inhoudelijk LIGHT

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K. Wiebes
3
Maar eens zien of hij zin en tijd heeft ;)
rheumatologe.blogspot.com/


Sehr geehrter Herr Dr. Kirsch,

Könnten Sie auf Ihrer Blogseite mal stellungnehmen zu Filgotinib von Galapagos?

Filgo steht kurz vor der Marktzulassung durch die FDA und EMA.

Die Galapagos-investoren sind momentan insbesondere daran interessiert, ob
Filgo eine eventuelle, (JAK-)klassenbreite sogen. “Black Box Warning” bekommt
und ob es möglicherweise zu beschränkungen bezüglich der 200Mg-Dosis kommen
wird.

Ich werde diese E-mail und Ihre eventuelle Stellungnahme (mittels Ihrer Blog-
Seite) auf Anlegerfora posten.

Mit freundlichen Grüssen,

K. Wiebes

www.glpg.com/press-releases
www.fiercepharma.com/pharma/abbvie-s-...
Wall Street Trader
2
Gilead Sciences to Release Second Quarter 2020 Financial Results on Thursday, July 30, 2020

FOSTER CITY, Calif.--(BUSINESS WIRE)-- Gilead Sciences, Inc. (Nasdaq: GILD) announced that its second quarter 2020 financial results will be released on Thursday, July 30, after the market closes. At 4:30 p.m. Eastern Time, Gilead’s management will host a conference call to discuss the company’s second quarter 2020 financial results and will provide a business update.

Don't forget to tune in for the conference call.

The live webcast of the call can be accessed at the company’s Investors page at investors.gilead.com. Please connect to the company’s website at least 15 minutes prior to the start of the call to ensure adequate time for any software download that may be required to listen to the webcast.

Galapagos

06 August, 2020

Half year 2020 results

Webcast 07 August 2020, 14.00 CET

Dial-in details coming soon
Wall Street Trader
5
3 Top Coronavirus Stocks to Buy Right Now

Adria Cimino Jul 19, 2020 at 9:00AM

Gilead Sciences

The U.S. Food and Drug Administration (FDA) granted Gilead Sciences (NASDAQ: GILD) emergency use authorization for its COVID-19 treatment, remdesivir, in May. The company donated its initial stock of the drug, but recently set a price and is now transitioning to selling the treatment. Gilead's investment has been steep. The company estimates it will have spent $1 billion by the end of the year. But at $2,340 per patient for a five-day treatment course, and considering a Journal of Virus Eradication report estimating it costs less than a dollar to produce a one-day dose of remdesivir, it's likely Gilead will make a profit.

There is a lot to Gilead besides coronavirus work. The biotech company's HIV drug sales are growing, led by blockbuster Biktarvy. The drug's revenue more than doubled in the first quarter, and Gilead said that in the U.S., Biktarvy is the No. 1 prescribed HIV treatment. Looking ahead, rheumatoid arthritis drug filgotinib may be another growth driver. The FDA is currently reviewing the drug and may issue a decision at any time. Gilead has already prepared for a second-half launch and hopes for approval in Europe and Japan by the end of the year.

Gilead's shares actually peaked on April 30, with a 29% gain from the start of the year. As attention turned to vaccine makers, the shares lost some steam, ultimately delivering an 18% increase for the first half. Gains moving forward might be slower than those of certain vaccine makers, but the overall path higher should be smoother.

www.fool.com/investing/2020/07/19/3-t...
Wall Street Trader
3
IN DARWIN’S FOOTSTEPS: ADAPTATION THROUGH INNOVATION IN RHEUMATOID ARTHRITIS

21 JULY 2020 | RHEUMATOLOGY

Bijlage:
Wall Street Trader
2
Next catalyst will be the FDA Potential approval of filgotinib and that's the most important one (biggest market).

De Europese geneesmiddelenautoriteit EMA geeft een positief advies voor het gebruik van de reumapil filgontinib van Galapagos.

Daarmee ligt de weg open voor de verkoop van het middel in Europa. Galapagos en zijn Amerikaanse partner Gilead moeten nog één horde nemen: de Europese Commissie. Die moet een definitief fiat geven voor de verkoop van het middel in de 27 EU-landen, Noorwegen, IJsland, Liechtenstein en het Verenigd Koninkrijk. Galapagos verwacht dat groen licht in het derde kwartaal.

