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Analyst reports 2020

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PCBatterij
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(Trivano.com) - Op 6 november 2020 hebben de analisten van Bryan Garnier hun beleggingsadvies voor Galapagos (GLPG; ISIN: BE0003818359) herhaald. Het advies van Bryan Garnier voor Galapagos blijft "kopen".

De analisten behouden hun koersdoel van 160,00 EUR.

Op 5 november 2020 publiceerde Galapagos kwartaalcijfers.
Wall Street Trader
2
Bryan Garnier & Co Galapagos (Buy) PT EUR 160

Victor Floc'h, 6 November 2020

• Yesterday evening, Galapagos presented uneventful Q3 figures (more on that below) as well as a new collaboration with OncoArendi on chitinase inhibitors in fibrosis. The two companies have indeed signed an exclusive collaboration and license agreement for the development of OncoArendi’s OATD-01. This asset is a phase II-ready chitotriosidase/ acidic mammalian chitinase (CHIT1/AMCase) inhibitor for the treatment of idiopathic pulmonary fibrosis (IPF) and other diseases with a fibrotic component. OncoArendi will receive an upfront payment of EUR 25 million and will be entitled to milestones payments up to EUR 320 million. On top of that, Galapagos will pay EUR2m for the right of first negotiation on any other programmes emerging from OncoArendi’s chitinase platform.

• We see this development as a new confirmation of Galapagos’ commitment to IPF and other fibrotic diseases. The company is indeed giving itself the means to succeed in this challenging indication with an extended portfolio: ziritaxestat in phase III with futility analysis from the ISABELA trial expected in H1 2021, ‘1205 in phase II (PINTA) with top line results anticipated before year’s end, and many more early stage compounds. While it is too early to tell if it will be a clinical success, we still believe this compound is a nice addition to their IPF portfolio.

• Regarding Q3 figures, nothing particularly new as the company is reiterating its operational cash burn guidance of EUR 490 to 520 million for full year 2020 while cash position amounted to EUR5.3 billion. We maintain our Buy rating and EUR160 target price.

KBC Securities Galapagos (Buy) PT EUR 138

Geen verrassingen in kwartaalupdate Galapagos

Het kwartaalrapport van Galapagos bevatte op financieel of operationeel vlak geen verrassingen. De groep presteerde in lijn met de verwachting en bracht geen nieuws van betekenis op het niveau van de pijplijn. Ook niet over de eventuele vooruitgang met filgotinib in de VS. In de marge van het rapport werd wel een nieuwe samenwerking met OncoArendi aangekondigd, waarbij Galapagos diens CHIT1/AMCase OATD-01 verder zal ontwikkelen in fase II voor fibrotische indicaties. KBC Securities-analist Lenny Van Steenhuyse bevestigt het "Kopen"-advies voor de aandelen.

Financieel plaatje

Galapagos rapporteerde een kwartaalomzet van 368,6 miljoen euro, volledig in overeenstemming met de verwachtingen en het resultaat van de erkenning van de opbrengsten van de Gilead-overeenkomst (316,6 miljoen) en mijlpaalbetalingen voor de goedkeuringen van filgotinib in Japan en Europa (90,2 miljoen).

De totale operationele uitgaven waren lager dan verwacht, aangezien de verkoop- en marketingkosten (S&M) stabiel bleven op 17,2 miljoen euro in plaats van de verwachte sterke groei in marketingkosten. In totaal kwamen de operationele kosten uit op 176,4 miljoen euro, wat resulteert in een operationeel verlies van 32,4 miljoen euro en een nettoverlies van 81,5 miljoen euro (51,2 miljoen euro negatief wisselkoerseffect).

De groep sloot het derde kwartaal af met 5,3 miljard euro cash op de rekening en handhaaft het vooruitzicht op een cashburn van 490 à 520 miljoen euro voor het volledige boekjaar 2020.

