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Ablynx

3.291 Posts
Pagina: «« 1 ... 103 104 105 106 107 ... 165 »» | Laatste | Omlaag ↓
  3. [verwijderd] 26 februari 2015 14:28
    quote:

    abelheira schreef op 26 februari 2015 13:58:

    [...]
    Ik zou toch de boot nog wat afhouden. Diegenen die in Galapagos zaten hebben ongeveer hetzelfde meegemaakt na het afhaken van o.a. GSK.
    Ja we gaan het horen om 15.00 van de Heer Moses.
    Laat hem maar van de berg afkomen.
    Na een terugtest on de 10 nu weer marginaal erboven voor wat het waard is.
    Daar is geen pijl op te trekken. Vanochtend was de opening 11.48 geen vuiltje aan de lucht...
    Nu al over 1 miljoen aandelen verhandeld. Dik 10 M€.
  8. [verwijderd] 26 februari 2015 15:42
    quote:

    de tuinman schreef op 26 februari 2015 15:38:

    [...]

    Ik merk idd dat slecht nieuws altijd verpakt word in jaar/kwartaal overzichten. Je zou bijna gaan denken om je aandelen voor die tijd te verkopen en daarna weer terug te kopen.
    Doet me denken aan Galapagos . Die weet/wist ook het schrappen van belangrijke partnerships goed te verbloemen .
  10. forum rang 6 de tuinman 26 februari 2015 15:51
    quote:

    Natte krant schreef op 26 februari 2015 14:45:

    Ablynx: “Lager advies op mager rapport”

    maar bij de detail rapportage zijn ze bij KBC weer een stuk postiever...rept men over opportuniteiten. Op welk niveau dat mogen we zelf uitvlooien :-)
    Het is een licht positief verslag met ook de pijnpunten genoemd vind ik.

    Ik vind het een duidelijk verhaal. Er zitten wel tegenvallers in het verslag maar ze geven ook duidelijk aan dat de koersval behoorlijk overdreven is.
    Het zal wel te maken hebben met de koersstijgingen de laatste maanden.
    Even een correctie, maar ik hoop toch wel dat we boven de € 10,- blijven.
  12. [verwijderd] 26 februari 2015 17:00
    quote:

    bioscience schreef op 26 februari 2015 15:52:

    [...]

    ???? Die is al aan het borrelen .

    Gaan we nog een keer onder 10 vandaag of wordt het morgen ?
    Het zal voorlopig wel kwakkelen worden hier
    aan de andere kant!
    De kopers kopen nu voor 10 - 10,50...dat is veel meer dan de kopers uit 2014..
    Maar eens kieken wat er beurt.
  13. aston.martin 26 februari 2015 18:01


    In september '13 steeg het aandeel Ablynx met 0,8 euro na het akkoord met Merck Serono. Rekening houdend met het aantal aandelen steeg de beurswaarde met ca. 38 miljoen euro.

    Vandaag daalt het aandeel Ablynx met 1,4 euro na het beëindigen van dit akkoord. Rekening houdend met het aantal aandelen daalt de beurswaarde met ca. 75 miljoen euro.

    Tussen beide tijdstippen liggen slechts 18 maanden. Dit betekent dat deze onderzoeken dus nog in een vroege onderzoeksfase zaten en er bijgevolg nog niet veel waarde gecreëerd werd. Ik begrijp deze koersdaling dan ook niet zo best en de grootte van de daling staat mijns inziens niet in verhouding met werkelijkheid. Kuddegedrag?

    Dat de eerste 5 kinderen met succes behandeld werden tegen RSV vind ik op dit ogenblik belangrijker omdat dit project reeds in fase is. Dit feit werd vandaag echter volledig genegeerd.

  15. silverwheaton 26 februari 2015 18:08
    quote:

    aston.martin schreef op 26 februari 2015 18:01:

    In september '13 steeg het aandeel Ablynx met 0,8 euro na het akkoord met Merck Serono. Rekening houdend met het aantal aandelen steeg de beurswaarde met ca. 38 miljoen euro.

    Vandaag daalt het aandeel Ablynx met 1,4 euro na het beëindigen van dit akkoord. Rekening houdend met het aantal aandelen daalt de beurswaarde met ca. 75 miljoen euro.

