Modality
Gene Therapy
MOA
SHP2i
Target
EGFR
Pathway
Neuroinflam
NBMM
Development Pipeline
Preclinical
~Oct 2015
→ ~Jan 2017
Phase 1
~Apr 2017
→ ~Jul 2018
Phase 2
~Oct 2018
→ ~Jan 2020
Phase 3
~Apr 2020
→ ~Jul 2021
NDA/BLA
Oct 2021
→ Sep 2030
NDA/BLACurrent
NCT07453481
359 pts·MM
2024-11→2030-09·Terminated
NCT04249554
182 pts·NB
2021-10→TBD·Not yet recruiting
541 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (1)
2030-09-274.5y awayPh3 Readout· MM
Trial Timeline
Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
NDA/BLA
Not yet…
NDA/BLA
Termina…
Catalysts
Ph3 Readout
2030-09-27 · 4.5y away
MM
TerminatedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07453481 | NDA/BLA | MM | Terminated | 359 | CfB |
| NCT04249554 | NDA/BLA | NB | Not yet recr... | 182 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-2191 | Pfizer | NDA/BLA | GLP-1R | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| Doxacagene | Sanofi | Approved | PSMA | |
| TAK-1836 | Takeda | Preclinical | EGFR | |
| VRT-1576 | Vertex Pharma | Phase 2/3 | RET | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| Daratuximab | BioMarin | Phase 1 | PRMT5 | |
| Zanurapivir | Neurocrine | NDA/BLA | EGFR | |
| Nirafotisoran | Jazz Pharma | Phase 2/3 | TROP-2 | |
| 369-4107 | Hansoh Pharma | Phase 2 | TNFα |