Modality
mRNA
MOA
HER2
Target
CFTR
Pathway
mTOR
NASHFSGSCholangiocarcinoma
Development Pipeline
Preclinical
~Dec 2014
→ ~Mar 2016
Phase 1
~Jun 2016
→ ~Sep 2017
Phase 2
Dec 2017
→ Jan 2027
Phase 2Current
NCT08766709
71 pts·FSGS
2017-12→2027-01·Not yet recruiting
71 total pts1 indication
Phase 3
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (2)
2025-07-089mo agoPDUFA· NASH
2027-01-039mo awayPh2 Data· FSGS
Trial Timeline
Q42018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027
P2
Not yet…
Catalysts
PDUFA
2025-07-08 · 9mo ago
NASH
Ph2 Data
2027-01-03 · 9mo away
FSGS
Not yet recruiting|StartCompletionToday
Trials (1)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT08766709 | Phase 2 | FSGS | Not yet recr... | 71 | PASI75 |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7809 | Pfizer | Phase 1 | DLL3 | |
| Nidasacituzumab | Eli Lilly | Approved | CFTR | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| Datoglumide | AbbVie | Approved | CFTR | |
| SNY-5894 | Sanofi | Approved | CFTR | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| TAK-9344 | Takeda | Phase 3 | CGRP | |
| Sovarelsin | BioMarin | Phase 2 | CFTR | |
| Fixatuximab | Legend Biotech | Preclinical | CFTR | |
| Doxasotorasib | Samsung Biologics | Phase 2/3 | CFTR |