Fortress Biotech Gains FDA Approval for Menkes Treatment

An announcement from Fortress Biotech ( (FBIO) ) is now available.

On January 13, 2026, Fortress Biotech and its majority-owned subsidiary Cyprium Therapeutics announced U.S. FDA approval of ZYCUBO (copper histidinate), the first and only approved treatment in the United States for Menkes disease in pediatric patients, a rare and often fatal X-linked copper transport disorder. The approval, which follows Sentynl Therapeutics’ assumption in December 2023 of full responsibility for developing and commercializing the therapy, triggered the issuance of a Rare Pediatric Disease Priority Review Voucher to be transferred from Sentynl to Cyprium, and entitles Cyprium to tiered royalties on net sales of ZYCUBO and up to $129 million in development and sales milestones. Supported by clinical data showing a nearly 80% reduction in risk of death and a marked improvement in median overall survival compared with untreated controls, ZYCUBO’s approval underscores Fortress’s growing track record of regulatory successes and monetizable assets in rare diseases, reinforcing its business model and potential value for shareholders while addressing a previously unmet medical need.

The most recent analyst rating on (FBIO) stock is a Hold with a $4.50 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.

Score is held back primarily by weak cash flow and ongoing operating losses despite improved reported net income and a better balance sheet. Technicals and the earnings/catalyst backdrop are supportive (strong trend, EMROSI launch traction, and FDA progress on CUTX-101), but valuation is not supported by a meaningful P/E or dividend.

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

More about Fortress Biotech

Fortress Biotech, Inc., a Nasdaq-listed biopharmaceutical company, operates a portfolio-based model through majority-owned subsidiaries such as Cyprium Therapeutics, focusing on the development and commercialization of therapies for rare and serious diseases. The company has recently expanded its presence in the specialty and rare disease space with multiple U.S. FDA drug approvals and portfolio transactions, including royalty- and milestone-bearing partnerships.

Average Trading Volume: 529,015

Technical Sentiment Signal: Hold

Current Market Cap: $133.5M

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