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Analyst reports 2019

382 Posts
Pagina: «« 1 2 3 4 5 6 ... 20 »» | Laatste | Omlaag ↓
  2. Wall Street Trader 10 juni 2019 10:38

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    Jefferies

    Some Welcome (+) Filgotinib Data - Safety Looks Quite Good

    Gilead Sciences, Inc. (GILD)

    PRICE TARGET (PT) $95.00

    Note: This Report was published on the 28th of March 2019.

    There have yet been no new report about the Jefferies Healthcare Conference in New York.
    Bijlage:
  3. [verwijderd] 10 juni 2019 14:17

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    quote:

    Wall Street Trader schreef op 10 juni 2019 10:38:

    Jefferies

    Some Welcome (+) Filgotinib Data - Safety Looks Quite Good

    Gilead Sciences, Inc. (GILD)

    PRICE TARGET (PT) $95.00

    Note: This Report was published on the 28th of March 2019.

    There have yet been no new report about the Jefferies Healthcare Conference in New York.
    Tiens, hoe is dit te rijmen met dit :
    www.beursadviespro.nl/signalen/galapa...
  5. Sentiment 10 juni 2019 14:21

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    quote:

    Toert schreef op 10 juni 2019 14:18:

    [...]

    aha, mijnen frank valt, dit was Jefferies voor Gilead. Oepsie...
    dit voor Gala: Jefferies geeft een buy advies voor het aandeel Galapagos met een koersdoel van EUR 130,00
  6. Wall Street Trader 10 juni 2019 16:31

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    Analyst Price Targets

    Cantor Fitzgerald Price Target $130

    SVBLeerink OUTPERFORM

    RBC Sector Perform

    Berenberg Bank Price Target € 140

    Barclays Capital Price Target € 140

    Degroof Petercam Price Target € 136

    Kempen Price Target € 135.00

    H.C. Wainwright & Co. Price Target $150

    KBC Price Target € 124

    Goldman Sachs Price Target € 108

    UBS Price Target € 91

    InsingerGilissen Bankiers Price Target € 130,00

    Morgan Stanley Target € 139

    Credit Suisse Price Target € 113

    Jefferies & Co. Price Target € 130

    Bryan Garnier & Co Price Target € 140

  7. avantiavanti 10 juni 2019 17:07

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    JP Morgan Cazenove
    Europe Equity Research
    10 June 2019

    Galapagos NV
    GLPG.AS, GLPG NA
    Overweight
    Price: €103.15 (07-Jun)
    Price Target: €125.00 (Dec-19)
    Filgotinib US filing scenario analysis suggests
    balanced risk/ reward into FDA pre-filing discussions
    GLPG, GLPG US
    Overweight
    Price: $120.42 (07-Jun)
    Price Target: $141.00 (Dec-19)

    Filgotinib US filing scenario analysis suggests
    balanced risk/ reward into FDA pre-filing discussions
    Bijlage:
  12. avantiavanti 19 juni 2019 16:45

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    Barclays

    EULAR bookended with good data from both FINCH trials + meeting with CMO

    Stock Rating/Industry View: Overweight/Positive
    Price Target: EUR 140.00
    Price (14-Jun-2019): EUR 108.60
    Potential Upside/Downside: 29%
    Tickers: GLPG NA / GLPG.AS

    FINCH 3 showed more positive trends to wrap up the conference
    We’ve wrapped up our stay in Madrid at the EULAR conference, feeling incrementally more confident in the commercial potential for filgotinib, after having seen the 24 week data for both the FINCH 1 (see: EULAR kicks off: FINCH 1 continuing to look good (12/06/19)) and FINCH 3 phase 3 trials in RA, as well as meeting with GLPG’s CMO, Walid Abi-Saab, MD. FINCH 3, which trialed filgotinib in patients who were methotrexate (MTX) naive in either filgotinib + MTX + a 200mg filgotinib monotherapy arm vs. placebo, showed the same trends that we saw in FINCH 1; efficacy data continued to improve from 12-24 weeks and safety continues to look extremely competitive.

