botensilimab (BOT) plus balstilimab (BAL) — Topline data
2026
Additional updates from ongoing company and investigator sponsored trials, including Phase 2 neoadjuvant CRC trials, are expected in 2026.Source filing
AGEN biotech catalysts & pipeline
AGENUS INC · Data as of 2026-09-08
Upcoming catalysts
botensilimab plus balstilimab (BOT/BAL) — NDA/BLA submission
during 2026
Based on existing data, we intend during 2026 to seek Accelerated Approval in the United States and Conditional Marketing Authorization in the European Union for BOT/BAL in that indication.Source filing
botensilimab plus balstilimab (BOT/BAL) — Full data
H2 2026
Further details from both studies are anticipated to be published in the second half of 2026.Source filing
botensilimab plus balstilimab (BOT/BAL) — Interim data
H2 2027
Interim pathologic response data: anticipated in the second half of 2027Source filing
botensilimab plus balstilimab (BOT/BAL) — Interim data
H2 2029
Interim analysis of EFS: anticipated in the second half of 2029Source filing
botensilimab plus balstilimab (BOT/BAL) — Full data
H2 2030
Final analysis of EFS: anticipated in the second half of 2030Source filing