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Lama Daila 3 juni 2020 21:44

1

www.investors.com/news/technology/ulc...

Why Bristol Myers' Success In Ulcerative Colitis Sent Arena Stock Flying

Bristol Myers Squibb (BMY) reported positive ulcerative colitis treatment data Tuesday, helping shares of rival Arena Pharmaceuticals (ARNA) to pop.

The study tested Bristol Myers' Zeposia in patients with moderate to severe ulcerative colitis. At weeks 10 and 52, the experimental ulcerative colitis treatment induced clinical remission and maintained remission, respectively.

Zeposia belongs to a class of oral drugs known as sphingosine-1-phosphate receptor modules, or S1P. This is the first time an S1P drug has shown strong effectiveness in ulcerative colitis treatment, suggesting these drugs could beat out another class called janus kinase inhibitors, or JAKs.

Arena is also testing out an S1P drug, etrasimod.

“We see this outcome validating for the S1P class in ulcerative colitis and supporting our optimistic, bullish stance toward Arena's etrasimod," RBC Capital Markets analyst Kennan MacKay said in a report to clients.

Rivals In Ulcerative Colitis Treatment

On the stock market today, Arena stock charged ahead 16.2% to 68.22. Shares of Bristol Myers rose 0.6% to 60.65.

Zeposia is already approved to treat a form of multiple sclerosis. But Bristol Myers is working to use it as an ulcerative colitis treatment. In the Phase 3 study, Zeposia proved as safe in ulcerative colitis patients as it did in prior studies, Bristol Myers said in a news release.

RBC's MacKay sees room for Arena's etrasimod to become the best in class S1P drug. He maintained his outperform rating on Arena stock. Overall, the study "may suggest the S1P class can outcompete JAKs in both safety and (effectiveness)," he said.
This could be troubling for Gilead Sciences (GILD) and Galapagos (GLPG) which are testing a JAK drug called filgotinib in ulcerative colitis treatment.

In Gilead and Galapagos' recent Phase 3 study, a low dose of filgotinib didn't show statistical superiority over a placebo for clinical remission at 10 weeks. A higher dose did reach statistical significance, however it was with a weak p-value. This means researchers aren't totally confident in the result.

Loureiro 3 juni 2020 22:11

0

quote:
Lama Daila schreef op 3 juni 2020 21:44:
www.investors.com/news/technology/ulc...

Why Bristol Myers' Success In Ulcerative Colitis Sent Arena Stock Flying

Bristol Myers Squibb (BMY) reported positive ulcerative colitis treatment data Tuesday, helping shares of rival Arena Pharmaceuticals (ARNA) to pop.

The study tested Bristol Myers' Zeposia in patients with moderate to severe ulcerative colitis. At weeks 10 and 52, the experimental ulcerative colitis treatment induced clinical remission and maintained remission, respectively.

Zeposia belongs to a class of oral drugs known as sphingosine-1-phosphate receptor modules, or S1P. This is the first time an S1P drug has shown strong effectiveness in ulcerative colitis treatment, suggesting these drugs could beat out another class called janus kinase inhibitors, or JAKs.

Arena is also testing out an S1P drug, etrasimod.

“We see this outcome validating for the S1P class in ulcerative colitis and supporting our optimistic, bullish stance toward Arena's etrasimod," RBC Capital Markets analyst Kennan MacKay said in a report to clients.

Rivals In Ulcerative Colitis Treatment

On the stock market today, Arena stock charged ahead 16.2% to 68.22. Shares of Bristol Myers rose 0.6% to 60.65.

Zeposia is already approved to treat a form of multiple sclerosis. But Bristol Myers is working to use it as an ulcerative colitis treatment. In the Phase 3 study, Zeposia proved as safe in ulcerative colitis patients as it did in prior studies, Bristol Myers said in a news release.

