regulatory
confidence high
sentiment positive
materiality 0.70
Elicio receives supportive FDA feedback on ELI-002 Phase 3 registrational strategy
Elicio Therapeutics, Inc.
- FDA aligned on Phase 3 study design: dose, schedule, patient population (KRAS-mutated pancreatic cancer), and DFS endpoint.
- Phase 2 AMPLIFY-7P study fully enrolled; interim DFS analysis expected H1 2025.
- Positive Phase 2 results could support rapid advancement into Phase 3 and potential BLA filing.
- ELI-002 is an off-the-shelf monotherapy for mKRAS cancers patients post-chemotherapy.