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BioPharma « Terug naar discussie overzicht

Genmab, de Deense parel

3.464 Posts, Pagina: « 1 2 3 4 5 6 7 8 9 10 11 12 13 14 ... 170 171 172 173 174 » | Laatste

Omlaag ↓

sheriff Grover 1 mei 2013 18:58

Genmab A/S: Genmab Announces Top-Line Phase II Results for Ofatumumab Combined with Bendamustine in Untreated and Relapsed Chronic Lymphocytic Leukemia
Company Announcement

-- 95% overall response rate and 43% complete response rate in patients with previously untreated chronic lymphocytic leukemia -- 74% overall response rate and 11% complete response rate in relapsed chronic lymphocytic leukemia -- Treatment was well tolerated with 87% of patients completing the full treatment course

Copenhagen, Denmark; May 1, 2013 - Genmab A/S (OMX: GEN) announced today top-line results from a Phase II study of ofatumumab in combination with bendamustine in patients with untreated or relapsed chronic lymphocytic leukemia (CLL).

A total of 97 patients were treated in the study and 87% of patients completed the full course of six cycles of therapy. The study population comprised 44 patients with untreated CLL and 53 patients with relapsed CLL. In patients with untreated CLL the overall response rate (ORR) was 95%, with a complete response (CR) rate of 43%. The ORR in patients with relapsed CLL was 74%, with a CR rate of 11%. Treatment with ofatumumab and bendamustine was well tolerated by patients in the study . The most common adverse reactions (>20% of patients) were neutropenia, nausea, rash, pyrexia and thrombocytopenia.

"These data show encouraging clinical responses in patients treated with ofatumumab plus bendamustine, a commonly used chemotherapeutic agent, in both untreated and relapsed CLL. This is only the first set of key data we expect to report for ofatumumab over the next 15 months. Data from five pivotal studies are due during this time period, including results from a Phase III study of ofatumumab in front line CLL during the first half of 2013," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

About the study This Phase II study included patients who had untreated and relapsed CLL. Patients in the study were treated with a maximum of 6 cycles of study treatment. All subjects received 3 cycles of ofatumumab plus bendamustine and were eligible for additional treatment cycles dependent upon response to treatment. The primary objective of the study was to evaluate the investigator-assessed overall response rate according to the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated National Cancer Institute-sponsored Working Group (NCIWG) guidelines, in two populations: subjects with untreated CLL and subjects with relapsed CLL treated with ofatumumab plus bendamustine.

About chronic lymphocytic leukemia CLL is the most common form of leukemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the United States of America alone in 2013. At present, no cure is available.

About ofatumumab Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops (Teeling et al 2006). Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline. Ofatumumab is marketed under the trade name ARZERRA® and is approved to treat chronic lymphocytic leukemia (CLL) in patients who are refractory to fludarabine and alemtuzumab in the US and EU as well as other territories. The approval was based on results from a pivotal study in this refractory patient population where 42% of patients responded to treatment with ARZERRA. These patients had a median duration of response of 6.5 months.

In the pivotal trial on which approval was based (total population n=154), the most common adverse reactions (â‰¥10%, all grades) to ofatumumab were neutropenia, pneumonia, pyrexia, cough, diarrhea, anemia, fatigue, dyspnoea, rash, nausea, bronchitis, and upper respiratory tract infections. The most common serious adverse reactions were infections (including pneumonia and sepsis), neutropenia, and pyrexia. A total of 108 patients (70%) experienced bacterial, viral, or fungal infections. A total of 45 patients (29%) experienced â‰¥Grade 3 infections, of which 19 (12%) were fatal. The proportion of fatal infections in the fludarabine- and alemtuzumab-refractory group was 17%.

ARZERRA is not approved for the treatment of untreated CLL anywhere in the world.

About Genmab A/S Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, ofatumumab (ARZERRA®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information visit www.genmab.com.

