Modality
Fusion Protein
MOA
FGFRi
Target
CDK2
Pathway
Hedgehog
RSV
Development Pipeline
Preclinical
~Mar 2017
→ ~Jun 2018
Phase 1
~Sep 2018
→ ~Dec 2019
Phase 2
~Mar 2020
→ ~Jun 2021
Phase 3
~Sep 2021
→ ~Dec 2022
NDA/BLA
Mar 2023
→ Oct 2025
NDA/BLACurrent
NCT08419930
2,608 pts·RSV
2023-03→TBD·Completed
NCT04118065
2,229 pts·RSV
2024-08→2025-10·Active
4,837 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-10-225mo agoPh3 Readout· RSV
Trial Timeline
Q2Q3Q42024Q2Q3Q42025Q2Q3Q4
NDA/BLA
Complet…
NDA/BLA
Active
Catalysts
Ph3 Readout
2025-10-22 · 5mo ago
RSV
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08419930 | NDA/BLA | RSV | Completed | 2608 | CfB |
| NCT04118065 | NDA/BLA | RSV | Active | 2229 | BodyWt |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| LLY-9749 | Eli Lilly | Phase 3 | C5 | |
| LLY-1956 | Eli Lilly | Phase 1/2 | BCMA | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| 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 | |
| Nirabrutinib | BioNTech | Phase 2/3 | CDK2 |