated as part of the PhIIa ORIGIN trial in ulcerative colitis. Though the drug did not demonstrate meaningful efficacy in UC, the trial did establish the drug as a tolerable therapeutic with favorable pharmacokinetics.
    
    Broadly, management has expressed interest in being a leader in innovative treatments for IPF: In addition to GLPG1205, management is evaluating ziritaxestat as part of the PhIII ISABELA trial in IPF, with an interim futility analysis expected in 1H21. Beyond GLPG1205 and ziritaxestat, management has at least three other assets in development for the indication, each addressing a separate mechanism of action. Based on the outcome of the PINTA trial, management has expressed interest in potentially investigating GLPG1205 in combination (with ziritaxestat), but would expect to see clean safety data from GLPG1205 prior to moving forward with this option.
    
    What are the potential outcomes for this event?
    
    Scenario 1: GLPG1205 Fully Reverses FVC Decline, Induces an Increase in FVC, and is Safe and Tolerable: The trial hits the primary endpoint. GLPG1205 is found to prevent the decline of forced vital capacity (FVC) in IPF patients and may also improve FVC. The product candidate is also found to be safe and tolerable.
    Scenario 2: GLPG1205 Achieves >25-50% Reduction Over Placebo+SoC in FVC Decline, is Safe and Tolerable: GLPG1205 demonstrates a sizeable numerical improvement in reduction in FVC decline versus placebo+SoC. The product candidate is also found to be safe and tolerable.
    Scenario 3: GLPG1205 is similar to placebo, or achieves a marginal reduction in FVC, or fails due to safety: GLPG1205 demonstrates no benefit (or a marginal benefit) versus SoC treatment or fails due to a safety signal.
    
    What are the potential stock implications from these outcomes?
    
    Scenario 1: We expect GLPG up 10-15%+ as this outcome reinforces a consensus view on the potential for the IPF pipeline and provides downside support to the PhIII ziritaxestat interim futility analysis in 1H21.
    Scenario 2: We expect GLPG up 5-10%+.
    Scenario 3: We expect GLPG down 0-5%.
    
    What is our base case expectation for this event? Our base case expectation is Scenario 2, whereby we expect GLPG1205 to demonstrate at least a 25% reduction versus placebo plus the SoC in forced vital capacity decline, with a tolerable safety profile.
    
    Sources:
    
    erj.ersjournals.com/content/32/1/170
    
    www.lung.ca/lung-health/lung-disease/...
    
    ajp.amjpathol.org/article/S0002-9440(...
    
    www.ncbi.nlm.nih.gov/pmc/articles/PMC...
12. avantiavanti 28 oktober 2020 06:50

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    Barclays 27 oktober 2020
    
    TOLEDO TO TAKE THE SALT OUT OF THE FILGO WOUND?
    
    

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13. pietje-2005 28 oktober 2020 07:04

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    Zou mooi zijn, als er een paar uitroeptekens achter staan, in plaats van een vraagteken ! :-(
    Afwachten, dus :-(
14. avantiavanti 28 oktober 2020 08:16

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    Cowen
    
    QUICK TAKE: COMPANY UPDATE
    October 27, 2020
    Price: $128.02 (10/27/2020 )
    Price Target: NA
    OUTPERFORM (1)
    
    TOLEDO COMPOUNDS INHIBIT SALTINDUCIBLE KINASES, BROAD CLINICAL PROGRAM ONGOING
    
    Phil Nadeau, Ph.D.
    
    THE COWEN INSIGHT
    For the first time today GLPG disclosed that its Toledo compounds are inhibitors of saltinducible
    kinases (SIKs). Preclinical data demonstrate that SIK inhibitors increase antiinflammatory
    cytokines and decrease pro-inflammatory, suggesting utility across a range
    of inflammatory diseases. 5 parallel POC studies are underway or planned, with initial data
    anticipated by Mid:21. Remain Outperform.
    
    Our Take: A Key Question Answered, 2021 Data Will Further Define Toledo's Promise.
    Since Galapagos first began discussing its Toledo program at its 2018 R&D day investors
    have been keen to know the target and learn about the preclinical data that has so excited
    GLPG. Today's unveil of the target as salt-inducible kinases (SIK) and discussion of the
    preclinical results was notable and interesting.
    
