Modality
mRNA
MOA
BCMA ADC
Target
TNFα
Pathway
STING
CSU
Development Pipeline
Preclinical
~Jun 2013
→ ~Sep 2014
Phase 1
~Dec 2014
→ ~Mar 2016
Phase 2
~Jun 2016
→ ~Sep 2017
Phase 3
~Dec 2017
→ ~Mar 2019
NDA/BLA
Jun 2019
→ May 2026
NDA/BLACurrent
NCT04659864
382 pts·CSU
2022-02→2026-05·Recruiting
NCT08160573
1,394 pts·CSU
2019-06→TBD·Recruiting
1,776 total pts1 indication
Approved
CompletedCurrentUpcoming
Catalysts (1)
2026-05-252mo awayPh3 Readout· CSU
Trial Timeline
Q3Q42020Q2Q3Q42021Q2Q3Q42022Q2Q3Q42023Q2Q3Q42024Q2Q3Q42025Q2Q3Q42026Q2Q3
NDA/BLA
Recruit…
NDA/BLA
Recruit…
Catalysts
Ph3 Readout
2026-05-25 · 2mo away
CSU
Recruiting|StartCompletionToday
Trials (2)
| NCT | Phase | Indication | Status | N | EP |
|---|---|---|---|---|---|
| NCT04659864 | NDA/BLA | CSU | Recruiting | 382 | UPCR |
| NCT08160573 | NDA/BLA | CSU | Recruiting | 1394 | LiverFat |
Competitors (10)
| Drug | Company | Phase | Target | MOA |
|---|---|---|---|---|
| ABB-3951 | AbbVie | Phase 2/3 | TNFα | |
| AZN-3724 | AstraZeneca | Preclinical | PSMA | |
| Olpatinib | GSK | Preclinical | PD-L1 | |
| GIL-9779 | Gilead Sciences | Phase 1 | IL-17A | |
| GIL-6239 | Gilead Sciences | Phase 2 | TNFα | |
| MRN-8225 | Moderna | Preclinical | TNFα | |
| Sovanaritide | Argenx | Phase 3 | TNFα | |
| 369-4107 | Hansoh Pharma | Phase 2 | TNFα | |
| Sematenlimab | Samsung Biologics | Phase 3 | PI3Kα | |
| VKT-4052 | Viking Therapeutics | Phase 2/3 | TNFα |