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Home  /  Forum  /  BioPharma  /  Genmab, de Deense parel

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Genmab, de Deense parel

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3.493 Posts
Pagina: «« 1 ... 14 15 16 17 18 ... 175 »» | Laatste | Omlaag ↓
  1. [verwijderd] 15 juli 2015 14:58
    Dank voor de link Sheriff Grover. Fair en transparant stuk van een Genmab believer en investeerder. Het blijft gissen, maar het lijkt erop dat FDA approval van Daratumumab -als daarvoor niets bijzonders gebeurt- mogelijk een extra trigger zal zijn voor de koers dan wel het startschot zal zijn voor een overnamestrijd. Mijn ervaring is dat de praktijk, zeker wat betreft timing, altijd net wat anders uitpakt. Gezien de al bestaande strategische partnerships, moet je idd denk
    ik in die richting kijken inzake mogelijke overnemers dan wel obstructors van een overname door een concurrent. Kortom, partnerships en Daratumumab approval zijn de cruciale issues-to-watch.
  2. [verwijderd] 25 juli 2015 15:07
    Aanvraag voor uitbreiding gebruik ofatumumab bij FDA. Weer een stapje in verdere ontwikkeling en toekomstige vercommercialisering van ofatumumab.

    Announcement
    sBLA submitted to US FDA for ofatumumab as maintenance therapy in relapsed CLL by Novartis
    Submission based on data from interim results of Phase III PROLONG study
    Copenhagen, Denmark; July 22, 2015 — Genmab A/S (OMX: GEN) announced today that a supplemental Biologics License Application (sBLA) has been submitted to the U.S. Food and Drug Administration (FDA) for the use of ofatumumab (Arzerra®) as maintenance therapy of patients with relapsed chronic lymphocytic leukemia (CLL). The application was submitted by Novartis under our ofatumumab collaboration.
    The application is based on interim results from a Phase III study, PROLONG (OMB112517) which evaluated ofatumumab maintenance therapy versus no further treatment in patients with a complete or partial response after second or third line treatment for CLL. Results from this trial were presented at the 2014 American Society of Hematology Annual Meeting.
    "The submission of the application to expand the label to use ofatumumab as a maintenance therapy for patients with relapsed CLL in the U.S. follows closely behind the marketing application for this indication in Europe. We are looking forward to the response from both the U.S. and European regulatory authorities, and hope that ofatumumab will soon become available for maintenance therapy of patients with relapsed CLL," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.
  4. [verwijderd] 1 augustus 2015 14:10
    Prima interview dat mooi inzicht geeft in focus en (partner) strategie van Genmab. Genmab wil duidelijk op eigen kracht groeien en presteren. Totdat er -mogelijk- een bod wordt gedaan, dan is dat een situatie alsdan. De waardecreatie nu zit in voortzetting van uitbouw platformtechnologie en verkoopsuccessen van (toekomstige) eigen geneesmiddelen. Geduld is voor ieder een schone zaak. In elk geval een (deels) Nederlands bedrijf om trots op te zijn. Dank voor de link Sheriff.
  5. sheriff Grover 14 augustus 2015 12:06
    Zeer positief stuk uit Australie ... van de 15 patienten bij 33 % in full remision en bij 50 % reductie van de kanker . Op of voor 7 sepetember nieuws of dara een priority review krijgt van de FDA zo ja waarschijnlijk dit jaar nog goedkeuring en op de markt . J&J staat in de startblokken en heeft aangegeven er helemaal klaar voor te zijn .

    www.news.com.au/national/breakthrough...

    Sheriff Grover
  6. sheriff Grover 14 augustus 2015 12:43
    Genmab Enters Commercial License Agreement with Novo Nordisk for DuoBody Technology

    Company Announcement
    • Two commercial DuoBody® technology licenses granted to Novo Nordisk
    • Genmab receives USD 2 million upfront payment

    Copenhagen, Denmark; August 14, 2015 — Genmab A/S (OMX: GEN) announced today it has entered an agreement to grant Novo Nordisk commercial licenses to use the DuoBody technology platform to create and develop bispecific antibody candidates for two therapeutic programs. The bispecific antibodies will target a disease area outside of cancer therapeutics. Under the terms of the agreement, Genmab will receive an upfront payment of USD 2 million from Novo Nordisk.

