Financials
Cash Data
- Monthly Burn
- Burn Trend
- Dilution Risk
- SEC Filing
Key Stats
Upcoming Catalysts
FDA decisions, readouts and PDUFA dates · scored by probability of approval
| Catalyst | Drug / Treatment | Stage | Prob. of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|
INBS Catalyst Timeline
Dated clinical, regulatory and corporate events for Intelligent Bio Solutions Inc.
Past FDA Catalysts and PDUFA Decisions
How INBS actually traded into and out of each decision
| Date | Drug | Catalyst | Stage | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|
| No matching catalysts | ||||||
Drug Pipeline Intelligence
No drug pipeline
Intelligent Bio Solutions Inc. is a medical device company. The clinical trials it takes part in test other companies' drugs, so it has no drug pipeline of its own to score.
Clinical Trial Results
Readouts, endpoints and source filings for every INBS program
| Drug Name | Indication | Phase | Date | Trial Results Summary | Title | Source |
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Inside Trades
| Insider | Side | Shares | Price | Value | Date |
|---|---|---|---|---|---|
| Boyages Steven ConstantineDirector | Grant/Award | 5,000 5,031 held | $0.00 | 03/18/2026 |
Hedge Fund 13F Activity
Hedge Funds invested in INBS
| Fund | % of Portfolio | Current MV | Shares Owned | Activity |
|---|---|---|---|---|
| No hedge fund reported a 13F position in INBS for Q2 2026. | ||||
Ownership Trends
INBS Short Interest
Shares sold short, counted twice a month.
Options Data
Option Volume
Option Chain Statistics
| Expiry | Call Vol | Put Vol | Vol P/C | Call OI | Put OI | OI P/C | IV Call | IV Call OI-Wtd | IV Call Vol-Wtd | IV Put | IV Put OI-Wtd | IV Put Vol-Wtd |
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Real-Time Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last | Vol | OI | Last | Vol | OI | |
| No data available | ||||||
Calls vs Puts by Expiry
Competitive positioning
How INBS ranks across every disease it competes in
INBS News
Intelligent Bio Solutions to Host Virtual Fireside Chat on September 24th at 4:30 p.m. ET
Intelligent Bio Solutions Inc. will host a virtual fireside chat on September 24, 2026, at 4:30 p.m. ET. The discussion will feature CEO Harry Simeonidis and VP Peter Passaris, focusing on the FDA 510(k) submission for their Intelligent Fingerprinting Drug Screening System. The event will also cover supporting clinical data and the company's commercial progress outside the U.S.
Read more →Intelligent Bio Solutions Submits FDA 510(k) Package for Intelligent Fingerprinting Drug Screening System, Seeking U.S. Market Clearance
Intelligent Bio Solutions Inc. has submitted a 510(k) premarket notification to the FDA for its Intelligent Fingerprinting Drug Screening System, which detects codeine. The submission is backed by extensive clinical data, showcasing high accuracy and usability. This regulatory step aims to facilitate entry into the lucrative U.S. drug screening market.
Read more →Intelligent Bio Solutions Achieves Above 98% Accuracy in Method Comparison Study, Supporting Planned 2026 FDA 510(k) Submission
Intelligent Bio Solutions Inc. announced that its Intelligent Fingerprinting Drug Screening System achieved over 98% accuracy in a Method Comparison Study. This study, conducted at three U.S. clinical sites, demonstrated significant improvements in sensitivity and maintained 100% specificity. The results are crucial for the company's upcoming FDA 510(k) submission, expected in September 2026.
Read more →Intelligent Bio Solutions Announces Private Placement of up to $15 Million to a Single Existing Institutional Investor Priced At-the-Market Under Nasdaq Rules
Intelligent Bio Solutions Inc. has announced a private placement of up to $15 million with an existing institutional investor, expected to yield approximately $5 million in gross proceeds. The placement includes shares and warrants, with specific terms for exercise and regulatory conditions. The funds will be used for working capital and general corporate purposes.