    We were also fortunate to have a meeting with GLPG’s CMO, who made us incrementally more comfortable about filgotinib’s efficacy vs. competitor JAK assets and also more comfortable about the asset’s safety profile; the company continues to believe that it is very unlikely that there will be any safety issues that arise from the MANTA trial. That being said, at this point, the path forward for filgotinib likely comes down to just how much data from MANTA the FDA wants to see. We continue to model filing in RA at the end of 2019, assume that partner Gilead files with priority review voucher such that the drug will launch in 3Q19.

    One interesting point from the conference overall is that clinicians seem to be increasingly optimistic about JAKs as a class and also seem very interested in the next generation JAKs (which contradicts our recent survey data; see: GLPG/NOVN/SAN: JAK survey - key EU takes (09/05/19)). Abbvie recently stated that it is not expecting to have an advisory committee meeting for its own JAK upadacitinib and also believes that it could have a label without a boxed warning for thromboembolic events. Whilst this may remove a competitive advantage for filgotinib, as we view it as extremely unlikely that filgotinib receives a boxed warning given the safety results from the FINCH trials, we would view this as an endorsement of safety for the class, which could help to accelerate updates across all JAK assets. That being said, we did get the sense that clinicians were impressed with the low rates of Herpes zoster and serious infections seen with filgotinib vs. other JAKs.

    Details from FINCH 3 presentation

    Presenter Dr. Rene Westhovens noted that the patient population for FINCH 3 were patients with very active disease and high disease activity. Duration of RA was rather long; mean was about 2 years but median was 0.4 years. Thus, it was surprising that these patients had not yet been exposed to MTX. 31-39.5% of patients had concurrent oral corticosteroid use.

    As with the FINCH 1 study, responses across both the primary endpoint (ACR20) and various secondary endpoints deepened over time.

    Whilst the 200mg dose did not meet statistical significance on the primary endpoint of ACR20, Dr. Westhovens noted that data for this dose looked particularly good across many of the secondary endpoints (and that perhaps in the future, more stringent endpoint such as ACR50 should be used as primary endpoints). He also noted that the speed of response on the efficacy endpoints was particularly impressive (with differentiation from placebo at just 2 weeks).

    He also noted that rates of remission deepened between 12 and 24 weeks; this is regardless of what measure one uses to judge remission. He also noted that there was almost no radiographic progression in ~80% of filgotinib treated patients.

    In terms of safety, over the 4 arms there was almost no difference in side effects. Serious infections were in low numbers and evenly distributed over the 4 arms; very few cases of herpes zoster were seen and there were no more side effects w/200mg vs. 100mg + MTX.

  13. avantiavanti 19 juni 2019 16:46

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    Vervolg Barclays

    Meeting with GLPG’s CMO, Walid Abi-Saab, MD
    Filgotinib
    When asked to comment on what the company found notable about the data presented this week vs. the initial findings in March, Dr. Abi-Saab noted that it’s very clear that response rates are continuing to increase for patients treated with filgotinib from weeks 12-24. He also noted the changes in the efficacy charts at week 14, which is due to the trial design; if a patient did not have a certain level of response by week 14, he/she would be removed from the trial and given SOC.

    For geographies where SOC was less than ideal, there was an incentive to stay in the trial (and he noted a bump in the placebo arms at various doses at week 14). This is viewed as further evidence that, for certain parts of the world, elements of the trial design likely led to higher placebo response rates.

    The differences in the filgotinib arms vs. the placebo arms largely remain constant, which raises questions when you have 50% of patients randomized to receive placebo. One possible explanation for this is that patients defined as MTX incomplete responders could have started responding to MTX when on the trial.

    The inclusion criteria required 12 weeks of MTX treatment and only 4 weeks of a stable dose MTX to then qualify as an incomplete responder, which the company admits may have been a suboptimal definition of what is an incomplete responder. For geographies such as Eastern Europe and South America, patients may not have been compliant on MTX for a myriad of reasons; when patients entered the trial, GILD administered MTX to all patients to ensure compliance in the control arm, which could help to explain the strong placebo response rates.

