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With the approval by the European Commission in November 2012.....

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  1. flosz 31 oktober 2012 23:35
    3D-PharmXchange coordinates the market launch of Glybera®, the first approved gene therapy in the Western world

    31 Okt 2012
    3D-PharmXchange is proud to have been chosen by uniQure BV, a leader in the field of human gene therapy to coordinate the market launch in 2013 of their lead product Glybera® for the treatment of lipoprotein lipase deficiency (LPLD). LPLD is a rare and severe disease for which no treatment was available. With the approval by the European Commission in November 2012, Glybera® became the first approved gene therapy in the Western world. We feel honored to be able to contribute to this landmark project.

    tinyurl.com/a9kdtuu

    www.youtube.com/watch?v=Vz6RwoESOn4 Oops Upside Your Head of even Apeldoorn bellen.....

  2. forum rang 10 rationeel 1 november 2012 00:58
    quote:

    flosz schreef:

    3D-PharmXchange coordinates the market launch of Glybera®, the first approved gene therapy in the Western world

    31 Okt 2012
    3D-PharmXchange is proud to have been chosen by uniQure BV, a leader in the field of human gene therapy to coordinate the market launch in 2013 of their lead product Glybera® for the treatment of lipoprotein lipase deficiency (LPLD). LPLD is a rare and severe disease for which no treatment was available. With the approval by the European Commission in November 2012, Glybera® became the first approved gene therapy in the Western world. We feel honored to be able to contribute to this landmark project.

    tinyurl.com/a9kdtuu

    www.youtube.com/watch?v=Vz6RwoESOn4 Oops Upside Your Head of even Apeldoorn bellen.....

    Goed nieuws Flosz:) Zegt het voort:)
  3. [verwijderd] 2 november 2012 08:29
    Persberciht van uniQure over goedkeuring door EU:

    uniQure’s Glybera® First Gene Therapy Approved by European Commission

    Nov 2, 2012

    uniQure’s Glybera® First Gene Therapy Approved by European Commission


    Glybera becomes the first gene therapy approved by regulatory authorities in the Western world
    First medication approved for patients with rare metabolic disorder Lipoprotein Lipase Deficiency
    Commercial roll-out to begin second half of 2013
    Validates uniQure’s unique AAV-based gene therapy platform


    Amsterdam, The Netherlands – November 2, 2012 – uniQure announced today it has received approval from the European Commission for the gene therapy Glybera® (alipogene tiparvovec), a treatment for patients with lipoprotein lipase deficiency (LPLD, also called familial hyperchylomicronemia) suffering from recurring acute pancreatitis. Patients with LPLD, a very rare, inherited disease, are unable to metabolize the fat particles carried in their blood, which leads to inflammation of the pancreas (pancreatitis), an extremely serious, painful, and potentially lethal condition. The approval makes Glybera the first gene therapy approved by regulatory authorities in the Western world.



    “Glybera’s approval means LPLD patients, for the first time, have a medical treatment option for a very complex and severe disease,” said Professor John Kastelein of the Department of Vascular Medicine at the Academic Medical Center of the University of Amsterdam, the Netherlands. “LPLD leads to acute and recurrent pancreatitis attacks, and in many patients causes early onset diabetes and cardiovascular complications. This therapy will have a dramatic impact on the lives of these patients. Currently their only recourse is to severely restrict the amount of fat they consume. By helping to normalize the metabolism of fat, Glybera prevents inflammation of the pancreas thereby averting the associated pain and suffering and, if administered early enough, the associated co-morbidities.”



    As part of the approval, patients will receive treatment with Glybera through dedicated centers of excellence and by specially trained doctors. uniQure will also build a patient registry to further improve the understanding of this devastating, under-researched disease and the effects of Glybera treatment. Marketing Authorisation covers all 27 European Union member states. uniQure is preparing to apply for regulatory approval in the US, Canada, and other markets.



