Genmab

	22/7 09:54 af GeorgeBest	Thanks for All the info E L :-)
	22/7 09:49 af E L	we saw this article before, and the funny thing is that it is using Dara instead of Isa ;-)
	22/7 09:48 af E L	Kiadis announces publication in Blood highlighting proof-of-concept to enhance potency of anti-CD38 antibodies with Kiadis’ K-NK004, recently licensed by Sanofi (link)
	22/7 09:30 af E L	So- a lot of attention in that call on Ofa.
	22/7 09:30 af E L	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.
	22/7 09:29 af E L	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.
	22/7 09:29 af E L	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,
	22/7 09:29 af E L	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?
	22/7 09:28 af E L	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.
	22/7 09:28 af E L	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.
	22/7 09:27 af E L	-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.
	22/7 09:27 af E L	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.
	22/7 09:26 af E L	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.
	22/7 09:26 af Helge Larsen/PI-redaktør	:-D
	22/7 09:26 af E L	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.
	22/7 09:25 af E L	hahaha, I can't say no anymore now, can I? Lazy Danes :-D
	22/7 09:20 af Helge Larsen/PI-redaktør	Then we will have the information in the chat-history. :-)
	22/7 09:19 af Helge Larsen/PI-redaktør	It´s ok to do it. :-)
	22/7 09:02 af E L	a few more comments on Ofa there, but maybe a bit too much to paste all here
	22/7 09:00 af E L	Transcript of Novartis earnings call (link) 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.
	22/7 07:46 af Stroka	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.
	22/7 07:10 af bibob	FDA approval sought for Selinexor in Myeloma after 1 prior line of therapy. (link)
	22/7 06:59 af bibob	God morgen. :-)
	22/7 06:20 af Helge Larsen/PI-redaktør	God morgen. :-)

	21/7 19:30 af DevOp	Og vi kan nok godt risikere, at det fortsætter nedad med dollarkursen (link)
	21/7 19:18 af bikube	Det er godt nok voldsomt, så hurtigt $ kursen falder. Det er ikke let at budgettere med.
	21/7 17:44 af StockBull	Tror bare Genmab følger den positive trend fra USA og samme når det vender. RSI er ved at nærme sig det niveau hvor der normalt kommer en retracement hvor vi skal 10% ned eller deromkring
	21/7 17:34 af gdn55	Husk stilhed før stormen.
	21/7 17:13 af E L	and i forgot earlier, i expect we hear something by August about what Genmab wants to do with Cami-t (link)
	21/7 17:03 af Solsen	And yes Helge - someone besides me have to think its time for taking profit.
	21/7 17:03 af Helge Larsen/PI-redaktør	Me too. :-D
	21/7 17:01 af Solsen	I take that :-)
	21/7 16:54 af E L	@Solsen then the rising Wedge will just turn into a rising Channel, with an upper trendline already at around 2700 . easy. ;-)
	21/7 16:47 af Helge Larsen/PI-redaktør	Pharma har vendt rundt til negativt terræn efter en flot start på dagen.
	21/7 16:45 af Solsen	Hvad gætter du at på udfaldet bliver, når Genmab forlader kanalen ?
	21/7 16:41 af StockBull	(link) kurstarget 2400
	21/7 16:30 af E L	they sure did!
	21/7 16:20 af Solsen	Biontech have almost tha same valuation as Genmab. Someone made a good investment in the IPO !
	21/7 14:47 af E L	BioNtech raising money again , Rights Offering for up to 6,681,850 Ordinary Shares Including Ordinary Shares Represented by American Depositary Shares
	21/7 14:25 af E L	in addition, we have a PDUFA for the Dara Candor regimen in November, filing Andromeda and some hope for Amivantamab BLA towards the end of the year...
	21/7 14:23 af E L	besides updates on what we got earlier this year, Tiso, with a possible BLA and data on other tumors, Epco, Enapotamab HexaDR5DR5...
	21/7 14:20 af E L	yes, it will be very different going forward, the amount of data we'll have to track for Genmab, it used to be simple with only Dara ;-)
	21/7 14:04 af Solsen	Data på PD-L1 x 4-1BB (Biontech samarbejdet) og ofa i RRMS er vigtige. Førstnævnte kan virkelig trække kursen, hvis data er så gode som vi håber. Jeg tror/håber, at det er nævnte data der gør, at JW tør udtale sig så positivt, som han gør. Andre data offentliggøres også indenfor 6 mdr.
	21/7 13:58 af Fritten	Udover at casen bare er god, hvilke kurstriggere ned/op ser i så indenfor de næste 3-6 måneder?
	21/7 11:36 af Solsen	Low dose - sc version with alle the advances and not depletion of all b-cells so infections wont be a problem. Ofa is a perfect drug for RRMS but not first mover. Exciting what Novatis can do in terms sales.
	21/7 11:28 af Solsen	The advantage for ofa is obviously. Mainly due the low dose. But Roche is is powerfull competitor.
	21/7 11:24 af E L	so it may even work in Ofa's advantage
	21/7 11:24 af E L	However, B cell depletion apparantly is not as bad for Ofa as it is for ocrevus, and, because of monthly dosing may be easier / faster to manage
	21/7 11:22 af E L	yes, i have also been thinking about a possible vaccine interfering with the launch; B cell depletion of anti-cd20 drugs may require a break/pause in treatment
	21/7 11:15 af Solsen	Sounds good but Roche will fight all they can. Impressing launch of Ocrevus they had.