Modality
Bispecific Ab
MOA
PI3Ki
Target
KIF18A
Pathway
Angiogenesis
SMANMOSD
Development Pipeline
Preclinical
~Apr 2017
→ ~Jul 2018
Phase 1
~Oct 2018
→ ~Jan 2020
Phase 2
~Apr 2020
→ ~Jul 2021
Phase 3
~Oct 2021
→ ~Jan 2023
NDA/BLA
Apr 2023
→ Nov 2029
NDA/BLACurrent
NCT05951097
1,358 pts·NMOSD
2023-04→2029-11·Terminated
NCT07906645
2,071 pts·SMA
2025-10→2025-05·Terminated
3,429 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-05-0811mo agoPh3 Readout· SMA
2029-11-253.7y awayPh3 Readout· NMOSD
Trial Timeline
Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
NDA/BLA
Termina…
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2025-05-08 · 11mo ago
SMA
Ph3 Readout
2029-11-25 · 3.7y away
NMOSD
Terminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05951097 | NDA/BLA | NMOSD | Terminated | 1358 | CfB |
| NCT07906645 | NDA/BLA | SMA | Terminated | 2071 | Biomarker |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Niranesiran | Johnson & Johnson | Phase 2 | KIF18A | |
| Tiramavacamten | Roche | Preclinical | SGLT2 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| Voxacilimab | AstraZeneca | Phase 1/2 | GLP-1R | |
| Capifutibatinib | Sanofi | Approved | PRMT5 | |
| Rimatenlimab | Novo Nordisk | Phase 2/3 | SGLT2 | |
| REG-3155 | Regeneron | Phase 1/2 | MDM2 | |
| Riluinavolisib | Moderna | NDA/BLA | KIF18A | |
| SRP-3270 | Sarepta | Phase 1/2 | SGLT2 | |
| NUV-2032 | Nuvalent | Preclinical | KIF18A |