Modality
Bispecific Ab
MOA
PCSK9i
Target
PI3Kα
Pathway
Cell Cycle
MGALL
Development Pipeline
Preclinical
~Apr 2013
→ ~Jul 2014
Phase 1
~Oct 2014
→ ~Jan 2016
Phase 2
~Apr 2016
→ ~Jul 2017
Phase 3
~Oct 2017
→ ~Jan 2019
NDA/BLA
Apr 2019
→ Nov 2030
NDA/BLACurrent
NCT03519502
1,515 pts·MG
2019-04→2030-11·Active
1,515 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2030-11-194.6y awayPh3 Readout· MG
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
NDA/BLA
Active
Catalysts
Ph3 Readout
2030-11-19 · 4.6y away
MG
Active|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03519502 | NDA/BLA | MG | Active | 1515 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxaderotide | Johnson & Johnson | NDA/BLA | PI3Kα | |
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| Rimamavacamten | Merck & Co | Phase 1 | PI3Kα | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| Fixazanubrutinib | Amgen | Phase 2 | PI3Kα | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| GMA-1468 | Genmab | NDA/BLA | PI3Kα | |
| INC-1261 | Incyte | Phase 1/2 | PRMT5 |