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Novartis (?)

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peebee
0
Life Sciences Partners richt zich op beleggingen in beursgenoteerde biotechbedrijven.

Beleggers kunnen vanaf woensdag investeren in een beleggingsfonds dat zich richt op beursgenoteerde biotechbedrijven. Dit meldt Fondsnieuws vrijdag. Life Sciences Partners heeft een belegd vermogen van 600 miljoen euro. Doel van het fonds is investeren in biotechbedrijven met een marktwaarde van zo'n 250 miljoen euro die beschikken over een kansrijke onderzoekspijplijn. In totaal zijn er zo'n 200 fondsen die in aanmerking komen waarvan LSP er zo'n 15 tot 20 selecteert voor zijn fonds. De namen van deze bedrijven maakt het fonds echter niet bekend.

Biotechbedrijven kenmerken zich door grote kostenposten tijdens de ontwikkeling van zijn producten. Pas na jaren van ontwikkelen, goede onderzoeksresultaten en toestemming van toezichthouders kan een product op de markt worden gebracht en kan er daadwerkelijk worden verdiend. Menig nieuw medicijn haalt nooit de laatste fase en heeft daardoor alleen maar geld gekost. Voor beleggers is het vaak erg lastig in te schatten welke bedrijven en medicijnen kansrijk zijn. Hierin wil Life Sciences Partners verandering brengen.

Door: ABM Financial News.
Info@abmfn.nl
Amsterdam: +31(0)20-845 40 59
Groningen: +31(0)50-711 39 93

flosz
0
quote:

flosz schreef:

Voor de liefhebber.

Feuerstein‘s Vertex: FDA Hep C Panel Live Blog

BETHESDA, Md. (TheStreet) -- An FDA advisory panel meets today to review a new hepatitis C drug from Vertex Pharmaceuticals(VRTX_).
The Vertex drug, known as telaprevir, is one of the most advanced entrants in a new class of oral drugs that acts directly against the hepatitis C virus and promises to radically improve cure rates while cutting treatment duration.
The same panel of FDA-appointed experts voted 18-0 Wednesday to recommend approval of a competing hepatitis C drug developed by Merck(MRK_).
Both telaprevir and boceprevir could be approved and launched later this year, transforming the way hepatitis C is treated and leading to blockbuster sales.
In a preliminary review of telaprevir posted to its web site Tuesday, the FDA agreed with Vertex's clinical data demonstrating that the drug increases cure rates for hepatitis C over standard treatment. The FDA raised some concerns about rash caused by telaprevir.
The FDA advisory panel will end Thursday's meeting with a vote on whether to recommend approval of telaprevir. FDA makes the final approval decision. The agency is expected to issue its ruling by May 23.
www.thestreet.com/story/11097109/1/ve...

Feuerstein op twitter: twitter.com/#!/adamfeuerstein

Ter aanvulling.
FDA Advisory Committee Unanimously Recommends Approval of Telaprevir for People with Hepatitis C
tinyurl.com/6ea782r

tinyurl.com/6jnlp84
flosz
1
Nieuwe (US) naam voor VRTX’s Hep.C drug telaprevir: INCIVEK!
(in-SEE-veck)