RBC's MacKay sees room for Arena's etrasimod to become the best in class S1P drug. He maintained his outperform rating on Arena stock. Overall, the study "may suggest the S1P class can outcompete JAKs in both safety and (effectiveness)," he said.
This could be troubling for Gilead Sciences (GILD) and Galapagos (GLPG) which are testing a JAK drug called filgotinib in ulcerative colitis treatment.

In Gilead and Galapagos' recent Phase 3 study, a low dose of filgotinib didn't show statistical superiority over a placebo for clinical remission at 10 weeks. A higher dose did reach statistical significance, however it was with a weak p-value. This means researchers aren't totally confident in the result.

Wellicht de reden van de daling van de koers van GLPG de laatste dagen.

[verwijderd] 3 juni 2020 23:42

5

@abelheira en Shortgala.

De BMS fase 3 studie met Ozanimod (ZEPOSIA) in colitis ulcerosa geeft het volgende:

True North (studienaam) met both primary endpoints, demonstrating highly statistically significant (p-value < 0.0001) results for induction of clinical remission at Week 10 and in maintenance at Week 52. The study also met key secondary endpoints of clinical response and endoscopic improvement in induction at Week 10 and in maintenance at Week 52.

verder nog...

The primary endpoints are the proportion of patients in clinical remission based on a composite clinical and endoscopic score (3-component Mayo Score) at Week 10 in the induction phase, and at Week 52 for the maintenance phase. Secondary endpoints include the proportion of patients achieving clinical response at Week 10 and Week 52, the proportion of patients with endoscopic improvement (endoscopy score =1) at Week 10 and Week 52, and clinical remission at Week 52 in patients that were in remission at Week 10.

The safety profile of Zeposia in the True North trial was consistent with that observed in previously reported trials

investors.bms.com/iframes/press-relea...

Het is een vrij summer persbericht met weinig gedetailleerde informatie vanuit BMS.

Bij Filgotinib 200mg binnen colitis Ulcerosa zie je de 1e 10 weken een score van p=0.0157 & p=0.0103.
Na 58 weken is de score van 200mg ook p>0.0001 en dus vergelijkbaar met Ozanimod.

Hierbij dient rekening te worden gehouden dat Filgotinib ook gedeeltelijk is onderzocht in de moeilijkere te behandelen UC-patiënten, die gefaald hebben op ENTYVIO & bijvoorbeeld HUMIRA c.q. STELARA.

Gilead geeft in persbericht SELECTION1 data heel duidelijk aan hoe de componenten van de MAYO-score zijn gebruikt om te komen tot de remissie %. Dit zie ik bij BMS niet terugkomen.

Dus een goed vergelijk is onmogelijk.

Etrasimod van Arena ligt 2,5 jaar achter. Dat blijft nog toekomstmuziek, en zo zullen er constant nieuwe en betere medicijnen komen, ook voor colitis ulcerosa.
Filgotinib is 1 van die medicijnen voor deel UC-patiënten. In de toekomst heeft Galapagos mogelijk GLPG3970 voor UC, en wie weet wel in combinatie met Filgotinib.

clinicaltrials.gov/ct2/show/NCT041765...

voda 4 juni 2020 07:36

1

Positieve werkzaamheid en veiligheid bij reumamiddel filgotinib van Galapagos

FONDS KOERS VERSCHIL VERSCHIL % BEURS
Galapagos
178,00 0,00 0,00 % Euronext Amsterdam

(ABM FN) Galapagos en partner Gilead Sciences hebben positieve resultaten gepresenteerd op het vlak van werkzaamheid en veiligheid voor hun reumamiddel filgotinib. Dit bleek uit een persbericht van het Belgisch-Nederlandse biotechbedrijf donderdagochtend.

De Finch1 en Finch3 testen voor het middel "tonen een aanhoudende werkzaamheid en een consistent veiligheidsprofiel aan voor de 52 weken behandeling met filgotinib bij reumapatiëntenpopulaties", aldus Galapagos.

De resultaten zullen verder uiteengezet worden tijdens het Europese E-congres voor reumatologie 2020.

