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Home  /  Forum  /  BioPharma  /  Clinuvel, de droom van elke belegger......

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Clinuvel, de droom van elke belegger......

2.596 Posts
Pagina: «« 1 2 3 4 5 6 ... 130 »» | Laatste | Omlaag ↓
  3. frank2you 2 februari 2007 20:32
    De koers is flink teruggevallen maar dit was te verwachten... sommigen denken op korte termijn en geloven nog steeds op een high te kunnen verkopen en bij een low zich weer in kunnen kopen..... trend heet zoiets geloof ik..... ik zie uit naar nieuwe records op zeer korte termijn.
  7. Henk Snaph 5 februari 2007 11:18
    quote:

    bertvv schreef:

    [quote=bertvv]
    Gezien, op 0.49 krijg ik ze niet binnen.
    finance.yahoo.com/q?s=UR9.F
    [/quote]

    Inmiddels binnen.
    Deze link is duidelijker
    de.finance.yahoo.com/q?s=UR9.F
    Dit is echter alleen maar de koers van Frankfurt. Via Xetra handel zijn er nog 156.000 verhandeld.

    Henks
  11. frank2you 5 februari 2007 13:58
    Inderdaad, winstnemingen waardoor de koers dik terugvalt. Echter deze maand zullen we de 60 eurocent drempel gaan nemen, dus nu een goed moment om in te stappen. Kijk niet alleen naar het aandeel op de frankfurter boerse maar ook in australie = asx en de verenigde staten. Dan pas kun je volumes gaan beoordelen.
  14. frank2you 6 februari 2007 22:18
    Hahaha...ja Bert...ik slaap goed....heb er het volste vertrouwen in dat dit een parel is die tot ongekende omgang kan groeien. Meld je aan op www.sharescene.com en dicussieer met de beleggers van het eerste uur in dit aandeel. Daartussen zitten mensen die meegedaan hebben aan de trials in Australie en ook mensen die persoonlijk kontakt hebben met de raad van bestuur. Erg interessant.
  16. frank2you 7 februari 2007 13:17
    Ok, was ik mezelf nog niet eens van bewust. Kom wel dagelijks kijken hier op IEX maar deed eigenlijk weinig mee aan discussies op het forum en al helemaal niet met de zogenaamde experts zoals Nikken en Co. Als je het zo goed weet hoef je geen loonslaaf meer te zijn is mijn mening maar goed.

    Wat clinuvel betreft....stabiel ronde de 50 eurocent. Weinig schokkend nieuws deze week.
    We wachten dit jaar op :

    - de ontwikkelingen van Fase III
    - de ontwikkelingen betr. de patenten.
    - het evt. samenwerken met een grote speler op de farm. markt.
    - het steeds meer bekendheid krijgen in de markt.

    Dus momenteel...geduld hebben en afwachten.

  18. frank2you 21 februari 2007 21:35
    Beste Svenhedin,

    Dit heeft er alles mee te maken dat er op dit moment 2 keer zoveel vraag is dan aanbod...of met andere woorden.... de aanbieders kunnen hogere prijzen vragen. Nog kort geleden zakte de koers van 60 cent terug naar 50 omdat er heel veel winstnemingen waren....dus veel meer aanbod dan vraag...waardoor de prijs daalde. De 50 cent is een sterke bodem gebleken, de 60 cent een drempel die naar mijn mening volgende maand gepasseerd wordt.

    gr.
    Frank
  19. [verwijderd] 22 februari 2007 04:16
    Weer zeer goed nieuws.
    The only way is up.

    Clinuvel reports first positive Phase II clinical trial results of CUV1647 in new indication -EPP
    Clinuvel Pharmaceuticals Limited (ASX:CUV) is pleased to announce that a Phase II trial of CUV1647 met its endpoints in Erythropoietic Protoporphyria (EPP) patients.
    View Announcement




    Clinuvel Pharmaceuticals Limited is the new name for Epitan Limited.

  20. [verwijderd] 22 februari 2007 04:49
    Volledig artikel.