    Tussen beide tijdstippen liggen slechts 18 maanden. Dit betekent dat deze onderzoeken dus nog in een vroege onderzoeksfase zaten en er bijgevolg nog niet veel waarde gecreëerd werd. Ik begrijp deze koersdaling dan ook niet zo best en de grootte van de daling staat mijns inziens niet in verhouding met werkelijkheid. Kuddegedrag?

    Dat de eerste 5 kinderen met succes behandeld werden tegen RSV vind ik op dit ogenblik belangrijker omdat dit project reeds in fase is. Dit feit werd vandaag echter volledig genegeerd.

    Mooie samenvatting van een bewogen dag. Ik zit er reeds een eeuwigheid in en blijf dat lekker achterover leunend verder doen! Lang leve 't gezond verstand! :)
  16. Acht 27 februari 2015 10:36
    Met dank aan de altijd waardevolle bijdragen van obelisk van beursig:
    door Obelisk » 27 Feb 2015 06:14

    Met dank aan Seeking Alpha:

    Question-and-Answer Session

    Jan De Kerpel - KBC Securities
    Hi, good afternoon. Thanks for taking my questions. I have three questions. First of all, on the RSV project you said that, there was a clear winter effect of mild winter on the recruitment what were actually other reasons for the slow recruitment, could you also share with us how many sites were open in the Northern Hemisphere at the start of this season versus how many were not yet open at this moment in time?

    And could you share with us, how many sites you anticipate to open in Australia and Asia? The second question is on caplacizumab. Which kind of elements are you looking for in Phase III trial design which are different from the acute setting at the Phase II TITAN trial, was if you could elaborate on that? Will you go for an SBA in your discussions with the FDA? And what timing of read out and submission for the BLA are you anticipating?

    The third question relates to Merck Serono, what areas I mean disease areas were the projects in that will be in worked on? And in what stage were they? I believe, Edwin that you also said during your presentation that they were going to use their resources elsewhere, maybe I misunderstood it, but if not could you elaborate a little bit on what you really mean by, that are you referring to the Pfizer deal? Thank you.

    Edwin Moses - Chief Executive Officer
    Okay, thanks very much, Jan. It's a lot of questions and we'll try and answer them more, but will start with your first question what you asked, first a little about RSV, what were the other reasons apart from the mild winter. The recruitment was challenging, you asked about how many sites were opened in beginning of the study in Europe and then you also asked about our intentions in terms of number sites in Australia and Asia. Dominique, do you want to deal?

    Dominique Tersago - Chief Medical Officer
    Yes, the things with the seasonal effect. We had about five sites opened towards the end of the year and at the beginning of this year that had increased to 12 sites that were able to recruit, but with it being a mild winter and the peak being not easy to predict and again the challenges of having parents’ consent to their infants be included in the clinical trial as an investigational product. Meant that possibly for some of the sites that were opened later, that the peak season was actually list [ph].

    With regard to the number of sites that we plan to open in Australia, we are looking at opening six sites there, but we're looking at opening a higher number than that in the Asian countries that we are currently investigating and what is worth pointing out because it is a seasonal disease, expanding sort of geographic spread to the southern hemisphere and Asia, we are now going to cover sort of full year potential for recruiting patient. So that we don't lose any months of recruitment because we're in the wrong geographic reason for that season.

    Edwin Moses - Chief Executive Officer
    If I can just add to that as well, I think one very important criteria is, we have very strict inclusion, exclusion criteria. It's a very vulnerable patient population and so it's very important that we only attempt to treat the right patients. So for instance, we don't treat very young patients. Patients who are one-month or two months old in this trial. We will intend to do that in the future trials because they're very important part of these potential groups of patients that could benefit from this product, but they're not the people that we should start with from a safety perspective.

    So there are reasons like that and we've also seen in the season that there seem to be a least [ph] in the sites that we were dealing with, a shift to other sites being younger patient group which will cement [ph] them more excluded. This varies from region-to-region as well as that we see where, for example Asia it appears that, the groups, the Asia, the groups admitted to hospital might be a little older. So that completes the question, try to answer now and caplacizumab.