Filgotinib is een geneesmiddel in onderzoek en is niet voor gebruik goedgekeurd door de FDA of andere regelgevende instanties. De werkzaamheid en veiligheid van filgotinib zijn niet vastgesteld.

Door: ABM Financial News.
pers@abmfn.be
Redactie: +32(0)78 486 481

© Copyright ABM Financial News B.V. All rights reserved.

voda 4 juni 2020 11:23

1

'Nieuwe resultaten Galapagos bevestigen beeld'

Gepubliceerd op 4 juni 2020 10:35 | Views: 2.353

Galapagos 11:02
180,40 +2,40 (+1,35%)

AMSTERDAM (AFN) - De nieuwe resultaten over filgotinib die biotechnoloog Galapagos samen met samenwerkingspartner Gilead publiceerde bevestigen het eerdere beeld. Dat constateren analisten van KBC Securities in een rapport.

Resultaten van twee onderzoeken naar de werking van het geneesmiddel wijzen op aanhoudende werkzaamheid tegen reumatoïde artritis. Het onderzoek laat ook zien dat het middel veilig is in gebruik, maakt het biofarmaceutische bedrijf bekend samen met samenwerkingspartner Gilead.

Filgotinib is een geneesmiddel in onderzoek, dat nog niet voor gebruik is goedgekeurd door medische toezichthouders. Onderzoeken naar de effectiviteit en veiligheid zijn belangrijk voor de goedkeuring door onder andere de Amerikaanse toezichthouder FDA om filgotinib op de markt te mogen zetten. KBC schat in dat de deadline daarvan in de loop van augustus zal zijn.

De marktvorsers hanteren een hold-advies op Galapagos. Het aandeel Galapagos stond donderdag omstreeks 10.20 uur 1,4 procent hoer op 180,30 euro.

pardon 4 juni 2020 15:16

0

Upadacitinib van AbbVie toont duurzaam voordeel in RA-onderzoeken
4 juni 2020 09:07 ET|Over: AbbVie Inc. (ABBV)|Door: Douglas W. House , SA News Editor
AbbVie (NYSE: ABBV ) kondigt positieve langetermijnresultaten aan van twee fase 3 klinische onderzoeken, SELECT-COMPARE en SELECT-MONOTHERAPY , waarbij Rinvoq (upadacitinib) wordt geëvalueerd bij patiënten met reumatoïde artritis (RA). De gegevens zijn gepresenteerd op EULAR.

Patiënten in het eerste onderzoek die dagelijkse doses van 15 mg upadacitinib met methotrexaat kregen, bleven verbeterde tekenen en symptomen van RA ervaren in week 72.

Patiënten in het tweede onderzoek die dagelijks 15 mg upadacitinib kregen, behielden hun verbeterde respons op week 84.

Gegevens van 96 weken uit een ander laat- stadiumonderzoek , SELECT-EARLY , toonden aan dat upadacitinib effectief was bij het remmen van structurele gewrichtsschade als monotherapie of in combinatie met methotrexaat.

Er werden geen nieuwe veiligheidssignalen waargenomen.

De FDA keurde de JAK-remmer voor RA in augustus 2019 goed. Deze werd in december 2019 in Europa goedgekeurd.

[verwijderd] 4 juni 2020 17:08

0

"De FDA keurde de JAK-remmer voor RA in augustus 2019 goed."
Met een Black Box warning die wijst op veiligheidsrisico's bij gebruik van het medicijn.

Het is maar net hoe je persbericht schrijft. Wel erg makkelijk om te zeggen dat er geen "nieuwe" veiligheidssignalen zijn waargenomen.

Lama Daila 4 juni 2020 22:56

5

www.fiercebiotech.com/biotech/gilead-...

“Galapagos is confident doctors will recognise filgotinib's favourable safety profile demonstrated across the Phase III program,” analysts at Jefferies wrote in a note to investors based on comments made by Galapagos CEO Onno van de Stolpe

Wall Street Trader 5 juni 2020 11:43

12

Gilead bolsters its case for blockbuster hopeful filgotinib as FDA ponders its decision

Natalie Grover June 4, 2020 10:32 AM EDT

Before remdesivir soaked up the spotlight amid the coronavirus crisis, Gilead’s filgotinib was the star experimental drug tapped to rake in billions competing with other JAK inhibitors made by rivals including AbbVie and Eli Lilly.

