Clinical Trials
19
6 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2007
Active, not recruiting
6
31.6%
Completed
8
42.1%
Recruiting
2
10.5%
Terminated
3
15.8%
No approval data available
- BerGenBio highlights a significant unmet need in STK11-mutated lung cancer, a substantial market opportunity for its AXL inhibitor, bemcentinib. - The FDA granted fast-track designation to BerGenBio's treatment, potentially expediting its development and regulatory review process. - Interim data from the BTBC 16 study, evaluating bemcentinib, is expected in early 2025, with final data anticipated as late as 2026. - CEO Martin Olin is stepping down, but will remain until a successor is named, ensuring a smooth leadership transition for the company.
- BerGenBio's AXL inhibitor receives FDA Fast Track designation, highlighting its potential in treating STK11-mutated cancers, addressing a significant unmet medical need. - The company's Q3 2024 earnings call revealed a stable financial position with $175 million NOK, funding operations until Q3 2025, despite a slight revenue decrease. - Interim data from the BTBC 16 study is expected in early 2025, while final data from the Phase 2 part could be available as late as 2026. - CEO Martin Olin's departure is not expected to impact ongoing activities, with a smooth transition planned until a successor is appointed.
