Modality
Multispecific
MOA
FcRni
Target
PD-L1
Pathway
Apoptosis
RSVWMThymoma
Development Pipeline
Preclinical
~May 2012
→ ~Aug 2013
Phase 1
~Nov 2013
→ ~Feb 2015
Phase 2
~May 2015
→ ~Aug 2016
Phase 3
~Nov 2016
→ ~Feb 2018
NDA/BLA
May 2018
→ Jun 2029
NDA/BLACurrent
NCT07327054
1,234 pts·Thymoma
2022-12→2025-02·Completed
NCT06413659
2,284 pts·RSV
2018-05→2029-06·Recruiting
3,518 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-02-221.1y agoPh3 Readout· Thymoma
2029-06-083.2y awayPh3 Readout· RSV
Trial Timeline
Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3
NDA/BLA
Recruit…
NDA/BLA
Complet…
Catalysts
Ph3 Readout
2025-02-22 · 1.1y ago
Thymoma
Ph3 Readout
2029-06-08 · 3.2y away
RSV
RecruitingCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07327054 | NDA/BLA | Thymoma | Completed | 1234 | ACR20 |
| NCT06413659 | NDA/BLA | RSV | Recruiting | 2284 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| ABB-2476 | AbbVie | Phase 1/2 | USP1 | |
| ABB-7516 | AbbVie | Phase 3 | PD-L1 | |
| Suracagene | GSK | Phase 3 | PRMT5 | |
| Olpatinib | GSK | Preclinical | PD-L1 | |
| BAY-3684 | Bayer | Approved | PD-L1 | |
| REG-6699 | Regeneron | Phase 2/3 | TIM-3 | |
| Zanufutibatinib | Intra-Cellular | NDA/BLA | CD38 | |
| Polatuximab | Nuvalent | Approved | PD-L1 | |
| VKT-6548 | Viking Therapeutics | Phase 2/3 | PD-L1 | |
| Voxaderotide | Viking Therapeutics | Approved | PD-L1 |