Monitor for study completion and subsequent FDA 510(k) submission. The stock may see volatility around regulatory milestones, but near-term trading is likely driven by broader market sentiment given the company's micro-cap status.
Price Chart
Executive Summary
Intelligent Bio Solutions initiated an Interference Study to support its FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System targeting opiate codeine detection. The study, enrolling 75 participants and expected to complete by mid-July 2026, is a routine clinical milestone that moves the regulatory process forward but does not constitute a near-term catalyst.
Key Facts
- Interference Study initiated to support FDA 510(k) submission for Intelligent Fingerprinting Drug Screening System for codeine detection.
- Study will enroll 75 healthy adult participants under undosed and dosed conditions.
- Expected completion by mid-July 2026; results to be included in FDA 510(k) submission package.
- Study conducted in partnership with CenExel Clinical Research, Inc., running concurrently with Method Comparison Study and following Cut-off Study started January 2026.
Financial Impact
No financial figures disclosed; study is a regulatory milestone with no direct revenue impact.
Risk Factors
- Study results may fail to demonstrate specificity, delaying or derailing FDA clearance.
- Regulatory timeline could slip beyond mid-July 2026.
- Company has limited cash runway and may require additional financing to complete development.
Market Snapshot
Investment Themes
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3312568 |
Filters
| Type | Now | ||||
|---|---|---|---|---|---|
Oct 21, 2026 5d ago | 10-K/A | $1.69 | awaiting T+20 | — | $1.69 (+0.30%) |
Oct 13, 2026 13d ago | 8-K | $1.45 | awaiting T+20 | — | $1.69 (+16.55%) |
Sep 24, 2026 4w ago | EFFECT | $1.71 $1.69 | ▲ +1.46% | ▲ +1.04% | $1.69 (+1.17%) |
Sep 15, 2026 5w ago | S-3 | $1.97 $1.48 | ▼ −24.87% | ▼ −28.05% | $1.69 (−14.21%) |
Sep 11, 2026 6w ago | 8-K | $2.07 $1.51 | ▼ −27.05% | ▼ −29.32% | $1.69 (−18.36%) |
Sep 9, 2026 6w ago | 8-K | $2.24 $1.59 | ▼ −29.02% | ▼ −30.96% | $1.69 (−24.55%) |
Sep 2, 2026 7w ago | 8-K | $2.30 $1.66 | ▲ +27.83% | ▲ +26.64% | $1.69 (+26.52%) |
Aug 19, 2026 9w ago | 8-K | $2.67 $2.05 | ▼ −23.22% | ▼ −21.70% | $1.69 (−36.70%) |
Aug 19, 2026 9w ago | Press Release | $2.67 $2.05 | ▲ +23.22% | ▲ +21.70% | $1.69 (+36.70%) |
Aug 17, 2026 10w ago | Press Release | $3.37 $2.05 | ▼ −39.17% | ▼ −37.19% | $1.69 (−49.85%) |
US Market Status
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