Modality
Cell Therapy
MOA
PLK4i
Target
KIF18A
Pathway
Neuroinflam
MMPSP
Development Pipeline
Preclinical
~Dec 2011
→ ~Mar 2013
Phase 1
~Jun 2013
→ ~Sep 2014
Phase 2
~Dec 2014
→ ~Mar 2016
Phase 3
~Jun 2016
→ ~Sep 2017
NDA/BLA
Dec 2017
→ May 2026
NDA/BLACurrent
NCT04105760
113 pts·MM
2017-12→2026-05·Active
113 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-05-101mo awayPh3 Readout· MM
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3
NDA/BLA
Active
Catalysts
Ph3 Readout
2026-05-10 · 1mo away
MM
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04105760 | NDA/BLA | MM | Active | 113 | HAM-D |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| AMG-2597 | Amgen | Phase 2/3 | CD38 | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A | |
| DNL-9555 | Denali | Phase 1/2 | KIF18A | |
| Lisoosocimab | Zealand Pharma | Approved | KIF18A | |
| Talatenlimab | Praxis Precision | Phase 1/2 | KIF18A | |
| Liravorutinib | Biomea Fusion | Phase 1/2 | GPRC5D | |
| Talainavolisib | Fate Ther | Approved | KIF18A | |
| SLD-2973 | Solid Bio | NDA/BLA | KIF18A | |
| CSL-7919 | CSL Limited | Preclinical | BTK |