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Fortress Biotech ( (FBIO) ) has provided an announcement.
On December 15, 2025, Fortress Biotech announced that the U.S. FDA accepted the resubmission of the New Drug Application for CUTX-101 as a Class 1 resubmission. The FDA provided a target action date of January 14, 2026, indicating a significant step forward in the company’s efforts to bring this drug to market.
The most recent analyst rating on (FBIO) stock is a Hold with a $3.00 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.
The overall stock score reflects significant financial challenges, including declining revenues and high leverage, which are major concerns. While technical indicators show some positive momentum, and the earnings call provided optimistic guidance, the negative valuation metrics and regulatory challenges weigh heavily on the stock’s outlook.
To see Spark’s full report on FBIO stock, click here.
More about Fortress Biotech
Fortress Biotech, Inc. operates in the biopharmaceutical industry, focusing on the development and commercialization of novel pharmaceutical products. The company is known for its commitment to advancing innovative therapies for patients with unmet medical needs.
Average Trading Volume: 729,313
Technical Sentiment Signal: Hold
Current Market Cap: $90.94M
For detailed information about FBIO stock, go to TipRanks’ Stock Analysis page.