inhoudelijk LIGHT

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Wall Street Trader
6
2 Clinical Trials updates

GLPG3667 inflammation

A Study to Evaluate the Effects of Single and Multiple Oral Doses of GLPG3667

clinicaltrials.gov/ct2/show/NCT04097938

Recruitment Status : Active, not recruiting
First Posted : September 20, 2019
Last Update Posted : June 17, 2020

GLPG1690

A Clinical Study to Test How Effective and Safe GLPG1690 is for Patients With Systemic Sclerosis (NOVESA)

Recruitment Status : Active, not recruiting
First Posted : January 9, 2019
Last Update Posted : June 17, 2020

clinicaltrials.gov/ct2/show/NCT03798366

voda
1
Rustig Galapagos

Het Belgisch-Nederlands biotechbedrijf Galapagos ligt er op lange termijn nog redelijk goed bij. Hoewel het aandeel dit jaar nauwelijks iets is opgeschoten, oogt het technisch plaatje zeker niet slecht.

Galapagos beweegt sinds begin 2015 in een stijgende trend, waarbij hogere toppen en bodems wijzen op aanhoudende vraag. Deze trend is meerdere keren onderbroken geweest door periodes van consolidatie, maar per saldo blijft de trend opwaarts gericht.

Dit jaar heeft de koers een volatiel verloop laten zien. Na de forse daling van begin dit jaar is de koers weer hard opgeveerd en werd de eerdere verzwakking ongedaan gemaakt. De recente correctie lijkt nu binnen de neutrale fase en boven de 200-dagenlijn een hogere bodem op te leveren.

Zodra de correctieve fase van de afgelopen weken wordt afgebroken kan Galapagos het vizier weer richten op de oude top van februari rond €252,90.

Galapagos maakt al sinds oktober 2018 deel uit van zowel de TA portefeuille van IEX Premium als de defensieve portefeuille van Tostrams. Zolang de uptrend intact is, houden we de posities goed vast.

www.iex.nl/Column/502304/TA-AEX-en-Ga...
Bijlage:
Wall Street Trader
5
Gilead Sciences is not just a Covid-19 play

US regulatory approval is also awaited for filgotinib, a treatment for rheumatoid arthritis that could also be effective in treating a wide range of other immunology ailments. Even if filgotinib has limited uses, Gilead will still have a blockbuster on its hands.

Investors should bear in mind that most drugs fall at one of several hurdles in the race to regulatory approval. However, success in finding any new treatment is potentially highly lucrative while patents last.

www.ii.co.uk/analysis-commentary/gile...

Wall Street Trader
4
At Galapagos, we discover and develop novel medicines. What makes us different is how we innovate. Our daring approach to discovery and development rests on the knowledge of disease biology that our own experts have built up over the past 20 years.

In the past, most medicines treated the symptoms of a disease. Today, we tackle
the disease itself. Our proprietary target discovery platform makes it possible to
identify the starting points of disease processes and develop novel medicines,
that address those starting points.

Pioneering for patients

We have been using this approach for our research consistently for over 20 years.
Thanks to this unique scientific approach, we have built a vast bank of
proprietary knowledge on disease biology. Together with a bullish ambition to
build our pipeline, this has led us to the extraordinary position we find ourselves
in today: over 40 unique compounds, more than half of which have gone into
clinical development.

Galapagos is progressing one of the largest pipelines in biotech, with small molecule programs addressing inflammation, fibrosis, and other diseases.

With 100 Clinical Trials currently running:

clinicaltrials.gov/ct2/results?spons=...

Bijlage:
NielsjeB
2
Small correction: 100 Clinical Trials have currently been sponsored in total. Ambition this year was to get 80 trials running concurrently. I thought this was overly ambitious before corona, currently I think this is impossible to achieve. But we'll see.
Wall Street Trader
4
Thanks for the addition NielsjeB. It has an impact, but it's a limited impact. It's a reality of life.
Onno and his team has always been very ambitious and setting the bar high.

The following conversation has been edited and condensed for clarity (March 25, 2020).

BIOPHARMA DIVE: You released a short update on March 22 about COVID-19
and its effects on filgotinib studies. Is there any more you can add about that
decision?


VAN DE STOLPE: Gilead decided that, due to the safety for patients, it would be
better to stop recruitment in the filgotinib studies. Filgotinib is a JAK1 inhibitor — and,
in inhibiting JAK1, you are compromising the immune system. We'll pick it back up
when things get back to a more normal situation.

