Modality
Radioligand
MOA
AuroraAi
Target
FGFR
Pathway
Proteasome
ACCCF
Development Pipeline
Preclinical
~Nov 2014
→ ~Feb 2016
Phase 1
~May 2016
→ ~Aug 2017
Phase 2
~Nov 2017
→ ~Feb 2019
Phase 3
~May 2019
→ ~Aug 2020
NDA/BLA
Nov 2020
→ Dec 2030
NDA/BLACurrent
NCT05147938
1,043 pts·CF
2023-11→2025-01·Recruiting
NCT07557667
214 pts·CF
2020-11→2030-12·Recruiting
1,257 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-01-231.2y agoPh3 Readout· CF
2030-12-144.7y awayPh3 Readout· CF
Trial Timeline
Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
NDA/BLA
Recruit…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2025-01-23 · 1.2y ago
CF
Ph3 Readout
2030-12-14 · 4.7y away
CF
Recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05147938 | NDA/BLA | CF | Recruiting | 1043 | ACR20 |
| NCT07557667 | NDA/BLA | CF | Recruiting | 214 | ACR20 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-1592 | Eli Lilly | NDA/BLA | FGFR | |
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| Doxarasimod | Merck & Co | NDA/BLA | FGFR | |
| AZN-7403 | AstraZeneca | Phase 2/3 | FGFR | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| REG-861 | Regeneron | Phase 2 | PARP | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| BGN-6990 | BeiGene | Phase 2/3 | BCMA |