Operationeel

• Het voorbije kwartaal ontving Galapagos van de Amerikaanse FDA een Complete Response Letter (CRL) in verband met de vergunningsaanvraag voor filgotinib als behandeling van reumatoïde artritis (RA). Gilead is in directe dialoog met het agentschap en verwacht in de komende periode extra informatie.
• Voor de MANTA- en MANTA RAy-studies zijn alle testpersonen gerekruteerd; Galapagos zit op schema om de resultaten in de eerste helft van 2021 vrij te geven.
• De fase IIb ROCELLA-studie met GLPG1972 voor de behandeling van osteoartritis (OA) toonde geen voordeel aan en de ontwikkeling is beëindigd.
• Het bedrijf is wel gestart met de brede klinische uitrol van GLPG3970 in zijn Toledo-programma, met eerste psoriasispatiënten die zijn behandeld in de fase Ib CALOSOMA-studie en met fase II-studies in reumatoïde artritis (RA) en ulceratieve colitis (UC) om vóór het jaareinde te beginnen.
• 1.200 van de 1.500 patiënten zijn ingeschreven in de fase III ISABELA-studies met Ziritaxestat als behandeling voor idiopatische longfibrose (IPF), op schema voor de futiliteitsanalyse in de eerste helft van 2021.
• Resultaten van de fase II PINTA-studie met GLPG1205 als behandeling voor idiopatische longfibrose (IPF) worden nog vóór het jaareinde verwacht.

Nieuwe deal met OncoArendi

Galapagos kondigde ook een samenwerking aan met het Poolse beursgenoteerde biotechbedrijf OncoArendi. Galapagos verkrijgt wereldwijd R&D- en commerciële rechten op OATD-01, de eerste verbinding die voortkomt uit OncoArendi's portefeuille van chitinaseremmers. Na het afronden van een fase I-studie bij gezonde vrijwilligers, streeft Galapagos ernaar om OATD-01 naar een fase II-studie te brengen voor IPF en mogelijk andere fibrotische ziekten.

Galapagos betaalt OncoArendi een voorschot van 25 miljoen en de partner komt in aanmerking voor 320 miljoen euro aan mijlpaalbetalingen en laag tweecijferige royalty's. Daarnaast betaalt Galapagos 2 miljoen euro voor het recht van eerste onderhandeling over alle activa die uit OncoArendi's chitinaseplatform komen.

De mening van KBC Securities

Met een operationele cashburn van ongeveer 390 miljoen tot dusver in 2020 lijkt het erop dat Galapagos wellicht aan de bovenkant van zijn verwachtingsvork voor de cash burn (490 à 520 miljoen) zal uitkomen, mogelijk zelfs eindigend boven die bovengrens.

Resterende katalysatoren voor het jaar zijn potentiële FDA-feedback aan Gilead voor filgotinib als behandeling voor RA in de Amerikaanse markt (MAJOR) en resultaten van de fase II PINTA-studie met GLPG1205 in IPF (Moderate).

Daarnaast juicht KBC Securities-analist Lenny Van Steenhuyse de inspanning toe om nieuwe activa aan de pijplijn toe te voegen, door middel van de aangekondigde deal. Fibrose blijft duidelijk de focus op het ontwikkelingsfront en de voorwaarden van de transactie zijn redelijk. Ter herinnering, Gilead heeft een optie om de Amerikaanse rechten in licentie te nemen voor alle Galapagos activa na fase IIb, voor een licentievergoeding van 150 miljoen dollar.

KBC Securities bevestigt het "Kopen"-advies en koersdoel van 138 euro.
Endless
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Fonds: Galapagos Guru: Jefferies & Co.
Advies: Houden Status: Actief
Koersdoel: € 118,00 Score: 0,00%
Startkoers: € 108,10 Huidige koers: € 101,00
Verw. rendement: 0,00% 6 november 2020 - 16:51u

Fonds: Galapagos Guru: Bryan Garnier & Co
Advies: Kopen Status: Actief
Koersdoel: € 160,00 Score: 0,00%
Startkoers: € 108,10 Huidige koers: € 101,10
Verw. rendement: 48,01% 6 november 2020 - 16:48u



Fonds: Galapagos Guru: KBC Securities
Advies: Kopen Status: Actief
Koersdoel: € 138,00 Score: 0,00%
Startkoers: € 108,10 Huidige koers: € 101,00
Verw. rendement: 27,66% 6 november 2020 - 16:47u
F_VR
1
(Trivano.com) - Op 9 november 2020 hebben de analisten van Credit Suisse hun beleggingsadvies voor Galapagos (GLPG; ISIN: BE0003818359) herhaald. Het advies van Credit Suisse voor Galapagos blijft "neutraal".

Het koersdoel wordt door Credit Suisse verlaagd van 129,00 EUR naar 105,00 EUR.