    We find it intriguing that the inhibition of SIKs has the ability to reduce the transcription of
    pro-inflammatory cytokines such as TNFa, IL-12 and IL-1ß while simultaneously enhancing
    the transcription of anti-inflammatory cytokines such as IL-10. This suggests a dual
    mechanism. Moreover, the activity of SIK inhibitors across a range of cell types such as
    MCs, DCs, T cells and B cells implies potential activity in a range of inflammatory conditions.
    Further encouraging was the robust activity in preclinical models of inflammatory diseases
    such as inflammatory bowel disease, psoriasis, psoriatic arthritis, rheumatoid arthritis,
    and systemic lupus as well as fibrotic diseases like graft vs host disease, IPF, and systemic
    sclerosis.
    
    That being said, as promising as the preclinical data appear to be, investors have learned to
    be cautious when extrapolating results from model systems to human clinical trials. This is
    particularly the case for a novel mechanism such as the inhibition of salt-inducible kinases.
    SIKs are widely expressed in the body and are thought to be involved in basic cellular
    processes such as lipid metabolism and gluconeogenesis. There is also some suggestion
    that SIKs can regulate tumor suppressors and have a role in tumorigenesis. In light of their
    ubiquitous expression and basic functions, clearly much remains to be learned about the
    efficacy and safety of using SIK inhibitors to treat inflammatory diseases. In some respects
    this morning's presentation raised as many questions as it answered.
    
    Clinical proof of concept data will be necessary to further define Toledo's promise. GLPG
    is currently conducting 3 proof of concept trials for lead candidate GLPG3970 in psoriasis,
    ulcerative colitis, and rheumatoid arthritis, with add'l studies in SLE and Sjogren's planned.
    With initial data from the first anticipated in Mid:21, the potential of GLPG3970 and GLPG's
    SIK inhibitors more generally should begin to come into better focus next year.
    
    The News: Today, at an R&D roundtable, Galapagos disclosed that the Toledo program is a
    series of salt-inducible kinase (SIK) inhibitors. Recall that at Galapagos’ 2018 R&D day, the
    company unveiled pre-clinical efforts toward a novel target for inflammation code-named
    "Toledo". The target and mechanism were not disclosed until today.
    The lead candidate in the Toledo program is GLPG3970, a selective SIK2/3 inhibitor.
    Galapagos has completed Ph. I healthy volunteer studies of Toledo compounds GLPG3312
    and GLPG3970. Management had previously decided to prioritize GLPG3970 over
    GLPG3312. GLPG3312 was designed to have exposure only in the GI tract for the treatment
    of IBD. GLPG believes that selective targeting was achieved. However, the downside is that
    without systemic exposure, GLPG was not able to measure changes in plasma biomarkers.
    GLPG3970, on the other hand, distributes to a range of tissues and has sufficient exposure
    to produce meaningful changes in biomarkers. These signals of target engagement gave
    GLPG more confidence in '3970's profile and so GLPG selected it for further development.
    
    Galapagos has also nominated for clinical development GLPG4605 (a SIK2/3 inhibitor) and
    GLPG4399 (a SIK3 inhibitor). Phase I data from GLPG4399 are anticipated in 2021.
    Galapagos disclosed preclinical data showing disease activity of GLPG3970 on three
    separate IBD models. Further, results indicated GLPG3970 induced macrophages
    polarization by decreasing pro-inflammatory M1 macrophages and increasing
    immunosuppressive M2 macrophages. In vivo studies also demonstrated an increase in proinflammatory cytokines and a decreased in anti-inflammatory cytokines. Taken together,
    these data support the proposed dual mechanism of action of GLPG3970 and SIK inhibition
    generally. Management reported the compound has also shown activity in models of
    psoriasis, arthritis, lupus, and fibrosis.
    
    Data on the Phase I single ascending and multiple-ascending dose study of ‘3970 in healthy
    volunteers showed the compound to be well tolerated with a PK profile supportive of once
    daily dosing. Ex-vivo analysis on participants’ whole-blood plasma confirmed the preclinical
    findings supporting the dual mechanism of action.
    
    Galapagos is conducting a broad proof of concept program for GLPG-3970 to validate
    its activity in a wide range of inflammatory and fibrotic indications including psoriasis,
    ulcerative colitis, rheumatoid arthritis, lupus (SLE) and Sjogren's. Management provided
    detail on three studies:
    CALOSOMA study: This Phase 1b trial is a double-blind, placebo-controlled study evaluating
    the safety, tolerability of GLPG3970 single and multiple ascending doses in up to 52 adults
    with moderate/severe psoriasis.
    SEA TURTLE study: Phase 2 trial in patients with moderate to severe UC. The double-blind,
    placebo-controlled trial will evaluate the efficacy, safety, tolerability of GLPG3970 in up to
    30 patients. The primary endpoint is the change from baseline in total Mayo Clinical Score
    (MCS).
    LADYBUG study: This Phase 2 trial is a double-blind, placebo-controlled study evaluating
    the efficacy, safety, tolerability of GLPG3970 in up to 25 participants with severely active
    RA and an inadequate response to methotrexate. The primary endpoint is change from
    baseline of DAS28 CRP at week 6.
    
