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BioPharma« Terug naar discussie overzicht

Genmab, de Deense parel

3.503 Posts
Pagina: «« 1 ... 30 31 32 33 34 ... 176 »» | Laatste | Omlaag ↓
  1. sheriff Grover 9 augustus 2016 20:46
    Ja al met al weer positief ... guidance idd iets naar boven bijgesteld ,duobody goed op weg , subcue naar phase 3 (zeer belangrijk kan er voor zorgen dat dara binnen 5 minuten kan toegediend worden en het verlengd het patent tm 2035 !) , filing 2e lijn komt er spoedig aan en met een beetje geluk snelle goedkeuring door FDA , Novartis nog volop bezig met arzerra en Darzalex sales van Juli de beste tot nu toe .

    De uitgaven gaan evenredig omhoog , er wordt meer geinvesteerd in de pijplijn de kosten gaan voor de baat uit zullen we maar zeggen .

    En ik sluit niet uit dat er wat geld naar de nieuwe meubeltjes in het nieuw te bouwen hoofdkwartier gaat ;o)

    Dat er btw wel mooi uit ziet !

    www.duravermeer.nl/Portals/0/20160118...
  2. sheriff Grover 10 augustus 2016 18:41
    Genmab Enters Commercial License Agreement with Gilead for DuoBody® Technology
    New commercial DuoBody technology platform collaboration with Gilead
    Genmab granted Gilead an exclusive license to create a bispecific antibody with the DuoBody technology and an option to obtain a second exclusive license
    Copenhagen, Denmark; August 10, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today it has entered an agreement to grant Gilead Sciences, Inc. an exclusive license and an option on a second exclusive license, to use the DuoBody® technology platform to create and develop bispecific antibody candidates for a therapeutic program targeting HIV. Under the terms of the agreement, Genmab will receive an upfront payment of USD 5 million from Gilead Sciences.

    Genmab is entitled to potential development, regulatory and sales milestones of up to USD 277 million for the first product and further milestones for subsequent products. In addition, Genmab will be entitled to single-digit royalties on Gilead's sales of any commercialized products. Similar terms would apply if Gilead exercises the option to the second license.

    "We are pleased to add this agreement with Gilead to our growing list of commercial collaborations for our innovative DuoBody platform and we are particularly excited that the potential for DuoBody bispecific antibodies for treating HIV will be explored," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

    This commercial license agreement follows a research collaboration between Genmab and Gilead Sciences for the DuoBody technology signed in 2014.

    This agreement is not expected to have a material impact on Genmab's 2016 financial guidance.

  3. sheriff Grover 11 augustus 2016 17:45
    quote:

    mr_robot schreef op 11 augustus 2016 15:09:

    Goed nieuws inderdaad! Helaas weinig effect op de koers van vandaag :(
    Wie weet waar we zonder het nieuws waren geeindigd .... ;o)

    Nee helaas het verkoop feest ging vandaag gewoon door , de hele dag aanbod. De heren hebben nu ruim 450 K shares gedumpt in twee dagen tijd .

    Gelukkig liet Danske Bank zich nog fors aan de koopkant zien en is de schade vandaag beperkt maar laten we hopen dat ze zo'n beetje uitverkocht zijn .

  4. [verwijderd] 11 augustus 2016 18:14
    "Last week, Bristol Myers (BMS) crumbled again, failing big time in lung cancer with Opdivo, and on Friday, lost $20 billion in market cap. All the large healthcare funds own lots of BMS shares, causing another blow to their portfolios. I think that today showed a desperate move by some of these funds to create liquidity by selling Genmab shares."
  5. [verwijderd] 12 augustus 2016 11:16
    @M4E
    SL 1149DKK hopelijk eruitgehaald want anders zijt ge ze kwijt.
    Heb er zelf nog 50 bijgekocht aan 1144,00DKK.
    Geloof er in voor de lange duur!Speculatietaks in Belgie verplicht meer op langere tijd te investeren(Zolang die stomme taks blijft die meer geld kost dan dat ze opbrengt)
  6. sheriff Grover 17 augustus 2016 22:05
    Genmab Announces Submission of Supplemental Biologics License Application to FDA for Daratumumab in Relapsed Multiple Myeloma

    Company Announcement

    sBLA submitted to U.S. FDA for daratumumab for treatment of patients with relapsed multiple myeloma
    Submission based on data from two Phase III studies, CASTOR and POLLUX
    Genmab to receive USD 15 million in milestone payments from Janssen
    Copenhagen, Denmark; August 17, 2016 — Genmab A/S (Nasdaq Copenhagen: GEN) announced today that its licensing partner, Janssen Biotech, Inc. has submitted a supplemental Biologics License Application (sBLA) to the U.S. Food and Drug Administration (FDA) for the use of daratumumab (DARZALEX®) in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for the treatment of patients with multiple myeloma who received at least one prior therapy. In July 2016, daratumumab was granted a Breakthrough Therapy Designation (BTD) in this patient population. The submission of the application triggers milestone payments totaling USD 15 million to Genmab from Janssen. The milestone payments were included in Genmab's financial guidance for 2016 that was published on August 9, 2016. In August 2012, Genmab granted Janssen an exclusive worldwide license to develop, manufacture and commercialize daratumumab.

    "We are thrilled that an application to expand the current label to include treatment of multiple myeloma patients who received at least one prior therapy has been submitted so soon after the initial FDA approval of daratumumab in November 2015. The data from the Phase III CASTOR and POLLUX studies on which the submission is based was unprecedented, meriting a Breakthrough Therapy Designation from the FDA. We believe that if approved, daratumumab has the potential to make a substantial positive impact in the treatment of patients with multiple myeloma who have relapsed on their previous therapy," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

    A request for Priority Review has been submitted by Janssen with this sBLA. The FDA will inform Janssen whether a Priority Review has been granted by calendar day 60 of their review starting today. If the FDA grants Priority Review, the review should be completed within 6 months from today.

    The submission includes data from two Phase III studies: the CASTOR study of daratumumab in combination with bortezomib and dexamethasone versus bortezomib and dexamethasone alone in patients with relapsed or refractory multiple myeloma, and the POLLUX study of daratumumab in combination with lenalidomide and dexamethasone versus lenalidomide and dexamethasone alone in patients with relapsed or refractory multiple myeloma. The submission also included data from the Phase I study of daratumumab in combination with pomalidomide and dexamethasone in relapsed or refractory multiple myeloma. These data will also be used as the basis for a potential regulatory submission to the European Medicines Agency (EMA).

    ir.genmab.com/releasedetail.cfm?Relea...

    Filing 2e lijn !
  7. [verwijderd] 17 augustus 2016 23:27
    Goed nieuws. Volgende belangrijke stap voor Darzalex. Fundamenteel allemaal op orde.
    Wat betreft koers: nu geduld hebben en rustig blijven in weer een volatiele dipfase. Het lijkt af en toe op een stap achteruit en twee stappen vooruit. Zo kom je per saldo overigens wel vooruit... Voor LT belegger is er weinig aan de hand.
    ir.genmab.com/releasedetail.cfm?Relea...
3.503 Posts
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