Modality
Fusion Protein
MOA
BCL-2i
Target
TIM-3
Pathway
Ferroptosis
NSCLCPNHTTR Amyloidosis
Development Pipeline
Preclinical
~Nov 2019
→ ~Feb 2021
Phase 1
~May 2021
→ ~Aug 2022
Phase 2
~Nov 2022
→ ~Feb 2024
Phase 3
~May 2024
→ ~Aug 2025
NDA/BLA
Nov 2025
→ Nov 2028
NDA/BLACurrent
NCT08051550
419 pts·NSCLC
2025-11→2028-11·Completed
419 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2028-11-022.6y awayPh3 Readout· NSCLC
Trial Timeline
2026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2028-11-02 · 2.6y away
NSCLC
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08051550 | NDA/BLA | NSCLC | Completed | 419 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5501 | Pfizer | Phase 1 | BTK | |
| RHH-3592 | Roche | Phase 1/2 | GIP-R | |
| Geliderotide | Novartis | NDA/BLA | IL-17A | |
| Tezecilimab | Takeda | NDA/BLA | Tau | |
| Rimaosocimab | Amgen | Preclinical | FXIa | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| Capifutibatinib | Incyte | Phase 3 | PCSK9 | |
| NBI-408 | Neurocrine | Phase 2/3 | KRASG12D | |
| Nidasacituzumab | United Therapeutics | Phase 1/2 | TIM-3 | |
| HAL-996 | Halozyme | Phase 1/2 | BCL-2 |