Fortress Biotech

What Fortress Biotech does

Fortress Biotech, Inc. (NASDAQ: FBIO) is a publicly traded biopharmaceutical holding company founded in 2006 by Lindsay A. Rosenwald that acquires, develops, and commercializes therapeutic products through a network of majority-owned subsidiaries and partner companies. The portfolio spans oncology, dermatology, rare diseases, neurology, pain management, infectious diseases, and CNS disorders, with three FDA-approved products launched between November 2024 and January 2026: Emrosi for rosacea (marketed by subsidiary Journey Medical, NASDAQ: DERM), UNLOXCYT for cutaneous squamous cell carcinoma (acquired by Sun Pharma in May 2025 with Fortress retaining a 2.5% royalty), and ZYCUBO for Menkes disease (developed by subsidiary Cyprium Therapeutics and licensed to Sentynl). Journey Medical additionally markets seven other branded dermatology products (Qbrexza, Targadox, Exelderm, Luxamend, Accutane, AMZEEQ, ZILXI) through specialty pharmacy distribution and GPO contracts covering approximately 150 million commercial lives.

The underlying technology consists of a portfolio-based drug development model leveraging exclusive worldwide licensing agreements with leading academic research institutions (City of Hope, Nationwide Children's Hospital, Duke University, and the University of Texas Health Science Center at Houston) to source therapeutic candidates across modalities including small molecules, CAR T cell therapies, oncolytic viruses, gene therapies, and cell-based therapeutics. Late-stage pipeline assets include dotinurad for gout (Phase 3, externally funded via Crystalys Therapeutics), CAEL-101 for AL amyloidosis (AstraZeneca), Triplex CMV vaccine (Phase 2), and IV Tramadol (NDA filed); early-stage and preclinical programs address glioblastoma, Pompe disease, and traumatic brain injury.

Fortress generates revenue through multiple streams: product sales from Journey Medical's dermatology franchise (the dominant contributor at approximately $15.9 million of the $16 million Q1 2026 consolidated revenue), royalty income from partnered and divested products (2.5% on UNLOXCYT, 3-12.5% tiered on ZYCUBO, 3% on dotinurad, 4.5% on IV Tramadol), equity appreciation in subsidiary and partner companies, and occasional capital raises through registered direct and public offerings. The Q1 2026 $108.4 million net income was materially driven by a one-time $205 million gross-proceeds sale of a Rare Pediatric Disease Priority Review Voucher by Cyprium Therapeutics following ZYCUBO's FDA approval. Fortress operates from Bay Harbor Islands, Florida, with 101-250 employees.

Name

Fortress Biotech

Legal name

Fortress Biotech, Inc.

Website

https://fortressbiotech.com

Company type

Public

Founded year

2006

Operating status

Operating

Headcount range

101–250 employees

Short description

Fortress Biotech is a publicly traded biopharmaceutical holding company (NASDAQ: FBIO) that acquires, develops, and commercializes therapeutic products across dermatology, oncology, and rare diseases through majority-owned subsidiaries including Journey Medical, Cyprium Therapeutics, and Mustang Bio, generating revenue from product sales, royalties, and equity holdings.

Ownership category

akta.pro rank

Product category

Specialty Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Pharmaceutical and Medicine Manufacturing (3254), Pharmaceutical Preparation Manufacturing (325412), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Neurology & Psychiatry (CNS) Pharmaceuticals (HLAIAAAF)

akta.pro secondary industries

Biologic API/Drug Substance Manufacturing Services (HLAAAKAA), Bio-based Pharmaceuticals, Nutraceuticals & Specialty Bioactives (EUAAAIAK), Neurology & CNS Specialty Pharmaceuticals (HLAIACAC)

Keywords

• Specialty pharmaceuticals
• Dermatology products
• Rare disease therapies
• Oncology drug development
• Biopharmaceutical licensing

Headquarters

HQ city

New York

HQ country

United States

HQ region

North America

Offices2 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Others

Revenue model

1. Product Revenue: Revenue from marketed pharmaceutical products including dermatology products marketed by Journey Medical (Emrosi, Qbrexza, Targadox, Exelderm, Luxamend, Accutane, AMZEEQ, ZILXI), and royalties from UNLOXCYT sales following Sun Pharma acquisition of Checkpoint
2. Royalty Income: Ongoing royalty streams from partner companies including 2.5% royalty on UNLOXCYT net sales, tiered royalties on ZYCUBO net sales (3%-12.5%), 3% royalty on dotinurad net sales, and various royalties from other partnered assets
3. Equity Holdings: Value creation through equity stakes in subsidiary and partner companies including Cyprium Therapeutics (80%), Urica Therapeutics (70%), Helocyte (84%), with dividend and equity income from portfolio companies
4. Capital Markets: Occasional registered direct offerings and public offerings to raise capital for operations including research, development, and acquisitions

Go-to-market motion2 records

Distribution channels3 records

Marketing channels4 records

Core offering

Fortress Biotech is a biopharmaceutical holding company that acquires, develops, and commercializes therapeutic products through a diversified portfolio of majority-owned subsidiaries. The company generates revenue from FDA-approved marketed pharmaceutical products (primarily dermatology products marketed by Journey Medical including Emrosi, Qbrexza, Targadox, Exelderm, Luxamend, Accutane, AMZEEQ, and ZILXI) along with royalties on partnered assets such as UNLOXCYT and ZYCUBO. Its development pipeline spans oncology, rare diseases, dermatology, neurology, pain management, and gene therapy.

