Modality
Fusion Protein
MOA
PCSK9i
Target
C5
Pathway
Notch
NBMSFTD
Development Pipeline
Preclinical
~Feb 2012
→ ~May 2013
Phase 1
~Aug 2013
→ ~Nov 2014
Phase 2
~Feb 2015
→ ~May 2016
Phase 3
~Aug 2016
→ ~Nov 2017
NDA/BLA
~Feb 2018
→ ~May 2019
Approved
Aug 2019
→ Dec 2026
ApprovedCurrent
NCT06017799
2,974 pts·MS
2019-08→2026-12·Completed
2,974 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2026-12-038mo awayPh3 Readout· MS
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
Approved
Complet…
Catalysts
Ph3 Readout
2026-12-03 · 8mo away
MS
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06017799 | Approved | MS | Completed | 2974 | 6MWD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-9749 | Eli Lilly | Phase 3 | C5 | |
| LLY-1184 | Eli Lilly | NDA/BLA | C5 | |
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| BAY-6035 | Bayer | Phase 1 | C5 | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| ARG-1250 | Argenx | Phase 2 | C5 |