Modality
Gene Editing
MOA
PCSK9i
Target
CDK2
Pathway
Innate Imm
PNHPAHOvarian Ca
Development Pipeline
Preclinical
~Apr 2019
→ ~Jul 2020
Phase 1
~Oct 2020
→ ~Jan 2022
Phase 2
~Apr 2022
→ ~Jul 2023
Phase 3
Oct 2023
→ Dec 2029
Phase 3Current
NCT08283707
2,492 pts·PAH
2023-10→2029-12·Completed
2,492 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (1)
2029-12-043.7y awayPh3 Readout· PAH
Trial Timeline
Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q4
P3
Complet…
Catalysts
Ph3 Readout
2029-12-04 · 3.7y away
PAH
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08283707 | Phase 3 | PAH | Completed | 2492 | eGFR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-3703 | Pfizer | Phase 1/2 | CDK2 | |
| NVS-3297 | Novartis | Preclinical | CDK2 | |
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| Fixainavolisib | Takeda | Preclinical | CDK2 | |
| AMG-1919 | Amgen | Phase 2/3 | CDK2 | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| AMG-415 | Amgen | Phase 1 | CDK2 | |
| AMG-9052 | Amgen | Phase 2/3 | CDK2 |