Hopelijk geen voorbode voor slechte resultaten PINTA.. :-(
@Aviantiavianti, zou jij misschien het rapport willen delen van Credit Suisse? Ik ben heel benieuwd naar de argumentatie.
avantiavanti
3
KBC Securities 10 november 2020

Galapagos - First patient treated with GLPG3667

Galapagos announces first dosing of a psoriasis patient in a phase Ib trial with GLPG3667. The company envision’s Toledo-like development, with phase II studies in PsA and UC anticipated in 2H21. While the compound’s MoA remains undisclosed, Galapagos has fostered long-time ambitions in TYK2(/JAK1)-targeting compounds.

News:
Yesterday evening, Galapagos announced the start of a phase Ib trial with GLPG3667 in psoriasis patients. GLPG3667 has a yet to be disclosed mode-of-action aimed at treating inflammatory conditions. The compound completed an initial phase I study in healthy volunteers and now proceeds in development, with a first psoriasis patient dosed. The phase Ib study is a randomized double-blind and placebo-controlled study taking place within Europe and will include 30 patients. Patients will be receiving either placebo or one of two dose levels of GLPG3667 in a 4-week once daily treatment regimen. Primary endpoint is the change from baseline in the PASI score after 4 weeks.
Galapagos anticipates to further develop GLPG3667 in phase II dose range finding studies in both psoriatic arthritis (PsA) and ulcerative colitis (UC) in the second half of 2021.

Our View:
Galapagos adds another clinical candidate to its roster of potential drugs in the inflammation and fibrosis fields. Considering the envisioned path forward for GLPG3667, the compound seems to be getting the star treatment as clinical development parallels the trajectory foreseen for prioritized Toledo compound GLPG3970. Also this compound has started a phase Ib trial in psoriasis to rapidly collect data and then move into no less then 5 phase II dose range finding studies. Interestingly, GLPG3667’s phase Ib in psoriasis patients is shorter compared to that of GLPG3790 (4 weeks vs 6 weeks) but is set to include slightly more patients (30 pts vs 25 pts).
While the compound’s MoA remains undisclosed, Galapagos has maintained ambitions developing a TYK2-targeting compound, either fully TYK2 specific or TYK2/JAK1, with initial TYK2/JAK1 compound GLPG3121 having been discontinued due to undesirable pharmacokinetics back in 3Q19.
TYK2 has remained in focus as an anti-inflammatory target with development ongoing at big pharma such as Bristol Myers-Squibb (BMS) and Pfizer. BMS took a chance on its internal TYK2 program after it was forced to divest an inflammation asset due to the merger with Celgene, opting to divest Celgene’s Otezla (sold to Amgen for $13.4bn) and retain its internal TYK2 program deucravacitinib. BMS’ compound has completed 2 phase III trials including a head-to-head comparison with Otezla. BMS has announced deucravacitinib has bested Otezla, but has yet to reveal the data. Not unlike GLPG3667’s envisioned trajectory, deucravacitinib is in development for psoriasis (phase III), followed by earlier stage trials in PsA, UC and SLE (phase II). Also Pfizer’s TYK2/JAK1 compound brepocitinib is on the cusp of a critical phase II readout in psoriasis patients.

Lenny Van Steenhuyse

Financial Analyst - Biotech & Pharma
avantiavanti
12
Note: lijvig rapport dus heb ik pdf compressed, zodat het hier past. Daarmee wat rafelig her en der. Maxim Group is recent gestart Galapagos te volgen.
Het rapport bevat ook veel basis info en is daarmee handig voor zij die Galapgos nog niet zo goed kennen denk ik.


Maxim Group 19 november 2020

Pressure on Shares from CRL Creates an Attractive Entry


Point- Initiating Coverage with a Buy Rating and $170 PT


Summary
• We are initiating coverage of Galapagos NV with a Buy rating and $170 PT.
Galapagos is an inflammatory and fibrotic disease company partnered with
Gilead (GILD - Buy) for commercialization.

• Filgotinib (Jyseleca) is approved in rheumatoid arthritis (RA) in Japan and EU,
but received a complete response letter (CRL) in the US. A Type A meeting is
planned by YE20 to determine the path forward in RA. Filings for ulcerative
colitis (UC) are expected in 1H21 in the EU and Japan, and in the US following
the MANTA study (data mid-2021), around the same time as a re-filing for RA.