    Let me start on the USA Phase III design and about SBA and about timing submission of BLA. On the Phase III design, we're not going to go into details on this call on that simply because we're still interacting with the regulatory authorities and we don't want to prejudice those discussions at all. We will come back to that in the future as soon as that Phase III design is being concerned. Dominique, do you want say about the SBA and about those questions?

    Dominique Tersago - Chief Medical Officer
    I think with regard to the SBA, what I can say is that the interaction that we had is regulators both in Europe and the US were actually very positive. They were very constructive, engaged discussions that we have with them and part of that engagement is also to allow us to progress on a more informal basis with the agencies to actually ensure that the expectations about the Phase III trial and our regulatory process as the procedures that we'll be following that those expectations are fully aligned.

    So we actually at this point prefer to continue with sort of informal discussions, as we feel that gives us the most flexibility and the needed feedbacks that we have. With regard to the read out for BLA submission. Clearly it's the Phase III trial, we're aiming to have that done. The size of that trial will be similar to the number of patient that we had included in the TITAN trial, with the positive results that we have in the feedback from the clinical experts and the design of the study that we're looking at the moment.

    We anticipate that trial will read out potentially during the review of period of the MAA for Europe. So that the BLA could follow shortly on that.

    Edwin Moses - Chief Executive Officer
    Okay and if I can just then the pick up your last question for Merck Serono. You asked about the areas we're involved in. I think a key part of that, research agreement we signed in 2013 with Merck Serono was that, the aim was to have a research group here at Ablynx that was able to interact with all the therapeutic activity, all the therapeutic division. So there were a number of broad areas that were involved in and what I was referring to, I think the more, every company, every pharmaceutical company has to from time-to-time review the priorities of its activities that's what every company does and I think we respect the fact that, we've seen for example activity of Merck Serono in the very large deal with Pfizer in immuno-oncology which we were clearly taking a considerable resource and we interpret that, might well lead to reprioritization from their site.

  17. Acht 27 februari 2015 10:36
    Vervolg:

    Jan De Kerpel - KBC Securities
    Okay, thank you very much. Just on the Merck Serono, you were not working with them on immuno-oncology? Correct.

    Edwin Moses - Chief Executive Officer
    We're not disclosing the detail of what we're actually doing with them that would be breaching the confidentiality of the agreement.

    Jan De Kerpel - KBC Securities
    Okay, thanks. I go back in the queue.

    Edwin Moses - Chief Executive Officer

    Peter Welford - Jefferies
    Thanks for taking my question. The first question is just with regards to coming back to caplacizumab. I wonder, if you could perhaps just [indiscernible], the difference and opinion between the Europeans and the FDA with regards to their assessment of the data and equally if you could comment with regards to given that, you're going to file for conditional approval in Europe, whether or not you're confident without having the Phase III data with sufficient, I guess health economic data from the TITAN trial to support favourable pricing and use in Europe or whether or not the Phase III trials, as you seem to suggest could potentially be used within the review.

    So trying and supplement the data that the Europeans will have and then secondly just on the outlook for cash burn of €70 million to €80 million. Does that or you assume no further funding or income from Merck Serono, that the Merck Serono collaboration ends or what sort of assumptions are based on that in that outlook? Thank you.

    Edwin Moses - Chief Executive Officer
    Thanks, Peter. Pick up those questions. The first question was to help you understand the different types of opinion that people have might caplacizumab data and Dominique will pick up on that.

    Dominique Tersago - Chief Medical Officer
    Okay, I think, just worth pointing out that. It depends really how you look at the results and if you look at the one of the key secondary endpoints that was presented just earlier. If you look at the current rate in the one month post-plasma exchange caplacizumab treatment period. You see that, the patients treated with caplacizumab there was 71% reduction in the number of patients who actually had a recurrence compared to the placebo treated patients.

    This can be seen as being a sufficient clinical benefit which can warrant in early approval on given the high end met medical need, but what we also saw is that, for a number of patients who have persistent low [indiscernible] for routine activity, when caplacizumab is stopped that prevention of those recurrences probably requires a longer duration of caplacizumab.