    The FINCH program was also the first JAK phase 3 program where auto-rescue was not permitted; if patients failed, they could not get open label filgotinib and had to go to standard of care (which was another incentive for patients to stay on the trial).

    Dr. Abi-Saab noted that GLPG has met with top KOLs in the field and that there has been no concern amongst clinicians regarding the efficacy of filgotinib in RA. KOLs are particularly enthused by the results on endpoints such as ACR50, ACR70 and clinical remission; higher thresholds than the primary endpoint that experts are now focused on. Interestingly, many PsA trials are now using ACR50 as the primary endpoint so perhaps it is time to shift within RA as well.

    When asked why DAS28 scores were used as the comparator for inferiority vs. Humira instead of ACR endpoints, Dr. Abi-Saab noted that the EMA prefers DAS28 LDA. Unfortunately, achieving superiority on these endpoints is more difficult from a standard deviation perspective. (We’d note that in recent commentary, Abbvie has stated that it does not expect to have a superiority claim vs. Humira in upadacitinib’s label, thus we do not view this as a competitive disadvantage for GLPG).

    Dr. Abi-Saab views the biggest reveal from the FINCH studies was the safety data from the additional 2200 patients exposed to filgotinib out of 3000 in the program; comparing this data to the long term extension data with DARWIN 3 (where patients now have 4 years of exposure), the safety story is very much aligned and makes the company feel more comfortable that there won’t be any safety “surprises” in other forthcoming trials.

    KOLs do perceive that there is a safety differential between filgotinib and upadacitinib. When looking at adverse events seen with upadacitinib, such as herpes zoster and serious infections, the rates do appear to be dose-dependent, whereas filgotinib does not have a signal for zoster or serious infection. Whilst there does not appear to be a dose-dependent relationship for VTE with upadacitinib, the rates seen are higher than that of filgotinib.

    Regardless, there will be a place in the market for both drugs; Humira and Enbrel have been very tough competitors but each has been a successful drug. JAKs as a class are the wave of the future beyond biologic treatment.

    That being said, whilst filgotinib will be the 4th JAK to market in RA, in other indications such as UC and Crohn’s, ankylosing spondylitis and psoriatic arthritis, filgotinib will be first or second to market.

    When asked about the partnership with Gilead, Dr. Abi-Saab commented that it is going very well and the CEOs of both companies have an extremely collaborative relationship. GILD’s new CEO Dan O’Day has been very engaged and has been actively participating in filgotinib development meetings. Filgotinib is the anchor of the partnership that could eventually lead to a broader set of treatments and perhaps combination therapies down the road. Dr. O’Day knows the I&I space well from his prior role at Roche (having launched Actemra) and has a deep understanding of what it takes to compete here.

    Dr. Abi-Saab confirmed that the preclinical elevated hormone levels seen in animal models that necessitated the need for the MANTA study have not been seen in human trials (and also that these were seen at much higher than human-equivalent doses). The company still doesn’t have a clear understanding of why this signal emerged, but noted that the MANTA study was necessary to be run as a separate study, as male hormone levels/sperm count can be extremely variable, even in healthy individuals. GILD and GLPG are taking a very aggressive screening approach in MANTA and MANTARay to ensure that it has the right patient population. It’s not totally surprising that the FDA wanted to take a more conservative approach given that fertility rates are dropping worldwide and that in patients with inflammatory disease many systems of the body are compromised, including the reproductive system. Whilst GLPG remains extremely confident that there will be no safety signals seen from this trial, the company wants to get the study done in order to temper the FDA’s concerns. Enrollment has been increasing since the treatment protocol was expanded and the target remains 250 patie[b]nts across both studies.

    Dr. Ali-Saab does not see any reason at this stage why the 200mg dose would not be approvable, from either a safety or an efficacy perspective. Whilst the 200mg dose performed better across efficacy endpoints, there was no uptick in adverse events from the 100mg dose.