    After an initial period of exclusivity for the two target combinations, Novo Nordisk has an option to maintain exclusivity or take the licenses forward on a non-exclusive basis. Genmab is entitled to potential development, regulatory and sales milestones of up to approximately USD 250 million for each exclusive license, or approximately USD 200 million for each non-exclusive license. In addition, Genmab will be entitled to single-digit royalties on sales of any commercialized products.

    "Our proprietary DuoBody technology can be used to create bispecific antibodies that target a wide variety of disease areas. Today's agreement with Novo Nordisk is an example of how we can leverage access to our unique state-of-the art antibody expertise and collaborations to generate diverse revenue streams in areas beyond cancer," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab."

    This agreement is not expected to have a material impact on Genmab's 2015 financial guidance.

    About the DuoBody Platform
    The DuoBody platform is Genmab's proprietary technology platform for the discovery and development of bispecific antibodies. Bispecific antibodies bind to two different epitopes (or "docking" sites) either on the same, or on different targets (also known as dual-targeting). Dual-targeting may improve binding specificity and efficacy in inactivating disease targets. Bispecific antibodies generated with the DuoBody platform may improve antibody therapy of cancer, autoimmune, and infectious and central nervous system disease. DuoBody molecules are unique in combining the benefits of bispecificity with the strengths of conventional antibodies, which allows DuoBody molecules to be administered and dosed the way other antibody therapeutics are. Genmab's DuoBody platform generates bispecific antibodies via a fast and broadly applicable process, which is easily performed at standard bench, as well as commercial manufacturing scale.
  8. sheriff Grover 17 augustus 2015 08:11
    Report Pursuant to Section 28a of the Danish Securities Trading Act

    ?PDF

    Company Announcement

    Copenhagen, Denmark; August 14, 2015 — Pursuant to Section 28a of the Danish Securities Trading Act, Genmab A/S (OMX: GEN) hereby, on behalf of managerial employees, makes public information on transactions by managerial employees and their related parties involving Genmab shares and related instruments, as follows:

    Name: Jan van de Winkel
    Reason: President & Chief Executive Officer
    Issuer: Genmab A/S
    ID code/ISIN: DK0010272202
    Description: Shares
    Transaction: Sale
    Trading date: August 14, 2015
    Market: NASDAQ OMX Copenhagen A/S
    Number: 150,000
    Value: DKK 93,000,000

    Jan van de Winkel has informed Genmab A/S that the majority of the proceeds from this sale of shares are intended to be reinvested in Genmab shares via exercise of warrants, some of which are close to expiry, as well as to be used for the payment of taxes liable in connection with this reinvestment in Genmab shares. As an overall result of the intended transactions Jan van de Winkel's aggregate shareholding in Genmab would increase in the near future.



    Nu maar hopen dat de markt dit positief opneemt ....
  9. sheriff Grover 27 augustus 2015 12:23
    Data Published in The New England Journal of Medicine Shows Daratumumab Monotherapy Induced Durable Responses in Heavily Pre-treated Relapsed or Refractory Multiple Myeloma Patients

    Media Release
    • New England Journal of Medicine (NEJM) publishes full data set of the first clinical study initiated using daratumumab monotherapy to treat patients with relapsed/refractory multiple myeloma
    • Data shows encouraging efficacy with a 36% response rate in the group treated with 16 mg/kg dose in part 2 of study
    • 65% of patients who responded to treatment in the 16mg/kg dose group in part 2 of study had not experienced disease progression 12 months after the start of treatment
    • Tolerable safety profile and no maximum tolerated dose was identified

    Copenhagen, Denmark; August 27, 2015 — Genmab A/S (OMX: GEN) announced today the New England Journal of Medicine (NEJM) has published the full data set from the initial Phase I/II study with daratumumab monotherapy treating patients with relapsed or refractory multiple myeloma. Patients that received 16 mg/kg in part 2 of the study had a median of 4 prior lines of therapy and 64% of these patients were refractory to both proteasome inhibitors (PIs) and immunomodulatory (IMiD) drugs, which are current standard of care treatments for multiple myeloma. The data showed a 36% response rate in the 16 mg/kg group in part 2 of the study, with responses that deepened over time. Sixty five percent of patients in this group that responded to treatment were progression-free twelve months following the start of treatment. For all patients in part 2, pneumonia and thrombocytopenia were the most common grade 3/4 adverse events (AEs; =5%). Infusion-related reactions were mild with no dose-dependent adverse events. In part 1 of the study, no maximum tolerated dose was identified up to 24 mg/kg.