Contact: Rachel Curtis Gravesen, Senior Vice President, Investor Relations & Communications T: +45 33 44 77 20; M: +45 25 12 62 60; E: r.gravesen@genmab.com

sloebervos 1 mei 2013 22:15

Ik heb in den tijd aandelen Genmab gekocht op de duitse beurs.Op mijn effektenrekening staan ze nu vermeld onder ticker GE9 en sedert 09/11/2011 staan ze gekwoteerd aan 3,96€.Kan iemand mij zeggen als hij ook dat probleem heeft gehad,of ze niet meer op de duitse beurs gekwoteerd zijn en wat er in dit geval moet of kan gebeuren.Ik heb een e-mail gestuurd naar de bank maar nog geen antwoord gekregen.Alvast bedankt voor een antwoord.

sheriff Grover 2 mei 2013 14:16

Nordea verhoogt koersdoel naar 220DKR , Danske Bank naar 190DKR .

Sheriff Grover

sheriff Grover 7 mei 2013 17:56

Genmab A/S: Genmab Announces Financial Results for the First Quarter of 2013

May 7, 2013; Copenhagen, Denmark; Interim Report First Quarter 2013

-- Arzerra® received approval in Japan -- Arzerra net sales increased 65% over Q1 2012 -- Manufacturing facility sold to Baxter -- Improved operating result by DKK 73 million over Q1 2012

"We expect 2013 to be another exciting and productive year at Genmab and are working hard to fulfill the objectives we set for this year. We were pleased to gain approval for Arzerra in Japan, the first Asian territory to give marketing authorization to the product, as well as to see growing sales during Q1. We recently reported impressive top line results from a Phase II study using ofatumumab together with bendamustine to treat CLL patients and look forward to reporting important Phase III data from our frontline CLL study with ofatumumab in the coming time," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

Financial Performance First Quarter

-- Genmab's revenue was DKK 160 million for the first quarter of 2013 compared to DKK 94 million for the corresponding period in 2012. The increase of DKK 66 million or 70% was mainly driven by higher Arzerra royalties, revenue related to our daratumumab collaboration with Janssen Biotech (Janssen) and the achievement of a milestone under our collaboration with GlaxoSmithKline (GSK). -- Operating expenses decreased 5% from DKK 138 million in the first quarter of 2012 to DKK 131 million in the first quarter of 2013. -- Operating income was DKK 29 million in the first quarter of 2013 compared to an operating loss of DKK 44 million in the corresponding period for 2012, an improvement of DKK 73 million. The improved operating result was driven by increased revenue and continued strong focus on cost control. -- The net result for discontinued operation amounted to a net income of DKK 42 million in the first quarter of 2013. The net income in 2013 related to the final few months of running costs of the Minnesota manufacturing facility of DKK 10 million prior to its divestiture and a gain on the sale of DKK 52 million. The facility maintenance cost amounted to DKK 10 million in the first quarter of 2012. -- On March 31, 2013, Genmab had a cash position of DKK 1,554 million. This represented a net increase of DKK 38 million from the beginning of 2013, which was primarily related to proceeds received from the sale of the manufacturing facility. The cash burn for the first quarter of 2012 was DKK 74 million.

