Monitor for study initiation and enrollment updates in H2 2026. The novel endpoint and regulatory alignment reduce design risk, but Phase 2b data are years away. No near-term catalyst beyond operational milestones.
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Executive Summary
Agomab announced the design of its Phase 2b NOV-ERA study for ontunisertib in Fibrostenosing Crohn's Disease, with FDA alignment on the novel primary endpoint of endoscopic passability. The study is on track to dose first participants in H2 2026. This is a clinical-stage biotech milestone with no financial data provided.
Key Facts
- FDA alignment on NOV-ERA Phase 2b study design for ontunisertib in Fibrostenosing Crohn's Disease (FSCD).
- Primary endpoint: endoscopic passability at Week 24, assessed by SES-CD narrowing score.
- Study to enroll up to 320 adult patients globally, randomized 1:1:1:1 to three dose levels (400 mg, 200 mg, 100 mg) or placebo.
- First participant dosing expected in H2 2026.
- Protocol cleared central IRB in the U.S. and received Health Canada approval; CTAs submitted in EU and Asia Pacific.
- No approved pharmacological therapies exist for FSCD, representing a large unmet medical need.
- Ontunisertib has FDA Fast Track Designation.
Financial Impact
No financial figures disclosed in the filing.
Risk Factors
- Clinical trial failure or negative efficacy/safety data.
- Regulatory delays in study initiation across multiple jurisdictions.
- Competition from other FSCD programs.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 6-K Filing (Primary) | 0001104659-26-076819 |
| Document: tm2618511d1_6k.htm | 0001104659-26-076819 |
| Document: 0001104659-26-076819-index-headers.html | 0001104659-26-076819 |
| Document: 0001104659-26-076819-index.html | 0001104659-26-076819 |
| Document: 0001104659-26-076819.txt | 0001104659-26-076819 |
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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