Het farmabedrijf laat voor het eerst weten onder welke merknaam filgotinib - in tabletten van 100 en 200 mg - in Europa op de markt zal komen: Jyseleca.

Amerika

Het goedkeuringsdossier voor de reumapil ligt ook bij de Amerikaanse geneesmiddelenautoriteiten op tafel. Die moet een oordeel vellen over de markttoelating van de mogelijke blockbuster op de Amerikaanse markt.

Reumatische artritis is een van de tien aandoeningen waarvoor filgotinib wordt getest. Er lopen ook patiëntenproeven voor andere aandoeningen, zoals psoriatische artritis.

Gilead kocht vorig jaar voor 3,5 miljard euro een inzagerecht in en exclusiviteit op alle belangrijke medicijnen die Galapagos ontwikkelt.
De Amerikaanse farmareus breidde parallel zijn aandelenbelang in het Mechels bedrijf voor 1 miljard euro uit tot bijna een kwart van het kapitaal.

www.tijd.be/ondernemen/farma-biotech/...
Wall Street Trader
5
3 Biotech Stocks With Big Incoming Catalysts

Cory Renauer
Jul 25, 2020 at 6:56AM

Biotech investors can get ready for a busy month full of stock-moving binary events. All of these companies are waiting for the FDA to make some very important approval decisions.

Here's what you should know about three of the most important approval decisions expected over the next several weeks.

2. Galapagos NV: Filgotinib for rheumatoid arthritis

This biotech from Belgium and its Californian partner, Gilead Sciences (NASDAQ:GILD), are eagerly awaiting an approval decision regarding filgotinib, an easy-to-swallow tablet that could become the next blockbuster treatment for rheumatoid arthritis. Neither partner has had anything to say about filgotinib's New Drug Application since they submitted it in December. Since the partners included a priority review voucher, the FDA's expected to issue an approval decision on or before Aug. 21, 2020.

In the EU, the European Medicines Agency (EMA) recently recommended the European Commission (EC) grant marketing authorization to filgotinib under the brand name Jyseleca. The EC doesn't necessarily need to follow the EMA's recommendation, but it usually does.

At the moment, Galapagos is a clinical-stage biotech without any products to sell. If filgotinib earns FDA approval, Galapagos will receive a tiered royalty percentage that tops out at 30% of sales as Gilead handles commercialization in the U.S. on its own.

Think further ahead

While FDA approvals could push these stocks up over the next several weeks, trying to chase short-term movements is a good way to underperform.
While it's important to understand events that can move biotech stocks overnight, investors need to think in decades, not weeks.

www.fool.com/investing/2020/07/25/3-b...

Wall Street Trader
4
Busy schedule ahead for the Investor Relations Team.

The company expects to report top-line results from the ROCELLA phase IIb trial of ‘1972 in osteoarthritis in H2.

Within the fibrosis portfolio, the company expects to report top-line results from PINTA ph II trial with ‘1205 in IPF and NOVESA ph IIa data of ‘1690 in SSc.

Events

September 07, 2020
Kepler Cheuvreux Autumn Conference
Virtual

September 09, 2020
Citi Biopharma Conference
Virtual

September 10, 2020
Knowledge for Growth
Ghent

September 14, 2020
MS Global Healthcare Conference
New York

September 15, 2020
Cantor Global Healthcare Conference
Virtual

September 17, 2020
BofA Virtual London September Global Healthcare Conference
Virtual

September 24, 2020
Bernstein 17th Annual SDC
Virtual

September 29, 2020
J.P. Morgan CEO call 2020
Virtual

October 01, 2020
Stifel – Immunology & Inflammation Summit
Virtual

November 17, 2020
Stifel Healthcare Conference
New York

Djurbus
3
Zou het kunnen dat we deze of volgende week al een FDA approval krijgen? Als ik kijk naar Gilead/Kite's KTE-X19 dan heeft de filing op 11 december plaatsgevonden. Twee maanden later, op 10 februari, is de PRV verleend en afgelopen vrijdag 24 juli kwam de approval. Ergo; de FDA ligt voor op schema? Of vergelijk ik nu als leek de spreekwoordelijke appels met peren?
winx09
1
Goed punt.
Zag vorige week ook onderstaande quote langskomen

FDA commissioner Stephen Hahn added that in the most recent fiscal year, FDA “reached a new high for priority applications filed — 72 — and total applications filed — 166 — and again are on track to meet or exceed most of our review performance goals.”