    Following this study, 16 mg/kg was chosen as the dose to be used in future daratumumab clinical studies. Daratumumab is being developed by Janssen Biotech, Inc. under an exclusive worldwide license to develop, manufacture and commercialize daratumumab from Genmab.

    "Patients who have relapsed or refractory multiple myeloma currently have very limited treatment options. The results from this first-in-human study of daratumumab, presented in full in The NEJM, show an impressive response rate and duration of response, particularly when you consider that patients in the study had received a large number of prior treatments," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

    Data from this study has been included in the Biologics License Application (BLA) submitted by Janssen to the U.S. Food and Drug Administration for daratumumab as a treatment for patients with multiple myeloma who have received at least three prior lines of therapy including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. The BLA submission was completed on July 9th 2015.

    About the study
    This two-part, Phase I/II, open-label study enrolled 32 patients in part 1, and 72 patients in part 2, 42 of which were in the 16 mg/kg dose group. Part 1 was a dose-escalation study with patients receiving weekly doses of daratumumab between 0.005 and 24 mg/kg of daratumumab.

    In part 2, 8 mg/kg and 16 mg/kg daratumumab were administered with different schedules. The primary endpoint of the study was safety. Secondary endpoints were pharmacokinetics, objective response according to International Myeloma Working Group (IMWG) uniform response criteria for myeloma, relative reductions in M-protein and free light chains, time to progression, response duration, progression-free and overall survival.

    About multiple myeloma
    Multiple myeloma is an incurable blood cancer that starts in the bone marrow and is characterized by an excess proliferation of plasma cells.1 Multiple myeloma is the third most common blood cancer in the U.S., after leukemia and lymphoma.2 Approximately 26,850 new patients will be diagnosed with multiple myeloma and approximately 11,240 people will die from the disease in the U.S. in 2015.3 Globally, it is estimated that 124,225 people will be diagnosed and 87,084 will die from the disease in 2015.4 While some patients with multiple myeloma have no symptoms at all, most patients are diagnosed due to symptoms which can include bone problems, low blood counts, calcium elevation, kidney problems or infections.5 Patients who relapse after treatment with standard therapies, including PIs or IMiDs, have poor prognoses and few treatment options.6

    About daratumumab
    Daratumumab is an investigational human IgG1k monoclonal antibody (mAb) that binds with high affinity to the CD38 molecule, which is highly expressed on the surface of multiple myeloma cells. It induces rapid tumor cell death through multiple immune-mediated mechanisms7, including complement-dependent cytotoxicity7, antibody-dependent cellular phagocytosis8 and antibody-dependent cellular cytotoxicity7, as well as via induction of apoptosis9 . Five Phase III clinical studies with daratumumab in relapsed and frontline settings are currently ongoing. Additional studies are ongoing or planned to assess its potential in other malignant and pre-malignant diseases on which CD38 is expressed, such as smoldering myeloma and non-Hodgkin lymphoma. Daratumumab has been granted Breakthrough Therapy Designation from the US FDA.

    Schitterende data van 29 % response rate naar 36 % !!
  13. [verwijderd] 28 augustus 2015 00:14
    Veelbelovende resultaten voor daratumumab...de lijn naar boven zet door. FDA approval volgende fase lijkt steeds grotere kans te hebben. Maar als altijd in biotech, eerst zien, dan geloven. Het glas lijkt echter meer dan halfvol. En blijven kijken naar de bewegingen van de big pharma t.a.v. dit geneesmiddel in het bijzonder en Genmab in het algemeen (als strategische partner dan wel overnamekandidaat).
  14. sheriff Grover 28 augustus 2015 11:57
    Hi Jeroen ,

    Ja het ziet er idd allemaal veelbelovend uit .. nog maximaal 10 dagen tot het besluit van de FDA re. priority review (07-09). Als die toegekend wordt dan kan er volgens mij niet veel meer fout gaan met de goedkeuring van Dara... 1 ding is zeker het worden een paar zeer enerverende laatste maanden van dit jaar !!!

    gr Sheriff Grover
  15. [verwijderd] 30 augustus 2015 16:57
    Zeker Sheriff Grover. De volatiliteit van de aandelenmarkt maakt het allemaal zelfs nog wat spannender. Dus grote kans dat Genmab -als biotech stock- in deze setting wederom flinke uitslagen naar boven en naar beneden gaat maken. Maar, uitgaande van approval, wel per saldo met een (flink) opgaande lijn.
  16. poolbeer 3 september 2015 08:14
    Major Shareholder Announcement