• Idiopathic pulmonary fibrosis is a potentially attractive market that Galapagos
is approaching with a franchise strategy similar to Vertex (VRTX - Hold) in
cystic fibrosis, developing a pipeline of potentially synergistic compounds;
ziritaxestat is in P3 (futility analysis in 1H21), and GLPG1205 is in P2 (data by
YE20).

• Conclusion. Following the CRL for filgotinib, GLPG shares have traded down
to a near 52-week low, taking the market cap to less than $2B above its cash
balance of $6.3B. However, little has fundamentally changed regarding the
safety/efficacy profile for the company's pipeline. With key events ahead, we
see significant upside in the GLPG story.
Bijlage:
Lama Daila
0
Maxim Group makes a market in Galapagos NV
Maxim Group expects to receive or intends to seek compensation for investment banking services from Galapagos NV in the next 3 months.
mercurius-adept
0
quote:

Lama Daila schreef op 20 november 2020 08:08:


Maxim Group makes a market in Galapagos NV
Maxim Group expects to receive or intends to seek compensation for investment banking services from Galapagos NV in the next 3 months.


tsja, zelfs nog meer:

"The research analyst(s) primarily responsible for the preparation of this research report have received compensation based upon various factors,
including the firm’s total revenues, a portion of which is generated by investment banking activities.

Maxim Group makes a market in Galapagos NV
Maxim Group expects to receive or intends to seek compensation for investment banking services from Galapagos NV in the next 3
months."
avantiavanti
6
Extract update Morgan Stanley 30 november 2020

Stock Rating Equal-weight
Price Target $159.00

Matthew Harrison, Connor Meehan

GLPG1205 leads to ~55% reduction in FVC decline: Mgt. announced topline results from the PhII PINTA study evaluating 100mg GLPG1205 (plus SoC) as a treatment for idiopathic pulmonary fibrosis (IPF), versus placebo (SoC only). The study enrolled 68 patients, and the primary endpoint was change in baseline forced vital capacity (FVC). At week 26, patients in the active group experienced an FVC decline of -34mL, versus -76mL for those treated with placebo. This benefit of 42mL represents a reduction in FVC decline of ~55%, which places this outcome near our base case expectation, as described in our CDI here. Mgt. further noted a correlation between FVC decline and change in pulmonary lobar volume, as measured by Functional Respiratory Imaging (FRI). Mgt. plans to present full results from the PINTA trial at an upcoming medical conference. On safety, the most frequent AEs associated with GLPG1205 alone were GI disorders, including nausea. There was a higher rate of early discontinuations and TEAEs in patients treated with '1205 plus nintedanib, including one death (from IPF exacerbation), though this is believed to be unrelated to treatment with '1205. No notable safety issues were observed in patients treated with '1205 plus pirfenidone. We don’t see any significant tolerability issues and note that standard of care already has GI side-effects. We believe these results could drive GLPG up 5%+ and await additional detail from mgt. regarding a planned PhIIb dose-finding study.
avantiavanti
4
Extract Bofa Securities 30 november '20


PINTA (IPF): small victory with +ve Ph2a but clinical utility remains a question mark

Maintain Rating: UNDERPERFORM
PO: 121.00 USD | Price: 122.61 USD
Equity | 30 November 2020

Key takeaways
Ph2 result of GLPG205 saw modest improvement in FVC (lung function surrogate) over control in IPF patients on background tx
Modest effect size and safety signals in combination with Ofev (1 of 2 standard of care) raise questions on clinical utility
We await clarification of clinical profile in detailed Ph2a data and future readout in dose-ranging Ph2b (to be initiated)
FULL REPORT
Ph2 +ve but modest effect size and safety signals raise qs

