Modality
mRNA
MOA
CDK2i
Target
HER2
Pathway
Ferroptosis
CholangiocarcinomaHCC
Development Pipeline
Preclinical
~Mar 2018
→ ~Jun 2019
Phase 1
~Sep 2019
→ ~Dec 2020
Phase 2
~Mar 2021
→ ~Jun 2022
Phase 3
~Sep 2022
→ ~Dec 2023
NDA/BLA
Mar 2024
→ Sep 2028
NDA/BLACurrent
NCT06840208
1,821 pts·Cholangiocarcinoma
2024-03→2028-09·Completed
NCT08440494
396 pts·HCC
2024-12→2027-12·Active
2,217 total pts2 indications
Approved
CompletedCurrentUpcoming
Catalysts (2)
2027-12-261.7y awayPh3 Readout· HCC
2028-09-162.5y awayPh3 Readout· Cholangiocarcinoma
Trial Timeline
Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q4
NDA/BLA
Complet…
NDA/BLA
Active
Catalysts
Ph3 Readout
2027-12-26 · 1.7y away
HCC
Ph3 Readout
2028-09-16 · 2.5y away
Cholangiocarcinoma
ActiveCompleted|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT06840208 | NDA/BLA | Cholangiocarcinoma | Completed | 1821 | OS |
| NCT08440494 | NDA/BLA | HCC | Active | 396 | PANSS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| Tirafotisoran | Roche | Phase 2 | CD38 | |
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-6870 | AstraZeneca | Phase 2/3 | EGFR | |
| Gozesotorasib | Bristol-Myers Squibb | NDA/BLA | HER2 | |
| 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 | |
| REG-2328 | Regeneron | Phase 1 | BCMA |