AgomAb Therapeutics AGMB
AgomAb Therapeutics (Nasdaq: AGMB) is a GI/hepatology drug developer. Its lead program, Ontunisertib (AGMB-129), is in Phase 2 for Fibrostenosing Crohn's disease.
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Ontunisertib (AGMB-129) | Fibrostenosing Crohn's disease | unclear | Phase 2 |
| AGMB-447 | — | unclear | Pre-clinical |
Recent results and decisions
- Oct 13, 2026started First patient dosed in the global Phase 2b NOV-ERA study (about 320 patients; primary endpoint endoscopic passability at Week 24).
today announced that the first patient has been dosed in NOV-ERA, the Company's global Phase 2b study evaluating ontunisertib in patients with symptomatic FSCD.
Filing - Oct 1, 2026positive 48-week OLE (n=49): favorable safety through up to 60 weeks, one FSCD-related event (balloon dilation), 3% annualized event rate, no surgeries.
Only one FSCD-related event, an EBD procedure, was reported during the study, corresponding to an annualized event rate of 3%.
Filing - Sep 14, 2026positive Phase 1 Part C in 10 IPF patients: generally favorable safety, lung-restricted PK, and >50% pSMAD3 reduction in BAL cells at 4.5 mg BID.
pSMAD3 reduction in BAL cells of >50% was achieved at the 4.5 mg BID dose, indicating robust target engagement in line with the results observed previously in healthy participants and supporting further clinical development of AGMB-447 for the treatment of IPF.
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
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