  14. avantiavanti 19 juni 2019 16:47

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    Vervolg Barclays

    Toledo
    When asked to comment on recent speculation that the target of the Toledo technology has been identified, management could not comment. It will be some time before the company officially reveals the target; likely sometime in 2020.
    Phase 1 testing of the first generation technology (‘3312) has started and second generation asset ‘3970 will enter phase 1 testing in 2H19. The difference between the first and second generation technologies is selectivity; the first generation asset is more gut-restricted. There is the potential for ‘3970 to begin testing in a number of different indications.

    When asked whether the company could consider a partnership to advance Toledo, Dr. Abi-Saab believes that the company is in a good position to move forward on its own at this point; the company strongly believes in the underlying science.

    GLPG 1690
    At the end of the summer (likely in September), the company will give an update on enrollment in the phase 3 ISABELA trials and should also be able to forecast when it will be able to give the futility analysis of the trial. So far, the trial is going well, though it is the first phase 3 trial the company will be running on its own and is of wide scope; there are 230 sites globally.

    Whereas data was shown at EULAR for nintedanib in treating pulmonary function decline associated with systemic sclerosis, GLPG is trialing GLPG 1690 in treating the underlying disease itself (NOVESA phase 2 trial). The trial is small, and GLPG believes there is still a lot to learn in terms of what endpoints the FDA views as important in this indication and should learn more as other assets proceed through the regulatory process.

    GLPG 1972
    GLPG views OA as a very high risk / high reward opportunity. The company has completed enrollment in ROCELLA phase 2b trial (ahead of schedule; original plan was 4Q19). Assets in this indication have struggled as, whilst many have shown an impact on cartilage in the knee, there has not been an improvement in pain/function (which is what the FDA is looking for). There is a strong desire amongst clinicians for an oral, disease-modifying drug in this indication.


  15. avantiavanti 19 juni 2019 16:59

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    J.P.Morgan Cazenove 17 juni 2019

    FINCH-3 data further confirms strong profile for filgotinib. Focus shifts to post Phase III meeting with the regulators.

    Overweight
    Price: €108.80 14 Jun 2019


    Over the weekend, we attended the European League Against Rheumatism (EULAR) annual congress in Madrid, Spain where the full data from the FINCH 3 trial was presented as a late breaking abstract in the late breaking abstracts session. In our view, as with the FINCH 1 data presentation, there were no surprises in the data, and so we believe the presentations of both studies further support our view that filgotinib has best in class safety profile with at least as strong efficacy compared to the rest of the JAK inhibitor class. The next key catalyst beyond EULAR for Galapagos is the communication of the outcome of the post Phase III meeting with the FDA, where we believe risk/ reward is fairly well balanced.

    Efficacy profile of filgotinib was in line with that previously disclosed, speed of onset of response and remission also confirmed for filgotinib, which appears to be a class effect. Data for week 24 ACR20/50/70 responses were presented which were in line with that previously disclosed by Gilead/ Galapagos. The presenter noted that even though this was a methotrexate naïve population, it was actually a population with fairly high disease activity as even though the median duration of RA was 0.4 years, the average duration was around 2 years and around 30-40% of patients were being treated with corticosteroids. In addition, data was presented which demonstrated that filgotinib was superior to placebo on ACR20, ACR50 and ACR70 (200mg + MTX only) responses as early as week 2, confirming the fast onset of action of filgotinib, which appears to be a feature of the JAK inhibitor class. Remission (DAS-28-CRP <2.6) data was also presented at week 12 for filgotinib which looks comparable to the 15mg dose of upadacitinib in the SELECT-EARLY trial. Given the data presented, we continue to believe that the efficacy profile of filgotinib is just as good if not slightly better than the other JAK inhibitors on the market or in registration.