Now, long term data on the drug — discovered by Gilead’s partners at Galapagos and posted as part of a virtual medical conference — have solidified the durability and safety of filgotinib in patients with rheumatoid arthritis, spanning data from three late-stage trials. An FDA decision on the drug is expected this year.

Last October, the companies showed that the drug’s 52-week data from the two main trials FINCH 1 and FINCH 3 were consistent with their 24-week results. On Thursday, further analyses of the data suggested that patients on the filgotinib arm had a numerical advantage in remission rates.

At the 24-week cutoff, 48% of patients enrolled in the higher 200 dose of filgotinib arm were in remission in the FINCH 1 trial that compared the drug to adalimumab (AbbVie’s Humira). By the end of 52 weeks, that remission rate rose to 52%. The percentage in the Humira arm rose too, but the numbers favored filgotinib across multiple measures of efficacy. Data from the FINCH 3 trial echoed that trend.

Filgotinib’s biggest rival is AbbVie’s Rinvoq — the replacement for its cash cow and world’s best selling drug Humira. Rinvoq is slated to be a blockbuster, but carries the dreaded black box warning for thrombosis, even though the event was rare in AbbVie’s development program.

The move by the FDA is more precautionary given that the JAK class of drugs has long been plagued by safety concerns. Pfizer’s JAK1/JAK3 inhibitor Xeljanz’s use has been blighted by regulatory restrictions after the higher dose of the blockbuster drug was found to be associated with the risk of blood clots and death. Eli Lilly’s JAK1/JAK2 Olumiant, meanwhile, was initially rejected by the US agency due to safety concerns — only to eventually secure approval for the lower dose. Lilly’s partner, Incyte, elected to walk away from co-funding the drug’s development as fears about the benefit-risk profile of the class of drugs accumulated.

Galapagos $GLPG, which once partnered with AbbVie on filgotinib, has presented itself as a safer alternative to its rivals using a pooled analysis of safety data compiled from seven rheumatoid arthritis trials. The analysis showed that the rate of venous thromboembolism, a key safety concern, was lower in patients given filgotinib versus those on placebo.

“While filg’s profile has been quite clean so far, given the history of Jak inhibitor approvals/rejections, we believe the biggest risk to the program remains if any safety imbalances (even if seemingly minor) emerge and derail approvability of the most active high dose (200mg) of the drug, or of the drug altogether,” noted RBC Capital Markets analyst Brian Abrahams in a note.

“In analyzing the detailed data, we do not see any major new concerns and continue to see a good likelihood of approval, with a low serious infection rate providing a potential safety advantage vs. competitors. However, we do see a slight imbalance in overall deaths for higher vs. lower dose filgotinib that could be scrutinized by the agency and may be a small risk to keep an eye on.”

Gilead paid $750 million upfront to partner with Galapagos years ago, expanding the collaboration to an up-to $5.1 billion deal last year. Filgotinib, which is at the heart of the deal, is also being tested for other autoimmune conditions such as Crohn’s disease, ulcerative colitis and psoriatic arthritis. Last October it was revealed the drug failed mid-stage studies in lupus and Sjögren’s disease.

Janus kinase (JAK) inhibitors are named after the two-faced Roman god Janus and the family consists of four enzymes: JAK1, JAK2, JAK3 and TYK2, which are associated with cytokine receptors on the surface of cells and form part of a pathway involved in inflammatory and immune responses.

endpts.com/gilead-bolsters-its-case-f...

de tuinman 5 juni 2020 13:10

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quote:
lmr schreef op 4 juni 2020 17:08:
"De FDA keurde de JAK-remmer voor RA in augustus 2019 goed."
Met een Black Box warning die wijst op veiligheidsrisico's bij gebruik van het medicijn.

