Monitor for study completion and FDA submission updates. No revenue or earnings impact until FDA clearance is obtained, which remains uncertain. The stock may see volatility on regulatory news but this filing alone is not a catalyst.
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Executive Summary
Intelligent Bio Solutions initiated an Interference Study on June 16, 2026, to support its FDA 510(k) submission for U.S. clearance of its fingerprint drug screening system for codeine detection. The study, enrolling 75 participants, is expected to complete by mid-July 2026 and will be included with other clinical data in the submission package. This is a routine regulatory milestone with no financial data disclosed.
Key Facts
- Initiated Interference Study for FDA 510(k) submission of Intelligent Fingerprinting Drug Screening System for codeine detection.
- Study will enroll 75 healthy adult participants; expected completion by mid-July 2026.
- Study runs concurrently with Method Comparison Study; follows Cut-off Study started January 2026.
- Partnered with CenExel Clinical Research, Inc. for the study.
- Results will be included in FDA 510(k) submission package along with data from Cut-off and Method Comparison studies.
Financial Impact
Not specified
Risk Factors
- FDA 510(k) clearance is not guaranteed and may be delayed or denied.
- Clinical study results may not meet FDA requirements for specificity and accuracy.
- Company has a small market cap ($6M) and limited financial resources; regulatory setbacks could be material.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 5 SEC documents filed with EDGAR.
| Document | Accession Number |
|---|---|
| 8-K Filing (Primary) | 0001493152-26-028898 |
| Exhibit: ex99-1.htm | 0001493152-26-028898 |
| Document: 0001493152-26-028898-index-headers.html | 0001493152-26-028898 |
| Document: 0001493152-26-028898-index.html | 0001493152-26-028898 |
| Document: 0001493152-26-028898.txt | 0001493152-26-028898 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 21, 2026 5d ago | 10-K/A | $1.69 | awaiting T+20 | — | $1.64 (−2.67%) |
Oct 13, 2026 13d ago | 8-K | $1.45 | awaiting T+20 | — | $1.64 (+13.10%) |
Sep 24, 2026 4w ago | EFFECT | $1.71 $1.69 | ▲ +1.46% | ▲ +1.04% | $1.64 (+4.09%) |
Sep 15, 2026 5w ago | S-3 | $1.97 $1.48 | ▼ −24.87% | ▼ −28.05% | $1.64 (−16.75%) |
Sep 11, 2026 6w ago | 8-K | $2.07 $1.51 | ▼ −27.05% | ▼ −29.32% | $1.64 (−20.77%) |
Sep 9, 2026 6w ago | 8-K | $2.24 $1.59 | ▼ −29.02% | ▼ −30.96% | $1.64 (−26.79%) |
Sep 2, 2026 7w ago | 8-K | $2.30 $1.66 | ▲ +27.83% | ▲ +26.64% | $1.64 (+28.70%) |
Aug 19, 2026 9w ago | 8-K | $2.67 $2.05 | ▼ −23.22% | ▼ −21.70% | $1.64 (−38.58%) |
Aug 19, 2026 9w ago | Press Release | $2.67 $2.05 | ▲ +23.22% | ▲ +21.70% | $1.64 (+38.58%) |
Aug 17, 2026 10w ago | Press Release | $3.37 $2.05 | ▼ −39.17% | ▼ −37.19% | $1.64 (−51.34%) |
US Market Status
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