Modality
Cell Therapy
MOA
FGFRi
Target
WEE1
Pathway
PI3K/AKT
ALS
Development Pipeline
Preclinical
~Apr 2013
→ ~Jul 2014
Phase 1
~Oct 2014
→ ~Jan 2016
Phase 2
~Apr 2016
→ ~Jul 2017
Phase 3
~Oct 2017
→ ~Jan 2019
NDA/BLA
Apr 2019
→ Jun 2025
NDA/BLACurrent
NCT05710563
1,483 pts·ALS
2019-04→2025-06·Not yet recruiting
NCT04923801
385 pts·ALS
2021-02→TBD·Recruiting
1,868 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2025-06-229mo agoPh3 Readout· ALS
Trial Timeline
Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3
NDA/BLA
Not yet…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2025-06-22 · 9mo ago
ALS
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05710563 | NDA/BLA | ALS | Not yet recr... | 1483 | UPCR |
| NCT04923801 | NDA/BLA | ALS | Recruiting | 385 | FEV1 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| LLY-9749 | Eli Lilly | Phase 3 | C5 | |
| LLY-1956 | Eli Lilly | Phase 1/2 | BCMA | |
| TAK-2403 | Takeda | Phase 2 | WEE1 | |
| Sovacapivasertib | Amgen | Phase 3 | WEE1 | |
| Fixaglumide | Genmab | Phase 2/3 | WEE1 | |
| SRP-9822 | Sarepta | Phase 3 | SOS1 | |
| Sovarasimod | Halozyme | Phase 1/2 | WEE1 | |
| Rimainavolisib | Illumina | Phase 2 | PD-1 | |
| Elrainavolisib | Roivant Sciences | Preclinical | Nectin-4 | |
| Bemavorutinib | Acadia Pharma | Phase 1/2 | WEE1 |