This impacts especially the Crohn's study and some of the smaller Phase 2 studies. It
does not impact the ulcerative colitis study because [enrollment] is completed and, of
course, rheumatoid arthritis neither because that study is completed. So it has an
impact, but it's a limited impact. It's a reality of life.

We have other studies ongoing that we haven't stopped. There, we have the
Roccella study, which is fully recruited and is reading out in the second half of the
year.

And then the important one is the ISABELA study for GLPG 1690 in ideopathic
pulmonary fibrosis. That study is still continuing to recruit
, although these patients are
also at risk, and even more at risk because they've got reduced lung function. This is
a deadly disease — when you have IPF, you have a window of three to four years.
So the need to find something that stops the progression of the disease is very high,
and we see a continuous interest of doctors to screen patients
to see if they're
eligible for inclusion in the trial.

Although there's a slowdown in those trials, we don't expect recruitment to stop there.
Of course, visibility is extremely limited, so things could change by the hour, by the
day.

You said the enrollment pauses had to do with the safety of patients who you
expect would be enrolled in these trials. Is that because of age, or is it due to
concerns about the drug's effects on the immune system?


VAN DE STOLPE: These are sick patients, and with sick patients in general their
immune system is not very high.

In Crohn's, it's a much younger population than in rheumatoid arthritis — rheumatoid
arthritis is 60, 65 years, and in Crohn's it can be 30, 40. It's not that you have an
elderly population, but [rather that] you have a weakened population because of the
disease. Then to come in with an immunosuppressant drug, that is not ideal in the
time of COVID-19.

Some of these paused studies have quite large estimated enrollments. Were
you close to completing enrollment on any of them, or was completion at least
several months away?

VAN DE STOLPE:
Only the Crohn's study is that large, because the ulcerative colitis
study is already fully recruited. In the Crohn's study, we still need quite a bit of
patients, but it has been slow recruiting anyway. It's difficult to find the right Crohn's
patients, and it'll just be on hold until we can pick it up again.

Is there any timeline for how long it might take before Galapagos resumes
enrollment into any of these studies?

VAN DE STOLPE:
No. If you see what's happening in the U.S. at the moment,
everything is closing down. We have no view on what's going to happen over there. I
don't think anybody can make a sensible calculation of when they'll be back. We see
some stabilization in Italy and we see Asia coming back up to action. But yeah, the
U.S. is just starting.

Before the trials were paused, what were the conversations like with your
partner Gilead?

VAN DE STOLPE:
These trials are run by Gilead, so it's their decision to do this. Of
course there was a discussion ... but we agree with [how] Gilead's taking the initiative
and action.

Gilead filed filgotinib in the U.S. late last year. Are there any concerns about the drug's review timeline at the FDA?

VAN DE STOLPE:
That's a good point. For now, we haven't heard any delays. There aren't any changes in timing. They are working from home, but if a number of these reviewers get ill, for example, it might have an impact on the timelines. If you look at what happened during previous crises, like a government shutdown or 9/11, the FDA didn't stop reviewing. So we don't anticipate a delay.

Filgotinib trials are halting enrollment because of patient safety concerns, but one could imagine that, if the drug is comes to market, those concerns would still be there. Are you having conversations about the challenges of giving this drug to patients in the rheumatoid arthritis community?

VAN DE STOLPE: I'm sure those discussions are being held.

All the drugs in rheumatoid arthritis are challenging the immune system. So you are one among a class. I don't think that's going to be the big change. People who have disease want to be treated — and [though] there's an additional risk of infections, it's clear they are aware of that. I don't know if people with milder forms of rheumatoid arthritis are stopping using drugs. I really can't tell. But if you have severe rheumatoid arthritis, you will use a drug. And then you have to be extremely careful not to get infected with this virus, that's for sure.

Wall Street Trader
12
While Gilead/Galapagos' Filgotinib Will Have to Contend with the Early Success of AbbVie's Rinvoq in the US Rheumatoid Arthritis Market, Eli Lilly's Olumiant is Likely to be the More Formidable Foe in the EU.
A stark contrast in use and preference of the JAK inhibitors between the two regions sets varying competitive landscapes for pipeline agents in rheumatoid arthritis

Spherix Global Insights
Jul 01, 2020, 04:30 ET


EXTON, Pa., July 1, 2020 /PRNewswire/ -- Analysis of the most recent semiannual report included in Spherix's RealTime Dynamix™: Rheumatoid Arthritis (EU) service, which captured the responses of 256 EU5 rheumatologists, reveals a distinct contrast between EU and US treatment patterns in rheumatoid arthritis (RA). Perhaps the most notable difference observed between the two geographies is in rheumatologists' self-reported use and perceptions of JAK inhibitors – a matter of particular importance as the class will likely expand even further before the end of 2020.

