Monitor for results of the systemic exposure study, which is the next key catalyst for the oral mucosal program. Without PK data, this remains a preclinical technical milestone with no near-term revenue or regulatory impact.
Price Chart
Executive Summary
Valion Bio announced the successful completion of formulation work to develop an oral mucosal version of its lead candidate Entolimod using Shear Kershman Laboratories' BioViscid platform. This is an early-stage technical milestone with no systemic exposure data yet — the next study will test whether the formulation delivers measurable amounts into the bloodstream. The filing contains no financial data, no regulatory submission, and no change to the existing injectable program.
Key Facts
- Valion and Shear Kershman Laboratories completed formulation work on an oral mucosal Entolimod using the BioViscid platform.
- The next milestone is a study to test whether the formulation produces measurable systemic exposure to Entolimod.
- Valion estimates the potential addressable opportunity for oral mucosal Entolimod at 10-40 times the injectable program, assuming supply to ~3.79 million military/fire/law enforcement personnel.
- The injectable Entolimod program remains Valion's stated priority.
- No financial figures, regulatory submissions, or changes to existing programs were disclosed.
Financial Impact
No financial figures reported; early-stage formulation milestone with no revenue or cost data.
Risk Factors
- Oral mucosal formulation may fail to demonstrate systemic exposure in upcoming studies.
- Regulatory approval under the FDA Animal Rule remains uncertain and years away.
- Addressable market estimates are speculative and depend on government procurement priorities and funding.
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001683168-26-007514 |
| Document: valion_ex9901.htm | 0001683168-26-007514 |
| Document: 0001683168-26-007514-index-headers.html | 0001683168-26-007514 |
| Document: 0001683168-26-007514-index.html | 0001683168-26-007514 |
| Document: 0001683168-26-007514.txt | 0001683168-26-007514 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 27, 2026 today | 8-K | $0.8950 | awaiting T+20 | — | $0.7820 (+12.63%) |
Oct 26, 2026 1d ago | 8-K | $0.8400 | awaiting T+20 | — | $0.7820 (−6.90%) |
Oct 22, 2026 5d ago | 8-K | $0.9560 | awaiting T+20 | — | $0.7820 (−18.20%) |
Oct 21, 2026 6d ago | EFFECT | $1.12 | awaiting T+20 | — | $0.7820 (+30.18%) |
Oct 21, 2026 6d ago | EFFECT | $1.12 | awaiting T+20 | — | $0.7820 (+30.18%) |
Oct 16, 2026 11d ago | S-3 | $1.16 | awaiting T+20 | — | $0.7820 (+32.59%) |
Oct 16, 2026 11d ago | DEF 14A | $1.16 | awaiting T+20 | — | $0.7820 (+32.59%) |
Oct 15, 2026 12d ago | 8-K | $1.23 | awaiting T+20 | — | $0.7820 (−36.42%) |
Oct 14, 2026 13d ago | 8-K | $1.45 | awaiting T+20 | — | $0.7820 (−46.07%) |
Oct 8, 2026 19d ago | 8-K | $2.21 | awaiting T+20 | — | $0.7820 (+64.62%) |
US Market Status
Subscribe to SecBot
Get Real-Time SEC Filing Intelligence
Comprehensive SEC filing analysis delivered the moment filings hit EDGAR. Sentiment scoring, impact analysis, and actionable insights for every material event.
Create a free account Live analysis, Telegram alerts, watchlists and the MCP server for subscribers