Modality
Radioligand
MOA
Menini
Target
MALT1
Pathway
PD-1/PD-L1
ALS
Development Pipeline
Preclinical
~Oct 2017
→ ~Jan 2019
Phase 1
~Apr 2019
→ ~Jul 2020
Phase 2
Oct 2020
→ Jan 2027
Phase 2Current
NCT04240180
551 pts·ALS
2020-10→2025-09·Terminated
NCT03629264
513 pts·ALS
2025-06→2027-01·Terminated
1,064 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2025-09-216mo agoPh3 Readout· ALS
2025-12-273mo agoFast Track· ALS
2026-10-287mo awayNDA· ALS
2027-01-2710mo awayPh3 Readout· ALS
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027
P2/3
Termina…
P2/3
Termina…
Catalysts
Ph3 Readout
2025-09-21 · 6mo ago
ALS
Fast Track
2025-12-27 · 3mo ago
ALS
NDA
2026-10-28 · 7mo away
ALS
Ph3 Readout
2027-01-27 · 10mo away
ALS
Terminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04240180 | Phase 2/3 | ALS | Terminated | 551 | PFS |
| NCT03629264 | Phase 2/3 | ALS | Terminated | 513 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Mavutenlimab | Johnson & Johnson | Phase 3 | Cl18.2 | |
| JNJ-8232 | Johnson & Johnson | NDA/BLA | MALT1 | |
| Ivorelsin | Eli Lilly | Approved | JAK1 | |
| BMY-7975 | Bristol-Myers Squibb | Phase 1 | MALT1 | |
| NVO-2974 | Novo Nordisk | NDA/BLA | PARP | |
| GSK-6516 | GSK | Phase 1/2 | MALT1 | |
| BII-5240 | Biogen | Phase 2/3 | MALT1 | |
| ALN-3958 | Alnylam | Phase 2 | MALT1 | |
| Cevisacituzumab | Alnylam | Preclinical | MALT1 | |
| ION-8812 | Ionis | Phase 1 | MALT1 |