    No new safety issues raised in the presentation, further confirming the best in class safety profile of filgotinib among the JAK inhibitors. Safety data presented for FINCH 3 was consistent with the Phase II DARWIN 3 study as well as the other trials in the Phase III FINCH programme (FINCH 1 and FINCH 2). No new safety signals were noted in the presentation. Rates of MACE and DVT/PE were very low (as previously disclosed in the GILD/ GLPG press release) and balanced with the methotrexate arm. Rates of infection were very low, and appear lower than the other JAK inhibitors in combination with MTX (filgotinib c.23/24% vs. Upa and Bari c.33-34%). In addition rates of opportunistic infection, serious infection and herpes zoster infection were also very low and appear lower with filgotinib compared to the other JAKs. Given this data, we believe that the best in class safety profile of filgotinib has been confirmed, at least as far out as 24 weeks. Beyond 24 weeks, the long term extension data from the DARWIN Phase II programme suggests a best in class safety profile (data presented out to 156 weeks), data from the FINCH 4 study (Long term extension study [up to 3 years] from FINCH 1-3) is expected to be presented in 2021, which we believe is likely to show consistent results with the DARWIN programme.

    JAK inhibitor sessions highlighted the relationship between dose, selectivity and potentially adverse events. In a number of JAK inhibitor sessions and symposia we attended, first it was unanimous that JAK 1 is a key therapeutic target. That said, JAK 2 may also have some additional efficacy as it also blocks the cytokine GM-CSF, a validated target, but also hits the hemopeoetic system (blood and platelets) which may have an impact on adverse events, although some physicians were keen to express that this is not fully proven. On JAK selectivity, the KoLs described the fact that JAK inhibitors are not necessarily more selective for one type of JAK over the others, but it was highlighted that it is dose dependent i.e. at high enough doses all JAK inhibitors will hit all JAKs, it also depends on the particular JAK expression of the patient. From our discussions with Galapagos, filgotinib was tested up to a dose of 400mg without showing significant inhibition of either JAK 2 (possibly associated with DVT/PE) or JAK 3 (possibly associated with increased infection risk), which is comforting given that the highest dose for filgotinib in clinical trials is 200mg and we believe this could account for the strong safety profile. Other JAKs have seen issues in their trials/ development programme. The recent Xeljanz DVT/PE warning at a dose double the recommended dose on the label for RA could be indicative that Xeljanz (a JAK 1/3 inhibitor) has crossed its threshold to also target JAK 2 potentially leading to the increased DVT/PE risk – further data is required to confirm this. Baricitinib (JAK 1/2) showed increased DVT/PE at the 4mg dose, leading to the FDA only approving the 2mg dose (4mg dose is approved ex-US) and also for Upadacitinib (JAK 1), AbbVie have not filed the higher 30mg dose (only the 15mg dose filed with the FDA), and we suspect the 30mg dose could be close to the threshold where Upa could start to hit JAK 2 or JAK 3. Again, further clinical and mechanistic data is required to confirm these trends, however given the data we have seen so far we remain confident in the selectivity and safety profile of filgotinib.
  17. forum rang 4 harvester 23 juni 2019 13:00

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    quote:

    wiegveld schreef op 23 juni 2019 11:27:

    Bijgaande presentatie is inhoudelijk interessant.
    Eerste deel is leerzaam over stand van zaken Reumatoide Artritis en welke medicatie.
    Filgo wordt door hem niet als uniek gezien....

    farmaactueel.nl/nieuws/webcast-bart-v...

    Veel dank voor het plaatsen.

    De spreker werkt bij Sint Maarten kliniek.
    Dat heeft een contract met ABBVIE zoals je weet.

    Hij zegt niets over de betere veiligheid van filgotinib en geeft alleen aan dat Upadacitinib volgend jaar op de markt komt en zegt dat hij geen idee heeft wanneer de andere JAK remmers op de markt komen.

    Hij zegt dus (impliciet, maar niet expliciet)alleen op basis van werking dat filgotinib helemaal niet veel anders is dan de andere JAK remmers, maar dat Galapagos het alleen handig heeft gepresenteerd.

    Wat mij overigens ook opviel is dat hij het had over filgotitinib in plaats van filgotinib terwijl hij bij andere medicijnnamen geen last had om die uit te spreken.

    Daarmee lijkt hij enigszins een (handig) gekleurde presentatie te geven.