    In all trials, GLPG3970 will be administrated orally once daily for 6 weeks. GLPG is also
    planning studies in SLE and Sjogren's which are expected to start late this year or early
    next.
    
    Initial top-line data from the proof-of-concept trials is anticipated around Mid-21. For
    indications which look promising, the next step will be to conduct larger and longer Phase
    IIb dose-ranging studies before advancing to Phase III confirmatory studies. GLPG expects
    to "Fast Track" psoriatic arthritis with the Ph. II dose ranging study to begin next year after
    the Phase Ib CALOSOMA trial. Gilead has an option to opt-in after Phase II.
    
15. avantiavanti 28 oktober 2020 12:21

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    Raymond James 27 oktober 2020
    
    Key Take-Away from TOLEDO Update: Y-Axis Not Included

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16. avantiavanti 28 oktober 2020 12:30

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    UBS 27 oktober 2020
    
    12-month rating Neutral
    12m price target €125.00
    
    Healing the SIK? Toledo target reveal does not change the investment case

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17. avantiavanti 28 oktober 2020 12:35

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    Stifel 27 oktober 2020
    
    Our target price for GLPG shares is $138. This is based on a probability-weighted, risk-adjusted NPV analysis. We assign $34, $2, $1, $5
    for filgotinib, GLPG1690, Other revenue, Other pipeline, respectively. We assign $96 of value for cash
    
    TOLEDO Program Reveal Not Thesis Changing; Still Very Much A "Show Me" Story

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18. Broer Konijn 28 oktober 2020 17:28

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    quote:

    avantiavanti schreef op 28 oktober 2020 12:35:

    Stifel 27 oktober 2020
    
    Our target price for GLPG shares is $138. This is based on a probability-weighted, risk-adjusted NPV analysis. We assign $34, $2, $1, $5
    for filgotinib, GLPG1690, Other revenue, Other pipeline, respectively. We assign $96 of value for cash
    
    TOLEDO Program Reveal Not Thesis Changing; Still Very Much A "Show Me" Story
    

    Poeh, daar is geen woord Frans bij. Ook hier druipt de twijfel en het wantrouwen er van af. Dat was in de Q&A van de webcast bij analisten merkbaar. Niet leuk, wel nuttig om te lezen.
    
    Merci, Broer Konijn
19. Loureiro 28 oktober 2020 17:45

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    quote:

    Broer Konijn schreef op 28 oktober 2020 17:28:

    [...]
    
    Poeh, daar is geen woord Frans bij. Ook hier druipt de twijfel en het wantrouwen er van af. Dat was in de Q&A van de webcast bij analisten merkbaar. Niet leuk, wel nuttig om te lezen.
    
    Merci, Broer Konijn
    

    Het vertrouwen in GLPG is volledig weg!
    Vroeger zou de koers op basis van de Toledo roundtable gevoelig gestegen zijn.
    Een van de mogelijkheden om dit vertrouwen te herstellen is aankopen van aandelen GLPG door het mgt.
    Met enthousiasme alleen gaan ze het vertrouwen niet herstellen. Geen woorden maar bewijzen = goede fase 2 en 3 resultaten.
    De analisten en kleine aandeelhouders beginnen dit ook in te zien, vandaar de minieme interesse momenteel in GLPG.
    
    
20. Endless 2 november 2020 18:07

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    Galapagos Guru: UBS
    Advies: Houden Status: Actief
    Koersdoel: € 125,00 Score: 0,00%
    Startkoers: € 101,40 Huidige koers: € 98,28
    Verw. rendement: 0,00% 2 november 2020 - 17:39u
21. Wall Street Trader 3 november 2020 12:35

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    Bryan Garnier & Co Galapagos (Buy) PT EUR 160
    
    Victor Floc'h, 3 November 2020
    
    Galapagos and its partner Gilead just announced that the European Medecines Agency (EMA) has validated the application for a supplemental indication to filgotinib. Following the recent approval in Rheumatoid Arthritis in Europe (and Japan), both companies have filed for ulcerative colitis based on the phase IIb/III SELECTION study. While uncertainty remains on the US filing/label, we are pleased to see that filgotinib is going at full speed in Europe.
    