This afternoon, GLPG announced positive Ph2a topline results from the PINTA study of GLPG1205 (GPR84) in idiopathic pulmonary fibrosis (IPF). While not a complete surprise given partial Ph2 validation from competitor's (Prometic) PBI-4050 with similar mechanism (GPR40/GPR84), today's new is a small victory for GLPG following some disappointing clinical/regulatory pipeline updates in 2020. Nonetheless, many questions remain before we assign value to GLPG1205, notably 1) clinical meaningfulness - GLPG reported modest (42mL) placebo adjusted FVC (lung function surrogate) across patients on top of standard of care (Esbriet, Ofev, or neither). We await stratification of the effect size by background therapy. In our prior checks, physicians view clinical meaningful threshold as 40-50mL when compared against best standard-of-care (vs. Esbriet or Ofev) and 80-100mL vs. local standard of care (placebo) for monotherapy; 2) Ph3 dose still uncertain - GLPG plans to next advance '1205 into a dose finding Ph2b trial, which suggests to us GLPG may plan to push dose to achieve higher efficacy and incorporate proper powering to ensure show stat. sig. benefit. The decision to dose optimize seems prudent as the company awaits futility analysis from Ph3 GLPG1690 sometime in 1H21 and R&D partner Gilead Sciences (GILD, covered by Geoff Meacham) might require further dose optimization to exercise opt-in rights on the program; 3) safety - whether '1205 can be safely combined with Ofev, given higher rate of early discontinuation and high grade adverse events were observed from '1205+Ofev; 4) unclear positioning vs. lead IPF asset GLPG1690 (autotaxin). We maintain Underperform given challenging pipeline story in the absence of re-rating catalysts near-term and risk of consensus trimming ests if GILD meaningfully culls the indications it commercializes with filgo.

GLPG has two assets in clinical development for IPF

GLPG's lead IPF asset, ziritaxestat (GLPG1690), is an autotaxin inhibitor which is in Ph3 development in IPF on top of standard of care, with an interim futility analysis due in 1H21E. In Ph2, GLPG1690 achieved a 95mL placebo adjusted FVC at week 12 compared to placebo (no background therapy). By comparison, GLPG1205's placebo adjusted effect size was smaller with 42mL at week 26, though allowing background Esbriet/Ofev likely had limited effect size compared to'1690 Ph2 trial (vs. placebo without background therapy). Nonetheless, given modest effect size seen with GLPG1205, we believe GLPG will likely explore higher doses to attain better efficacy in Ph2b, though safety signals in combination with Ofev may limit room for dose escalation. Currently, we forecast '1690 to generate $1.8bn global end-user sales or €570m royalty revenue to '1690 (both nominal, non-risk adjusted) in 2030E. We assign a 45% likelihood of success (POS) to GLPG1690 but do not assign value to '1205 given unclear positioning vs. '1609 at current stage.
avantiavanti
3
Extract RBC Capital Markets 30 november '20

GLPG US - Another IPF Drug Shows Promising Signals, Though Remains Early

RBC Capital Markets, LLC
Brian Abrahams (Analyst) (212) 858-7066
Leonid Timashev (Associate)


Sector: Biotechnology
Rating: Sector Perform
Impact: Incrementally Positive


Today, after market close, Galapagos reported topline results from the ph.II PINTA IPF trial, and we had a chance to catch up with the company. The data to us are incrementally positive, though some safety signals will need to be better understood to gauge its potential role within GLPG's widening IPF portfolio and translatability to future studies. Pipeline has shown some signals of early promise of late though filgotinib regulatory path and partnership remains overhang; remain at Sector Perform.


'1205 shows solid improvements in FVC. 100mg once-daily GLPG1205 on top of standard of care achieved placebo-adjusted forced vital capacity decline of 42mL at 26 weeks (-76mL on placebo vs -34mL on treatment). For comparison, standard of care treatments nintedanib and pirfenidone have been shown to reduce FVC decline by 50%, with nintedanib showing a reduction of 115mL per year vs 240mL per year on placebo; at 24wks FVC in nintedanib-treated patients was ~46mL below baseline vs ~110 in placebo. By comparison, FVC in PINTA was down -34mL vs baseline on treatment – suggesting incremental gains in function. However, we await full data to assess the consistency across pts (though GLPG indicated all arms performed comparably) and baseline characteristics.

Safety still needs further assessment. GLPG reported no "relevant safety signals" for '1205 alone or in combination with pirfenidone, noting the most common AEs with '1205 alone were GI-related, including nausea. However, a higher rate of early discontinuations and high-grade TEAEs. The precise nature of the combination AEs was not disclosed but we note nintedanib is associated with anorexia and nausea; whether '1205 exacerbated nintedanib-associated AEs was not disclosed, but we expect greater clarity after full results are presented at an upcoming medical meeting. Nonetheless, the company was still optimistic about moving forward in a nintedanib combo, and indicated a plan for a drug-drug interaction study to gain greater clarity on the AEs arising from '1205-nintedanib combination, ahead of the next study.