Gilead/Galapagos' selective JAK1 inhibitor, filgotinib, is projected to gain US FDA approval for the treatment of RA by the end of summer, with EU authorization expected to follow – making it the fourth JAK inhibitor commercially available in both regions. However, the competitive landscape is markedly different in the EU than in the US and should pose different challenges for the agent, while other market dynamics could impact the success of this launch.

In the US, swift adoption of AbbVie's Rinvoq is already eroding the leadership position of Pfizer's Xeljanz, the first-to-market and historically dominant JAK inhibitor in RA. According to the Q2 2020 report included in a parallel service tracking the US RA market, while Xeljanz still has the highest brand share among JAK agents, Rinvoq has made rapid and positive in-roads in adoption and has already eclipsed the brand share of Eli Lilly's Olumiant. In fact, when prompted to select their preferred JAK inhibitor if limited to only one for the treatment of RA, 58% of US rheumatologists chose Rinvoq (up from 49% in Q1 2020), while 38% chose Xeljanz (down from 46% in the same timeframe) – placing Olumiant in a very distant third.

Contrary to the market dynamics reported in the US, Olumiant holds the top spot among European rheumatologists, and both Rinvoq and filgotinib will have to win over prescribers if they want to overcome Lilly's JAK's solid positioning. Indeed, brand share for Olumiant across the pond has steadily increased year over year and currently garners a greater percentage of the market than all available JAK agents (including newly authorized Rinvoq). When EU5 rheumatologists were asked to choose their preferred JAK inhibitor in RA, Olumiant was favored by far and large over both Xeljanz and Rinvoq – a drastically different outcome than what was reported in the US.

Differences in the respective launch timings and approved labeling of each JAK inhibitor between the two regions are key contributing factors to the substantial disparity between prescribing. For example, Olumiant was FDA approved for the treatment of RA in 2018, giving Xeljanz a six-year head start in the US market. On the other hand, Olumiant received EMA authorization for the RA indication one month prior to Xeljanz (both in 2017), evening out the playing field in the EU regarding the timing aspect.

However, while both the 2mg and 4mg doses of Olumiant are approved in the EU, only the 2mg dose is available in the US. Subsequently in the EU5, more than half of surveyed rheumatologists believe that Olumiant is the best option regarding cardiovascular (CV) side effects and overall risk/benefit profile (likely due to having the choice between a perceived "safer" 2mg dosing option and more efficacious 4mg dosing option). In the US, where Pfizer's brand has tenure and is the preferred JAK for CV side effects, newcomer Rinvoq beats out Olumiant and Xeljanz as the most preferred brand when it comes to the overall risk/benefit profile. Of note, nearly one-third of US rheumatologists indicated they would prescribe substantially more Olumiant if the 4mg dose was approved.

One outcome of a growing JAK class is earlier use in the treatment algorithm and the impact it has on class cycling. Rheumatologists in both regions report more pre-biologic JAK use in addition to an increased propensity to prescribe back-to-back JAK inhibitors before moving on to other mechanisms of action. This is particularly true in cases of a first-line JAK failure due to waning efficacy, where the percent of US respondents who report they will prescribe a second JAK has increased four-fold over the past year. With additional class expansion on the horizon, this treatment pattern is only likely to become more common.

Despite the dominance of the current JAK class in both the US and EU5, filgotinib is already top-of-mind for rheumatologists, with both regions reporting they are the most familiar with Gilead/Galapagos' pipeline asset over other late stage agents, including Merck/EMD Serono's evobrutinib, Roche/Genentech's fenebrutinib, Astella's peficitinib, GSK's otilimab, and Abivax's ABX464. Furthermore, when prompted to choose just one agent they would most like to see gain EMA/FDA approval, the majority of both EU and US rheumatologists selected filgotinib.

www.prnewswire.com/news-releases/whil...

winx09
1
quote:

Wall Street Trader schreef op 30 juni 2020 11:16:


Thanks for the addition NielsjeB. It has an impact, but it's a limited impact. It's a reality of life.
Onno and his team has always been very ambitious and setting the bar high.
....