    Company Announcement
    Thursday 22nd February 2007
    Melbourne, Australia
    Clinuvel reports first positive Phase II clinical trial results of
    CUV1647 in new indication - Erythropoietic Protoporphyria
    (EPP)
    Clinuvel Pharmaceuticals Limited (ASX:CUV) is pleased to
    announce that a Phase II trial of CUV1647 met its endpoints in
    Erythropoietic Protoporphyria (EPP) patients (see Appendix I).
    The preliminary results of this photo-provocation trial showed that
    CUV1647 significantly delayed or abrogated the onset of pain
    induced by light stimulation. Furthermore, additional anecdotal
    reports from the diaries of all patients indicated that they were able
    to expose themselves to sunlight, without suffering the
    characteristic pain of EPP.
    EPP is currently one of four key indications that Clinuvel is
    investigating to pursue market approval of CUV1647. With these
    favourable results, Clinuvel intends to advance to Phase III as
    soon as possible, pending regulatory approval.
    Background to the disease
    EPP is a genetic condition characterised by severe light-sensitivity
    (phototoxicity) of the skin. It is a rare disorder (caused by a fault in
    heme synthesis) that affects between one in 200,000 and 750,000
    people. This condition mostly occurs in people with a fair-skinned
    complexion and is characterised by excruciating pain, swelling, and
    scarring (mostly hands and face). Typically, the pain experienced
    by these patients requires treatment with analgesics or antiinflammatory
    agents throughout their lives. EPP patients are often
    forced to remain shielded indoors, a lifelong behaviour that gravely
    affects their lives.
    Results
    The open label trial began in September 2006 at Triemli Hospital in
    Zürich, Switzerland. In the trial a controlled source of polychromatic
    light (light of multiple wavelengths) was used to emulate exposure
    of the skin to natural sunlight. Patients with clinically confirmed
    EPP were administered CUV1647 via two subcutaneous
    resorbable implants at two months intervals.
    In all 5 patients, the time to provoke pain (photoprovocation) was
    markedly prolonged (range: 384% - 1266%). The difference
    between the measurements of the photo-provocation times on
    days 0, 30, 60 and 90 days was statistically significant (p=0.0069).
    The increase in melanin density in EPP patients measured on days
    0, 30, 60 and 90 (measured at six anatomical sites) yielded
    statistical significance (p=0.0029).
    Discussion of the results
    Despite the limited number of patients in this trial, significance was
    obtained which indicated the potential efficacy of CUV1647 as a
    photo-protective drug for EPP patients. This potential efficacy was
    confirmed by the diary reports of all 5 patients.
    As a result of this clinical outcome, Clinuvel has decided to
    advance its clinical program in EPP by conducting multicenter trials
    in the near future in both Europe and Australia. This decision will
    accelerate the development of CUV1647 by proceeding directly to
    a multicentre trial in EPP, under conditions of use, i.e. in spring and
    summer, when these patients suffer the most.
    Clinuvel’s CEO, Dr Philippe Wolgen said:
    “This is an important outcome for us as it is a preliminary
    demonstration of efficacy in a new clinical indication for the
    company. It is both promising and exciting that we may have
    demonstrated the potential to improve ‘quality of life’ in a group of
    patients who do not seem to have a remedy for their incapacitating
    disease. One should know that infants affected by EPP most often
    suffer an isolated childhood due to their undiagnosed, severe pain.
    It often takes years of suffering and withdrawal before their parents
    and physicians recognise EPP. Notwithstanding the encouraging
    outcome so far, this study was not placebo controlled. The
    conclusive evidence will only come when we administer the drug in
    the upcoming multicenter controlled trials, under environmental
    conditions during the seasons.”
    These trial results further add to the safety and efficacy profile of
    CUV1647.”
    Appendix I Following Code of Best Practice ASX
    Name of trial
    Phase II, Open Label Photo-provocation Study to Evaluate the Safety and
    Efficacy of Subcutaneous Resorbable Implants of CUV1647 in Patients with
    Erythropoietic Protoporphyria (EPP)
    Blinding status
    Open label study
    Treatment method, frequency, dose levels
    One 20 mg resorbable biocompatible implant of CUV1647 administered
    underneath the skin into the fatty region above the hip (iliac crest) every two
    months for a 12 month period (six doses in total).
    Number of subjects
    Nine *
    Subject selection criteria
    Patients aged 18 to 70 years who have been diagnosed with EPP.
    Primary endpoint
    1. Time taken for the development of symptoms provoked during
    photoprovocation by a standardized light source (wavelength 380-650nm)
    onto the dorsum of the hand as predilection place and exposed area of the
    skin.
    Secondary Endpoints
    2. The number and severity of phototoxic reactions;
    The level of melanin density in the skin (6 areas measured);
    The quality of life.
    Safety and tolerability.
    * Following efficacy found in the first 5 patients treated, it was decided to terminate this
    Phase II trial and accelerate the development of CUV1647 by applying for permission to
    advance to an expanded multicentre trial in EPP trial to be conducted in Europe and
    Australia. The remaining 4 patients of the trial in Zürich are likely to be enrolled in the
    Phase III study (pending on regulatory approval).
    Trial location
    Triemli Hospital, Birmensdorferstrasse 497, CH-8063 Zürich, Switzerland
    About Clinuvel Pharmaceuticals Limited
    Clinuvel Pharmaceuticals Limited (ASX:CUV) is an Australian
    biopharmaceutical company developing its leading drug CUV1647 for the
    treatment of UV-related skin disorders. Clinuvel’s pioneering work aims to
    assist in preventing the global problem of UV related skin disorders, by
    developing CUV1647 in areas of unmet medical need.
    Phase I and II human clinical trials using CUV1647 have demonstrated
    that it is well tolerated and no significant safety concerns have been
    identified to date.
    Clinuvel is presently preparing to start further Phase II and begin Phase
    III clinical trials, with a view to complete them in 2009. Over the next few
    years and following completion of the clinical development program,
    Clinuvel will work closely with global regulators to facilitate market
    approval of CUV1647.
    For more information contact:
    Kate Liscombe, Investor Relations
    Clinuvel Pharmaceuticals Limited, Tel: +61 3 9660 4900
    investorrelations@clinuvel.com
    -End-
    Clinuvel is an Australian biopharmaceutical company focussed on developing its leading drug candidate, CUV1647, for a range of UV-related skin
    disorders resulting from exposure of the skin to harmful UV radiation.
    Pharmaceutical research and development involves long lead times and significant risks. Therefore, while all reasonable efforts have been made
    by Clinuvel to ensure that there is a reasonable basis for all statements made in this document that relate to prospective events or developments
    (forward-looking statements), investors should note the following:
    • actual results may and often will differ materially from these forward-looking statements;
    • no assurances can be given by Clinuvel that any stated objectives, outcomes or timeframes in respect of its development programme for
    CUV1647 can or will be achie
2.596 Posts
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