GLPG is developing multiple assets for IPF with different mechanisms of action setting up possible combination therapies. GLPG is expecting futility analysis from ziri in IPF in 1H21 and is guiding to start a ph.IIb study of chitinase inhibitor '4716 with partner OncoArendi in 2021. With multiple assets targeting different aspects of disease (recall, '1205 targets inflammation by inhibiting GPR84 on macrophages), the company has a shot at developing combination approaches using pipeline assets. However, we note the basic biology of IPF remains poorly understood, limiting conclusions drawn about potential combinations at this stage.
avantiavanti
5
Extract update Credit Suisse 30 november 2020

Galapagos NV - Positive Topline Results from Phase 2 PINTA Trial; IPF Assets Continue to Support Evolving GLPG story

As anticipated, Galapagos announced today positive topline results for its investigational GPR84 antagonist GLPG1205 in its phase 2 PINTA Proof of Concept trial (randomized, double-blind, placebo-controlled) in idiopathic pulmonary fibrosis (IPF) patients. While not powered for statistical significance, patients treated with '1205 vs. placebo + top of standard of care (nintedanib, pirfenidone or neither) demonstrated a numerically smaller decline in FVC at (-76mL on pbo vs. -34mL on '1205)--suggesting interesting efficacy of the asset in IPF patients. Per the company, the decline in pbo arm FVC was in line with expectations for SoC. Given the challenges in treating IPF, we are encouraged with these data and look to better understand the molecule's potential in the planned phase 2b trial. Still, we remain acutely focused on the path-forward for filgotinib in the US and updates from the ISABELLA 1/2 program of '1690 in IPF (futility analysis expected early next year).

Our conversation with the Galapagos management team at the CS Healthcare Conference earlier this month highlighted previewed the top-line results of the '1205 program in IPF. Recall, the trial investigated a 100mg once-daily oral dose of GLPG1205 and included a total of 68 patients who were administered GLPG1205 or placebo (2:1 randomization) for 26 weeks and could remain on their standard of care as background therapy. Based on the results of this trial, Galapagos anticipates making further progress GLPG1205 in a dose finding ph 2b trial. Specifically, Galapagos wants to better understand the performance of patients treated with nintedanib to finalize plans for a phase 2b trial.

All in, IPF assets continue to be an important piece of the company's evolving commercial story. GLPG continues to believe the unmet need is meaningful and there is a significant opportunity, but it also remains cognizant that it is important to get a better efficacy and tolerability data. GLPG hopes to differentiate among competitors with superior efficacy and tolerability. Moving forward, the company plans to submit full results of the PINTA trial to a future medical conference and peer-reviewed medical journals. Beyond positive topline results from this trial, the pending CRL resolution in the U.S. remains as an overhang on the GLPG stock, in our view. As a reminder, Gilead is currently leading the interaction with the FDA and the upcoming Type A meeting will be an important update for what would be the next steps for CRL. The safety study data are expected in the first half of 2021.

Top-line clinical data: Results from the study indicated that patients receiving GLPG1205 at week 26 on top of standard of care showed a smaller FVC decline -- difference of 42mL vs placebo on top of standard of care (-76mL on placebo; -34mL on treatment). Whereas the study was not powered to show statistical significance, the FVC trend was consistent across the 3 treatment strata. Additionally, it was observed that the change in pulmonary lobar volume (as measured by FRI) correlates with the FVC decline, and no relevant safety signals were observed for the drug alone and on top of pirfenidone. The most frequently reported AEs were gastrointestinal disorders, such as nausea. The higher rate of early discontinuations and high grade TEAEs were observed in the treatment arm of GLPG1205 + nintedanib and there was one death due to an exacerbation of IPF, which was determined to be unrelated to study treatment, according to the company. Overall, GLPG remains encouraged by the consistent changes observed across treatment strata, using different analytical method (including FRI) considering the limitations of this early clinical study. The KOL, Dr. Toby Maher, also noted that it is important to better understand long-term tolerability of the drug but believes PINTA results warrant further investigation. All in, the management team is encouraged by a second novel mechanism of action from its platform showing early signs of activity in IPF.

About GLPG1205 and the fibrosis portfolio: Recall that Galapagos currently has several drug candidates with distinct mechanisms of action in its portfolio aimed at building a fibrosis franchise. This includes ziritaxestat (GLPG1690, autotaxin inhibitor) in the ISABELA Phase 3 program in IPF, ziritaxestat in the NOVESA Phase 2 trial in systemic sclerosis, GLPG1205, GLPG4716 (chitinase receptor inhibitor) preparing for Phase 2 in IPF, and GLPG4124 and GLPG4586, currently in pre-clinical development. GLPG1205 is a small molecule selectively functionally antagonizing GPR84.