    “The final approval of Glybera from the EC marks a major step forward in making gene therapies available not only for LPLD but also for a large number of rare diseases with a very high unmet medical need,” says Jörn Aldag, CEO of uniQure. “The EC’s approval is an important validation of our innovative product platform and offers strong support for our other advanced development programs, which focus on acute intermittent porphyria, Sanfilippo B, hemophilia B and Parkinson’s disease.”



    About Glybera®

    uniQure has developed Glybera as a therapy for patients with the genetic disorder lipoprotein lipase deficiency, an orphan disease for which no treatment existed. The disease is caused by mutations in the LPL gene, resulting in highly decreased or absent activity of LPL enzyme in patients. This enzyme is needed in order to break down large fat-carrying particles that circulate in the blood after each meal. When such particles, called chylomicrons, accumulate in the blood, they may obstruct small blood vessels. Excess chylomicrons result in recurrent and severe acute inflammation of the pancreas, called pancreatitis, the most debilitating complication of LPLD. Glybera has orphan drug designation in the EU and US. LPL Deficiency affects 1-2 persons per million.



    Glybera has been tested in three interventional clinical studies conducted in the Netherlands and in Canada, in which a total of 27 LPLD patients participated. In all three clinical trials, Glybera was well tolerated, with no relevant safety issues observed. Data from these clinical trials indicate that a single dose administration of Glybera resulted in a long-term biological activity of the LPL protein. For further information on LPLD visit www.lpldeficiency.com.



    Lipoprotein lipase is a key ‘first step’ enzyme in the metabolism of lipoproteins following fat intake with diet. In clinical studies a transient reduction in triglycerides for up to 12 weeks in individual patients could be observed. Furthermore, Glybera allows expression of the LPL protein in injected muscle which is reflected by the improvement of postprandial chylomicron (CM) metabolism observed in a small subset of patients. Glybera (alipogene tiparvovec) contains the human lipoprotein lipase (LPL) gene variant LPLS447X in a vector. The vector comprises a protein shell derived from adeno-associated virus serotype 1 (AAV1), the promoter, a posttranscriptional regulatory element and AAV2 derived inverted terminal repeats.



    Glybera is indicated for adult patients diagnosed with familial lipoprotein lipase deficiency (LPLD) and suffering from severe or multiple pancreatitis attacks despite dietary fat restrictions. The diagnosis of LPLD has to be confirmed by genetic testing. The indication is restricted to patients with detectable levels of LPL protein.



    The most commonly reported adverse reaction is pain in extremity occurring in approximately one third of patients. Given the small patient population and size of the cohorts, observed adverse reactions do not provide a complete perspective on the nature and frequency of these events.



    About uniQure

    uniQure is a world leader in the development of human gene based therapies. uniQure product pipeline of gene therapy products in development comprise hemophilia B, acute intermittent porphyria, Parkinson’s disease and SanfilippoB. Using adeno-associated viral (AAV) derived vectors as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate probably the world’s first stable and scalable AAV manufacturing platform. This proprietary platform can be applied to a large number of rare (orphan) diseases caused by one faulty gene and allows uniQure to pursue its strategy of focusing on this sector of the industry. uniQure's largest shareholders are Forbion Capital Partners and Gilde Healthcare, two of the leading life sciences venture capital firms in the Netherlands. Further information can be found at www.uniqure.com.





    For further enquiries:

    Jörn Aldag
    CEO
    uniQure
    Tel : +31 20 566 8014
    j.aldag@uniQure.com

    Hans Herklots
    Managing Director
    Capricorn One
    Tel: +41 79 598 7149
    capricorn1@bluewin.ch

    Mike Sinclair
    Partner
    Halsin Partners
    Tel : +44 20 7318 2955
    msinclair@halsin.com

    Close



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  4. Prof. Dollar 2 november 2012 08:52
    Allemaal gefeliciteerd!

    Laten we het wereldnieuws in kaart brengen:

    RTL-Z:
    www.rtl.nl/components/financien/rtlz/...

    Telegraaf:
    www.telegraaf.nl/dft/bedrijven/amt/13...

