Fortress Biotech
🇺🇸United States
- Country
- 🇺🇸United States
- Ownership
- Public
- Established
- 2006-01-01
- Employees
- 186
- Market Cap
- $46.7M
- Introduction
Fortress Biotech, Inc. engages in the manufacture and commercialization of novel pharmaceutical products and product candidates. It operates through the Dermatology Product Sales and Pharmaceutical and Biotechnology Product Development segments. Its products include Ximino, Targadox, Exelderm, Ceracade, and Luxamend. The company was founded in 2006 and is headquartered in Bay Harbor Islands, FL.
FDA Announces Priority Review for CUTX-101 to Treat Menkes Disease
FDA accepted CUTX-101 NDA for Menkes disease treatment, granting it priority review with a target action date of June 30, 2025. CUTX-101, with breakthrough therapy and orphan drug designations, showed an 80% reduction in death risk in treated patients. Menkes disease, a rare pediatric condition, lacks FDA-approved treatments, with high mortality by age 2-3.
FDA accepts Sentynl's Menkes disease therapy NDA
FDA accepted Sentynl Therapeutics' CUTX-101 NDA for priority review to treat Menkes disease, a rare pediatric condition. The therapy, developed with Fortress Biotech, shows significant survival improvement. If approved, it could receive a rare pediatric disease PRV, with Cyprium retaining voucher rights and potential $129m in royalties and milestones.
Fortress Biotech’s Subsidiary Cyprium Therapeutics Receives FDA Acceptance for CUTX-101 NDA Review
Fortress Biotech's subsidiary, Cyprium Therapeutics, achieved a milestone with FDA's acceptance of CUTX-101's NDA for priority review, targeting June 30, 2025. Sentynl Therapeutics, now handling CUTX-101's development and commercialization, may grant Cyprium royalties and up to $129M in milestones. Fortress holds 76% of Cyprium.
FDA accepts Sentynl’s Menkes disease therapy NDA for priority review
The FDA has accepted Sentynl Therapeutics' CUTX-101 for priority review to treat Menkes disease, a rare genetic disorder. Sentynl took over development from Cyprium Therapeutics, which could receive up to $129m and retain a priority review voucher. CUTX-101 has shown significant survival improvement and holds multiple FDA designations.
Zydus Lifesciences arm application for Menkes disease treatment gets USFDA priority review
Sentynl Therapeutics, Inc., owned by Zydus Lifesciences and Fortress Biotech, announced FDA's acceptance of CUTX-101 NDA for Menkes disease treatment. CUTX-101 showed significant survival improvement, with a 80% death risk reduction. FDA set a target action date of June 30, 2025. CUTX-101 could be the first FDA-approved therapy for Menkes disease.
FDA accepts Sentynl's CUTX-101 NDA for priority review
The FDA has accepted Sentynl Therapeutics' NDA for CUTX-101, a treatment for Menkes disease, for priority review. CUTX-101, developed with Fortress Biotech, shows significant survival improvement in early treatment. It holds FDA fast track and orphan drug designations, with a PDUFA target action date of 30 June. Cyprium could earn up to $129m from Sentynl.
Sentynl Therapeutics Announces U.S. FDA Acceptance and Priority Review of New Drug Application for CUTX-101
CUTX-101, a potential first FDA-approved treatment for Menkes disease, received a six-month priority review with a PDUFA target action date of June 30, 2025. Early treatment showed a nearly 80% reduction in death risk, significantly improving survival rates for this rare pediatric disease.
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review for CUTX-101
CUTX-101, a treatment for Menkes disease, received FDA Priority Review with a PDUFA target date of June 30, 2025. Cyprium Therapeutics, eligible for royalties and up to $129M in milestones, retains ownership of any Priority Review Voucher. CUTX-101 showed significant survival improvement in trials.
Fortress Biotech and Cyprium Therapeutics Announce U.S. FDA Acceptance and Priority Review of NDA for CUTX-101 for Treatment of Menkes Disease
CUTX-101, a treatment for Menkes disease, has been granted Priority Review by the FDA with a PDUFA target action date of June 30, 2025. Cyprium Therapeutics, eligible for royalties and up to $129 million in milestones, retains ownership of any Priority Review Voucher. CUTX-101 showed significant survival improvement in clinical trials.
Fortress Biotech's CUTX-101 Gets FDA Priority Review for Rare Menkes Disease Treatment
Fortress Biotech and Cyprium Therapeutics announced FDA's Priority Review for CUTX-101, targeting Menkes disease treatment, with a PDUFA date of June 30, 2025. CUTX-101 showed an 80% reduction in death risk in trials. If approved, it could be the first FDA-approved Menkes disease treatment.
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