    Ik zou daarom hier niet te veel waarde aan hechten voor jouw aandelenpositie in ABBVIE.

    Voorlopig heeft de FDA ook nog niets gezegd over de markttoelating van upadacitinib. Wellicht krijgt voor de nu aangevraagde lagere dosis ook nog een waarschuwing mee vanwege de bijwerkingen.

    In hwet verhaal viel mij inzake rituximab onderzoek had gedaan voor het toepassen van een lagere dosis na de start, waarmee in de toepassing de kostprijs vergelijkbaar wordt met de methrotexaat behandeling en dat hij in de toekomst meer monotherapie toepassingen ziet.

  18. [verwijderd] 23 juni 2019 13:06

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    quote:

    wiegveld schreef op 23 juni 2019 11:27:

    Bijgaande presentatie is inhoudelijk interessant.
    Eerste deel is leerzaam over stand van zaken Reumatoide Artritis en welke medicatie.
    Filgo wordt door hem niet als uniek gezien....

    farmaactueel.nl/nieuws/webcast-bart-v...

    Ronduit teleurstellend voor wat betreft filgotinib, deze presentatie van Bart van den Bemt:

    "Filgotinib is echt niet die grote doorbraak zoals het slim is neergezet door Galapagos. Het is eigenlijk gewoon de zoveelste JAK remmer."

    Dat kan dan zo zijn voor wat betreft effectiviteit, niet voorwat betreft bijwerkingen. Maar:

    Niets in zijn presentatie over veel beter safety profiel van filgotinib betreffende infecties, HerpesZoster of DVT/PE.

    Hij praat even over bijwerkingen van JAK remmers in het algemeen, waarin hij de verhoogde kans op HerpesZoster uitlicht. Dit terwijl hij de safety data van filgonitib laat zien, waarop te zien is dat de HerpesZoster incidence rate van filgotinib hetzelfde is als placebo en lager dan bij Humira!
    Niets over veel beter safety profiel van filgotinib vergeleken met de andere JAKs betreffende infecties, HerpesZoster (meer dan 2x zo laag als bij andere JAKs) of DVT/PE.

    Hij kan filgotinib niet eens uitspreken ('Filgo....filgotitinib').

    De helft van zijn presentatie ging over een onderzoek met rituximab waar hij zelf (via de St maartenskliniek) bij betrokken was. Ik heb het gevoel dat hij geen feeling met (en weinig kennis over) de JAKs heeft.
  19. Lingus 23 juni 2019 13:22

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    Het "slimme neerzetten", daar maakt hij zich zelf schuldig aan door te focussen op effectiviteit en het wegmoffelen van het verschil in bijwerkingen tussen de JAK-remmers. Het succes van filgotinib zal gelukkig niet afhangen van de subjectieve kijk van Bart op de JAK-remmers. De wereld is groter dan de Sint Maartenskliniek.
  20. Lingus 23 juni 2019 13:30

    • Lingus

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    Overigens wel interessant: de te starten trial om het booster effect van cobicistat (nota bene van Gilead) met tofacitinib te onderzoeken. Daarmee zou de dosis tofacitinib gehalveerd kunnen worden. Het zou me niet verbazen als Gilead/Galapagos binnenkort een zelfde trial starten met filgotinib.
  21. forum rang 4 Lang 23 juni 2019 15:13

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    quote:

    Lingus schreef op 23 juni 2019 13:22:

    Het "slimme neerzetten", daar maakt hij zich zelf schuldig aan door te focussen op effectiviteit en het wegmoffelen van het verschil in bijwerkingen tussen de JAK-remmers. Het succes van filgotinib zal gelukkig niet afhangen van de subjectieve kijk van Bart op de JAK-remmers. De wereld is groter dan de Sint Maartenskliniek.
    Klopt, maar de Maartenskliniek is wel een redelijke autoriteit op dit gebied. Maar ik woon er praktisch naast, dus zal er eens langs gaan, met een PowerPoint, dat zal ze leren..;-)
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