***************

Hepatitis C:
Preparing for Launch of INCIVEKTM (telaprevir)
• Vertex today announced that it intends to use the name INCIVEK (in-SEE-veck) as the trade name for telaprevir. If approved, telaprevir will be marketed by Vertex as INCIVEK in the U.S.
• Vertex recently completed its FDA Antiviral Drugs Advisory Committee meeting for INCIVEK (telaprevir). At the conclusion of the meeting, the committee voted unanimously (18-0) to recommend FDA approval of INCIVEK (telaprevir) for people with genotype 1 chronic hepatitis C who were not treated previously and those who were treated previously but not cured with currently available medicines. Vertex expects the FDA to provide its formal decision on the New Drug Application for INCIVEK (telaprevir) by May 23.
• Vertex's collaborator, Janssen-Cilag International NV, is awaiting a formal decision from the European Medicines Agency (EMA) on its Marketing Authorisation Application (MAA) for telaprevir in the EU. The EMA accepted telaprevir for accelerated assessment, which is granted to new medicines of major public health interest. Vertex believes that Tibotec, a division of Janssen-Cilag, may receive a response on the MAA in the second half of 2011.
• Vertex's entire commercial function is in place and prepared for the planned launch of INCIVEK (telaprevir). Approximately 200 field-based employees have been hired to date to support the future use of INCIVEK (telaprevir) across the United States following the planned launch, including a sales team of 115 therapeutic specialists and others who will support the future sale of INCIVEK (telaprevir).
Phase 3b Study of Twice-daily Dosing of INCIVEK (telaprevir)
• Patient enrollment is ongoing in a Phase 3b clinical trial to evaluate twice-daily dosing of INCIVEK (telaprevir; 1,125 mg; BID) compared to three-times-daily dosing of INCIVEK (telaprevir; 750 mg; q8h) in combination with Pegasys® (pegylated-interferon alfa-2a) and Copegus® (ribavirin) for people with chronic genotype 1 hepatitis C. The study, known as OPTIMIZE, does not include a control arm of pegylated-interferon and ribavirin alone. Sustained viral response (SVR or viral cure) data from OPTIMIZE are expected as early as the second half of 2012, which could support the submission of a supplemental NDA for twice-daily (BID) dosing of INCIVEK (telaprevir) by the end of 2012.
Phase 2 Combination Study of INCIVEK (telaprevir) and VX-222
• Vertex is conducting a Phase 2 clinical trial evaluating multiple 12- and 24-week response-guided regimens of INCIVEK (telaprevir) dosed in combination with Vertex's lead investigational polymerase inhibitor, VX-222, for the treatment of hepatitis C. The study currently includes three treatment arms. Two of the treatment arms are fully enrolled and are evaluating four-drug combinations of INCIVEK (telaprevir; 1,125 mg; BID), VX-222 (400 mg or 100 mg; BID), pegylated-interferon and ribavirin. Vertex expects to complete enrollment in the second quarter of 2011 in a three-drug treatment arm that will evaluate an all-oral, interferon-free regimen of INCIVEK (telaprevir; 1,125 mg), VX-222 (400 mg) and ribavirin dosed twice daily. A final arm may be added to the trial per protocol based on data from other arms of the study. In April, Vertex announced interim results from this study and expects to present additional data from the study in the second half of 2011.
Phase 3 Study of INCIVEK (telaprevir) in People Co-infected with the Hepatitis C Virus (HCV) and Human Immunodeficiency Virus (HIV)
• In February, Vertex reported interim results from a Phase 2 clinical trial of INCIVEK (telaprevir) dosed in combination with pegylated-interferon and ribavirin in people who are infected with genotype 1 chronic hepatitis C and HIV. Based on these results, Vertex plans to initiate in the second half of 2011 a Phase 3 study of INCIVEK (telaprevir) dosed in combination with pegylated-interferon and ribavirin in people co-infected with HCV and HIV. The Phase 3 trial will be designed to generate data that, if positive, could support the submission of a supplemental NDA for this population.
Phase 2 Study of INCIVEK (telaprevir) to Evaluate 3-month Treatment Regimens
• In the third quarter of 2011, Vertex plans to initiate a clinical trial to evaluate a 12-week treatment regimen of INCIVEK (telaprevir) dosed in combination with pegylated-interferon and ribavirin for people who have a specific genetic marker, known as CC, near the IL28B gene. In April, Vertex announced data from retrospective analyses that evaluated the relationship between variations at the IL28B gene and a patient's response to treatment with INCIVEK (telaprevir), pegylated-interferon and ribavirin. These data support the initiation of the study to evaluate 12-week treatment regimens for certain patients.
Phase 2 Post-Transplant Study of INCIVEK (telaprevir)
• Earlier in 2011, Vertex completed a drug-drug interaction study of INCIVEK (telaprevir) dosed with immunosuppressive agents that are commonly used following a liver transplant. In the fourth quarter of 2011, Vertex plans to initiate a Phase 2 study in the U.S. of INCIVEK dosed in combination with pegylated-interferon and ribavirin in people with recurrent hepatitis C following a liver transplant.

investors.vrtx.com/releasedetail.cfm?...

Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that it will webcast its presentations at the Deutsche Bank 36th Annual Health Care Conference on Wednesday, May 4, 2011 at 10:40 a.m. EDT and at the Bank of America Merrill Lynch Health Care Conference on Tuesday, May 10, 2011 at 9:20 a.m. PDT (12:20 p.m. EDT).
investors.vrtx.com/releasedetail.cfm?...
flosz
0
FDA Approves INCIVEK™ (telaprevir) for People with Hepatitis C
www.fda.gov/NewsEvents/Newsroom/Press...

-79% of people treated for the first time achieved a SVR (viral cure) with INCIVEK combination treatment-
-Vertex launches a comprehensive financial assistance and patient support program-
-Conference call today at 11:00 a.m. ET to provide more information on the commercialization of INCIVEK-

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vertex Pharmaceuticals Incorporated (Nasdaq: VRTX) today announced that the U.S. Food and Drug Administration (FDA) has approved INCIVEK™ (telaprevir) tablets for a broad group of people with genotype 1 chronic hepatitis C with compensated liver disease (some level of damage to the liver but the liver still functions), including cirrhosis (scarring of the liver). INCIVEK (in-SEE-veck) is approved for people who are new to treatment, and for people who were treated previously but who did not achieve a viral cure (relapsers, partial responders and null responders). INCIVEK is given for 12 weeks in combination with pegylated-interferon and ribavirin, two other medicines approved to treat hepatitis C. After the first 12 weeks, all patients stop receiving INCIVEK and continue treatment with pegylated-interferon and ribavirin alone for an additional 12 weeks or 36 weeks of treatment. With INCIVEK combination treatment, more than 60 percent of people treated for the first time, as well as those who relapsed after previous therapy, are expected to complete all treatment in 24 weeks — half the time needed if they were to take pegylated-interferon and ribavirin alone. All other patients will receive a total of 48 weeks of treatment. INCIVEK will arrive in pharmacies this week.
The approval of INCIVEK was based on data from three Phase 3 studies, which showed that people who received INCIVEK combination treatment achieved significantly higher rates of sustained viral response (SVR, or viral cure) compared to those who received pegylated-interferon and ribavirin alone, regardless of their prior treatment experience:

People new to treatment: 79 percent vs. 46 percent

People who were treated previously but did not achieve a viral cure:
-- Relapsers: 86 percent vs. 22 percent
-- Partial responders: 59 percent vs. 15 percent
-- Null responders: 32 percent vs. 5 percent