Read more →Intelligent Bio Solutions Reports Fiscal 2026 Full-Year Revenue Growth of 38% Year-over-Year, Driven by Reader Installed Base and High-Margin Cartridge Growth
Intelligent Bio Solutions Inc. reported a 38% increase in fiscal 2026 revenue, reaching $4.2 million, driven by a growing reader installed base and consumable cartridge sales. The company achieved a gross profit margin of 48.63%, up from 40.85% the previous year. Significant progress was made towards FDA clearance, with a submission planned for the second half of 2026. The company continues to expand its commercial presence across various safety-critical industries.
Read more →Intelligent Bio Solutions Strengthens Quality Management Credentials with ISO Recertification
Intelligent Bio Solutions Inc. has announced the recertification of its Intelligent Fingerprinting Drug Screening business to the ISO 13485:2016 quality management standard. This recertification, effective from October 14, 2026, aligns with the FDA's updated Quality Management System Regulation. The company is actively pursuing FDA clearance for its drug screening system, which aims to enhance workplace safety through rapid testing.
Read more →Intelligent Bio Solutions Announces Completion of Method Comparison Study for the Intelligent Fingerprinting Drug Screening System
Intelligent Bio Solutions Inc. announced the completion of its Method Comparison Study for the Intelligent Fingerprinting Drug Screening System, crucial for its FDA 510(k) submission. The study involved 135 participants across three U.S. sites and aimed to validate the system's operational effectiveness. The company is now focused on data analysis and finalizing its submission package, targeting the U.S. market in late 2026.
Read more →Intelligent Bio Solutions Completes Usability Study Supporting FDA 510(k) Submission
Intelligent Bio Solutions Inc. has completed a Usability Study for its Intelligent Fingerprinting Drug Screening System, supporting its FDA 510(k) submission for codeine detection. Conducted with CenExel Clinical Research, the study demonstrated that operators without specialist training could effectively use the system. The company plans to submit its 510(k) package in H2 2026 as it aims to enter the U.S. drug screening market.
Read more →Intelligent Bio Solutions Completes Interference Study Examining the Impact of Everyday Substances on Intelligent Fingerprinting System
Intelligent Bio Solutions Inc. has completed its Interference Study for the Intelligent Fingerprinting Drug Screening System, which is crucial for its FDA 510(k) submission for codeine detection. Conducted with CenExel Clinical Research, the study evaluated the impact of common substances on test accuracy. The company aims to enter the U.S. drug screening market in H2 2026.
Read more →Intelligent Bio Solutions Achieves Key Milestone Ahead of Planned FDA 510(k) Submission, Advancing Toward Planned U.S. Market Entry
Intelligent Bio Solutions Inc. has successfully addressed all cybersecurity and software review items in preparation for its FDA 510(k) submission, which is scheduled for the second half of 2026. This milestone positions the company favorably for entry into the lucrative U.S. drug screening market, targeting codeine detection as its initial indication. The company's innovative fingerprint-based testing system promises rapid, non-invasive results, enhancing its market potential.
Read more →Intelligent Bio Solutions Completes Precision Testing, Strengthening FDA 510(k) Submission Package Ahead of Planned Entry into Multi-Billion-Dollar U.S. Drug Screening Market
Intelligent Bio Solutions Inc. has completed precision testing for its Intelligent Fingerprinting Drug Screening System, a crucial step in its FDA 510(k) submission. The testing demonstrated reliable performance across various conditions, supporting the system's suitability for drug screening. The company aims to enter the lucrative U.S. market once FDA clearance is obtained.
Read more →Intelligent Bio Solutions Initiates Clinical Study Supporting FDA Clearance and Planned U.S. Market Entry
Intelligent Bio Solutions Inc. has initiated an Interference Study to support its FDA 510(k) submission for its Intelligent Fingerprinting Drug Screening System. This study, conducted in partnership with CenExel Clinical Research, aims to validate the system's accuracy in the presence of common substances. Results are expected by mid-July 2026 and will be included in the FDA submission package.