Business Progress First Quarter to Present

-- February: The Minnesota manufacturing facility was sold to Baxter Healthcare (Baxter) Corporation for USD 10 million. -- March: Arzerra received approval in Japan for use in patients with relapsed/refractory CD20-positive chronic lymphocytic leukemia (CLL). The approval triggered a milestone payment of DKK 20 million from GSK to Genmab. -- April: The US Food and Drug Administration (FDA) granted Fast Track designation for daratumumab. This designation covers patients with multiple myeloma who have received at least three prior lines of therapy including a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or are double refractory to a PI and an IMiD. -- April: GSK reported net sales for Arzerra for the first quarter of 2013 of GBP 20.5 million, an increase of 65% over Q1 2012, resulting in royalty income of DKK 36 million to Genmab. A large portion of the rest of the world sales in the first quarter of 2013 were related to the supply of ofatumumab for clinical trials run by other companies, and as such does not reflect ongoing commercial demand. -- April: The U.S. Court of Appeals for the Federal Circuit upheld the U.S. District Court's judgment in favor of GSK in a patent infringement case involving Arzerra brought against GSK by Genentech and Biogen Idec. -- May: Reported impressive top line data from a Phase II study of ofatumumab in combination with bendamustine in patients with untreated or relapsed CLL. The overall response rate (ORR) in the study was 95% in previously untreated patients and 74% in patients with relapsed CLL. -- May: The US FDA granted Breakthrough Therapy Designation for daratumumab for the treatment of patients with multiple myeloma who have received at least three prior lines of therapy including a PI and an IMiD or who are refractory to a PI and an IMiD.

Outlook Genmab is maintaining its 2013 financial guidance as announced on March 7, 2013.

[verwijderd] 15 mei 2013 12:54

Stijgt en stijgt en stijgt. Was ook hard nodig voor de beleggers die er al jaren geleden in zijn gestapt. Zit zelf nog met een gemiddelde van rond de 3oo DKR.
Interessante discussies over Genmab: www.euroinvestor.com/exchanges/nasdaq...
Met wat Google translate kom je een heel eind.
Groeten,
RO57

sheriff Grover 16 mei 2013 17:06

Ro 57 , met een beetje geluk heb je dit jaar je geld nog terug :o) vandaag weer een sterke dag DKR 180 ... arzerra data in juni worden belangrijk als die daadwerkelijk goed zijn en ze kunnen voor first in line opteren dan ziet het er erg goed uit IMHO

gr Sheriff Grover

[verwijderd] 16 mei 2013 20:02

@ sheriff Grover,

fase 3 studie in front line CLL is toch gedurende eerste 6 maanden van 2013?
De uitkomst daarvan zal dus nog wel even op zich laten wachten.
Groeten,
Ro 57

sheriff Grover 16 mei 2013 20:58

Ro57 valt toch wel mee ?? we zitten in maand 5 tenslotte ? ;O)

benito c. 17 mei 2013 10:37

Bedankt, Grover, voor het ons telkens op de hoogte houden.

[verwijderd] 17 mei 2013 10:53

Gezien de grote koersstijging van de laatste periode zou er wel eens zeer goed nieuws uit deze fase3 studie kunnen komen.

Een koers van momenteel 190DKK is relatief nog vrij laag. GSK kocht haar bijna 10% belang jaren geleden voor naar wat ik heb begrepen ruim 400DKK. De successen worden na jaren van hard werken meer en meer zichtbaar.
Johnson&Johnson heeft vorig jaar mazzel gehad met de aankoop van haar 10% belang.

Zelf heb ik gelukkig op de lage koersen ook nog flink bijgetankt. Crucell was mijn eerste belegging in biotech. Die club werd via een vies spel overgenomen. Genmab zie ik hopelijk niet opgeslokt worden en zelfstandig doorstoten naar de absolute wereldtop. Een koers van 800DKK eind 2014 lijkt mij niet onrealistisch nu naast de successen Daratumumab de breakthrough status heeft gekregen van de FDA.

[verwijderd] 17 mei 2013 11:33

Het zal toch niet waar zijn!! 300DKK is een schijntje. Waarom betalen ze nu de successen daar zijn een stuk minder dan een paar jaar geleden? Ik word helemaal ziek van die pharmareuzen.

'Glaxo heeft interesse in Genmab'

LONDEN (AFN/BLOOMBERG) - De Britse farmaceut GlaxoSmithKline heeft interesse in een overname van het Deense biotechnologiebedrijf Genmab. Dat meldde de Daily Mail vrijdag op basis van ,,geruchten in de markt''.