    Duitsland
    www.wallstreet-online.de/nachricht/50...

    US
    www.marketwatch.com/story/uniqures-gl...

    Spanje
    noticias.lainformacion.com/salud/gene...
  6. Prof. Dollar 2 november 2012 10:14
    quote:

    flosz schreef op 2 november 2012 09:45:

    Dank je wel zoef, Fantastisch!
    Hartelijk Gefeliciteerd @ allen.
    Hans Preusting: uniQure, introducing Glybera the first gene therapy approved in the Western world: www.pharmatelevision.com/VideoHandler...
    Zeer interessant video-interview!

    Ik kijk uit naar komende ontwikkelingen en de financiering ervan. En hoop toch echt dat ze particuliere investeerders geen oor aan naaien.

    - Goedkeuring nu op zak, mogelijk eerste inkomsten vanaf half 2013.
    - Goedkeuring als inzet voor marktaanvraag US en Canada, start 2013.

    Vragen:
    1 Er staat in persbericht ook 'other markets', iemand een idee welke dat zijn?
    2 En heeft iemand een idee hoelang de procedures in de US en Canada zijn?
  9. flosz 2 november 2012 11:17
    Gevonden op de deurmat….
    Opbrengst van Glybera wordt over de eerste 15 jaar voorzichtig geschat op ca € 250 mio en redelijk gelijkmatig verdeeld.
    **********************

    Jörn Aldag, UniQure’s chief executive, said he would probably charge €250,000 a year for five years for the drug, a similar amount to Cerezyme, another “orphan drug” for a very rare disease. That would indicate a total bill of €1.25m per patient.
    www.iex.nl/Forum/Topic/1286507/2/Morg...
  10. flosz 2 november 2012 14:18
    Europe approves high-price gene therapy

    By Ben Hirschler
    LONDON | Fri Nov 2, 2012 7:59am EDT

    (Reuters) - European officials have approved the Western world's first gene therapy drug from a small Dutch biotech company, in a milestone for the novel medical technology that fixes faulty genes.
    The formal clearance from the European Commission paves the way for a launch next summer of the treatment for an ultra rare genetic disease that will cost around 1.2 million euros ($1.6 million) per patient, a new record for pricey modern medicines.

    After more than 20 years of experiments and a series of disappointments, the EU approval of Glybera, which treats the genetic disorder lipoprotein lipase deficiency (LPLD), is a significant boost for the gene therapy field.
    Joern Aldag, chief executive of Amsterdam-based uniQure, said more such treatments would follow and argued a high price was justified because gene therapy restored natural body function and did not just offer a short-term fix.
    "This provides higher benefit to patients than the classical protein replacement strategy and this is why we think we should be fairly and adequately compensated," he said in a telephone interview on Friday.
    Patients with LPLD, which affects no more than one or two people per million, are unable to handle fat particles in their blood and are at risk of acute and potentially fatal inflammation of the pancreas.

    The approval follows a positive recommendation from the European Medicines Agency in July.
    The privately owned firm is now working with governments on potential pricing strategies, which are likely to vary from country to country, ahead of the commercial roll-out from the second half of 2013.
    Aldag said some countries preferred the idea of a one-off payment at the time of treatment but others were interested in an annuity system, which would probably involve charging around 250,000 euros a year for five years.
    That kind of annual charge would put Glybera in a similar price range to expensive enzyme replacement therapies for other rare diseases, such as Cerezyme for Gaucher disease from Sanofi's Genzyme unit.
    www.reuters.com/article/2012/11/02/us...
  11. [verwijderd] 2 november 2012 17:44
    USA pers:
    There's important news today from the gene therapy front. UniQure won approval for its gene therapy for an extremely rare condition from the European Commission, making the Netherlands-based biotech's product the first gene therapy approved in the Western World. And the first-of-its-kind regulatory nod provides another sign of recovery for the injured field.

