Modality
ERT
MOA
AuroraAi
Target
PLK4
Pathway
Wnt
FTD
Development Pipeline
Preclinical
~Oct 2012
→ ~Jan 2014
Phase 1
~Apr 2014
→ ~Jul 2015
Phase 2
~Oct 2015
→ ~Jan 2017
Phase 3
~Apr 2017
→ ~Jul 2018
NDA/BLA
Oct 2018
→ Jul 2028
NDA/BLACurrent
NCT07652372
157 pts·FTD
2018-10→2028-07·Completed
157 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (2)
2026-10-136mo awayEMA Filing· FTD
2028-07-102.3y awayPh3 Readout· FTD
Trial Timeline
Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
NDA/BLA
Complet…
Catalysts
EMA Filing
2026-10-13 · 6mo away
FTD
Ph3 Readout
2028-07-10 · 2.3y away
FTD
Completed|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07652372 | NDA/BLA | FTD | Completed | 157 | OS |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| Voxarasimod | Merck & Co | Phase 1/2 | CD19 | |
| TAK-5300 | Takeda | Phase 1 | SMN2 | |
| DSN-791 | Daiichi Sankyo | NDA/BLA | Aβ | |
| REG-861 | Regeneron | Phase 2 | PARP | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| Bemanesiran | BioNTech | Phase 3 | PLK4 | |
| BGN-6990 | BeiGene | Phase 2/3 | BCMA | |
| Peminaritide | Sarepta | NDA/BLA | PLK4 | |
| Pexaosocimab | United Therapeutics | NDA/BLA | PLK4 | |
| Semasacituzumab | Jazz Pharma | Phase 2 | AHR |