Het is maar net hoe je persbericht schrijft. Wel erg makkelijk om te zeggen dat er geen "nieuwe" veiligheidssignalen zijn waargenomen.

Klinkt eigenlijk heel negatief.

Broer Konijn 5 juni 2020 13:19

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Good stuff WST, thanks!
Much appreciated during these difficult weeks.....

Cheers, Broer Konijn

Wallander 5 juni 2020 13:47

0

quote:
Broer Konijn schreef op 5 juni 2020 13:19:
Good stuff WST, thanks!
Much appreciated during these difficult weeks.....

Cheers, Broer Konijn

Op deze zin na dan: However, we do see a slight imbalance in overall deaths for higher vs. lower dose filgotinib that could be scrutinized by the agency and may be a small risk to keep an eye on.”

Laten we hopen dat dit geen issue wordt.

Broer Konijn 5 juni 2020 14:04

0

Zeker, dat wil echter niet zeggen dat het niet een zeer lezenswaardig en informatief stuk is. Risico's zijn er altijd. Zeker in biotech.

Mvg BK

Bioteg71 5 juni 2020 14:04

0

quote:
Wallander schreef op 5 juni 2020 13:47:
[...]

Op deze zin na dan: However, we do see a slight imbalance in overall deaths for higher vs. lower dose filgotinib that could be scrutinized by the agency and may be a small risk to keep an eye on.”

Laten we hopen dat dit geen issue wordt.

kan ook te maken hebben met onderliggend lijden, hoeft dus niets te maken te hebben met de 200mg.

[verwijderd] 5 juni 2020 14:06

2

Mark Genovese over safety van de Jak inhibitors in 2018, wellicht al bekend bij sommigen, maar vind het toch interessant. Filgotinib wordt nu ook te veel met tunnelvisie bekeken: wel/geen bbw lijkt nu nog het enige dat telt. Gevaar is dat beleggers voorbij gaan aan de potentie van Filgotinib. En met of zonder bbw, die potentie is enorm. Eerst was het Manta, nu is het de bbw. Maar zoals Rekyus al betoogde, als de offensieve marketing van Gilead/Galapagos op gang komt, zal deze hele discussie naar de achtergrond verdwijnen en is het enige wat telt de sales.

JAK inhibitors for RA: Is VTE risk overblown?

Publish date: February 15, 2018
Author(s): Bruce Jancin

EXPERT ANALYSIS FROM RWCS 2018
MAUI, HAWAII – Rheumatologists, regulatory agencies, and the pharmaceutical industry all have gone off the deep end in their fretting over what appears to be a low rate of venous thromboembolic events in the major randomized trials of the oral Janus kinase inhibitors for RA, Mark C. Genovese, MD, asserted at the 2018 Rheumatology Winter Clinical Symposium.
“The reality is all of our drugs pose potential risks. Unfortunately, I think that at least for the moment, the field has turned all attention in one direction: VTE [venous thromboembolic] events. I suspect there’s some truth [to the possible associated risk]. Certainly we are seeing these events. The question is, how overdone is this?” according to Dr. Genovese, professor of medicine and cochief of the division of immunology and rheumatology at Stanford (Calif.) University.

He left no doubt he thinks this is a matter of lost perspective. “I think the upadacitinib data has been entirely overshadowed by concerns about VTEs,” he said. “In the last year, we saw three significant phase 3 studies on upadacitinib arrive in the rheumatology community, and I think the only thing we talked about was VTEs.”

All parties interested in developing Janus kinase (JAK) inhibitors for the treatment of RA began to freak out about a possible increase in VTEs when in April 2017 the Food and Drug Administration turned down Eli Lilly and Incyte’s initial application for marketing approval of the JAK inhibitor baricitinib. Among the problems the agency cited was evidence of potential thrombotic risk. The VTE rate in baricitinib clinical trials up to 48 weeks in duration was 0.53 events/100 patient-years, with no significant difference in risk between the2-mg and 4-mg doses. This appears to be a class effect for the oral JAK inhibitors, as low rates of VTE, albeit numerically higher than in placebo-treated controls, have also been recorded in the RA development programs for tofacitinib (Xeljanz) as well as the investigational agents filgotinib and upadacitinib, the rheumatologist noted.

