Galapagos - GLPG

[sparrow]

Systemic Sclerosis : tot nu toe, met geen enkele molecule is er wat succes gerealiseerd kunnen worden ! Waarschijnlijk is er meer fundamenteel onderzoek noodwendig om het ontstaan te doorgronden , en vervolgens een therapeutische aanpak te ontwikkelen .

Ok, dus binnenkort hier een PB over en de koers weer naar beneden dus.

[sanderus]

Nieuw op CT. Studie met glpg1205.

Evaluation of Mass Balance and Absolute Bioavailability of GLPG1205

https://www.clinicaltrials.gov/ct2/show ... w=2&rank=1

[sanderus]

Nog een nieuwe studie met de Toledo molecule glpg3970.

A Study to Assess Relative Bioavailability of and Effect of Food on a New Oral Tablet Formulation of GLPG3970

https://www.clinicaltrials.gov/ct2/show ... w=2&rank=1

[B_B]

GALÁPAGOS NV: OPPORTUNITY THROUGH ADVERSITY?
1 day ago

Heading into the summer of 2020, things looked promising for Galápagos NV. In early June, the Belgian biotech and its partner, Gilead Sciences, announced the results of their phase III clinical trial for filgotinib, a JAK1 inhibitor designed to treat patients with moderate to severely active rheumatoid arthritis (RA). According to the study, “The data demonstrate sustained efficacy and a consistent safety profile with up to 52 weeks of filgotinib across RA populations.” Despite these positive indications, Gilead Sciences received a complete response letter (CRL) from the United States Food and Drug Administration (FDA) specifying that filgotinib was not ready for approval. After publicizing this disappointing news, Galápagos’ stock immediately (NASDAQ: GLPG) took a massive hit and has been on the decline ever since. With the stock currently trading at around $100 compared to nearly $275 in February of 2020, many investors see Galápagos as a value stock and are hoping to buy low and sell high. But, is this really a good strategy? Keep reading to find out…

.....

What’s next for Galápagos?
Just as diversifying investments in the stock market mitigates risk, diversifying clinical pipelines creates a safety net should studies not go as planned. Fortunately, Galápagos has a diverse clinical pipeline to offset potential issues such as the failure of filgotinib in the RA indication. Right behind filgotinib, Galápagos has another inhibitor in phase III clinical trials for idiopathic pulmonary fibrosis, ziritaxestat. The company is expecting futility results for the phase III trial to arrive in 2021. A futility clinical trial contains a smaller subset of patients that provide a first look into the safety and efficacy of a drug. The results of this trial will provide Galápagos with the necessary information to determine if continuing with a broader phase III study is worthwhile. Additionally, in September of 2020, the company reported positive topline results for a phase II study of ziritaxestat for a different indication, systemic sclerosis.

Ziritaxestat along with the ongoing clinical trials for filgotinib in the various indications other than RA mentioned above provide Galápagos with several potential opportunities in the future.

Buy, sell, or hold?
Galápagos and Gilead missed a multibillion-dollar opportunity by failing to achieve approval for filgotinib in the RA indication from the FDA. For this reason, the stock price has fallen by a whopping 63% compared to last year. However, in my opinion, Galápagos’ stock is undervalued given all of the studies for filgotinib and idiopathic pulmonary fibrosis in process. With this information in mind, I would recommend investing in Galápagos; nevertheless, I caution investors that they should not expect returns in the near future. Creating a drug is a grueling, lengthy process with much potential for failure. Although the company has many phase III trials ongoing, it may still be several years before it receives approval for one of its inhibitors in the United States. Regardless, I do expect Galápagos’ stock price to increase from the current value of about $100 because of its diverse clinical pipeline.

https://www.sickeconomics.com/2021/01/1 ... s-nv-glpg/

[WeQu]

Iemand die de conference gaat volgen vandaag?
https://www.vfb.be/Media/Default/pdf/ga ... are-co.pdf

[Lama Daila]

Iemand die de conference gaat volgen vandaag?
https://www.vfb.be/Media/Default/pdf/ga ... are-co.pdf

Ik ga proberen te volgen.

[B_B]

Iemand die de conference gaat volgen vandaag?
https://www.vfb.be/Media/Default/pdf/ga ... are-co.pdf

Vanmiddag, hopelijk verrassend positief.

Vorige week vreemde koersbeweging in US.
Het lijkt net of de koers niet omhoog of omlaag mag, maar gelijk moet blijven.

[nete]

Vorige week vreemde koersbeweging in US.
Het lijkt net of de koers niet omhoog of omlaag mag, maar gelijk moet blijven.

Zou dat niet te maken hebben met korte termijn traden ?

[ZyppBe]

Even geen tijd om uitgebreid te posten, nieuwsgierigen kunnen slides bekijken:

https://twitter.com/BertrandBio

[Lama Daila]

Hier een paar topics die in genoteerd had:
* GLPG3667 is een TYK2-inhibitor: eerst in PsA, fase2a (dose range finding study) in 2021
* 3 eerste Toledo-POC’s: resultaten worden gerapporteerd midden 21. Na de POC’s, zijn de fase2b studies al gepland om snel te starten
* Ziri (GLPG1690 in IPF): > 1300 patiënten nu gerekruteerd
* Futility analyse nog steeds 1H21. Zelfs als slechts 1 dosis de criteria haalt van het comité dan gaat de studie door met de 2 dosissen. Voornaamste criteria: likelihood of being superior to placebo in primary endpoint
* Cash is dus geen probleem, maar is uitsluitend bedoeld voor R&D of kleine M&A. De deal met Gilead maakt het niet mogelijk om eigen aandelen in te kopen
* De groei (personeelsbestand) is sinds de tegenvaller met filgotinib in de US wel gepauzeerd. Er wordt daarvoor nu gewacht op resultaten van Ziri.
* GLPG1205 (PINTA): men wil eerst extra testen starten met verschillende dosissen alvorens te beslissen over fase3. De safety issues in de arm in combinatie met nintedanib is daarvoor de aanleiding.
* Markt Japan voor Jyseleca: ongeveer 70% van Europa.