BerGenBio (BGBIO) : FDA grants fast track designation

 Edison Investment Research Limited

BerGenBio (BGBIO): FDA grants fast track designation 
16-Jun-2021 / 07:00 GMT/BST 
=---------------------------------------------------------------------------------------------------------------------- 
 
London, UK, 16 June 2021 
 
BerGenBio (BGBIO): FDA grants fast track designation 
BerGenBio (BGBIO), a pioneer in AXL biology and the development of AXL inhibitors, has two clinical-stage assets: 
selective tyrosine kinase inhibitor bemcentinib and functional blocking monoclonal antibody tilvestamab. FDA has 
granted bemcentinib fast track designation in combination with an anti-PD-L1 agent for the treatment of AXL-positive 
advanced/metastatic NSCLC patients (without driver mutations) who have progressed following first-line treatment. BGBIO 
has also presented data from the ongoing BGBC003 Phase II trial (in combination with LDAC) at EHA, which supports the 
safety and efficacy profile seen to date in elderly relapsed AML patients. Notably durable responses were observed in 
the relapsed AML setting (ORR of 31%; 5/16) and median overall survival of 13.3 months (data still immature). We value 
BGBIO at NOK4.72bn or NOK53.8/share. 
 
We value BerGenBio at NOK4.72bn or NOK 53.8/share. Our forecasts remain unchanged. The drivers are bemcentinib in 
second-line NSCLC (peak sales USD1.2bn, NOK37.2/share) and AML (peak sales USD598m, NOK12.2/share) plus the COVID-19 
opportunity (peak sales USD300m, NOK5.4/share), offset by payments due to Rigel. 
Click here to view the full report or here to sign up to receive research as it is published. 
 
All reports published by Edison are available to download free of charge from its website 
www.edisongroup.com 

https://www.marketscreener.com/quote/stock/BERGENBIO-ASA-34541487/news/BerGenBio-BGBIO-nbsp-FDA-grants-fast-track-designation-35617503/