The strong OLE data de-risk ontunisertib's safety and efficacy signal in FSCD, a large unmet need. The upcoming NOV-ERA Phase 2b initiation is the next key catalyst. Monitor enrollment timelines and any interim data readouts.
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Executive Summary
Agomab announced positive 48-week open-label extension (OLE) results from the Phase 2a STENOVA trial of ontunisertib in Fibrostenosing Crohn's disease (FSCD). The data showed a favorable long-term safety profile, a low annualized FSCD-related event rate of 3% (one endoscopic balloon dilation, no surgeries), and radiological stricture stabilization over up to 60 weeks. The company plans to initiate the global NOV-ERA Phase 2b study in the coming months, supporting the drug's potential in a high-unmet-need indication with no approved anti-fibrotic therapies.
Key Facts
- 94% of eligible patients (49/52) rolled over into the OLE study, indicating strong patient acceptance.
- Annualized FSCD-related event rate of 3% (one EBD, no surgeries) over up to 60 weeks, vs. published rates of 23-35% in comparable populations.
- 97% of evaluable patients were in clinical remission by CDAI at Week 48 of the OLE.
- No signals of cardiac injury, pro-inflammatory effects, vasculitis, liver toxicity, or thrombotic events.
- Systemic exposure remained low and gut-restricted, consistent with Phase 1 data.
- Global NOV-ERA Phase 2b study (up to 320 patients, three dose levels vs. placebo) to initiate in coming months.
- Ontunisertib has U.S. FDA Fast Track Designation.
Financial Impact
No financial figures disclosed; clinical-stage biotech with no approved products or revenue.
Risk Factors
- Phase 2b NOV-ERA trial may fail to meet primary endpoint (endoscopic passability at Week 24).
- Cross-trial comparisons to 23-35% event rates are not head-to-head and may not replicate.
- Ontunisertib is not yet approved; regulatory and commercial risks remain.
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3372696 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 22, 2026 4d ago | Insider Buy | $9.26 | awaiting T+5 | — | $8.57 (−7.45%) |
Oct 13, 2026 13d ago | 6-K | $8.69 $9.11 | ▲ +4.83% | ▲ +4.38% | $8.57 (−1.38%) |
Oct 13, 2026 13d ago | Press Release | $8.69 $9.11 | ▲ +4.83% | ▲ +4.38% | $8.57 (−1.38%) |
Oct 1, 2026 25d ago | 6-K | $8.65 $9.22 | ▲ +6.59% | ▲ +5.29% | $8.57 (−0.92%) |
Oct 1, 2026 25d ago | Press Release | $8.65 $9.22 | ▲ +6.59% | ▲ +5.29% | $8.57 (−0.92%) |
Sep 14, 2026 6w ago | 6-K | $12.16 $11.49 | ▼ −5.51% | ▼ −7.64% | $8.57 (−29.52%) |
Sep 14, 2026 6w ago | Press Release | $12.16 $11.49 | ▼ −5.51% | ▼ −7.64% | $8.57 (−29.52%) |
Sep 11, 2026 6w ago | 6-K | $12.28 $11.70 | ▼ −4.72% | ▼ −4.83% | $8.57 (−30.21%) |
Aug 10, 2026 11w ago | 6-K | $14.85 $13.73 | ▼ −7.54% | ▼ −7.14% | $8.57 (−42.29%) |
Jun 23, 2026 17w ago | 6-K | $12.68 $11.87 | ▼ −6.39% | ▼ −8.10% | $8.57 (−32.41%) |
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