To help further contextualize these data we've provided phase 3 data of both Pirfenidone (Figure 1) and Nintedanib (Figure 2) In pdf bijlage:



Bijlage:
Wall Street Trader
3
Bryan Garnier & Co Galapagos (Buy) PT EUR 160

Victor Floc'h, 1 December 2020

Positive PINTA results confirm ‘1205 potential in IPF

• Galapagos just reported positive results with GLPG1205 in IPF patients in PINTA proof-of-concept trial. As a reminder, study’s objective was to assess the change from baseline in forced vital capacity (FVC) decline, an established measure of pulmonary function in idiopathic pulmonary fibrosis (IPF). At week 26, patients receiving ‘1205 on top of standard of care showed a smaller FVC decline, with a difference of 42mL versus placebo on top of standard of care (-76mL on placebo; -34mL on treatment).

• Even though the study was not powered to show statistical significance, those data still suggest that ‘1205 has an activity in IPF, a highly fatal disease. Alongside ‘1690, Galapagos may have in hands a second novel mechanism of action in IPF, further expanding their portfolio. However, it is still too early to say if this asset has a potential as monotherapy or if it has to be seen only as an add-on to ‘1690. It is worth bearing in mind that ‘1690 showed even more impressive results from its phase IIa back in 2017 by not only reducing lung function decline but preventing it. Those results were so impressive that it led Galapagos to bring this asset straight into phase III.

• Galapagos is now expecting to further study ‘1205 through a dose-finding phase IIb trial, in order to better understand its profile in combination with nintedanib (one of the few drugs on the market). While we see those results as very positive given it is a high-risk disease area for drug development, we are still not quite sure it has a potential by itself, making it difficult to add it to our valuation. However, we are not ruling out that it may prove itself as a good combination candidate which could further strengthen ‘1690 potential at some point.

KBC Securities Galapagos (Buy) PT EUR 139

KBC Securities heeft dinsdag het koersdoel voor Galapagos verhoogd van 138,00 naar 139,00 euro bij handhaving van het koopadvies.

Galapagos rapporteert resultaten van zijn fase II PINTA-studie met GLPG1205 bij patiënten met idiopathische longfibrose (IPF). Die test levert positieve, maar niet statistisch significante resultaten op bij patiënten die GLPG1205 toegediend kregen tegenover patiënten die een placebo ontvingen. Hoewel het op dit punt niet duidelijk is in welke mate de verbinding een verbetering oplevert ten opzichte van bestaande behandelingen, is Galapagos van plan om een fase IIb-studie op te starten om de juiste dosering te bepalen.

Het koersdoel stijgt bij KBC Securities van 138 naar 139 euro, omdat de kans op succes in het waarderingsmodel opgetrokken werd van 30% naar 40%. Het “Kopen”-advies blijft behouden.

Analist Lenny Van Steenhuyse kijkt uit naar de uitkomst van de gesprekken tussen Gilead en de FDA over de 200mg dosis filgotinib voor de behandeling van reumatoïde artritis (RA) voor de Amerikaanse markt.

Galapagos rapporteerde maandagavond de resultaten van de fase II PINTA-studie met GLPG1205 bij patiënten met longfibrose. Die test levert een positieve, maar niet statistisch significante, daling op van FVC in die patiënten die GLPG1205 toegediend kregen ten opzichte van patiënten die een placebo ontvingen, zo merkten de analisten van KBC op.

Ondanks dat niet duidelijk is in welke mate de behandeling een verbetering oplevert ten opzichte van bestaande therapieën, is Galapagos toch van plan om een fase IIb dosis-onderzoek te starten.

KBC verhoogde het koersdoel, omdat de kans op succes in het waarderingsmodel opgetrokken werd van 30 naar 40 procent.

KBC blijft echter toch vooral benieuwd naar de uitkomst van de gesprekken tussen Gilead en de FDA over de 200mg dosis Filgotinib voor reumatoïde artritis op de Amerikaanse markt.

Kempen

Kempen will host a CEO fireside chat / investor group call today at 3pm CET/ 9am ET.

