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FDA Requests More Info from Intelligent Bio Solutions

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FDA Requests More Info from Intelligent Bio Solutions

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

On September 17, 2025, Intelligent Bio Solutions announced that the FDA requested additional information for its Intelligent Fingerprinting Drug Screening System, necessitating a resubmission of the 510(k) notification. This request follows the company’s initial submission in December 2024 and subsequent responses to over 70 questions in August 2025. The FDA’s feedback is part of the process for this first-of-its-kind device, and the company remains confident in its technology’s capabilities. While awaiting U.S. clearance, Intelligent Bio Solutions continues to expand its international business, maintaining commercial progress globally.

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 reflects significant financial challenges and valuation concerns, which are partially offset by positive corporate developments. The company’s strategic initiatives, including FDA submissions and global partnerships, offer potential growth opportunities, but financial instability remains a critical risk.

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. The company is focused on revolutionizing portable testing through its Intelligent Fingerprinting Drug Screening System, which analyzes fingerprint sweat to detect recent drug use. The system is designed for use in safety-critical industries and is marketed to sectors such as construction, manufacturing, transport, and logistics outside the U.S.

Average Trading Volume: 177,981

Technical Sentiment Signal: Sell

Current Market Cap: $15.44M

Learn more about INBS stock on TipRanks’ Stock Analysis page.

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