Modality
ERT
MOA
KIF18Ai
Target
HER2
Pathway
Lipid Met
HSWMBladder Ca
Development Pipeline
Preclinical
~Dec 2017
→ ~Mar 2019
Phase 1
~Jun 2019
→ ~Sep 2020
Phase 2
~Dec 2020
→ ~Mar 2022
Phase 3
~Jun 2022
→ ~Sep 2023
NDA/BLA
Dec 2023
→ Apr 2030
NDA/BLACurrent
NCT08665800
731 pts·Bladder Ca
2023-12→2030-04·Recruiting
731 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2030-04-254.1y awayPh3 Readout· Bladder Ca
Trial Timeline
2024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2030-04-25 · 4.1y away
Bladder Ca
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08665800 | NDA/BLA | Bladder Ca | Recruiting | 731 | Mayo |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7550 | Pfizer | Phase 3 | Aβ | |
| Ribosacituzumab | Roche | Approved | Cl18.2 | |
| RHH-8482 | Roche | Phase 1 | BTK | |
| Pexatenlimab | Novartis | Phase 1/2 | GPRC5D | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 | |
| BMR-8526 | BioMarin | Phase 1/2 | CD38 | |
| ROI-9675 | Roivant Sciences | NDA/BLA | HER2 |