Modality
Cell Therapy
MOA
IL-17i
Target
CDK2
Pathway
Amyloid
SMANB
Development Pipeline
Preclinical
~Aug 2015
→ ~Nov 2016
Phase 1
~Feb 2017
→ ~May 2018
Phase 2
Aug 2018
→ Oct 2031
Phase 2Current
NCT07655315
1,981 pts·SMA
2021-04→2027-07·Not yet recruiting
NCT08461284
311 pts·NB
2018-08→2031-10·Recruiting
2,292 total pts2 indications
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-07-081.3y awayPh3 Readout· SMA
2031-10-285.6y awayPh3 Readout· NB
Trial Timeline
Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3Q4
P2/3
Recruit…
P2/3
Not yet…
Catalysts
Ph3 Readout
2027-07-08 · 1.3y away
SMA
Ph3 Readout
2031-10-28 · 5.6y away
NB
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07655315 | Phase 2/3 | SMA | Not yet recr... | 1981 | EDSS |
| NCT08461284 | Phase 2/3 | NB | Recruiting | 311 | VA |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| SNY-2289 | Sanofi | Phase 2/3 | CD38 | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 | |
| Zanuratamab | Gilead Sciences | Phase 1/2 | CDK2 | |
| Elrarapivir | Vertex Pharma | NDA/BLA | PRMT5 | |
| Nirabrutinib | BioNTech | Phase 2/3 | CDK2 |