    After years of development, uniQure has permission to market its therapy, Glybera, for certain patients with lipoprotein lipase deficiency (LPLD) in the European Union. The patients have an enzyme deficiency that robs them of the ability to metabolize fat-laden particles in their blood, leading to inflammation of the pancreas and other complications such as diabetes. Glybera, which is indicated for patients whose disease can be controlled with diet and suffer from pancreatitis, is designed to mend the genetic defect underpinning the ailment.

    One to two patients in a million have the disease, making it an extremely rare condition. Yet patients with the disorder lack treatment options, so Glybera has a unique position in a niche market. UniQure plans to follow up the EC nod for the drug with regulatory submissions in the U.S., Canada and other markets.

    "Glybera's approval means LPLD patients, for the first time, have a medical treatment option for a very complex and severe disease," said Prof. John Kastelein of the Department of Vascular Medicine at the Academic Medical Center of the University of Amsterdam, the Netherlands, in a statement. "LPLD leads to acute and recurrent pancreatitis attacks, and in many patients causes early onset diabetes and cardiovascular complications. This therapy will have a dramatic impact on the lives of these patients. Currently their only recourse is to severely restrict the amount of fat they consume."

    Regulators had turned down the therapy repeatedly before supporting its approval, Reuters has reported. Those were just mild setbacks in what until recent years was a luckless field: Some patients on experimental gene therapy developed leukemia and one U.S. teen died, the BBC reported. Yet in recent years groups such as uniQure and Cambridge, MA-based Bluebird Bio have generated upbeat results and renewed faith in the field among investors.

    Yet there are all kinds of questions to answer about reimbursement. For instance, what's the value of a therapy that could correct a genetic defect for life with a single dose?

  15. flosz 5 november 2012 07:46
    Gene therapy hits European market
    A treatment for patients who cannot produce enough of an enzyme that is crucial for breaking down fat has become the first gene therapy product to make it onto the market in the western world.
    Amsterdam-based biotech company uniQure said today that the European Commission had approved its Glybera (alipogene tiparvovec) product for a subset of those suffering with familial hyperchylomicronemia, also called lipoprotein lipase deficiency (LPLD).
    Europe’s drug regulator had already recommended the drug for approval in July and the Commission’s move is largely a rubber stamp. It is, though, a significant moment for gene therapies, which have had trouble moving from bench to bedside (see ‘Europe nears first approval for gene therapy‘).
    “The final approval of Glybera from the EC marks a major step forward in making gene therapies available not only for LPLD but also for a large number of rare diseases with a very high unmet medical need,” said Jörn Aldag, CEO of uniQure, in a statement.
    But whether it heralds a new dawn for the area is uncertain. Writing for Nature earlier this year(Gene therapies need new development models www.iex.nl/Forum/Topic/1286507/3/Morg... ) , Fulvio Mavilio, the scientific director of Genethon in Evry, France, warned that “Although the approval of Glybera is a positive move, it is unlikely to herald a new age of gene therapies — not without significant changes to the system. It is no coincidence that no gene therapy has yet been approved in the United States and that no other gene-therapy product is being considered by regulators in Europe.”

    blogs.nature.com/news/2012/11/gene-th...
  16. DAGEVOS 5 november 2012 21:23
    uniQure Provides Business Update for the Third Quarter 2012

    Nov 5, 2012

    uniQure Provides Business Update for the Third Quarter 2012

    Amsterdam, The Netherlands – November 5, 2012 – uniQure B.V., a leader in the field of human gene therapy, today provided its non-audited business update on its trading for the period to September 30, 2012.

    Key Highlights
    Glybera® Marketing Authorisation Application approved by European Commission; Glybera becomes the first gene therapy approved by regulatory authorities in the Western world
    First gene therapy in the Western world to reach important regulatory approval milestone, culminating 40 years of research
    First therapy for LPL deficient patients, a severe disease with no alternative treatment
    Validates uniQure’s unique AAV-based gene therapy platform, consisting of a modular, plug-and-play vector system and unrivaled GMP manufacturing capabilities on a commercial scale
    Heralds new phase in uniQure’s development, including potential revenues from sales and partnerships
    Technology platform can now be leveraged to find solutions for many more severe genetic and other disorders

    Jörn Aldag, CEO of uniQure, commented: “We believe that after Glybera’s approval gene therapy is at the beginning of a period of rapid growth similar to the development of the antibody business in the last decade. uniQure’s gene therapy business is now well placed to deliver on the significant value that we have built up over many years. The validation of Glybera as the first gene therapy product to be approved in EU underpins the expertise developed at uniQure and the value of the other programs in our pipeline. We are extremely excited by this significant success.”

