Modality
mAb
MOA
CAR-T CD19
Target
SHP2
Pathway
Complement
Hemophilia APsAWet AMD
Development Pipeline
Preclinical
~Sep 2011
→ ~Dec 2012
Phase 1
~Mar 2013
→ ~Jun 2014
Phase 2
~Sep 2014
→ ~Dec 2015
Phase 3
~Mar 2016
→ ~Jun 2017
NDA/BLA
~Sep 2017
→ ~Dec 2018
Approved
Mar 2019
→ Jul 2031
ApprovedCurrent
NCT05566899
295 pts·Hemophilia A
2019-03→TBD·Completed
NCT06542998
469 pts·PsA
2024-08→2027-03·Active
NCT08203742
2,991 pts·PsA
2022-03→2031-07·Terminated
3,755 total pts2 indications
CompletedCurrentUpcoming
Catalysts (2)
2027-03-1211mo awayPh3 Readout· PsA
2031-07-165.3y awayPh3 Readout· PsA
Trial Timeline
2019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
Approved
Complet…
Approved
Termina…
Approved
Active
Catalysts
Ph3 Readout
2027-03-12 · 11mo away
PsA
Ph3 Readout
2031-07-16 · 5.3y away
PsA
ActiveCompletedTerminated|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05566899 | Approved | Hemophilia A | Completed | 295 | EFS |
| NCT06542998 | Approved | PsA | Active | 469 | CR |
| NCT08203742 | Approved | PsA | Terminated | 2991 | DAS28 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| RHH-1546 | Roche | Phase 2/3 | C5 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| MRK-1380 | Merck & Co | Preclinical | SHP2 | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| Datoglumide | AbbVie | Approved | CFTR | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| GIL-2259 | Gilead Sciences | Approved | SMN2 | |
| MRN-7409 | Moderna | NDA/BLA | SHP2 | |
| BII-4342 | Biogen | Phase 2/3 | CGRP |