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Genmab — Juli 2020

Planlagt Fastgjort Låst Flyttet Genmab
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Denne tråd er blevet slettet. Kun brugere med emne behandlings privilegier kan se den.
  • S Offline
    S Offline
    Stroka
    wrote on sidst redigeret af
    #803

    Genmab i rekord får lagt 18,5 pct. til kursmålet hos Bernstein

    06:40
    Det amerikanske finanshus Bernstein har løftet sit kursmål for Genmab med 18,5 pct. til 2275 kr. fra 1920 kr.

    Samtidig holdes der fast i den positive anbefaling outperform, fremgår det af data fra Bloomberg News.

    Genmab-aktien er - ligesom store dele af det danske marked - inde i en god periode lige nu, og tirsdag sluttede aktien atter i rekord, da den steg med 0,1 pct. til 2340 kr.

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    • E Offline
      E Offline
      E_L
      wrote on sidst redigeret af
      #804

      Transcript of Novartis earnings call https://finance.yahoo.com/news/edited-transcript-novn-earnings-conference-214116224.html When you look at our late-stage pipeline, just to go through some of the key assets in detail, ofatumumab, we continue to have very good discussions with FDA. We're on track for our action date in September of 2020, no major issues. And happy to, of course, answer any questions, but we feel very good about where we are in that discussion and the ongoing label negotiation.

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      • E Offline
        E Offline
        E_L
        wrote on sidst redigeret af
        #805

        a few more comments on Ofa there, but maybe a bit too much to paste all here

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        • Helge_LarsenPI-redaktørH Offline
          Helge_LarsenPI-redaktørH Offline
          Helge_LarsenPI-redaktør
          wrote on sidst redigeret af
          #806

          It´s ok to do it. 🙂

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          • Helge_LarsenPI-redaktørH Offline
            Helge_LarsenPI-redaktørH Offline
            Helge_LarsenPI-redaktør
            wrote on sidst redigeret af
            #807

            Then we will have the information in the chat-history. 🙂

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            • E Offline
              E Offline
              E_L
              wrote on sidst redigeret af
              #808

              hahaha, I can't say no anymore now, can I? Lazy Danes 😄

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              • E Offline
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                E_L
                wrote on sidst redigeret af
                #809

                we're very much looking forward to bringing ofatumumab to market. And we believe the FDA now has all the data they need to give us the green light. What is most compelling about ofatumumab is that it can give patients the possibility to live relapse-free for 9 to 10 years. What ofatumumab does is it effectively depletes B cells. This is the most efficacious way to treat MS. We've also developed this product specifically for MS with a favorable safety.

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                • Helge_LarsenPI-redaktørH Offline
                  Helge_LarsenPI-redaktørH Offline
                  Helge_LarsenPI-redaktør
                  wrote on sidst redigeret af
                  #810

                  😄

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                  • E Offline
                    E Offline
                    E_L
                    wrote on sidst redigeret af
                    #811

                    It's also dosed precisely to sustain B cell depletion and it comes in a subcu injection. This has the potential to truly change how physicians treat MS in first line and first switch. Our focus in these past months has been to make it as easy as possible to prescribe and access this product.

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                    • E Offline
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                      E_L
                      wrote on sidst redigeret af
                      #812

                      We've invested significantly in patient services and are rethinking our onboarding to make it seamless and flexible. Our launch will be tailored in a very different environment but with a very different approach, state-by-state, prescriber-by-prescriber. And as soon as we get the green light from FDA, we'll be ready to launch.

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                      • E Offline
                        E Offline
                        E_L
                        wrote on sidst redigeret af
                        #813

                        -Yes. So the timing for ofa was based on, as you remember, the 3-month extension from the FDA. And the timelines currently are in the mid-September time frame. I don't have the exact date, but it's mid-September. And so we're negotiating the aspects of label with FDA. And we expect to reach those timelines, as Vas presented earlier.

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                        • E Offline
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                          E_L
                          wrote on sidst redigeret af
                          #814

                          So we really feel that there's no better time to bring a highly efficacious and safe treatment that can be administered at home to MS patients considering the context. Our initial focus will be to really drive the broad adoption with MS specialists and general neurologists. And we're using a really highly agile approach between face-to-face and virtual outreach. We've actually developed a digital affinity score for physicians to understand where they are and how much digital promotion we can do.

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                          • E Offline
                            E Offline
                            E_L
                            wrote on sidst redigeret af
                            #815

                            We're also leveraging our learnings from recent launches and facing significant focus on patient services to ensure seamless and flexible onboarding. So that's really -- our objective is to make sure that patients can access quickly and easily ofatumumab. We expect to see ramp-up in 2021 as we see the conversion of patients to product in ex U.S. towards the second half of 2021.

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                            • E Offline
                              E Offline
                              E_L
                              wrote on sidst redigeret af
                              #816

                              Q- Vas, you mentioned that you were in final labeling discussions with FDA on ofatumumab. Given it was filed as an sBLA and Arzerra has a black box warning, should we be expecting a black box warning for ofa?

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                              • E Offline
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                                E_L
                                wrote on sidst redigeret af
                                #817

                                A- Yes. So on Arzerra, I think the black box warning specifically refers to both PML cases and HBV reactivation. And looking at the mechanism of ofatumumab, if you think about the overall approach, what we've actually looked at for ofatumumab is the fastest B cell repletion. So when patients are actually receiving subcu injections,

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                                • E Offline
                                  E Offline
                                  E_L
                                  wrote on sidst redigeret af
                                  #818

                                  they have very low and very quick recovery of their B cells. So in return, in the studies for ASCLEPIOS I and II, we did not see any cases of PML and we also did not see any cases of HBV reactivation. So you can -- I think the FDA will accurately reflect what was in our ASCLEPIOS I and II studies. And I believe that will be the readthrough in terms of how we will have the label moving forward.

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                                  • E Offline
                                    E Offline
                                    E_L
                                    wrote on sidst redigeret af
                                    #819

                                    And we expect to get a new trade name, which will actually reflect both the efficacy and safety of the label. So we will get a new brand name associated with this. So I think this would be a different overall label and brand name for ofatumumab.

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                                    • E Offline
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                                      E_L
                                      wrote on sidst redigeret af
                                      #820

                                      So- a lot of attention in that call on Ofa.

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                                      • E Offline
                                        E Offline
                                        E_L
                                        wrote on sidst redigeret af
                                        #821

                                        Kiadis announces publication in Blood highlighting proof-of-concept to enhance potency of anti-CD38 antibodies with Kiadis’ K-NK004, recently licensed by Sanofi https://www.globenewswire.com/news-release/2020/07/22/2065517/0/en/Kiadis-announces-publication-in-Blood-highlighting-proof-of-concept-to-enhance-potency-of-anti-CD38-antibodies-with-Kiadis-K-NK004-recently-licensed-by-Sanofi.html

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                                        • E Offline
                                          E Offline
                                          E_L
                                          wrote on sidst redigeret af
                                          #822

                                          we saw this article before, and the funny thing is that it is using Dara instead of Isa 😉

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