Fortress Biotech's Subsidiary Nears Key FDA Decision, Shares Rise 3%
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jan 13 2026
0mins
Source: NASDAQ.COM
- FDA Decision Approaching: Fortress Biotech's subsidiary Cyprium Therapeutics is awaiting a key FDA decision on CUTX-101, expected by January 14, 2025, marking the therapy's second attempt; if approved, it will be the only FDA-approved treatment for Menkes disease.
- Stock Price Surge: In anticipation of the FDA decision, Fortress Biotech's shares rose over 3% in premarket trading to $4.40, reflecting market optimism regarding the company's potential future revenues.
- Milestone Rewards: Cyprium Therapeutics stands to receive up to $129 million in aggregate development and sales milestone payments from its partner Sentynl Therapeutics, along with royalties on net sales of CUTX-101, significantly enhancing the company's financial outlook.
- Disease Context: Menkes disease, caused by mutations in the ATP7A gene, has a high mortality rate in untreated patients, often between ages 2 and 3, making the successful launch of CUTX-101 crucial for providing much-needed treatment options, thus holding significant social and market implications.
Get Free Real-Time Notifications for Any Stock
Monitor tickers like FBIO with instant alerts to capture every critical market movement.
Sign up for free to build your custom watchlist and receive professional-grade stock notifications.
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.
Sanofi Secures EU Approval for Teizeild, Demonstrating Significant Efficacy in Type 1 Diabetes
- New Drug Approval: Sanofi's Teizeild receives EU approval as the first disease-modifying therapy for Stage 2 Type 1 Diabetes, demonstrating a median delay of 48.4 months to Stage 3 T1D, significantly enhancing patient quality of life and strengthening the company's competitive position in diabetes treatment.
- FDA Approval: Fortress Biotech's ZYCUBO gains FDA approval as the first treatment for Menkes Disease, showing nearly an 80% reduction in mortality risk when used early, laying a solid foundation for future market expansion and revenue growth.
- Acquisition Deal: Boston Scientific's $14.5 billion acquisition of Penumbra reflects its strategic expansion in interventional therapies, expected to enhance its leadership in vascular treatments and drive future revenue growth.
- Clinical Trial Progress: Creative Medical's CELZ-201 shows significant improvement in 79% of patients in the ADAPT trial for chronic lower back pain, indicating the therapy's clinical potential and likely attracting further investment and partnership opportunities.
Continue Reading
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.
- Survival Rate Improvement: Results indicate that children receiving early treatment with ZYCUBO had nearly an 80% lower risk of death, with a median overall survival of 177.1 months compared to 17.6 months in the control group, highlighting the drug's critical role in improving patient outcomes.
- Positive Market Reaction: Following the FDA approval, Fortress Biotech's stock surged over 12% in premarket trading, with investor sentiment shifting from 'bullish' to 'extremely bullish', reflecting strong market confidence and growth potential for the drug.
Continue Reading