Modality
Cell Therapy
MOA
HER2
Target
SHP2
Pathway
Fibrosis
UCADHD
Development Pipeline
Preclinical
~Sep 2013
→ ~Dec 2014
Phase 1
~Mar 2015
→ ~Jun 2016
Phase 2
~Sep 2016
→ ~Dec 2017
Phase 3
Mar 2018
→ Dec 2030
Phase 3Current
NCT05978820
2,052 pts·UC
2018-03→2028-01·Not yet recruiting
NCT03253594
398 pts·UC
2022-12→2030-12·Completed
NCT06753517
2,620 pts·UC
2025-11→2027-02·Not yet recruiting
5,070 total pts1 indication
NDA/BLA
Approved
CompletedCurrentUpcoming
Catalysts (4)
2026-05-162mo awayFast Track· ADHD
2027-02-2311mo awayPh3 Readout· UC
2028-01-071.8y awayPh3 Readout· UC
2030-12-164.7y awayPh3 Readout· UC
Trial Timeline
2018Q2Q3Q42019Q2Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3Q42027Q2Q3Q42028Q2Q3Q42029Q2Q3Q42030Q2Q3Q4
P3
Not yet…
P3
Complet…
P3
Not yet…
Catalysts
Fast Track
2026-05-16 · 2mo away
ADHD
Ph3 Readout
2027-02-23 · 11mo away
UC
Ph3 Readout
2028-01-07 · 1.8y away
UC
Ph3 Readout
2030-12-16 · 4.7y away
UC
CompletedNot yet recruiting|StartCompletionToday
Trials (3)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT05978820 | Phase 3 | UC | Not yet recr... | 2052 | DAS28 |
| NCT03253594 | Phase 3 | UC | Completed | 398 | EDSS |
| NCT06753517 | Phase 3 | UC | Not yet recr... | 2620 | ORR |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| PFE-7809 | Pfizer | Phase 1 | DLL3 | |
| LLY-8903 | Eli Lilly | Preclinical | CD47 | |
| NVS-5126 | Novartis | Phase 3 | SHP2 | |
| MRK-1380 | Merck & Co | Preclinical | SHP2 | |
| ABB-1817 | AbbVie | Phase 3 | SHP2 | |
| AZN-8281 | AstraZeneca | Phase 1 | SHP2 | |
| AZN-8478 | AstraZeneca | NDA/BLA | SHP2 | |
| SNY-7254 | Sanofi | Phase 2 | CFTR | |
| Datobrutinib | Sanofi | Phase 3 | Aβ | |
| TAK-9344 | Takeda | Phase 3 | CGRP |