Modality
Multispecific
MOA
IL-13i
Target
TROP-2
Pathway
Innate Imm
FLPVMeso
Development Pipeline
Preclinical
~Jan 2015
→ ~Apr 2016
Phase 1
~Jul 2016
→ ~Oct 2017
Phase 2
~Jan 2018
→ ~Apr 2019
Phase 3
~Jul 2019
→ ~Oct 2020
NDA/BLA
Jan 2021
→ Sep 2025
NDA/BLACurrent
NCT06754697
1,845 pts·PV
2021-01→2025-09·Completed
NCT03644811
1,527 pts·FL
2022-04→TBD·Terminated
3,372 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-09-276mo agoPh3 Readout· PV
Trial Timeline
2021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q4
NDA/BLA
Complet…
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2025-09-27 · 6mo ago
PV
CompletedTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06754697 | NDA/BLA | PV | Completed | 1845 | EDSS |
| NCT03644811 | NDA/BLA | FL | Terminated | 1527 | CR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| RHH-7975 | Roche | Phase 3 | FXIa | |
| NVS-4076 | Novartis | Preclinical | TROP-2 | |
| NVS-8902 | Novartis | Preclinical | TROP-2 | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| BMY-4586 | Bristol-Myers Squibb | Preclinical | KRASG12C | |
| Zanumavacamten | GSK | Phase 2/3 | TROP-2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| Ribozanubrutinib | Regeneron | Phase 1 | CDK4/6 | |
| ION-1378 | Ionis | NDA/BLA | TROP-2 |