Modality
Gene Therapy
MOA
CDK4/6i
Target
BCMA
Pathway
Wnt
ACCNMOSDGIST
Development Pipeline
Preclinical
~Jul 2009
→ ~Oct 2010
Phase 1
~Jan 2011
→ ~Apr 2012
Phase 2
~Jul 2012
→ ~Oct 2013
Phase 3
~Jan 2014
→ ~Apr 2015
NDA/BLA
~Jul 2015
→ ~Oct 2016
Approved
Jan 2017
→ Feb 2029
ApprovedCurrent
NCT07122428
1,085 pts·NMOSD
2017-01→2029-02·Recruiting
NCT04354853
1,442 pts·ACC
2018-04→TBD·Active
NCT03766806
2,073 pts·GIST
2020-01→2026-02·Completed
4,600 total pts3 indications
CompletedCurrentUpcoming
Catalysts (2)
2026-02-261mo agoPh3 Readout· GIST
2029-02-202.9y awayPh3 Readout· NMOSD
Trial Timeline
2017Q2Q3Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2
Approved
Recruit…
Approved
Active
Approved
Complet…
Catalysts
Ph3 Readout
2026-02-26 · 1mo ago
GIST
Ph3 Readout
2029-02-20 · 2.9y away
NMOSD
RecruitingActiveCompleted|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07122428 | Approved | NMOSD | Recruiting | 1085 | PASI75 |
| NCT04354853 | Approved | ACC | Active | 1442 | SeizFreq |
| NCT03766806 | Approved | GIST | Completed | 2073 | EASI-75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-5767 | Pfizer | Phase 1/2 | BET | |
| LLY-1956 | Eli Lilly | Phase 1/2 | BCMA | |
| RHH-1969 | Roche | Approved | BET | |
| ABB-8696 | AbbVie | Phase 3 | BCMA | |
| AZN-4015 | AstraZeneca | Preclinical | BCMA | |
| Ivocapivasertib | Bristol-Myers Squibb | Phase 1 | BET | |
| Zorimavacamten | Bristol-Myers Squibb | Preclinical | Cl18.2 | |
| Fixatenlimab | GSK | Phase 1/2 | JAK1 | |
| REG-2328 | Regeneron | Phase 1 | BCMA | |
| VRT-4938 | Vertex Pharma | Preclinical | HER2 |