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 $1.2bn, NOK37.2/share) and AML (peak sales $598m, NOK12.2/share) plus the COVID-19 opportunity (peak sales $300m, NOK5.4/share), offset by payments due to Rigel. 

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