This begs the question of whether these VTE rates are significantly higher than background rates in patients with RA or other rheumatologic diseases, which are known to be elevated relative to the general population. Indeed, a retrospective study of insurance claims data by investigators at Brigham and Women’s Hospital, Boston, concluded that the VTE rate in RA patients was 0.61 events/100 patient-years, 120% greater than in a matched patient population without RA. After fully adjusting for comorbid conditions and demographics, the relative risk increase associated with RA dropped to 40%, still significantly higher than in controls.

Similarly, Canadian investigators conducted a meta-analysis of 25 studies with VTE data in patients with RA, systemic lupus erythematosus, Sjögren’s syndrome, systemic sclerosis, or inflammatory myositis. This meta-analysis included 10 studies of more than 5.2 million RA patients and nearly 900,000 controls. The conclusion: each of these rheumatic diseases was associated with a VTE rate more than three times higher than in the general population.

“Patients with RA are at higher risk for VTE than those without RA. It’s unfortunate, and it’s certainly something I don’t think many of us have thought much about before. It’s something we don’t often get to see and something we don’t like to think about,” the rheumatologist observed.

Dr. Genovese admitted to a degree of personal frustration with the current tunnel vision focus on VTEs in JAK inhibitor trials. At the 2017 annual meeting of the American College of Rheumatology he presented the results of the phase 3 SELECT-BEYOND study in which 499 RA patients who had previously failed to respond or were intolerant to biologic therapy were randomized to once daily upadacitinib at 15 or 30 mg or placebo on top of background methotrexate. At week 12, the ACR 20 response rate was 65% for upadacitinib at 15 mg, 56% at 30 mg, and 28% in placebo-treated controls.

“That’s almost a 40% placebo-adjusted response rate. In fact, it’s the highest response I’ve ever seen in a biologic inadequate-responder population. This really looked pretty good, but I don’t think anyone ever took notice. Why not? Because we were all worried about VTE,” he said.

There were in fact a handful of VTEs in upadacitinib-treated patients, Dr. Genovese was quick to note. But he was more impressed by the week 12 ACR 20 responses in patients who had previously failed on three or more biologics: 71% with upadacitinib at 15 mg and 50% at 30 mg, compared with 23% in controls. Moreover, among patients with a baseline history of failure to respond to anti–interleukin-6 therapy, the week 12 ACR 20 rate was 56% with upadacitinib at 15 mg and 58% at 30 mg, versus 20% in controls.

“This looks like a pretty effective drug for patients who’ve failed everything else in our practice,” he commented.

Dr. Genovese reminded his audience that the rheumatology community has a history of overreacting to safety signals in the early days after introduction of new therapies. Examples: tuberculosis with tumor necrosis factor inhibitors, lymphoma with abatacept (Orencia), lymphoma with anti–tumor necrosis factor agents, and cardiovascular events with anti–interleukin-6 inhibition.

“PML [progressive multifocal leukoencephalopathy] is a breathtaking side effect with rituximab [Rituxan], but we’ve gotten over that. We recognize that it’s a potential problem, but we still prescribe rituximab,” the rheumatologist noted. “We’re probably going to need to address the issue of which of our patients are potentially at higher risk for VTE, and maybe we avoid this class in those patients. Like we now do as we look at patients we think are at increased risk for infection, or multiple sclerosis, or TB, we may also need to think of VTE risk.”

But the scale of VTE risk that available data link with JAK inhibition shouldn’t be allowed to torpedo this highly promising class of medications, he argued. There is a pressing unmet need for new therapies for RA with novel mechanisms of action. Only about one-half of patients on contemporary biologic therapies are still on that agent 5 years after initiating therapy.

