Modality
Radioligand
MOA
CAR-T CD19
Target
FcRn
Pathway
Cell Cycle
MG
Development Pipeline
Preclinical
~Apr 2020
→ ~Jul 2021
Phase 1
~Oct 2021
→ ~Jan 2023
Phase 2
Apr 2023
→ Aug 2026
Phase 2Current
NCT03904021
461 pts·MG
2023-04→2026-08·Terminated
461 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-08-064mo awayPh3 Readout· MG
Trial Timeline
Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3
P2/3
Termina…
Catalysts
Ph3 Readout
2026-08-06 · 4mo away
MG
Terminated|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03904021 | Phase 2/3 | MG | Terminated | 461 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Cevizanubrutinib | Johnson & Johnson | Preclinical | FcRn | |
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| Gelinaritide | AbbVie | Preclinical | FcRn | |
| Datoglumide | AbbVie | Approved | CFTR | |
| Talalemzoparlimab | Gilead Sciences | Phase 1 | FcRn | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| Sovafutibatinib | Moderna | Approved | FcRn | |
| BII-4342 | Biogen | Phase 2/3 | CGRP | |
| ITC-879 | Intra-Cellular | Approved | FcRn | |
| Talasotorasib | Exelixis | Preclinical | APOC3 |