    Company Announcement
    • Major shareholder announcement for Genmab A/S

    Copenhagen, Denmark; September 2, 2015 — Genmab A/S (OMX: GEN) announces under reference to Section 29 of the Danish Securities Trading Act that FIL Investments International has informed us that, as of September 1, 2015, FMR LLC (Fidelity Management and Research) have increased their indirect ownership in Genmab A/S to 5,932,213 shares, which amounts to 10% of the share capital and voting rights in Genmab A/S.
  17. sheriff Grover 3 september 2015 12:46
    Positief ! Fidelity heeft nu 10 % en kan dus een (te) lage overnameprijs blokkeren . Bijkomend zijn het specialisten in Biotech en weten dus ook wat er in de VS voor goede Biotech aandelen betaald wordt.Voor een appel en een ei Genmab overnemen gaat vanaf nu niet meer lukken !
  18. sheriff Grover 4 september 2015 20:28
    Priority Review is binnen ! (PDUFA) target date of March 9, 2016 maar laten we hopen dat dat toch wel een beetje sneller kan met een beetje geluk dit jaar nog op de markt ...

    U.S. FDA Grants Priority Review for Daratumumab for Double Refractory Multiple Myeloma


    Company Announcement
    • U.S. FDA grants Priority Review to daratumumab
    • PDUFA target date has been set to March 9, 2016

    Copenhagen, Denmark; September 4, 2015 — Genmab A/S (OMX: GEN) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the Biologics License Application (BLA) for daratumumab. The BLA is for daratumumab as a treatment for patients with multiple myeloma who have received at least three different lines of therapy including both a proteasome inhibitor and an immunomodulatory agent (IMiD) or who are double refractory to a proteasome inhibitor and an IMiD. A rolling BLA submission was started by Genmab's licensing partner, Janssen Biotech, Inc. in June and was completed on July 9, 2015. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

    Priority Review is an FDA designation for drugs that treat a serious condition and may provide a significant improvement in safety or efficacy. The FDA aims to complete its review of the daratumumab BLA within six months and has assigned a Prescription Drug User Fee Act (PDUFA) target date of March 9, 2016.

    "We are pleased that the FDA has granted Priority Review for daratumumab in double refractory multiple myeloma. If approved, daratumumab has the potential to make a real difference in the lives of people who have run out of other treatment options for multiple myeloma," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

    The BLA submission includes data from the Phase II study (Sirius MMY2002) of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a PI and an IMiD, or who are double refractory to a PI and an IMiD. However, safety and efficacy data from the Phase I/II study (GEN501) and safety data from three other studies, have also been included in the BLA submission. Daratumumab received a Breakthrough Therapy Designation for this indication from the FDA in May 2013.

  20. sheriff Grover 9 september 2015 22:04
    Genmab Announces European Regulatory Submission for Daratumumab in Double Refractory Multiple Myeloma

    Company Announcement
    • MAA submitted to EMA by Janssen for daratumumab in multiple myeloma
    • Submission mainly based on data from Phase II study (Sirius MMY2002)

    Copenhagen, Denmark; September 9, 2015 — Genmab A/S (OMX: GEN) announced today that Janssen-Cilag International NV (Janssen) has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for daratumumab. The submission is for daratumumab as a treatment for patients with multiple myeloma who have received at least three different lines of therapy including both a proteasome inhibitor (PI) and an immunomodulatory agent (IMiD) or who are double refractory to a PI and an IMiD. The submission triggers a milestone payment of USD 10 million to Genmab from Janssen. The milestone was included in Genmab's financial guidance for 2015. In August 2012, Genmab granted Janssen Biotech, Inc. an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

    This submission in Europe follows the completion of the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) in July this year. Both regulatory submissions include data from the Phase II study (Sirius MMY2002) of daratumumab in multiple myeloma patients who have received at least three prior lines of therapy including both a PI and an IMiD, or who are double refractory to a PI and an IMiD. However, safety and efficacy data from the Phase I/II study (GEN501) and safety data from three other studies have also been included in the submission.

    "The submission of the European regulatory application for daratumumab is another significant milestone in the development of daratumumab. We have seen very promising clinical data and believe daratumumab could provide an important new treatment alternative for multiple myeloma patients if approved," said Jan van de Winkel, Ph.D, Chief Executive Officer of Genmab.

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