Modality
Bispecific Ab
MOA
HER2
Target
PSMA
Pathway
Innate Imm
ACCRCC
Development Pipeline
Preclinical
~Feb 2012
→ ~May 2013
Phase 1
~Aug 2013
→ ~Nov 2014
Phase 2
~Feb 2015
→ ~May 2016
Phase 3
~Aug 2016
→ ~Nov 2017
NDA/BLA
Feb 2018
→ Aug 2026
NDA/BLACurrent
NCT05334055
1,955 pts·ACC
2021-11→TBD·Recruiting
NCT06696403
1,285 pts·ACC
2018-02→2026-08·Terminated
3,240 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-08-165mo awayPh3 Readout· ACC
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q4
NDA/BLA
Termina…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2026-08-16 · 5mo away
ACC
RecruitingTerminated|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05334055 | NDA/BLA | ACC | Recruiting | 1955 | PASI75 |
| NCT06696403 | NDA/BLA | ACC | Terminated | 1285 | MRD |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7809 | Pfizer | Phase 1 | DLL3 | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| AZN-3724 | AstraZeneca | Preclinical | PSMA | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| Doxacagene | Sanofi | Approved | PSMA | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| GSK-2051 | GSK | Phase 1 | PSMA | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| GIL-2445 | Gilead Sciences | Phase 2/3 | PSMA | |
| BII-1564 | Biogen | Phase 2 | PSMA |