INCIVEK (750 mg) is given as two 375-mg tablets three times daily. It is packaged in weekly boxes that include daily blister strips to help patients keep track of their doses.
Rash and anemia are the most serious side effects associated with INCIVEK. The most common side effects reported with INCIVEK combination treatment include fatigue, itching, nausea, diarrhea, vomiting, anal or rectal problems, and taste changes.
"Hepatitis C can lead to liver failure, cancer and the need for a transplant, and for the past decade, the best we could offer patients was a year of difficult treatment that resulted in a viral cure for fewer than half of them," said Ira Jacobson, M.D., Chief of the Division of Gastroenterology and Hepatology, Weill Cornell Medical College and principal investigator for a Phase 3 study of INCIVEK. "With INCIVEK, 79 percent of people new to treatment achieved a viral cure."
"Today marks a turning point in the fight against hepatitis C, particularly for people who have been living with this silent disease for decades, hoping for a better chance of a viral cure," said Matthew Emmens, Chairman, President and Chief Executive Officer of Vertex. "The approval of INCIVEK was only possible thanks to more than 4,000 people who volunteered for our clinical studies, the doctors, nurses and coordinators who managed the studies, and our own pioneering scientists who have worked for more than 15 years to bring this new medicine to people with hepatitis C."
Vertex has 200 field-based employees across the United States, including a 115-person sales team, who are ready to support the introduction of INCIVEK. The sales team has an average of more than 14 years of experience bringing medicines to people who need them, including eight years of direct experience with antiviral medicines for diseases such as hepatitis C.
Helping People with Hepatitis C Get INCIVEK
The people who work at Vertex understand that medicines can only help patients who can get them. With that in mind, the company today introduced a comprehensive financial assistance and patient support program to help people get INCIVEK who might not otherwise be able to afford it. The program will help people with hepatitis C learn about insurance benefits for their medicines, give INCIVEK for free to eligible patients who do not have insurance and provide coverage for co-pay or co-insurance costs associated with INCIVEK for people who meet certain program criteria. Additionally, patients will have access to nurses through a 24-7 hotline by which they can receive support, guidance and educational materials about hepatitis C and its treatment. Vertex will also provide nurses and doctors with educational tools and resources so they can offer support and care to people with hepatitis C before, during and after the treatment process.
For eligible patients, the program includes the following:
• Insurance Benefits Research and Support: Vertex case managers will research patients' insurance benefits for INCIVEK combination treatment, assist people with insurance appeals and help guide them to other forms of financial support, including Vertex's free medicine and co-pay programs;
• FREE MEDICINE PROGRAM: VERTEX WILL GIVE INCIVEK FOR FREE TO PEOPLE WHO DO NOT HAVE INSURANCE AND HAVE AN ANNUAL HOUSEHOLD INCOME OF $100,000 OR LESS; and
• Co-Pay Support: Vertex will cover co-pay or co-insurance costs up to 20 percent of the total cost of INCIVEK for people who have private insurance plans that cover INCIVEK, regardless of their household income. For people covered by government insurance, Vertex will also make donations to the independent, non-profit Patient Access Network Foundation, which has a fund to provide co-pay support to people taking hepatitis C medicines.
More information about this program is available by calling 1-855-837-8394 or visiting www.INCIVEK.com.
investors.vrtx.com/releasedetail.cfm?...
patient
0
• FREE MEDICINE PROGRAM: VERTEX WILL GIVE INCIVEK FOR FREE TO PEOPLE WHO DO NOT HAVE INSURANCE AND HAVE AN ANNUAL HOUSEHOLD INCOME OF $100,000 OR LESS; and
• Co-Pay Support: Vertex will cover co-pay or co-insurance costs up to 20 percent of the total cost of INCIVEK for people who have private insurance plans that cover INCIVEK, regardless of their household income. For people covered by government insurance, Vertex will also make donations to the independent, non-profit Patient Access Network Foundation, which has a fund to provide co-pay support to people taking hepatitis C medicines.

Na het beluisteren van de webcast van Vertex over de goedkeuring van Incivek (telaprevir) komt het prijskaartje op $49.200 per behandeling.
De inschatting van het aantal patienten dat niet verzekerd is en een besteedbaar inkomen hebben van minder dan $100.000 schat Vertex op 5%.
Het merendeel van de patienten 60% is commercieel verzekerd en 35% heeft een overheids verzekering. Ze gaan het dus niet gratis weggeven.
De 20% vergoeding is een verkapte korting op de prijs, voor de verzekeraars die het voorschrijven aan hun patienten.
Een andere opmerking die is blijven hangen is dat Vertex blijft doorgaan met het testen van verschillende behandelingen om de Soc te verbeteren en in duur te verkorten. Incevek is voor Vertex het medicijn dat als basis dient voor een verdere groei naar een volwaardig biocompany.
harrysnel
1
Heb ook de webcast van Vertex beluisterd. Hier de punten die mij opgevallen zijn:

Incivek (telaprevir) wordt hoger in de markt gezet qua prijs dan Victrelis van Merck. Tijdens Q & A bleek dat Vertex niet over verschil in prijs met specifieke concurrentie (lees Merck) wil praten. Commerciele strategie is erop gebaseerd dat de behandelende artsen het beste middel voor hun patient kiezen om hep-c te genezen. Focus van communicatie dus naast patient vooral ook op arts. Incivek leidt tot "sustained viral response" bij 79% van behandelde patienten (huidige SOC (peg-interferon + ribavirin)= 46%). Voorts wordt behandelduur verkort van 48 bij huidige SOC naar 24 weken. Dus "selling proposition" is gebaseerd op het benadrukken dat therapie met Incivek bijna dubbel zo effectief is in de helft van benodigde behandeltijd. Voor het bestrijden van de bijwerkingen is speciaal medisch handboek opgesteld. De kosten verbonden aan hep-c voor de samenleving als geheel rechtvaardigen volgens Vertex ook economisch de gehanteerde verkoopprijs van net onder de $50k.

