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Intelligent Bio Solutions Updates FDA Clearance Timeline

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Intelligent Bio Solutions Updates FDA Clearance Timeline

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Intelligent Bio Solutions ( (INBS) ) has shared an update.

On September 26, 2025, Intelligent Bio Solutions announced an update on their timeline for FDA 510(k) clearance of their Intelligent Fingerprinting Drug Screening System for codeine. Following feedback from the FDA, the company plans to initiate clinical studies by the end of 2025, aiming for clearance in the second half of 2026. This strategic move is expected to enhance their market positioning by expanding their product’s reach into the U.S. market, beyond its current forensic use, while maintaining growth in international markets.

The most recent analyst rating on (INBS) stock is a Hold with a $1.50 price target. To see the full list of analyst forecasts on Intelligent Bio Solutions stock, see the INBS Stock Forecast page.

Spark’s Take on INBS Stock

According to Spark, TipRanks’ AI Analyst, INBS is a Neutral.

The overall stock score is primarily impacted by the company’s weak financial performance, characterized by consistent losses and negative cash flows. Technical analysis suggests a bearish trend, with the stock trading below key moving averages. Valuation metrics are unfavorable, with a negative P/E ratio and no dividend yield, further weighing down the score.

To see Spark’s full report on INBS stock, click here.

More about Intelligent Bio Solutions

Intelligent Bio Solutions Inc. is a medical technology company specializing in intelligent, rapid, non-invasive testing solutions. Their primary product, the Intelligent Fingerprinting Drug Screening System, utilizes fingerprint sweat analysis to screen for recent drug use, including opiates, cocaine, methamphetamine, and cannabis. The company targets safety-critical industries such as construction, transportation, logistics, and mining, with a significant presence in 24 countries.

Average Trading Volume: 211,227

Technical Sentiment Signal: Sell

Current Market Cap: $12.35M

See more data about INBS stock on TipRanks’ Stock Analysis page.

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