De vraag is alleen of beleggers zitten te wachten op een goedkeuring gezien de koersontwikkeling van afgelopen week. Iets van 10 jaar ben ik aandeelhouder en dan werk je toe naar de eerste goedkeuring. pffffff
Als je in januari had geweten dat na de Europese blessing en vlak voor de FDA goedkeuring de koers op 165 zou staan, had je alvast hypotheek 2,3,en 4 gaan regelen. Als je toen ook nog hardop had durven zeggen dat de koers na goedkeuringen wellicht niet eens de 180 zou halen, was je waarschijnlijk aan de verkeerde kant van de vitrine in het Boerhaave museum terecht gekomen.

Maar het is wat het is.
winx09
1
@Bosebox. ik haal mijn reactie uit analisten draadje even naar dit draadje om die ander schoon te houden.

quote:

Bosebox schreef op 27 juli 2020 13:54:


...
Opvallend dat ze Atopic Dermatitis als indicatie voor Filgo een ‘missed opportunity’ noemen. Abbvie is hier wel ingesprongen met Upadacitinib. Een grote misser dus van het vorige Gilead management, evenals het veel te traag opstarten van de Manta studies. Dat had beter gekund, maar gedane zaken nemen geen keer, en we mogen allen zeer blij zijn met de nieuwe huidige Gilead top met O’day als captain.

...


mbt Atopic Dermatitus, zou het niet onderzoeken van deze ziekte met Filgo niet uit de koker van Galapagos zelf kunnen komen ? Ten tijde van de licentie name van Filgo was er namelijk nog een veelbelovend molecuul MOR106 op dit gebied actief binnen de Gala pipeline.

mbt Manta. Ook daar heeft Gala een rol gespeeld. Bezoekers aan de nieuwjaarsborrel (de eerste in Boerhaave ?) kunnen zich wellicht de uitwisseling tussen Onno en Dr Bob herinneren. De lacherige toon, over dit onderzoekje wat er wel even doorheen gefietst zou worden, staat mij nog goed bij. Management is daar tijdens de AVA in 2019 op aangesproken maar reageerde daar zeer korzelig op.

Weet niet of het onder O'Day beter wordt. kijkend naar de tijdlijn van AS heb ik mijn twijfels.
Bosebox
0
Dank voor de input winx. MOR106 kan ik inkomen vanuit Gala kant, echter vanuit Gilead bekeken is niets minder dan een gemiste kans. Kan best zijn dat, zeker met Onno aan het roer, Galapagos meer invloed had destijds op voortgang en visie Filgo dan wij denken.

De AS tijdlijn geef ik voordeel van de twijfel. Corona + er is duidelijk prioriteit gegeven aan PsA met opstart Penguin studies. Wellicht ivm grotere commerciële opportuniteit. Mijn kennis omtrent tijdspad, aanvraag, regelgeving, opzet, start van klinische studies schiet echter tekort om het tijdspad van AS te beoordelen.
Wall Street Trader
8
ViewPoints: Gilead, Galapagos win small victory in fight to differentiate filgotinib

(Ref: ViewPoints Desk)
July 28th, 2020
By: Michael Flanagan

Gilead Sciences and Galapagos have argued strenuously that filgotinib is different than the rest of the JAK inhibitor crowd and their case got a boost from regulators – albeit not the ones that matter most.

The backstory

JAK inhibitors like Pfizer’s Xeljanz (tofacitinib), Eli Lilly’s Olumiant (baricitinib) and AbbVie’s Rinvoq (upadacitinib) have carved out a sizable niche in the rheumatoid arthritis (RA) market thanks to their robust effectiveness and the attractive convenience of oral administration. One cloud hanging over the class is a black box that FDA has slapped on all three of the approved drugs warning about the risk of infections and thrombotic events. (See ViewPoints: AbbVie's JAK stuck in a black box.)