“Virtually all our patients are partial responders. Everybody gets some benefit. But true remission is achieved by only a minority,” Dr. Genovese said. “The gap between where we are and where we want to be is actually much greater than we often perceive.”

He reported having financial relationships with AbbVie, which is developing upadacitinib, and more than a dozen other medical companies.

www.mdedge.com/anticoagulationhub/art...

Wallander 5 juni 2020 14:12

0

quote:
Broer Konijn schreef op 5 juni 2020 14:04:
Zeker, dat wil echter niet zeggen dat het niet een zeer lezenswaardig en informatief stuk is. Risico's zijn er altijd. Zeker in biotech.

Mvg BK

Eens.

Wall Street Trader 5 juni 2020 14:17

6

Hey Elliot Rabbit,

sometimes you just need to stay calm and just let things come to you...

In the long run this stock downfall is just a pullback in a bull-market pause.
Investors should use weakness to add the stock to their portfolios.

Onno his willingness to create further value from the pipeline is huge and his dealmaking skills will be highly relevant to strike one or more partnerships.

Several catalysts could drive the stock in coming months:

Half Year results: 6th August 2020

filgotinib EU approval and launch 2H20

filgotinib US approval/label information 2H20

GLPG 1972 ROCELLA phase 2b readout in OA 2H20

(GLPG1972 a potentially overlooked asset, which could have an outsized impact on the stock)

ziritaxestat NOVESA ph. 2 SSc data 2H20

GLPG 1205 PINTA ph. 2 IPF data 2H20

ziritaxestat ISABELA futility update 1H21

Toledo 3970 ph. 2 data 2H20

filgotinib DIVERSITY phase 3 enrollment complete (CD) 2021

filgotinib ulcerative colitis (potential) launch 2021

filgotinib Crohn's disease potential launch 2022

Hang in there... and let Gilead's and Galapagos teams do their job!

MrBiggy 5 juni 2020 14:28

4

Ik had dit document laatst al een keer ergens in de nacht gelezen en gemeld, gezien Galapagos met IPF al ver is.. en deze week hebben overheden een vorm van Joint Venture opgericht tbv Covid-19 ... kan het onderzoek van Galapagos misschien een enorme boost geven!
even vrij vertaald:

"In december 2019 kwamen er rapporten uit Wuhan, China, van een ernstige acute luchtwegaandoening veroorzaakt door ernstig acuut respiratoir syndroom coronavirus 2 (SARS-CoV-2). Eind april 2020 was bevestigd dat meer dan 3 miljoen mensen besmet waren, waarvan meer dan 1 miljoen alleen in de VS en meer dan 215.000 doden. De symptomen die samenhangen met COVID-19 zijn divers, variërend van milde symptomen van de bovenste luchtwegen tot ernstig acuut respiratoir distress-syndroom. De belangrijkste risicofactoren voor ernstige COVID-19 worden gedeeld met idiopathische longfibrose (IPF), namelijk toenemende leeftijd, mannelijk geslacht en comorbiditeiten zoals hypertensie en diabetes. De rol van antifibrotische therapie bij patiënten met IPF die een SARS-CoV-2-infectie oplopen, en de wetenschappelijke reden voor hun voortzetting of stopzetting, is echter slecht gedefinieerd. Bovendien zijn verschillende goedgekeurde en potentiële antifibrotische verbindingen beoordeeld in modellen van acute longbeschadiging en virale longontsteking. Gegevens van eerdere coronavirusinfecties zoals ernstig acuut ademhalingssyndroom en ademhalingssyndroom in het Midden-Oosten, evenals opkomende gegevens van de COVID-19-pandemie, suggereren dat er aanzienlijke fibrotische gevolgen kunnen zijn na een SARS-CoV-2-infectie. Antifibrotische therapieën die beschikbaar zijn of in ontwikkeling zijn, kunnen waardevol zijn bij het voorkomen van ernstige COVID-19 bij patiënten met IPF, hebben het potentieel om ernstige COVID-19 te behandelen bij patiënten zonder IPF en kunnen een rol spelen bij het voorkomen van fibrose na SARS-CoV-2 infectie".

www.thelancet.com/journals/lanres/art...