    Business Update

    The CHMP provided a positive opinion on Glybera’s Marketing Authorisation Assessment in July 2012; this was followed in October 2012 by the formal approval, under exceptional circumstances, of the European Commission. This approval will now permit uniQure to launch Glybera for commercial sales throughout the 27 EU member states. In addition, there are certain other territories in which it will be possible to launch Glybera based on the EU approval. First commercial sales of Glybera in Europe are expected in Summer 2013.

    The Company is now exploring registration of Glybera in North America and is developing its strategy for interaction with relevant regulators.

    Progress on uniQure’s other pipeline programs continues strongly. The Phase I/II clinical trial in acute intermittent porphyria patients is expected to start before the end of 2012. The study is being carried out by our partner, Digna Biotech, at the University of Navarra in Spain. The program is funded by a European grant.

    A Phase I study in Parkinson’s disease, sponsored by the US National Institute of Neurological Disorders and Stroke, and funded by the US National Institutes of Health is expected to treat its first patient also before the end of 2012. This program has been extensively developed by our collaborative partner University of California San Francisco.

    Encouraging progress also continues on our SanfilippoB and Hemophilia B programs, with both expected to begin clinical development within the next 12 months.


    About uniQure

    uniQure is a world leader in the development of human gene based therapies. In addition to its lead product, Glybera, which is now approved for commercialization in EU, uniQure has a product pipeline of further gene therapy products in development for hemophilia B, acute intermittent porphyria, Parkinson’s disease and SanfilippoB. Using adeno-associated viral (AAV) derived vectors as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate probably the world’s first stable and scalable AAV manufacturing platform. This proprietary platform can be applied to a large number of rare (orphan) diseases caused by one faulty gene and allows uniQure to pursue its strategy of focusing on this sector of the industry. uniQure's largest shareholders are Forbion Capital Partners and Gilde Healthcare, two of the leading life sciences venture capital firms in the Netherlands. Further information can be found at www.uniqure.com or www.lpldeficiency.com.


    For further enquiries:

    Jörn Aldag
    CEO
    uniQure
  18. [verwijderd] 6 november 2012 18:12
    En dan dit....

    First Gene Therapy Glybera (Finally) Gets EMA Approval
    By Nuala Moran
    Staff Writer

    LONDON – The first gene therapy to be approved in a Western regulated market finally made it over the finishing line on Thursday when the European Medicines Agency (EMA) gave the nod to Glybera after considering the treatment for lipoprotein lipase deficiency (LPL) for the fourth time.

    The developer, uniQure BV, is now looking at filing for FDA approval on the basis of the same clinical data that eventually convinced the EMA. "I'm pretty certain [the FDA] will accept it," CEO Jörn Aldag told BioWorld International.

    "I'm happy," he added. "We can tell people we're number one; we've done it. Glybera is approved, and gene therapy is something that the EMA now permits us to bring to patients."

    The historic approval is not only a breakthrough for gene therapy, but it also heralds a significant advance in the EMA's views of how clinical benefit should be assessed in rare diseases with high unmet medical need, where there are not enough patients to deliver statistically significant trial results. The much-studied file for Glybera (alipogene tiparovec) holds details of 27 patients only.

    The drawn-out process of approving Glybera has led the EMA into uncharted waters. In January, the European Commission refused to give its usual rubber stamp when the EMA recommended for the second time that Glybera be rejected, taking the unprecedented action of telling the agency to think again. Then, when its Committee for Medicinal Products for Human use (CHMP) vetoed Glybera for the third time in April, the EMA did not refer the negative verdict to the European Commission for approval, but took an internal decision to send Glybera back to the CHMP once more.