Gilead and Galapagos are looking to horn in on the action with filgotinib, which they say is differentiated by its relative specificity for JAK1 that leads to a better safety profile. To support their claims, the partners point to data such as a pooled analysis of three Phase III trials and one Phase IIb study showing a lower thrombotic event rate for those receiving filgotinib (one event in 2,088 patients) compared to placebo (three events in 1,039 patients).

What happened

On July 24, Gilead and Galapagos announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion for filgotinib – newly dubbed Jyseleca – for the treatment of RA in adults with moderate-to-severe RA who have not responded or tolerated one or more disease modifying anti-rheumatic drugs (DMARDs).

A crucial feature of the agency’s opinion, which is expected to be finalised by the European Commission in 3Q20, is that it recommended approval of both a 100-mg and 200-mg dose of the once-daily JAK1 inhibitor.

What matters most

A marketing application for Jyseleca is also under review in the US, where a differentiated label is believed to be vital if Gilead and Galapagos are to make significant inroads with a fourth-to-market JAK inhibitor. The partners’ pie-in-the-sky dream is to avoid a black box warning or, barring that, for there to at least be some useful information suggestive that Jyseleca’s safety is better than the others.

The EMA’s decision to give its blessing to the higher 200-mg dose of Jyseleca could thus be seen as a boost to the partners’ hopes, as higher doses of Olumiant and Rinvoq were not approved by the same agency due to concerns about thrombotic events.

There is some debate among analysts about whether the EMA’s recommendation offers any hints on the FDA’s thought process.

HC Wainwright analyst Debjit Chattopadhyay called this week’s news an “incremental positive” as it validated Gilead/Galapagos’ contention that all JAK inhibitors need not be treated exactly the same. “To date, Jyseleca's safety profile has been consistent with its mechanism of action, i.e., minimal impact on the EPO or JAK2 pathways, which translates into a differentiated haematologic and deep vein thrombosis/pulmonary embolism profile, the potential cornerstone in the upcoming commercial battle,” he remarked.

Matthew Harrison of Morgan Stanley is more dubious about there being any read-through, noting that “while the recommendation includes both 100-mg and 200-mg doses, the 200-mg dose level had been less of a focus for EU regulators, so we do not see this outcome as surprising or indicative of what could happen in the US.”

The bigger picture

Rinvoq is the most recent entrant having been launched in 2H19. The drug’s market share has already shot past Olumiant and is steadily cutting away at Xeljanz’s dominant position, which key opinion leaders indicate is a credit to Rinvoq’s better efficacy profile and AbbVie’s deft marketing touch.

However, for the time being anyway, those same physicians are more circumspect about whether Gilead will be able to hit the market even later and have a similarly disruptive impact.

The company’s main challenges boil down to the consensus expectation that Jyseleca’s label will be similarly burdened by a black box warning, meaning that its safety profile will not be seen as sufficiently different, which may be compounded by Gilead’s lack of commercial presence in the rheumatology setting. (See Therapy Trends – Rheumatoid Arthritis: KOL Views.)

What next?

The Street does not have long to wait for a decision from the FDA, which is expected to reach a verdict on Jyseleca by sometime next month.

www.firstwordpharma.com/node/1744430


Wall Street Trader
11
Inflammatory Disease Pipeline (updated)

Filgotinib
MANTA/MANTA-RAy enrollment completion
Bijlage:
NielsjeB
4
quote:

Wall Street Trader schreef op 30 juli 2020 22:16:


Inflammatory Disease Pipeline (updated)

Filgotinib
MANTA/MANTA-RAy enrollment completion

Thanks!
Bijlage:
Kermit_007
3
Wat ik toch opvallend vind op slide 21 is de expliciete vermelding van het exceptionele safety profile van Filgo in RA bij de Eular data readouts . Duidt toch nogmaals op vertrouwen en misschien toch ook een indicatie van waar zij op rekenen mbt FDA approval?
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