December 01, 2020

Kempen, Investor Group call Virtual
avantiavanti
2
Maxim Group 1 december 2020

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PT $170

Building-Out The IPF Franchise; Positive Phase 2 Data Reported for GLPG1205
Bijlage:
Rekyus
6
Waarom twijfelen aan de waarde van de analyse van de Maxim Group inclusief koersdoel? Omdat men open is over het commerciële belang dat wordt nagestreefd met de publicatie van een rapport over Galapagos? En wat dan te zeggen over al die andere rapporten van financiële analisten met hun verborgen agenda’s, hun dubbele bodems, hun bewuste beïnvloeding van concurrentieverhoudingen ten behoeve van de eigen clientèle, het dienstbaar zijn aan de geheime handelsstrategieën van de eigen zakenbank en ga zo maar door?

Wat er ook van zij, Maxim heeft beter dan menige concurrent door waar het Galapagos om te doen is, namelijk een zo breed mogelijk IPF-programma ontwikkelen dat sterke overeenkomsten vertoont met de opzet van het CF-programma van het succesvolle Vertex. Naast middelen tegen inflammatoire ziektes moet dat de tweede pijler onder Galapagos worden. Synergistisch werkende moleculen moeten niet alleen de efficacy naar een hoger niveau tillen, maar ook ook voor een (tijdelijke) marktdominantie in dit ziektedomein zorgen. Dat vertaalt zich in hoge prijzen en opbrengsten, maar zeker ook in een aanmerkelijk betere medicamenteuze behandeling.

Maxim merkt in het eerdere rapport op: "Idiopathic pulmonary fibrosis is a potentially attractive market that Galapagos is approaching with a franchise strategy similar to Vertex (VRTX - Hold) in cystic fibrosis, developing a pipeline of potentially synergistic compounds; ziritaxestat is in P3 (futility analysis in 1H21), and GLPG1205 is in P2 (data by YE20)."

GLPG 1205 is een werkzame stof die voor een stand-alone behandeling wellicht matig geschikt is, maar in combinatie met (met name) ziritaxestat tot betere klinische uitkomsten leidt dan ingeval van een monotherapie met laatstgenoemde. Dat gebeurt dan met een werkingsmechanisme dat fundamenteel anders aangrijpt dan het primair inzetbare middel, ziritaxestat. Dat leidt niet alleen tot een optelsom in termen van werkzaamheid of - zij het zelden -in meer dan dat. Het maakt het bijvoorbeeld ook mogelijk om lager te doseren om hinderlijke of ernstige bijwerkingen te ontlopen bij gelijkblijvende werkzaamheid..
NielsjeB
3
quote:

Rekyus schreef op 2 december 2020 10:25:


[..]
GLPG 1205 is een werkzame stof die voor een stand-alone behandeling wellicht matig geschikt is, maar in combinatie met (met name) ziritaxestat tot betere klinische uitkomsten leidt dan ingeval van een monotherapie met laatstgenoemde. Dat gebeurt dan met een werkingsmechanisme dat fundamenteel anders aangrijpt dan het primair inzetbare middel, ziritaxestat. Dat leidt niet alleen tot een optelsom in termen van werkzaamheid of - zij het zelden -in meer dan dat. Het maakt het bijvoorbeeld ook mogelijk om lager te doseren om hinderlijke of ernstige bijwerkingen te ontlopen bij gelijkblijvende werkzaamheid..

Wellicht heb ik de resultaten van een 1690/1205-combinatiestudie over het hoofd gezien? Het zal niet zo bedoeld zijn, Rekyus, maar ik vind dat je hier veel te kort door de bocht gaat. Nog even los van het feit dat er geen combinatiestudie loopt, zijn de resultaten van eerdere combinatiestudies die Galapagos uitvoerde ook niet meteen iets om mee te koop te lopen.

Ik zou graag wat meer onderbouwing zien van je stellingen.
Broer Konijn
0
quote:

Broer Konijn schreef op 1 december 2020 18:14:


In Maxim we trust....... ?

Vriendelijke groet, Broer Konijn


Hoi Reykus,

Als je (nuttige) post een reactie was op mijn bovenstaande post wil ik toelichten dat die niet was bedoeld om vraagtekens te zetten bij het rapport van Maxim.
Het was een uiting van hoop op betere tijden voor het aandeel Galapagos gemengd met twijfel en frustratie door de immer onder druk staande koers van het aandeel waar maar geen einde aan lijkt te komen.
Excuus voor het eventuele misverstand.

Vriendelijke groet, Broer Konijn
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