Genmab — Maj 2018

[JohnW]

Skulle Alcyone godkendelsen i EU ikke komme i denne måned?

[Legolas23]

D. 21 maj, men der skal være sikkerhed for vi rammer inden for salgsguidiance.

[Bulder]

Det er US, der har dato senest 21. maj. CHMP- (EU) anbefalingen er ikke kommet endnu. Når den kommer går der 60 dage til den endelige afgørelse. Genmab venter endelig afgørelse i august.

[Mayflower]

Noget positivt om TV eller ofa vil være rigtig godt. No one likes a one-trick pony.

[Sukkeralf]

[Plimsoller]

Alcyone er primært for EU såvidt jeg kan forstå, men hvad er så primært for USA, og hvor er vi med det?

[Sukkeralf]

Dara-Rev-Dex - fase III kommer i sensommeren, så filing omkring årsskiftet og godkendelse sommer 2019

[E_L]

@Sukkeralf I cant figure out what drug Spicer is talking about; is it HuMax-AXL-ADC?

[E_L]

coincidentally this HuMax-AXL-ADC Safety Study in Patients With Solid Tumors is now looking to recruit almost 300 patients, alsmost 2x what they said first https://clinicaltrials.gov/ct2/history/NCT02988817?A=5&B=6&C=merged

[E_L]

also: "The Expansion part of the trial has been initiated " ; i read that as :
they started phase 2 ?

[Sukkeralf]

I think he mentioned AXL molecules (probably Bemcentinib) in combination with Pemblizumab (Keytruda) and Erlotinib (Tarceva). BergenBio´s Bemcentinib is in clinical studies with both.

[Sukkeralf]

Just a link to show that AXL becomes more and more intresting

[E_L]

ok thx

[Joakim_Von_And]

Dejligt at se kursen kryber op ad under lille omsætning,, det kunne godt blive ved nogle dage tror jeg..

[Sukkeralf]

And thanks for AXL ADC link - I think that is very positive for Genmab

[E_L]

yes, i agree. the rationale to enlarge the trial could be as simple as 'it is cheaper for us due to the cost split with Seatlle Genetics', but my guess is that they are expanding to other cancers... Really exciting

[Sukkeralf]

They dont have cost split with AXL - here it a regular licens deal - milestones and royalty to SA

[Sukkeralf]

SG'

[Sukkeralf]

It must be because safety looks fine and maybe they have allready seen some efficacy and wants to be aggressive

[Her_for_at_lære]

Dejligt at se kursen går op. Hvad er det der driver den frem? Forventninger til Q1 den 8. Maj?