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Forecast
The analysts' average price target is €4.48 (+151.69%). The median is €4.48 (+151.69%).
| Buy |
6 |
| Hold |
0 |
| Sell |
0 |
News Go to news feed
FDA sets PDUFA date for Fortress Biotech's Menkes therapy on Jan. 14, 2026
The FDA accepted the resubmission of the marketing application for CUTX-101, a copper-histidinate therapy for Menkes syndrome, as a Class 1 filing and set a new PDUFA date of Jan. 14, 2026. The resubmission follows a CRL dated Sept. 30, 2025, which cited manufacturing-compliance issues but raised no safety or efficacy concerns. Sentynl Therapeutics filed the revised application; Cyprium/Fortress retain rights to royalties, milestone payments and a potential Rare Pediatric Disease priority review voucher. There is currently no FDA-approved treatment for Menkes syndrome. » More on de.investing.com
Fortress Biotech: subsidiary resubmitted FDA application for CUTX-101 for Menkes syndrome
Sentynl Therapeutics, a subsidiary of Zydus, has resubmitted the New Drug Application (NDA) for CUTX-101, a copper histidinate for the treatment of Menkes syndrome in children, to the FDA and notified Cyprium Therapeutics, which is majority-owned by Fortress Biotech. The FDA had previously issued a Complete Response Letter for the original application on October 1, 2025. Cyprium retains the rights to a potential Priority Review Voucher and is entitled to royalties and milestone payments of up to $129 million upon successful approval. » More on de.investing.com
Financials
| (EUR) | June 2026 | YoY |
|---|---|---|
| Revenue | 16.4m | 17.78% |
| Gross profit | 10.17m | 4.46% |
| Net profit | -410.07k | 103.12% |
| EBITDA | 3.01m | 142.16% |
Fundamentals
| Metric | Value |
|---|---|
Market capitalization | €59.77m |
Number of shares | 33.35m |
52-week high/low | €4.06 - €1.64 |
| Dividends | No |
Beta | 1.25 |
P/E ratio | 0.61 |
PEG ratio | 0.00 |
P/B ratio | 0.39 |
P/S ratio | 0.97 |
Company profile
Fortress Biotech, Inc., a biopharmaceutical company, develops and commercializes pharmaceutical and biotechnology products. The company markets dermatology products, such as Ximino capsules to treat only inflammatory lesions of non-nodular moderate to severe acne vulgaris; Targadox for severe acne; Exelderm cream for ringworm and jock itch symptoms; Ceracade for dry skin conditions; Luxamend for dressing and managing wounds; and Accutane capsules for severe recalcitrant nodular acne. It also develops late stage product candidates, such as intravenous Tramadol for the treatment of post-operative acute pain; CUTX-101, an injection for the treatment of Menkes disease; MB-107 and MB-207 for the treatment of X-linked severe combined immunodeficiency; Cosibelimab for metastatic cancers; CK-101 for the treatment of patients with EGFR mutation-positive NSCLC; CAEL-101 for the treatment of amyloid light chain amyloidosis; Triplex vaccine for cytomegalovirus; and CEVA101 for the treatment of severe traumatic brain injury in adults and children. The company's early stage product candidates include MB-102 for blastic plasmacytoid dendritic cell neoplasm; MB-101 for glioblastoma; MB-104 for multiple myeloma and light chain amyloidosis; MB-106 for B-cell non-hodgkin lymphoma; MB-103 for GBM & metastatic breast cancer to brain; MB-108; MB-105 for prostate and pancreatic cancers; and BAER-101. Its preclinical product candidates comprise AAV-ATP7A gene therapy; AVTS-001 gene therapy; CK-103 BET inhibitor; CEVA-D and CEVA-102; CK-302, an anti-GITR; CK-303, an anti-CAIX; ConVax; and ONCOlogues, and oligonucleotide platform. It has collaboration arrangements with universities, research institutes, and pharmaceutical companies. The company was formerly known as Coronado Biosciences, Inc. and changed its name to Fortress Biotech, Inc. in April 2015. Fortress Biotech, Inc. was incorporated in 2006 and is based in Bay Harbor Island, New York.
| Name | Fortress Biotech Inc |
| CEO | Lindsay A. Rosenwald |
| Headquarters | Bay Harbor Islands,
fl USA |
| Website | |
| Industry | Chemicals |
| IPO | 17/11/2011 |
| Employees | 78 |
Deep Dive
Ticker symbols
| Exchange | Symbol |
|---|---|
NASDAQ | FBIO |