Interessant (ook voor Octoplus) zijn de opmerkingen over nieuwe onderzoeken met Incivek en behandelwijze van Hep-c. Komt onderzoek naar:
- gebruik specifiek bij Afro-Americans
- patieneten met specifieke genetische opmaak (zou 1/3 van non-responders kunnen verklaren)
- patienten met hiv/hcv co-infection
- recurring hep-c na levertransplantatie
- dosering 2 maal per dag (= nu 3x 2 pillen)
- patienten met cirrose

Verder tijdens Q&A bleek dat goedkeuring in Europa eind dit jaar wordt verwacht. Vertex wilde niet ingaan op deal Merck/Roche en dan specifiek op de vraag of zij ook zo'n deal nastreven. Wel de opmerking dat deel van salesforce juist afkomstig is van Roche/Merck. Opbrengsaten van verkopen Incivek zullen gebruikt worden voor investeringen in andere produkten. Nieuwe data mbt Cystic Fibrosis in June bij congres in Europa.

Itt patient heb ik niet kunnen beluisteren dat ze SOC willen verbeteren; focus lag m.i. op het duidelijk maken van de voordelen van Incivek en het ontwikkelen van toepassingsmogelijkheden in combinatie met huidig SOC.
flosz
0
Uit J&J
Pharmaceuticals Business Review

HCV Market: Changing Paradigm –Rapid Growth
2010 WW Sales: $2.7B
CAGR 2010-2015: 27%

Hepatitis C: Building a Leadership Position

2 protease inhibitors in late clinical development
–Telaprevir and TMC 435
–Protease inhibitors potential cornerstone of combination therapy
•Investigating compounds with a 2ndand 3rdmechanism of action
•Through Virco, exploring integrated solutions

tinyurl.com/3uchrl8
Vanaf slide 27.
[verwijderd]
0
[verwijderd]
1
Hum weinig nieuws tot nu op deze link.
Wel wat meer overzicht.

Weet nu wel waar de ziekenhuizen ze liggen waar de boel getest word.

of ziet iemand nog een verassing ?

Een ding Locteron kan nog heel wat wegen in slaan /Onderzoek Octo idem naar mijn meening.

Zoek maar weer verder .

( Hoop niet nog 3 maanden )en dan een oude schoen. :)

Trust

Gr zz

[verwijderd]
0
Ha Flosz, vraagje jij zult je wel verdiept hebben in Octo jou kennende, is het waard om erin te gaan? op zich ziet het er funda niet echt verkeerd uit!!

Grt. Yok
[verwijderd]
0
Ja of Nee je zal wel een E mail krijgen.:}

Denk dat ie meer voor de pil is. maar als ie niet werkt is er toch nog het spuitje.

Vloeibaar doet het wel goed deze 4 days off.

gr zz
flosz
2
Deze week (@de liefhebber)Nature’s Supplement: Hepatitis C

Infecting around 120 million people worldwide, hepatitis C virus (HCV) is more common than HIV yet it is a neglected epidemic. Diagnosis is hard, treatment is arduous, and there is no vaccine. However, for the first time in decades, new drugs are about to be launched that could substantially improve treatment and herald a new era of HCV awareness.
www.nature.com/nature/outlook/hepatit...

Hepatitis C
www.nature.com/nature/journal/v474/n7...

A smouldering public-health crisis
Long overshadowed by HIV, the hepatitis C virus is starting to take its toll. And the heat is on to find and treat those affected.
www.nature.com/nature/journal/v474/n7...

Therapeutics: New drugs hit the target
With two recently approved drugs and dozens more in the pipeline, hepatitis C treatment will improve over the next decade.
www.nature.com/nature/journal/v474/n7...

Perspective: Miles to go before we sleep
New drugs are generating much excitement, but a cure for all will take generations of therapies, argues Charles Rice
www.nature.com/nature/journal/v474/n7...

Pharmacogenomics: Playing the odds
Can doctors calculate a patient's chance of being cured by searching their DNA? Hepatitis C researchers are starting to make this a reality.
www.nature.com/nature/journal/v474/n7...

Perspective: Recognizing resistance
The hepatitis C virus is endemic among injection drug users, who could harbour treatment-resistant viruses. We need to adapt to this reality, says Diana Sylvestre
www.nature.com/nature/journal/v474/n7...