[verwijderd] 5 juni 2020 14:39

0

quote:
Wall Street Trader schreef op 5 juni 2020 14:17:
Hey Elliot Rabbit,

sometimes you just need to stay calm and just let things come to you...

In the long run this stock downfall is just a pullback in a bull-market pause.
Investors should use weakness to add the stock to their portfolios.

Onno his willingness to create further value from the pipeline is huge and his dealmaking skills will be highly relevant to strike one or more partnerships.

Several catalysts could drive the stock in coming months:

Half Year results: 6th August 2020

filgotinib EU approval and launch 2H20

filgotinib US approval/label information 2H20

GLPG 1972 ROCELLA phase 2b readout in OA 2H20

(GLPG1972 a potentially overlooked asset, which could have an outsized impact on the stock)

ziritaxestat NOVESA ph. 2 SSc data 2H20

GLPG 1205 PINTA ph. 2 IPF data 2H20

ziritaxestat ISABELA futility update 1H21

Toledo 3970 ph. 2 data 2H20

filgotinib DIVERSITY phase 3 enrollment complete (CD) 2021

filgotinib ulcerative colitis (potential) launch 2021

filgotinib Crohn's disease potential launch 2022

Hang in there... and let Gilead's and Galapagos teams do their job!

klinkt bijna dwingend overtuigend. We zullen zien.

NielsjeB 5 juni 2020 15:17

4

quote:
MrBiggy schreef op 5 juni 2020 14:28:
Ik had dit document laatst al een keer ergens in de nacht gelezen en gemeld, gezien Galapagos met IPF al ver is.. en deze week hebben overheden een vorm van Joint Venture opgericht tbv Covid-19 ... kan het onderzoek van Galapagos misschien een enorme boost geven!
even vrij vertaald:

"In december 2019 kwamen er rapporten uit Wuhan, China, van een ernstige acute luchtwegaandoening veroorzaakt door ernstig acuut respiratoir syndroom coronavirus 2 (SARS-CoV-2). Eind april 2020 was bevestigd dat meer dan 3 miljoen mensen besmet waren, waarvan meer dan 1 miljoen alleen in de VS en meer dan 215.000 doden. De symptomen die samenhangen met COVID-19 zijn divers, variërend van milde symptomen van de bovenste luchtwegen tot ernstig acuut respiratoir distress-syndroom. De belangrijkste risicofactoren voor ernstige COVID-19 worden gedeeld met idiopathische longfibrose (IPF), namelijk toenemende leeftijd, mannelijk geslacht en comorbiditeiten zoals hypertensie en diabetes. De rol van antifibrotische therapie bij patiënten met IPF die een SARS-CoV-2-infectie oplopen, en de wetenschappelijke reden voor hun voortzetting of stopzetting, is echter slecht gedefinieerd. Bovendien zijn verschillende goedgekeurde en potentiële antifibrotische verbindingen beoordeeld in modellen van acute longbeschadiging en virale longontsteking. Gegevens van eerdere coronavirusinfecties zoals ernstig acuut ademhalingssyndroom en ademhalingssyndroom in het Midden-Oosten, evenals opkomende gegevens van de COVID-19-pandemie, suggereren dat er aanzienlijke fibrotische gevolgen kunnen zijn na een SARS-CoV-2-infectie. Antifibrotische therapieën die beschikbaar zijn of in ontwikkeling zijn, kunnen waardevol zijn bij het voorkomen van ernstige COVID-19 bij patiënten met IPF, hebben het potentieel om ernstige COVID-19 te behandelen bij patiënten zonder IPF en kunnen een rol spelen bij het voorkomen van fibrose na SARS-CoV-2 infectie".

www.thelancet.com/journals/lanres/art...

Thanks! Hier nog een pdf-variant, misschien iets makkelijker te lezen.

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