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Fortress Biotech Receives FDA Response on CUTX-101

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Fortress Biotech Receives FDA Response on CUTX-101

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Fortress Biotech ( (FBIO) ) has shared an announcement.

On October 1, 2025, Fortress Biotech, Inc. announced that the U.S. Food and Drug Administration issued a complete response letter for their product CUTX-101 (copper histidinate). This development may impact the company’s operations and its positioning within the pharmaceutical industry, as regulatory feedback can influence product timelines and stakeholder expectations.

The most recent analyst rating on (FBIO) stock is a Buy with a $17.00 price target. To see the full list of analyst forecasts on Fortress Biotech stock, see the FBIO Stock Forecast page.

Spark’s Take on FBIO Stock

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

Fortress Biotech’s overall stock score is primarily impacted by its challenging financial performance, characterized by declining revenues and high leverage. However, positive technical indicators and a beneficial corporate event provide some support. The valuation remains a concern due to negative earnings and lack of dividends.

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

More about Fortress Biotech

Average Trading Volume: 748,624

Technical Sentiment Signal: Hold

Current Market Cap: $116M

Find detailed analytics on FBIO stock on TipRanks’ Stock Analysis page.

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