    The news is a triumph for uniQure (formerly Amsterdam Molecular Therapeutics), which has invested €50 million (US$60.8 million) in developing Glybera, of which it was forced to lavish €15 million on the protracted regulatory process. The impact of that was such that just before the EMA turned down Glybera for the third time in May, Amsterdam Molecular Therapeutics was de-listed, with the gene therapy assets being signed over to privately held uniQure. (See BioWorld Today, April 23, 2012.)

    Alastair Kent, director of Genetic Alliance UK, which represents more than 150 patient groups, said, "The decision the CHMP has finally made is the right one and a significant one. Gene therapy is not a panacea, but it does have the potential to address very significant unmet needs."

    But he told BioWorld International, "It's a shame Glybera had to go round in this ridiculous circle so many times; the EMA needs to look at its procedures."

    Putting the glory to one side, with pricing and reimbursement and marketing strategy still to be decided, the commercial significance for uniQure of the approval of Glybera is not clear at this point. "It's too early to talk about the commercial implications," Aldag said. "We don't know about pricing or the number of patients, though we estimate there are between 1 ,000 to 5,000 worldwide."

    UniQure ended work on Glybera when the EMA turned it down for the second time in October 2011. "We stopped all work and abandoned all the structures. We will now go ahead and rebuild," Aldag said. "There are two possible roads: one a partnership, the other doing it ourselves."

    The EMA is recommending approval of Glybera as a treatment for LPL under exceptional circumstances, meaning it will be administered at a few specialist centers. "We might need three clinics in Germany, two in Holland, for example, and so it will take a limited number of people to bring [Glybera] to patients," Aldag said.

    Patients with LPL are unable to process fat particles in the bloodstream, which accumulate to cause severe attacks of pancreatitis. "Patients with LPL are afraid of eating a normal meal because it can lead to acute and extremely painful inflammation of the pancreas, often resulting in a visit to intensive care," Aldag noted. "Now, for the first time, a treatment exists for these patients that not only reduces this risk of getting severely sick, but also has a multiyear beneficial effect after just a single injection."

    The need for a single treatment marks a divide between Glybera and enzyme replacement therapies for similar inherited enzyme deficiency disorders, which must be administered on a chronic basis. Marketed enzyme replacement therapies cost between €150,000 and €450,000 per patient, per annum, and Aldag thinks the pricing for Glybera should be a multiple of some price in that range to reflect the fact that a one off-treatment with Glybera has an effect that lasts over years.

    For Aldag, one of the most frustrating aspects of the regulatory delay was that neither the CHMP nor its expert advisory group, the Committee for Advanced Therapies (CAT), had any safety concerns about Glybera's use of an adeno-associated virus vector to deliver working copies of the LPL gene into muscle cells to enable production of the enzyme in the cells.

    "If the CAT had been dubious [about safety] I wouldn't have done anything, but with the CAT clearly positive it had to be pursued. Sometimes you just get the feeling something is wrong, and you need to do something," Aldag said.

    The CHMP's recommendation that Glybera be approved under exceptional circumstances means uniQure will be required to set up a registry to monitor outcomes in patients treated with Glybera, which the EMA will review.

    In its defense, Tomas Salmonson, acting chair of the CHMP, said the established ways of assessing the benefits and the risks of Glybera were undermined by the extreme rarity of the condition and also by uncertainties associated with data provided. "In close cooperation with the CAT we have worked out a way to ensure robust and close follow-up of the quality, safety and efficacy of Glybera."

    Christian Schneider, chair of the CAT, said he was concerned about reports of differences between the two committees during the approval process, noting, "The scientific assessment of the CAT and the CHMP were not far apart. The dossier is maybe a unique case where the ultra-rarity of the disease, its fluctuating rather than continuously progressing clinical course and the complexity of the scientific data led to difficult scientific decision-making."

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