INTELLIGENT BIO SOLUTIONS INC. — Form 8-K
Filed September 9, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 78/100
What the filing says
Intelligent Bio Solutions submitted a 510(k) premarket notification to the FDA on September 9, 2026, seeking clearance for its Intelligent Fingerprinting Drug Screening System for codeine detection. The submission includes clinical data demonstrating 98%+ accuracy, 94%+ sensitivity, and 100% specificity from studies conducted at three independent U.S. sites with 18,000+ hours of data collection. FDA clearance is expected to enable U.S. commercialization in the multi-billion-dollar drug screening market, where the technology is already deployed outside the U.S.
Why this rating
FDA submission is pivotal milestone for $11.7M-cap company; success could unlock multi-billion-dollar U.S. market entry. High clinical performance data strengthens approval odds. Execution risk remains—outcome unknown—but event materially changes trajectory if approved.
Tradability signal
NO TRADE
No trade: only ~$0k traded in the last 30 min — too illiquid to enter and exit.
Derived from this site's own measured outcomes + live price/liquidity at analysis time. An experiment, not investment advice.
Price action (we called it positive)
before filing · preread $2.24 ▲ 4.19% | at our read · unknown $2.15 | +10 min · unknown $2.15 ▲ 0.00% | +30 min · unknown $2.15 ▲ 0.00% | +1 hr · unknown $2.16 ▲ 0.47% | +4 hrs pending |
The stock had already moved -4.02% between hitting EDGAR and our read finishing — deltas above are measured from our read.
Quotes via Yahoo Finance at capture time; sessions other than regular hours are labeled. Not investment advice. How accurate are our calls? →
See more from September 9, 2026.
EDGAR·FLOW summarizes public SEC EDGAR filings with automated analysis. Materiality scores and stock-impact predictions are algorithmically generated and are not investment advice. Always verify against the source filing on SEC.gov.