BerGenBio - Progressing towards key inflection points
BerGenBio has presented two positive datasets for its lead asset bemcentinib in acute myeloid leukaemia (AML) and myelodysplastic syndromes (MDS) at ASH 2020. Following these data, we anticipate a registrational Phase III study of bemcentinib plus low-dose cytarabine (LDAC) in relapsed elderly AML patients to start in 2021. We still forecast the NDA submission for this indication in 2023 (FDA fast-track has been granted). Bemcentinib is an oral, first-in-class, highly selective AXL tyrosine kinase inhibitor in Phase II development for a range of cancers and could be the first selective AXL inhibitor to market. Data from the Phase II study in second-line NSCLC in combination with Keytruda are expected at WCLC (for details see our initiation report, Bemcentinib leading the AXL charge). We value BerGenBio at NOK59.1 per share.BerGenBio is a clinical stage biopharmaceutical company focused on developing innovative drugs for aggressive, drug resistant cancers. Co.'s lead product, BGB324, is a selective, potent and orally available small molecule AXL inhibitor. It is in Phase II clinical development, as a single agent and in combination with marketed immuno-oncology drugs, in three cancer indications with potential: Acute myeloid leukaemia; Advanced non-small-cell lung cancer and Triple negative breast cancer. Co. is also developing a diversified pre-clinical pipeline of selective AXL inhibitors, including biologics and small molecules.
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