    As a reminder, Galapagos/Gilead received a CRL from the US FDA last August for filgotinib’s NDA. FDA requested data from the safety studies MANTA and MANTA-RAy studies before completing its review of the NDA. Based on observations from previous trials and literature on JAK inhibitors, which point to very limited if any evidence on the impact of JAK on spermatogenesis, we believe it is very unlikely that MANTA will show toxicity. However, we are more concerned by FDA remarks on the overall benefit/risk profile of the filgotinib 200mg dose. Even though the recent approvals from Europe and Japan for both doses are reassuring, it is still difficult to assess what could drive the FDA’s decision in favour of the 200mg approval. We expect MANTA data in 1H21E, allowing a potential resubmission by Q2 2021e and a 2022e US launch.
    
    It is fair to say also that UC is the second largest indication for filgotinib in our projected PS estimates with USD700m out of a total of USD5.5bn towards 2030. Galapagos is having co-promotion rights in some EU countries.
    
    Toledo target family unveiled
    
    Galapagos held a virtual R&D roundtable event to present in more details its Toledo programme (announced back in 2018) whose target and mechanism was unknown until then. It appears that this programme is based on a series of Salt-Inducible Kinase (SIK) inhibitors who have exhibit a very promising dual mode of action in inflammatory conditions. Indeed, the preclinical package suggests that SIK inhibitors are increasing anti-inflammatory cytokines and decrease pro-inflammatory ones making it a very promising family of compounds for both inflammatory and fibrotic conditions. From this family, Galapagos has presented three compounds (GLPG3970, ‘4605 & ‘4399), the former being their lead asset and already evaluated in multiple ongoing clinical trials.
    
    SIK inhibition is expected to work as a “master switch”
    
    While current therapies for inflammatory diseases are only focusing on immune suppression of the pro-inflammatory part of the disease, the Toledo family of compounds is believed to work on both the immunoregulatory and the pro-inflammatory part to restore the immune balance on which its ‘dual mode of action’ is based. If it is clinically proven, this family of compounds would therefore established itself as a master switch for autoimmune diseases. According to Galapagos, the inhibition of SIKs has the power to reduce the transcription of pro-inflammatory cytokines such as IL-1ß, TNFa and IL-12 while increasing the transcription of anti-inflammatory cytokines such as IL-10. Furthermore, first preclinical data presented by the company suggest that SIK inhibitors have an activity on a large range of cell types (DCx, T cells, MCs and B cells) implying potential activity in multiple inflammatory diseases such as: psoriasis, inflammatory bowel diseases, psoriatic arthritis, rheumatoid arthritis, systemic lupus as well as fibrotic diseases (idiopathic pulmonary fibrosis or systemic sclerosis).
    
    First PoC data from ‘3970 expected in 2021
    
    Indeed, ‘3970 data package has so far given Galapagos the confidence to take this asset into multiple proof of concept studies running in parallel. This compound is a selective SIK2/3 inhibitor which has delivered promising efficacy signals in various models (psoriasis, skin fibrosis, lung fibrosis, arthritis and psoriatic arthritis). Its phase I trial in healthy volunteers has confirmed that it was well tolerated with a PK profile supportive of once daily dosing. Based on these promising results, Galapagos has initiated multiple proof-of-concept studies in various indications (‘CALOSOMA’ in Psoriasis, ‘SEA TURTLE’ in ulcerative colitis and ‘LADYBUG’ in rheumatoid arthritis) with first results expected mid-2021. Following PoC results, the company expects to conduct larger phase IIb dose-ranging studies before advancing into phase III studies. Galapagos believes that its strategy could then allow to significantly fast-track ‘3970 with a phase III trial expected to start in 2023. Beyond ‘3970, we are expecting phase I results from ‘4399 next year which could lead to initiation of multiple PoC studies.
    
    KBC Securities Galapagos (Buy) PT EUR 138
    
    De Europese regelgever geeft goedkeuring voor de aanvraag van een vergunning door Galapagos/Gilead voor de behandeling van patiënten met matige tot ernstige colitis ulcerosa met 200mg Filgotinib, die onvoldoende respons tonen of intolerant zijn voor conventionele therapie of biologische geneesmiddelen. KBC Securities-analist Lenny Van Steenhuyse verwacht dat de formele goedkeuring in de tweede helft van 2021 een feit zal zijn en is niet verrast door het nieuws. Ondertussen zal Gilead met de Amerikaanse regelgever FDA bespreken of er een weg vooruit is voor de toediening van 200mg Filgotinib voor de behandeling van patiënten met reumatoïde artritis in de VS.
    
    De aankondiging heeft bij KBCS geen impact op het “Kopen”-advies en 138 euro koersdoel.