Modality
ERT
MOA
TYK2i
Target
Nectin-4
Pathway
Autophagy
AMLNBLGS
Development Pipeline
Preclinical
~Sep 2016
→ ~Dec 2017
Phase 1
Mar 2018
→ Aug 2026
Phase 1Current
NCT06839922
2,204 pts·AML
2018-03→2026-08·Recruiting
2,204 total pts1 indication
Phase 2
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-02-092mo agoPDUFA· AML
2026-08-255mo awayPh2 Data· AML
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
P1/2
Recruit…
Catalysts
PDUFA
2026-02-09 · 2mo ago
AML
Ph2 Data
2026-08-25 · 5mo away
AML
Recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06839922 | Phase 1/2 | AML | Recruiting | 2204 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| Lisonaritide | Eli Lilly | Phase 3 | IL-13 | |
| Zorisotorasib | AstraZeneca | Phase 1 | WRN | |
| SNY-8628 | Sanofi | NDA/BLA | B7-H3 | |
| DSN-1421 | Daiichi Sankyo | Phase 3 | Nectin-4 | |
| Voxacagene | Gilead Sciences | Phase 2/3 | SOS1 | |
| Sotosacituzumab | Vertex Pharma | Phase 1 | MET | |
| Sotorapivir | Moderna | Approved | FLT3 | |
| Olpainavolisib | Moderna | Phase 1 | Menin | |
| ARG-4339 | Argenx | Phase 2 | BCL-2 |