Clinical Trials
5
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
2001
Active, not recruiting
2
40.0%
Terminated
1
20.0%
Unknown
2
40.0%
No approval data available
- GENFIT reports encouraging Phase 1b data showing GNS561 combined with MEK inhibitor trametinib achieved disease stabilization in all four evaluable patients with advanced KRAS-mutated cholangiocarcinoma. - The combination therapy demonstrated tumor shrinkage in a subset of heavily pretreated patients, with the best response showing a 20% reduction approaching partial response threshold. - No dose-limiting toxicity has been observed to date, enabling recruitment of a third patient cohort and positioning the combination as a potential breakthrough for this difficult-to-treat cancer. - Phase 2 initiation is targeted for the second half of 2026, with recommended Phase 2 doses expected in the first half of 2026.
- GENFIT reported a net profit of €1.5 million for 2024, driven by €67.0 million in revenues including a €48.7 million milestone payment and royalties from Iqirvo® (elafibranor) sales in PBC. - The company secured a transformative non-dilutive royalty financing agreement worth up to €185 million, significantly extending its cash runway beyond 2027. - GENFIT is advancing five complementary programs targeting Acute-on-Chronic Liver Failure (ACLF), with key clinical data readouts expected by the end of 2025.
