Modality
Fusion Protein
MOA
AuroraAi
Target
CD123
Pathway
mTOR
PAH
Development Pipeline
Preclinical
~Jun 2012
→ ~Sep 2013
Phase 1
~Dec 2013
→ ~Mar 2015
Phase 2
~Jun 2015
→ ~Sep 2016
Phase 3
~Dec 2016
→ ~Mar 2018
NDA/BLA
~Jun 2018
→ ~Sep 2019
Approved
Dec 2019
→ May 2028
ApprovedCurrent
NCT05742107
134 pts·PAH
2023-06→2025-10·Not yet recruiting
NCT04905409
1,212 pts·PAH
2019-12→2028-05·Recruiting
1,346 total pts1 indication
CompletedCurrentUpcoming
Catalysts (2)
2025-10-036mo agoPh3 Readout· PAH
2028-05-262.2y awayPh3 Readout· PAH
Trial Timeline
Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3
Approved
Recruit…
Approved
Not yet…
Catalysts
Ph3 Readout
2025-10-03 · 6mo ago
PAH
Ph3 Readout
2028-05-26 · 2.2y away
PAH
RecruitingNot yet recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05742107 | Approved | PAH | Not yet recr... | 134 | FEV1 |
| NCT04905409 | Approved | PAH | Recruiting | 1212 | PANSS |
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-7737 | Regeneron | Preclinical | CD123 | |
| REG-861 | Regeneron | Phase 2 | PARP | |
| MRN-5715 | Moderna | NDA/BLA | CDK4/6 | |
| BGN-6990 | BeiGene | Phase 2/3 | BCMA | |
| Semasacituzumab | Jazz Pharma | Phase 2 | AHR | |
| ILM-2412 | Illumina | Phase 3 | PLK4 | |
| Ivotuximab | Madrigal Pharma | Phase 2 | CD123 |