INBS Stock Falls After Clinical Study Win: FDA Progress Fails To Lift Shares

• The study evaluated the device’s ability to detect codeine in 40 adults.
• The company has begun the second phase of its program, which is expected to be completed by June 2026.
• Intelligent Bio Solutions will also begin an Interference Study to evaluate how the device performs in real-world environments.

Intelligent Bio Solutions (INBS) announced on Thursday the successful completion of its initial clinical study, which is needed to seek U.S. Food and Drug Administration (FDA) approval for its fingerprint-based drug testing system.

Despite the seemingly positive update, INBS shares slumped 10% on Thursday, following a 7% decline in the previous session.

What Was The Study About?

The study evaluated the device’s ability to detect codeine in 40 adults and confirmed its accuracy using standard laboratory testing methods. INBS added that it has begun the second phase of its program, which it expects to complete by June 2026.

Alongside the Method Comparison and Usability Study, the company will also begin an Interference Study to evaluate how the device performs when exposed to substances commonly found in real-world environments. The study is expected to be completed by the end of July 2026.

"The U.S. drug screening market is a significant commercial opportunity for Intelligent Bio Solutions. The on-schedule completion of our Cut-off Study validates our clinical approach and keeps us firmly on track toward our FDA 510(k) submission and planned commercial launch," said Harry Simeonidis, President and CEO at INBS.

The company said its non-invasive fingerprint technology has advantages over traditional urine, oral fluid, and blood testing methods. 

Last week, the company received European Patent EP3752831, which relates to improving fingerprint chemical analysis by accounting for fingerprint deposition volume. This marks the company’s eighth European patent.

How Did Retail Traders React?

Retail sentiment on Stocktwits remained 'bullish' over the past 24 hours, amid 'high' message volumes.

One user said the stock will climb back up to $3 by Monday.

Year-to-date, the stock has slumped more than 40%.

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