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Fortress Biotech’s Subsidiary Resubmits NDA for CUTX-101

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Fortress Biotech’s Subsidiary Resubmits NDA for CUTX-101

TipRanks Black Friday Sale

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

On November 14, 2025, Sentynl Therapeutics, a subsidiary of Zydus Lifesciences, resubmitted the NDA for CUTX-101 to the FDA, a treatment for Menkes disease in pediatric patients. Cyprium retains ownership of any Priority Review Voucher from the NDA approval and stands to gain royalties and up to $129 million in development and sales milestones.

The most recent analyst rating on (FBIO) stock is a Hold with a $2.50 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 is primarily impacted by the company’s financial instability, characterized by declining revenues and high leverage. While the earnings call provided some positive insights regarding new product performance and future growth potential, the technical analysis and valuation metrics remain weak, contributing to a lower overall score.

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. Its subsidiary, Cyprium Therapeutics, Inc., is involved in creating treatments for rare diseases, with a market focus on pediatric conditions.

Average Trading Volume: 1,028,438

Technical Sentiment Signal: Hold

Current Market Cap: $77.96M

See more insights into FBIO stock on TipRanks’ Stock Analysis page.

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