Modality
Cell Therapy
MOA
CDK2i
Target
Menin
Pathway
Fibrosis
FLRSV
Development Pipeline
Preclinical
~Mar 2012
→ ~Jun 2013
Phase 1
~Sep 2013
→ ~Dec 2014
Phase 2
~Mar 2015
→ ~Jun 2016
Phase 3
~Sep 2016
→ ~Dec 2017
NDA/BLA
Mar 2018
→ Mar 2029
NDA/BLACurrent
NCT05164455
2,591 pts·RSV
2018-03→2029-03·Completed
NCT07591826
75 pts·FL
2021-08→TBD·Not yet recruiting
2,666 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (1)
2029-03-253.0y awayPh3 Readout· RSV
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
NDA/BLA
Complet…
NDA/BLA
Not yet…
Catalysts
Ph3 Readout
2029-03-25 · 3.0y away
RSV
CompletedNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05164455 | NDA/BLA | RSV | Completed | 2591 | CfB |
| NCT07591826 | NDA/BLA | FL | Not yet recr... | 75 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| LLY-8369 | Eli Lilly | Approved | Menin | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| NVS-1475 | Novartis | Phase 2 | Menin | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| Tirasotorasib | Takeda | NDA/BLA | IL-17A | |
| Mavuglumide | Bayer | Approved | GLP-1R | |
| DSN-3066 | Daiichi Sankyo | Phase 3 | IL-13 | |
| GIL-9227 | Gilead Sciences | Phase 2/3 | GPRC5D |