    And that's a question of whether you want to have that data upfront, you see those results upfront or if you want to see before you're giving approval or you expect that, the unmet need is high enough to warrant that early approval as of the data which supports that. So it's again, it's a question of, I think you also have to realize that the European regulation and the FDA they work in somewhat different sort of legal and social medical environments and that when it comes to benefit risk assessment, there are various factor that play a role there.

    Edwin Moses - Chief Executive Officer
    Thanks, Dominique and just to answer your question, when we think of going for conditional approval. Do we have enough data? We've already taken the TITAN data and talked to a number of payors [ph] and healthcare opinion leaders to establish release preliminary thoughts on pricing levels believe that the data, that we already have from the TITAN study can support those pricing levels as you say, we may be able to use some of the data from the Phase III that will be in progress to support that.

    And then finally to coming back to your question on the Merck Serono. Yes, we have assumed in our budget for this year and net cash burn that we've given you. We have assumed that Merck Serono will not proceed further with the deal that we sign in 2013. So that's already included in the cash burn forecast.

    Peter Welford - Jefferies
    Okay, that's great. Thank you.

    - See more at: beursig.nl/forum/viewtopic.php?f=4&am...
  18. Acht 27 februari 2015 10:39
    Vervolg

    Roderick Verhelst - Petercam
    Good afternoon, thank you for taking my questions. On RSV, how certain are you that you will be finishing recruitment before year end because it's you're required at the start of the RSV trial that you would complete it by your present data by fourth quarter. So how certain can we be that you will be able to close recruitment by year end and the second question is on caplacizumab.

    What was the main difference between how do you European authorities and then the US authorities look through the data of caplacizumab because one opted wanted to go for an conditional approval, while the other opted not to do that? So what was the main issue and how should we look into that? Thank you.

    Edwin Moses - Chief Executive Officer
    Thanks, Roderick. The second question, just answered to Peter Welford. So I think we'll just leave it through the answer that Dominique gave then and assuming in particular that you want to pick [indiscernible]. The first question in terms of the RSV timing. We always made it clear, if you look to for instance, our most recent presentation JP Morgan that we had mitigation strategies and therefore we are planning to look at countries where the RSV season was later, such as Australia.

    I don't think any companies particularly moving into an areas such as RSV or any other can give you a categorical assurance, but it can finish certain clinical trial on time. You make certain assumptions and build them into your planning. I think what the good news is, over the last few months. We've learned an awful lot about RSV and the clinical centers in which it is treated and how best to think about these trials going forward.

    So it's an expertise that we're building up all the time. And with their assumptions around the type of sites that we will intend to include in the study in other regions of the world. We come to the conclusion that we expect to finish the trial before the end of 2015. If that's conclusion with the change, we're certain to let you know.

    Roderick Verhelst - Petercam
    But you're quite confident that, with the number of sites that you currently planning to open that it will be enough.

    Edwin Moses - Chief Executive Officer
    We're confident with the assumptions that we made, that, that's the right planning, but you got to keep on reviewing things like any clinical study as every company running clinical studies on that.

    Roderick Verhelst - PetercamTrung Huynh - Jefferies Group
    Hi, Edwin. Just two from me. The first one, how much more does Ablynx need to do to complete CMC infrastructure for caplacizumab and how long do you think, this will take? And the second, with Merck expected to terminate this collaboration, do you still expect to begin the Phase I oncology trial with ALX-0751? Thanks.

    Edwin Moses - Chief Executive Officer
    Okay, just on the CMC question. I think that, what we indicated is that, we're carrying out process validation work at the moment on the new formulation, which we shown by equivalence to the lyophilised formulation and that's on the critical path now, that's why, even conditional filing will happen in the first half of 2017. So that's, that gives you an indication there the work that we emphasis around the CMC.

    In terms of the Merck Serono, there may be a little bit of confusion there. Those things are separate, so there were a series of deals with Merck Serono from 2008, 2010, 2011. In which, we referred to the so-called CoCo deals and the research deal that we're talking about in September, didn't include that oncology programme that's a completely separate programme, that we've mentioned in the press release is one that Merck has decided not to proceed with Merck Serono decided not to proceed those at this time.

