Modality
Gene Editing
MOA
PCSK9i
Target
PSMA
Pathway
Incretin
MCLEoECSU
Development Pipeline
Preclinical
~Aug 2009
→ ~Nov 2010
Phase 1
~Feb 2011
→ ~May 2012
Phase 2
~Aug 2012
→ ~Nov 2013
Phase 3
~Feb 2014
→ ~May 2015
NDA/BLA
~Aug 2015
→ ~Nov 2016
Approved
Feb 2017
→ Apr 2031
ApprovedCurrent
NCT03975705
2,324 pts·MCL
2018-05→2027-03·Terminated
NCT07724545
1,264 pts·MCL
2017-02→2031-04·Active
3,588 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2027-03-2712mo awayPh3 Readout· MCL
2031-04-285.1y awayPh3 Readout· MCL
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q42031Q2Q3
Approved
Active
Approved
Termina…
Catalysts
Ph3 Readout
2027-03-27 · 12mo away
MCL
Ph3 Readout
2031-04-28 · 5.1y away
MCL
ActiveTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT03975705 | Approved | MCL | Terminated | 2324 | CR |
| NCT07724545 | Approved | MCL | Active | 1264 | EFS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| MRK-8368 | Merck & Co | Phase 3 | ALK | |
| AZN-3724 | AstraZeneca | Preclinical | PSMA | |
| Ribofutibatinib | AstraZeneca | Phase 2/3 | SOS1 | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| Doxacagene | Sanofi | Approved | PSMA | |
| GSK-2051 | GSK | Phase 1 | PSMA | |
| Polazasiran | Amgen | Phase 2 | LAG-3 | |
| GIL-2445 | Gilead Sciences | Phase 2/3 | PSMA | |
| Cevitinib | Regeneron | Phase 3 | FGFR | |
| BII-1564 | Biogen | Phase 2 | PSMA |