Glaxo zou een bod overwegen van 300 Deense kroon (zo'n 40,24 euro) per aandeel. Glaxo is op dit moment de op twee na grootste aandeelhouder van Genmab met een belang van 9,9 procent. Het Amerikaanse Johnson & Johnson heeft 10,6 procent van het Deense bedrijf in handen. Zowel Glaxo als J&J hebben samenwerkingsverbanden met Genmab.

Op de beurs in Oslo maakte het aandeel Genmab een koerssprong op de berichtgeving, naar het hoogste niveau sinds augustus 2009. Het aandeel is zo'n 191 Deense kroon waard. Genmab werd in 1999 opgericht in Kopenhagen en heeft 180 medewerkers in dienst. Het heeft in Nederland onderzoek- en ontwikkelingslaboratoria in Utrecht. Verder is er een klinisch ontwikkelingsteam in Denemarken en een administratieve tak in de Verenigde Staten.

Een zegsman van GlaxoSmithKline wilde geen commentaar geven op het bericht in de Daily Mail.

(ANP Redactie AFN/Economie, email economie(at)anp.nl, +31 20 560 6070)
17-05-2013 11:19:16

[verwijderd] 17 mei 2013 11:45

Mijn exit-alias is gebaseerd op TomTom, maar kennelijk is 'nomen est omen' ook hier van toepassing. Zo zie ik de afgelopen jaren telkens mijn pareltjes overgenomen worden. Meestal op een vieze manier. Hopelijk kan grootaandeelhouder Stienstra er in dit geval nog een stokje voor steken en een redelijkere prijs van rond de 500DKK bedingen.

[verwijderd] 17 mei 2013 11:55

quote:
sheriff Grover schreef op 13 maart 2013 14:39:
Stap voor stap gaat het er beter uitzien ....

Nordea heel positief rapport uitgebracht met een koersdoel van DKR 148 ,

conclusie Nordea:

At our target price of DKK 146 per share, Genmab moves up to around

Immunogen's level in tech value, but is still 25% below Algeta and Isis and

40% below Thrombogenics and Swedish Orphan Biovitrum.

www.algeta.com/

www.thrombogenics.com/

www.isip.com/Pipeline/Therapeutic-Are...

www.sobi.com/

We have chosen quite a broad biopharma and biotech peer group that

illustrates the major value gap between Genmab and some of highest

valued peers, such as Pharmacyclics, Onyx, Medivation and Algeta. The

tech value gap between Genmab and some of these loss-making

biopharma peers is five to tenfold, which is food for thought. To look

specifically at one company, Pharmacyclics in the US has a tech value of

around USD 6bn, ie ten times that of Genmab. Pharmacyclics has one

project in phase III, two in phase II and one in phase I and partnerships

with Janssen and Servier. We acknowledge that Pharmacyclics' lead

programme, Ibrutinib, has been characterised as a breakthrough compound

by the FDA and it could very well be the "next big thing" within

lymphomas, but this is still a very large value gap to Genmab.

Furthermore, Genmab's Daratumumab could very well be the "next big

thing" in multiple myeloma and it cannot be ruled out that it could be

selected as breakthrough therapy too.

En hier een stuk over Genmab duobody in een toonaangevend amerikaans tijdschrift pnas :

www.pnas.org/content/early/2013/03/08...

Sheriff Grover

Tienvoud = 1239 DKK!!!!!!
Daratumumab heeft de breakthrough status binnen!!!

Conclusie: GSK wil met 300DKK slechts 25% van de waarde bieden.

benito c. 17 mei 2013 12:12

quote:
exit na cijfers Q1-2013 schreef op 17 mei 2013 11:55:
[...]

Tienvoud = 1239 DKK!!!!!!
Daratumumab heeft de breakthrough status binnen!!!

Conclusie: GSK wil met 300DKK slechts 25% van de waarde bieden.

Ik zou me niet zo druk maken. Met J & J ook als grootaandeelhouder zal er een behoorlijke prijs op tafel moeten komen.