    So that's quite separate from the research agreement that we've been referring to.

    Trung Huynh - Jefferies Group
    Okay, great thanks.

    Sachin Soni - Kempen
    Good afternoon, everyone. My question is regarding ALX-0061. Can you reveal the dose, what doses are you going to test because it just is three doses that are and on - as a follow-up on that one, primary endpoint is ACR20 is that endpoint sufficient enough to trigger the OP 10 or would you need to see something more than ACR20 as such in totality and what could that be? Thanks a lot.

    Edwin Moses - Chief Executive Officer
    Sachin, we can't tell you the doses unfortunately. We regard that its' proprietary information, so we're not revealing that. And I leave Dominique, join for the question round is that ACR20 sufficient?

    Dominique Tersago - Chief Medical Officer
    Well, ACR20 is still a new front for regulatory process, it's still a relevant parameter and we have a ACR50 and ACR70 as secondary endpoint to number of other measures of clinical response rheumatoid arthritis with regard to what you give the deal and I think that's also confidential information and it's the relevant endpoints are and the data is being collected in the studies to ensure that we'll have read outs that will allow that assessment to be made by AbbVie.

    Edwin Moses - Chief Executive Officer
    But you're right to assume, I think that's part of your question. Sachin, I think as part of your question. Sachin, ACR20 is not sufficient to drive a commercial decision. Of a efficacy indications that what really drive those commercial decisions.

  19. Acht 27 februari 2015 10:39
    Vervolg:

    Sachin Soni - Kempen
    And just as a follow-up on this one. So I do understand safety comes into play, but we say, when we move from 12-week to 24-week a 100% response in a dose arm at this level. When you're designing this trial, what is a number which would really make you happy? Do you really need to cross ACR20 or ACR70 or anything above ACR60 would be fine or should we just look at Actemra and that is number, which is going to announce.

    Edwin Moses - Chief Executive Officer
    I think what we've indicated is that, as you're saying if you look at the data that we published on the same IIa study and you look at the ACR50 response. We saw something like 71% of patients achieve an ARC50 score and from what we can tell in the literature, if you look at something like Humira, we generally believe that some like 40% to 45% of patients will see, an ACR50 response.

    Therefore, you can see that our results from that obviously much smaller group of patients in the Phase IIa were substantially proven or published in the literature. I think it's fair to say that AbbVie another or so expect this necessarily to achieve the same levels in a much expanded more heterogeneous study in a Phase IIb. So we don't have to reproduce those data in order for that trigger AbbVie moving forward, but we clearly have to do substantially better than the current product on the market, but you're right also, that there are other criteria related not just to efficacy but to safety, which we also have to achieve.

    Sachin Soni - Kempen
    That's helpful. Thanks a lot.

    Operator

    As there are no further questions at this time. I would like hand the call back to Mr. Edwin Moses for any concluding remarks.

    Okay, well thank you everybody for joining the call. I think that was very useful discussion. We really had a very good 2014, lots of events happening and starting in 2015 as our pipeline becomes more mature and we continue to consider further the opportunity to commercialize the first off products that might reach the market, which is caplacizumab that could reach the market in 2018. Thank you very much for joining us and good afternoon.

    - See more at: beursig.nl/forum/viewtopic.php?f=4&am...
    Okay, thank you.
  20. [verwijderd] 27 februari 2015 14:14
    Ik zag deze koersdoelen op beursig nog voorbij komen..ziet er toch nog gewoon goed uit. Ja ik weet ook dat koersdoelen niet zaligmakend zijn maar toch ze helpen mee en als ze de verkeerde kant op wijzen dan zijn het catalysatoren zullen we maar zeggen. Welnu here are the results

    Advies/koersdoel Petercam:
    Van kopen naar opbouwen, koersdoel van 8,50 naar 13!

    Advies/koersdoel KBC Securities:
    Kopen, koersdoel van 18 naar 17

    Advies/koersdoel Jefferies:
    Kopen, koersdoel 15 - See more at: beursig.nl/forum/viewtopic.php?f=4&am...
3.291 Posts
Pagina: «« 1 ... 103 104 105 106 107 ... 165 »» | Laatste |Omhoog ↑

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