Modality
Gene Editing
MOA
CAR-T BCMA
Target
EZH2
Pathway
Amyloid
Ewing Sarcoma
Development Pipeline
Preclinical
~Nov 2011
→ ~Feb 2013
Phase 1
~May 2013
→ ~Aug 2014
Phase 2
~Nov 2014
→ ~Feb 2016
Phase 3
~May 2016
→ ~Aug 2017
NDA/BLA
~Nov 2017
→ ~Feb 2019
Approved
May 2019
→ Oct 2028
ApprovedCurrent
NCT05073255
1,571 pts·Ewing Sarcoma
2019-05→2026-05·Active
NCT06306282
1,195 pts·Ewing Sarcoma
2022-10→2028-10·Completed
2,766 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2026-05-081mo awayPh3 Readout· Ewing Sarcoma
2028-10-262.6y awayPh3 Readout· Ewing Sarcoma
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
Approved
Active
Approved
Complet…
Catalysts
Ph3 Readout
2026-05-08 · 1mo away
Ewing Sarcoma
Ph3 Readout
2028-10-26 · 2.6y away
Ewing Sarcoma
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05073255 | Approved | Ewing Sarcoma | Active | 1571 | PANSS |
| NCT06306282 | Approved | Ewing Sarcoma | Completed | 1195 | UPCR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxacilimab | Pfizer | Phase 2 | TYK2 | |
| NVO-9087 | Novo Nordisk | Phase 1/2 | Tau | |
| DSN-2247 | Daiichi Sankyo | NDA/BLA | EZH2 | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| REG-8074 | Regeneron | Phase 2/3 | KRASG12C | |
| HAL-9635 | Halozyme | Phase 2/3 | EZH2 | |
| JAZ-8729 | Jazz Pharma | Phase 2/3 | FcRn | |
| ACA-2691 | Acadia Pharma | Phase 3 | BCMA | |
| Olpasotorasib | Structure Ther | Preclinical | C5 | |
| AGI-4446 | Agios | Phase 3 | PSMA |