Modality
Fusion Protein
MOA
Anti-Tau
Target
CD19
Pathway
JAK/STAT
SCDALS
Development Pipeline
Preclinical
~Jul 2014
→ ~Oct 2015
Phase 1
~Jan 2016
→ ~Apr 2017
Phase 2
Jul 2017
→ Mar 2026
Phase 2Current
NCT08083437
953 pts·ALS
2019-01→2026-02·Completed
NCT05749107
2,308 pts·ALS
2017-07→2026-03·Completed
3,261 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-02-231mo agoPh2 Data· ALS
2026-03-152w agoPh2 Data· ALS
Trial Timeline
Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2
P2
Complet…
P2
Complet…
Catalysts
Ph2 Data
2026-02-23 · 1mo ago
ALS
Ph2 Data
2026-03-15 · 2w ago
ALS
Completed|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08083437 | Phase 2 | ALS | Completed | 953 | HAM-D |
| NCT05749107 | Phase 2 | ALS | Completed | 2308 | EDSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-8662 | Pfizer | NDA/BLA | CD19 | |
| RHH-7558 | Roche | Phase 1 | SGLT2 | |
| NVS-5439 | Novartis | Preclinical | BET | |
| NVS-6974 | Novartis | Preclinical | CD19 | |
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| NVO-9630 | Novo Nordisk | Phase 2 | CD3 | |
| REG-2172 | Regeneron | Phase 1/2 | PCSK9 | |
| BGN-3305 | BeiGene | Phase 2 | BCMA | |
| Sovarasimod | Halozyme | Phase 1/2 | WEE1 | |
| Voxamavacamten | Corcept | Approved | BET |