[verwijderd] 17 mei 2013 12:27

Zouden Glaxo en Johnson&Johnson de buit al onderling verdeeld hebben (allebei 1 blockbuster en Glaxo de rest van de veelbelovende technologie en patenten)?
Een overname tegen een prikkie van slechts 300DKK lijkt mij normaliter tot mislukken gedoemd.

Hopelijk kan Stienstra de boel blokkeren!!!!!

sheriff Grover 17 mei 2013 14:11

Hi Benito geen dank ..maar er is weer meer iets minder nieuws genentech geeft niet op vooralsnog in het patent verhaal ..

Genmab A/S: Genentech and Biogen Idec Have Filed for a Re-hearing of U.S. Court of Appeals Decision in the Arzerra Patent Infringement Case

Company Announcement

-- Genentech and Biogen Idec have filed for re-hearing in the United States

Copenhagen, Denmark; May 17, 2013 - Genmab A/S (OMX: GEN) announced today that Genentech and Biogen Idec have filed for a re-hearing en banc (i.e. before all judges of the court) in the appeal case, where the U.S. Court of Appeals for the Federal Circuit recently upheld the U.S. District Court's judgment in favor of GlaxoSmithKline (GSK). The appeal case relates to a patent infringement case involving Arzerra® brought against GSK by Genentech and Biogen Idec.

Genentech and Biogen Idec claim that the decision from the US court of appeals announced on April 16, 2013 in favor of GSK was against court precedent and request the US court of appeals to reconsider the case. The court of appeals will now decide whether to grant the rehearing.

Genentech and Biogen Idec originally filed the lawsuit in 2010 in the U.S. District Court for the Southern District of California claiming that Arzerra infringed U.S. Patent No. 7,682,612 covering methods of treating Chronic Lymphocytic Leukemia (CLL) with CD20 antibodies. GSK denied infringement and claimed the patent was invalid and unenforceable. An initial judgement by the court in favor of GSK in December 2011 was subsequently appealed by Genentech and Biogen Idec. In April 2013 the US court of appeals upheld the original decision by the US district court in favor of GSK.

sheriff Grover 29 mei 2013 19:28

Genmab A/S: GSK and Genmab Announce Positive Top-line Results from Pivotal Study of ARZERRA® (ofatumumab) Combined with Chlorambucil in Previously Untreated Chronic Lymphocytic Leukemia

Company Announcement

-- Median 22.4 month progression free survival in patients treated with ofatumumab plus chlorambucil, an improvement of 9.3 months compared to chlorambucil alone -- No unexpected safety findings

Copenhagen, Denmark and London UK; May 29, 2013 - Genmab A/S (OMX: GEN) and GlaxoSmithKline plc (GSK) announced today that their Phase III study of ARZERRA® (ofatumumab) in combination with chlorambucil versus chlorambucil alone in patients with previously untreated chronic lymphocytic leukemia (CLL) met its primary endpoint of progression free survival (PFS) as assessed by an Independent Review Committee (IRC).

A total of 447 patients were enrolled in the study. A 9.3 month improvement in the time a patient lived without worsening of their disease (median PFS) was seen in patients randomized to ofatumumab and chlorambucil compared to patients randomized to chlorambucil alone (22.4 months vs. 13.1 months; Hazard Ratio 0.57; p<0.001).

There were no unexpected safety findings. The most common (â‰¥1%) serious adverse events as reported by the investigator within 60 days of last treatment were neutropenia [including febrile neutropenia] (5%), anaemia (4%), pneumonia (4%), and pyrexia (2%). Infusion reactions were mild to moderate in severity with 3% of infusion reactions reported as serious.

"We are delighted with the positive results from this trial which we believe may lead to ofatumumab plus chlorambucil as an additional treatment option for the care of patients with CLL," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "We look forward to submitting the study results, including secondary endpoints, to the International Workshop on CLL (iwCLL) in Cologne, Germany this September."