Filgotinib trials are halting enrollment because of patient safety concerns, but one could imagine that, if the drug is comes to market, those concerns would still be there. Are you having conversations about the challenges of giving this drug to patients in the rheumatoid arthritis community?

VAN DE STOLPE: I'm sure those discussions are being held.

All the drugs in rheumatoid arthritis are challenging the immune system. So you are one among a class. I don't think that's going to be the big change. People who have disease want to be treated — and [though] there's an additional risk of infections, it's clear they are aware of that. I don't know if people with milder forms of rheumatoid arthritis are stopping using drugs. I really can't tell. But if you have severe rheumatoid arthritis, you will use a drug. And then you have to be extremely careful not to get infected with this virus, that's for sure.




- Niels heeft natuurlijk gelijk. De rest van het jaar moeten er 2 studies per week opgestart worden om aan de 80 te komen, wat denk je zelf ?

- De laatste vraag aan Onno is hopelijk ook door Michele Manto gelezen. Want was niet een van de voordelen van Filgo (en Voq) dat er al binnen 2 weken goede werking van het medicijn was, terwijl dat bij biologics maanden kan duren ? Is de beslissing om tijdelijk te stoppen met je medicatie, bv vanwege veel covid gevallen in je omgeving, niet makkelijker te maken als je op een Jak zit ? Of kan je na een tijdelijke stop met een biologic niet effectiever herstarten met een JAK ? Zijn dit soort zaken uberhaupt wel eens uitgezocht ?, zo niet tijd voor een onderzoekje @Walid
NielsjeB
7
Voor de geïnteresseerden veel achtergrondinformatie (webinar) bij toepassing van FRI (van FLUIDDA) in COVID-19 en IPF. FLUIDDA en Galapagos maken onderdeel uit van het COVID-19 consortium.

Vanaf minuut 39 gaat het over FRI in IPF.

channel.royalcast.com/chiesi/#!/chies...
Woman in Chains32
0
quote:

NielsjeB schreef op 2 juli 2020 12:36:


Voor de geïnteresseerden veel achtergrondinformatie (webinar) bij toepassing van FRI (van FLUIDDA) in COVID-19 en IPF. FLUIDDA en Galapagos maken onderdeel uit van het COVID-19 consortium.

Vanaf minuut 39 gaat het over FRI in IPF.

channel.royalcast.com/chiesi/#!/chies...



NielsjeB,

"FLUIDDA en Galapagos maken onderdeel uit van het COVID-19 consortium"


Kan je dit verder duiden..
maxen
7
quote:

Woman in Chains32 schreef op 2 juli 2020 15:00:


..
NielsjeB,

"FLUIDDA en Galapagos maken onderdeel uit van het COVID-19 consortium"


Kan je dit verder duiden..

Bij Fluidda hebben ze een speciale covid19 pagina, waarop staat:

www.fluidda.com/covid19/

"Members of the consortium are, amongst others:
Trudell Galapagos"


Achtergrond voor de lezer: Fluidda is het bedrijf achter de imaging en modelling van de longen (FRI techniek), die Galapagos gebruikt in de IPF trials van 1690.
C200
0
Novel methodology to perform incurred sample reanalysis (ISR) on dried blood spot (DBS) cards - Experimental data using darolutamide and filgotinib

onlinelibrary.wiley.com/doi/abs/10.10...
NielsjeB
0
quote:

Woman in Chains32 schreef op 2 juli 2020 15:00:


[...]


NielsjeB,

"FLUIDDA en Galapagos maken onderdeel uit van het COVID-19 consortium"


Kan je dit verder duiden..

Niet echt. Logo van Galapagos stond op de consortium-pagina (vanaf minuut 22). Ik denk dat we er ons niet teveel van voor moeten stellen. Maar goed dat ze kennis en capaciteit beschikbaar stellen.
Wall Street Trader
6
Upcoming Events

August 06, 2020

Half year 2020 results

Webcast August 07, 2020, 14.00 CET

September 07, 2020

Kepler Cheuvreux Autumn Conference (Virtual)

