Fortress Biotech's CUTX-101 NDA Resubmission Accepted by FDA with Target Date of January 14, 2026
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 15 2025
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Source: Newsfilter
- FDA Acceptance: Fortress Biotech and its subsidiary Cyprium Therapeutics announced that the FDA has accepted the resubmission of the NDA for CUTX-101, with a target action date of January 14, 2026, marking a significant advancement in the treatment of Menkes disease that could improve survival rates in pediatric patients.
- Priority Review Status: The resubmission is classified as a Class 1 resubmission, indicating the FDA's recognition of the drug's potential value, and if approved, it could present substantial market opportunities, particularly in the rare disease sector.
- Milestone Rewards: Cyprium is eligible to receive up to $129 million in aggregate development and sales milestone payments, which not only enhances the company's financial position but also propels its further development in rare disease treatments.
- Collaborative Development: Sentynl Therapeutics has assumed full responsibility for the development and commercialization of CUTX-101, demonstrating Fortress's strategic flexibility and market adaptability, potentially laying the groundwork for future product line expansions.
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Analyst Views on FBIO
Wall Street analysts forecast FBIO stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for FBIO is 10.75 USD with a low forecast of 4.50 USD and a high forecast of 17.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
2 Analyst Rating
2 Buy
0 Hold
0 Sell
Moderate Buy
Current: 3.380
Low
4.50
Averages
10.75
High
17.00
Current: 3.380
Low
4.50
Averages
10.75
High
17.00
About FBIO
Fortress Biotech, Inc. is a biopharmaceutical company focused on acquiring and advancing assets. The Company has eight marketed prescription pharmaceutical products and over 20 programs in development, with its majority-owned and majority-controlled partners and subsidiaries and partners and subsidiaries it founded and in which it holds significant minority ownership positions. Its portfolio is being commercialized and developed for various therapeutic areas, including oncology, dermatology, and rare diseases. Its dermatology products include Emrosi, Qbrexza, Amzeeq, Zilxi, Exelderm, Targadox, and Luxamend. Its late-stage product candidates include CUTX-101 (copper histidinate injection for Menkes disease), Triplex (cytomegalovirus (CMV) vaccine), and CAEL-101 (monoclonal antibody for AL amyloidosis). Its early and mid-stage product candidates include Dotinurad (urate transporter (URAT1) inhibitor for gout), MB-101 (IL13Rα2 CAR T Cell Program for Glioblastoma), and others.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
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FDA Approves ZYCUBO for Menkes Disease, Cyprium to Earn Up to $129M in Milestones
- FDA Approval: The U.S. FDA has officially approved ZYCUBO (formerly CUTX-101) for treating Menkes disease in children, marking it as the first FDA-approved treatment for this rare condition, significantly enhancing Fortress Biotech's market position in the rare disease sector.
- Milestone Earnings: Cyprium Therapeutics stands to earn tiered royalties and up to $129 million in potential development and sales milestones from Sentynl, which will substantially bolster the company's financial performance and support future R&D efforts.
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