"As the aim of treating CLL, particularly in the frontline setting, is to maximize progression free survival while minimizing side effects, we are therefore encouraged by these promising results," said Dr. Kathy Rouan, Vice President BioPharmaceutical Development, GlaxoSmithKline. "We are planning regulatory submissions in the EU, US, and other regions in the coming months."

About the study This Phase III study (NCT00748189) included patients with previously untreated CLL considered inappropriate for fludarabine-based therapy. Patients in the study were randomized 1:1 to treatment with up to twelve cycles of ofatumumab in combination with chlorambucil or up to twelve cycles of chlorambucil alone. The primary endpoint of the study was PFS according to the International Workshop for Chronic Lymphocytic Leukaemia (IWCLL) updated 2008 National Cancer Institute-sponsored Working Group (NCIWG) guidelines, using an independent endpoints review committee.

About chronic lymphocytic leukemia CLL is the most common form of leukemia in adults. Based on estimates by the American Cancer Society, CLL will account for more than 15,680 new cases and more than 4,580 deaths in the United States of America alone in 2013. At present, no curative chemotherapy is available.

About ARZERRA (ofatumumab) Ofatumumab is not approved or licensed anywhere in the world for use in patients who have not received treatment for CLL. For Full US Prescribing Information, please visit: us.gsk.com/html/medicines/index.htmland visit health.gsk.com/ for the EU SPC for the approved indication.

Ofatumumab is a human monoclonal antibody which targets an epitope on the CD20 molecule encompassing parts of the small and large extracellular loops (Teeling et al 2006). Ofatumumab is being developed under a co-development and commercialization agreement between Genmab and GlaxoSmithKline.

About GSK GSK is one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better, and live longer. For further information please visit www.gsk.com.

About Genmab A/S Genmab is a publicly traded, international biotechnology company specializing in the creation and development of differentiated human antibody therapeutics for the treatment of cancer. Founded in 1999, the company's first marketed antibody, ofatumumab (Arzerra®), was approved to treat chronic lymphocytic leukemia in patients who are refractory to fludarabine and alemtuzumab after less than eight years in development. Genmab's validated and next generation antibody technologies are expected to provide a steady stream of future product candidates. Partnering of innovative product candidates and technologies is a key focus of Genmab's strategy and the company has alliances with top tier pharmaceutical and biotechnology companies. For more information

sheriff Grover 6 juni 2013 19:14

Presentatie gegeven bij Jefferies voor de geintereseerden : wsw.com/webcast/jeff77/gen/ , moet bekennen dat IMHO ze er goed voor staan ; begrijp me niet verkeerd de data moeten het doen/bewijzen maar ze zitten vol goede ideen en vooral dat Hexabody platform zou wel eens een hit kunnen worden all IMHO !

Sheriff Grover

p.s Nordea heeft koersdoel verhoogt naar 272 DKR

benito c. 6 juni 2013 19:30

Het kan inderdaad snel veranderen. Ik had ze bijna op 40 verkocht, omdat ik dacht dat het nooit meer wat zou worden. Het enige feit dat ze meer cash hadden dan de beurswaarde heeft me weerhouden. Pas toen J en J instapte stonden wat mij betreft de seinen op groen, enerzijds omdat die wel weten wat ze doen, anderzijds dat ze tegen een toen acceptabele koers voldoende geld in kas kregen. Helaas toen niet bijgekocht.

sheriff Grover 6 juni 2013 20:13

Benito nou ik heb ze ook wat vervloekt :o) ik dacht precies hetzelfde ... maar ik durf nu wel te stellen als ze goede arzerrea data kunnen laten zien begin volgend jaar en idd dat hexabody verhaal van de grond krijgen dat de een (gsk?) of de ander (j&J) niet langer kunnen blijven toekijken en een bod gaan doen , als ze deze koersen kunnen vasthouden of nog wat hoger dan is een bid van 500DKR halverwege '14 volgens mij niet ondenkbaar ........En dan is het eind goed al goed !

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