Global health: A uniquely Egyptian epidemic
Egypt has the highest prevalence of hepatitis C worldwide. And the epidemic will soon peak. Prevention demands political will, ample funding and a change in mindset.
www.nature.com/nature/journal/v474/n7...

Research technique: The murine candidate
Small animals that mimic human hepatitis C infection will help researchers pinpoint weakness in the viral life cycle.
www.nature.com/nature/journal/v474/n7...

Vaccines: A moving target
The hepatitis C virus has a set of cunning ways to evade immunity, but researchers are turning the immune system on it.
www.nature.com/nature/journal/v474/n7...

Diagnostics: A testing journey
Results ready in minutes and more efficacious drugs will help find and treat the hundreds of millions of carriers.
www.nature.com/nature/journal/v474/n7...

Perspective: Test and treat this silent killer
The scourge of the hepatitis C virus in the United States is woefully underestimated. Brian R. Edlin reckons it's time the infection is given the priority it demands.
www.nature.com/nature/journal/v474/n7...
flosz
0
quote:

yokyok schreef op 3 juni 2011 09:29:

Ha Flosz, vraagje jij zult je wel verdiept hebben in Octo jou kennende, is het waard om erin te gaan? op zich ziet het er funda niet echt verkeerd uit!!

Grt. Yok
Hoi yok, die keuze dien je zelf te maken, zo ook het verwerken van de verzamelde hoofd- en bijzaken, in de blender en opslurpen met een rietje.
Groetjes
[verwijderd]
0
quote:

flosz schreef op 9 juni 2011 10:57:

Deze week (@de liefhebber)Nature’s Supplement: Hepatitis C

Infecting around 120 million people worldwide, hepatitis C virus (HCV) is more common than HIV yet it is a neglected epidemic. Diagnosis is hard, treatment is arduous, and there is no vaccine. However, for the first time in decades, new drugs are about to be launched that could substantially improve treatment and herald a new era of HCV awareness.
www.nature.com/nature/outlook/hepatit...

Hepatitis C
www.nature.com/nature/journal/v474/n7...

A smouldering public-health crisis
Long overshadowed by HIV, the hepatitis C virus is starting to take its toll. And the heat is on to find and treat those affected.
www.nature.com/nature/journal/v474/n7...

Therapeutics: New drugs hit the target
With two recently approved drugs and dozens more in the pipeline, hepatitis C treatment will improve over the next decade.
www.nature.com/nature/journal/v474/n7...

Perspective: Miles to go before we sleep
New drugs are generating much excitement, but a cure for all will take generations of therapies, argues Charles Rice
www.nature.com/nature/journal/v474/n7...

Pharmacogenomics: Playing the odds
Can doctors calculate a patient's chance of being cured by searching their DNA? Hepatitis C researchers are starting to make this a reality.
www.nature.com/nature/journal/v474/n7...

Perspective: Recognizing resistance
The hepatitis C virus is endemic among injection drug users, who could harbour treatment-resistant viruses. We need to adapt to this reality, says Diana Sylvestre
www.nature.com/nature/journal/v474/n7...

Global health: A uniquely Egyptian epidemic
Egypt has the highest prevalence of hepatitis C worldwide. And the epidemic will soon peak. Prevention demands political will, ample funding and a change in mindset.
www.nature.com/nature/journal/v474/n7...

Research technique: The murine candidate
Small animals that mimic human hepatitis C infection will help researchers pinpoint weakness in the viral life cycle.
www.nature.com/nature/journal/v474/n7...

Vaccines: A moving target
The hepatitis C virus has a set of cunning ways to evade immunity, but researchers are turning the immune system on it.
www.nature.com/nature/journal/v474/n7...

Diagnostics: A testing journey
Results ready in minutes and more efficacious drugs will help find and treat the hundreds of millions of carriers.
www.nature.com/nature/journal/v474/n7...

Perspective: Test and treat this silent killer
The scourge of the hepatitis C virus in the United States is woefully underestimated. Brian R. Edlin reckons it's time the infection is given the priority it demands.
www.nature.com/nature/journal/v474/n7...

En dat Alles van een site.
AB
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