Modality
Nanobody
MOA
HER2
Target
PD-1
Pathway
Cell Cycle
FSGS
Development Pipeline
Preclinical
~Aug 2015
→ ~Nov 2016
Phase 1
~Feb 2017
→ ~May 2018
Phase 2
~Aug 2018
→ ~Nov 2019
Phase 3
~Feb 2020
→ ~May 2021
NDA/BLA
~Aug 2021
→ ~Nov 2022
Approved
Feb 2023
→ Apr 2027
ApprovedCurrent
NCT07917540
1,837 pts·FSGS
2023-02→2027-04·Not yet recruiting
1,837 total pts1 indication
CompletedCurrentUpcoming
Catalysts (1)
2027-04-241.1y awayPh3 Readout· FSGS
Trial Timeline
Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2
Approved
Not yet…
Catalysts
Ph3 Readout
2027-04-24 · 1.1y away
FSGS
Not yet recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT07917540 | Approved | FSGS | Not yet recr... | 1837 | CR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7809 | Pfizer | Phase 1 | DLL3 | |
| JNJ-7458 | Johnson & Johnson | Phase 1/2 | PD-1 | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| Pexaosocimab | Daiichi Sankyo | Phase 2 | PD-1 | |
| MRN-8133 | Moderna | Phase 2 | PD-1 | |
| Semazasiran | BeiGene | Phase 1 | PD-1 | |
| Rimainavolisib | Illumina | Phase 2 | PD-1 |