September 10, 2020

Knowledge for Growth, Ghent

September 14, 2020

MS Global Healthcare Conference, New York

CATALYSTS

Filgotinib EU approval and launch 2H20
Filgotinib US approval/label information 2H20
Filgotinib Japan approval 2H20
GLPG 1972 ROCELLA phase 2b readout in OA 2H20
(Triggering a 60-day opt-in period for Gilead for US rights, Servier has ex-US rights)
ziritaxestat NOVESA ph. 2 SSc data 2H20
GLPG 1205 PINTA ph. 2 IPF data 2H20
Toledo 3970 3970 ph. 2 data 2H20 (The Biggest Pharma market in the world)


Wall Street Trader
5
Top Wall Street analysts are betting on stocks like Tesla, Uber & Gilead for the third quarter.
Published Sun, Jul 5 2020


Gilead Sciences

RBC Capital’s Brian Abrahams has just selected Gilead Sciences as his top stock pick for the third quarter of 2020. This five-star analyst has a buy rating on GILD with a stock price forecast of $88, indicating 16% upside potential from current levels.

So far year-to-date, Gilead shares have soared 17%, boosted by optimism over the company’s investigational coronavirus treatment remdesivir. However, Abrahams believes the company has much more to offer than just remdesivir. He highlights the underappreciated potential for Gilead’s Biktarvy, a complete regimen for the treatment of HIV.

“We believe Biktarvy’s strong profile and robust launch, along with favorable demographic and pricing dynamics, will underpin good HIV franchise sustainability through at least 2025” the analyst told investors on July 2. With nearer-term competitive threats overblown, he expects this to maintain a strong foundation for GILD’s valuation going forward.

What’s more, Abrahams sees the company’s selective JAK1 inhibitor filgotinib for inflammatory diseases as a ‘potential blockbuster’ in the pipeline. “Overall, we expect sentiment to remain more positive, with continued strong commercial execution and… pipeline diversification helping drive share appreciation” the RBC analyst concludes.

youtu.be/TmYuQlpRl6Y?t=112

www.cnbc.com/2020/07/05/bet-on-stocks...
Lama Daila
2
www.investegate.co.uk/e-therapeutics-...

As a demonstration of the growth potential for the business, on 10 June 2020, e-therapeutics announced a collaboration agreement with leading biotechnology company Galapagos to identify new therapeutic approaches to modulate a specific mechanism involved in idiopathic pulmonary fibrosis (IPF) and potentially in other fibrotic indications. In the short-term it is expected that the collaboration will make a material contribution to the cash position of the Company, with the Company also being eligible to receive pre-clinical, clinical development and commercial milestone payments.

“Short term” en “material contribution” zijn natuurlijk vage begrippen,

Vermoedelijk gaat het hier nog steeds over de “near-term payments” nog voorafgaand op de eerste milestones die zouden kunnen volgen uit deze samenwerking:
Under the terms of the deal, financial details of which were not disclosed, e-therapeutics will receive upfront and near-term payments material to the cash position of the company. e-therapeutics is also eligible to receive pre-clinical and clinical development and commercial milestone payments.
Ooievaar
0
Dat ziet er goed uit voor Gilead Wall Street Trader! Gelukkig heb ik in mijn porto.....
Wall Street Trader
3
quote:

Ooievaar schreef op 8 juli 2020 09:03:


Dat ziet er goed uit voor Gilead Wall Street Trader! Gelukkig heb ik in mijn porto.....


With Gilead and Galapagos you get the best of both worlds.

Bijlage:
Wall Street Trader
1
5 FDA approval decisions to watch in the 3rd quarter

PUBLISHED July 8, 2020


Gilead's filgotinib for rheumatoid arthritis

For Gilead and partner drugmaker Galapagos, much is riding on filgotinib. The drug is at the center of a research collaboration between the two companies, first inked in 2015 and then expanded with a $5.1 billion pact last year.

Part of a class of drugs called JAK inhibitors, filgotinib is aimed first at rheumatoid arthritis, a chronic condition for which it will have much competition. Three other JAK inhibitors, Pfizer's Xeljanz, Eli Lilly's Olumiant and AbbVie's Rinvoq, are already approved for rheumatoid arthritis, which is also commonly treated with biologic drugs like Humira.

Some analysts on Wall Street see filgotinib as safer than its JAK-blocking rivals, but the FDA appears to be viewing the risk of blood clots as characteristic of the drug class.

Gilead and Galapagos still think filgotinib can stand out and are counting on an August approval from the FDA to prove it. Clearance for rheumatoid arthritis would be the first step in proving the drug's future for other inflammatory conditions, like Crohn's disease, uveitis and psoriatic arthritis.

www.biopharmadive.com/news/fda-approv...

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