Preclinical safety data is a positive but early-stage de-risking step; the next catalyst is data from the planned therapeutic efficacy study. Monitor for results from that study and any regulatory interactions under the FDA Animal Rule.
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Executive Summary
Valion Bio announced positive safety results from a government-funded preclinical study of its lead drug candidate Entolimod in a mouse model of acute radiation syndrome (ARS). The study found no treatment-related toxicity, supporting advancement to a planned fully funded therapeutic efficacy study. The filing is a routine preclinical update with no financial data or regulatory decision.
Key Facts
- AFRRI safety study of Entolimod in 20 male C57BL/6 mice showed no evidence of treatment-related toxicity over 14 days
- No statistically significant differences in body weight, hematologic profiles, or serum chemistry between Entolimod and saline groups
- Next milestone is a fully funded AFRRI therapeutic efficacy study in a GI-ARS mouse model evaluating survival and GI recovery
- Entolimod has FDA Fast Track and Orphan Drug designations for ARS
- Company market cap is approximately $2M
Financial Impact
No financial figures disclosed; the next therapeutic study is described as fully funded by the government partner
Risk Factors
- Preclinical results may not translate to human efficacy or safety
- Company has a very small market cap ($2M) and may face capital constraints
- No timeline provided for the next study or potential regulatory submission
Market Snapshot
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001437749-26-033850 |
| Exhibit: ex_1032442.htm | 0001437749-26-033850 |
| Document: 0001437749-26-033850-index-headers.html | 0001437749-26-033850 |
| Document: 0001437749-26-033850-index.html | 0001437749-26-033850 |
| Document: 0001437749-26-033850.txt | 0001437749-26-033850 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 29, 2026 3d ago | 8-K | $0.6168 | awaiting T+20 | awaiting T+20 | $0.5500 (−10.83%) |
Oct 27, 2026 5d ago | 8-K | $0.7819 | awaiting T+20 | awaiting T+20 | $0.5500 (+29.66%) |
Oct 26, 2026 6d ago | 8-K | $0.8400 | awaiting T+20 | awaiting T+20 | $0.5500 (−34.52%) |
Oct 22, 2026 10d ago | 8-K | $0.9560 | awaiting T+20 | awaiting T+20 | $0.5500 (−42.47%) |
Oct 21, 2026 11d ago | EFFECT | $1.12 | awaiting T+20 | awaiting T+20 | $0.5500 (+50.89%) |
Oct 21, 2026 11d ago | EFFECT | $1.12 | awaiting T+20 | awaiting T+20 | $0.5500 (+50.89%) |
Oct 16, 2026 16d ago | S-3 | $1.16 | awaiting T+20 | awaiting T+20 | $0.5500 (+52.59%) |
Oct 16, 2026 16d ago | DEF 14A | $1.16 | awaiting T+20 | awaiting T+20 | $0.5500 (+52.59%) |
Oct 15, 2026 17d ago | 8-K | $1.23 | awaiting T+20 | awaiting T+20 | $0.5500 (−55.28%) |
Oct 14, 2026 18d ago | 8-K | $1.45 | awaiting T+20 | awaiting T+20 | $0.5500 (−62.07%) |
US Market Status
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