Read more →Intelligent Bio Solutions to Participate in Planet MicroCap Las Vegas Conference over June 16-18
Intelligent Bio Solutions Inc. will participate in the Planet MicroCap Conference from June 16-18, 2026, in Las Vegas. The company's management will present on June 17 and engage in one-on-one investor meetings. Their Intelligent Fingerprinting Drug Screening System aims to revolutionize portable drug testing with rapid results.
Read more →Intelligent Bio Solutions Commences Multi-Site Method Comparison Study for FDA 510(k) Submission
Intelligent Bio Solutions Inc. has commenced a multi-site Method Comparison Study to support its FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System. The study aims to validate the system's accuracy and performance in real-world workplace settings, involving 135 participants. Results will be included in the FDA submission package, expected by July 2026.
Read more →Intelligent Bio Solutions Reports Fiscal Third Quarter Revenue Growth of 46% Year-over-Year
Intelligent Bio Solutions Inc. reported a 46% increase in revenue for the fiscal third quarter, driven primarily by a 59% rise in cartridge sales. The company achieved a gross profit margin of 50.5%, reflecting enhanced operational efficiencies. With nine-month revenue reaching $3.07 million, INBS is well-positioned for growth as it approaches key FDA regulatory milestones.
Read more →Intelligent Bio Solutions Initiates Validation Study for Rapid Drug Screening Cartridge Targeting 70% Faster Results
Intelligent Bio Solutions Inc. announced a validation study to enhance its drug screening technology, targeting results in under three minutes. This improvement aims to capture the growing roadside drug testing market, projected to reach $1.62 billion by 2030. The study seeks to confirm preliminary findings and advance towards a two-minute testing goal.
Read more →Intelligent Bio Solutions Advances Upcoming FDA 510(k) Submission, Successfully Completes Penetration Testing with No Major Vulnerabilities Identified
Intelligent Bio Solutions Inc. has successfully completed penetration testing as part of its FDA 510(k) submission, identifying no major vulnerabilities. The company has also implemented security upgrades to enhance its drug testing technology. These developments are expected to strengthen its regulatory submission and open new revenue opportunities in the U.S. drug screening market.
Read more →Intelligent Bio Solutions Completes Clinical Cut-off Study, Advances FDA 510(k) Clinical Program Targeting Multi-Billion-Dollar U.S. Drug Screening Market
Intelligent Bio Solutions Inc. completed its initial clinical Cut-off Study, supporting its FDA 510(k) submission for the Intelligent Fingerprinting Drug Screening System. The study confirmed codeine detection levels and was finalized by March 2026. The company is now moving forward with a Method Comparison and Usability Study, expected to conclude by June 2026.
Read more →Intelligent Bio Solutions Strengthens European IP Portfolio with Eighth Patent Grant
Intelligent Bio Solutions Inc. has received its eighth European patent, enhancing its intellectual property portfolio related to fingerprint sweat drug testing technology. The new patent focuses on contextualizing chemical analysis with fingerprint deposition volume, improving the interpretation of test results. This advancement reinforces the company's market position and supports its innovative, non-invasive testing solutions.
Read more →Intelligent Bio Solutions Successfully Manufactures and Ships First Readers with New Partner, Accelerating Scale and Driving Gross Margin Expansion in Anticipation of Planned U.S. Entry
Intelligent Bio Solutions Inc. has successfully manufactured and shipped its first drug screening readers in collaboration with Syrma Johari, marking a significant step towards scaling production. The partnership is expected to yield over 40% in annual production cost savings and improve gross margins by approximately 20 percentage points. The company has also doubled its in-house production capacity for lateral flow test strips, enhancing its operational capabilities ahead of its planned U.S. market entry in 2026.
Read more →