Product overview

Fortress Biotech is an innovative biopharmaceutical company operating a diversified portfolio model with multiple marketed prescription pharmaceutical products and development-stage product candidates. The portfolio spans several therapeutic areas including oncology, dermatology, rare diseases, neurology, pain management, infectious diseases, and rheumatology. Marketed products include UNLOXCYT™ (cosibelimab-ipdl) for cutaneous squamous cell carcinoma, ZYCUBO® (copper histidinate) for Menkes disease, and Emrosi™ for rosacea, along with multiple dermatology products (Qbrexza®, Targadox®, Exelderm®, Luxamend®, Accutane®, AMZEEQ®, ZILXI®) marketed by subsidiary Journey Medical Corporation. The development pipeline includes late-stage candidates such as Dotinurad (gout, Phase 3), CAEL-101 (AL amyloidosis), Triplex (CMV vaccine, Phase 2), and IV Tramadol (pain management, NDA filed), as well as early-stage and preclinical programs in CAR-T cell therapies, gene therapy, and cell-based therapeutics for glioblastoma, Pompe disease, and traumatic brain injury.

Differentiator

Problem solved

Functional benefit

Brands

• ZYCUBO: Copper histidinate injection for the treatment of Menkes disease, approved by FDA in January 2026
• UNLOXCYT
• Emrosi
• Qbrexza
• Triplex

Products and services

• Emrosi (DFD-29) 40mg Minocycline Hydrochloride Modified-Release Capsules for the treatment of inflammatory lesions of rosacea in adults. Marketed by Journey Medical Corporation (majority-owned subsidiary).
• Qbrexza Prescription medication for the treatment of hyperhidrosis (excessive sweating). Marketed by Journey Medical Corporation.
• Targadox Prescription medication for the treatment of acne. Marketed by Journey Medical Corporation.
• Exelderm Prescription antifungal medication for the treatment of fungal infections. Marketed by Journey Medical Corporation.
• Luxamend Prescription wound care product. Marketed by Journey Medical Corporation.
• Accutane (Isotretinoin) Prescription medication for the treatment of recalcitrant nodular acne. Marketed by Journey Medical Corporation.
• AMZEEQ Prescription medication for the treatment of acne. Marketed by Journey Medical Corporation.
• ZILXI Prescription medication for the treatment of acne. Marketed by Journey Medical Corporation.
• ZYCUBO (CUTX-101, copper histidinate) Copper histidinate injection approved by FDA in January 2026 as the first and only treatment for Menkes disease in the United States. Developed by subsidiary Cyprium Therapeutics with royalties and milestone payments from partner Sentynl Therapeutics.
• UNLOXCYT (cosibelimab-ipdl) FDA-approved anti-PD-L1 antibody immunotherapy for the treatment of metastatic or locally advanced cutaneous squamous cell carcinoma. Acquired by Sun Pharma in 2025; Fortress receives 2.5% royalty on net sales.
• Dotinurad Next-generation, once daily oral URAT1 inhibitor being developed for the treatment of gout. In Phase 3 development by Crystalys Therapeutics as of October 2025. Urica Therapeutics (subsidiary) maintains equity position and receives 3% royalty on future net sales.
• CAEL-101 (Anselamimab) First-in-class anti-amyloid antibody designed to improve organ function by reducing or eliminating amyloid deposits in patients with amyloid light chain (AL) amyloidosis. Developed by AstraZeneca (acquired Caelum Biosciences); Fortress receives 42% of future proceeds from milestone payments.
• Triplex Universal, multi-antigen T-cell immunotherapeutic vaccine for controlling cytomegalovirus (CMV) in stem cell and solid organ transplant recipients. Currently in Phase 2 development at Helocyte, Inc.
• IV Tramadol Intravenous formulation of tramadol intended for the management of moderate to moderately severe postoperative pain. NDA filed; in development at Avenue Therapeutics with 4.5% royalty to Fortress.
• ATX-04 (Clenbuterol) Well-characterized small-molecule β2-adrenergic agonist in clinical development for the treatment of Pompe disease. Acquired by Avenue Therapeutics from Duke University in February 2026.
• MB-101 (IL13Rα2 CAR T) Chimeric antigen receptor (CAR) T cell therapy for the treatment of recurrent glioblastoma (GBM). In Phase 1 development at Mustang Bio, Inc. in partnership with City of Hope.
• MB-108 (C134 Oncolytic Virus) Next-generation oncolytic virus that can replicate in tumor cells but not in normal cells, for the treatment of glioblastoma. In Phase 1 development at Mustang Bio, Inc.
• MB-109 Combination therapy combining MB-101 CAR T cell therapy with MB-108 oncolytic virus, designed to make cold glioblastoma tumors hot to improve efficacy of CAR-T therapy. In preclinical development at Mustang Bio.
• AAV-ATP7A Gene Therapy Adeno-associated virus (AAV)-based gene therapy intended for use in combination with CUTX-101 for the treatment of Menkes disease and related copper transport disorders. 80% owned by Cyprium Therapeutics.
• CEVA-102 First cell product produced by CEVA-D, being developed for the treatment of severe traumatic brain injury (TBI) in adults and children. 80% owned by Cellvation.
• CEVA-D Novel bioreactor device that enhances the anti-inflammatory potency of bone marrow-derived cells without genetic manipulation, using wall shear stress to suppress TNF-α production. For traumatic brain injury treatment. 80% owned by Cellvation.

Quantifiable outcome

• Q1 2026 net income of $108.4 million vs net loss of $12.7 million in Q1 2025
• +3 more outcomes

Named customers5 records

Segments4 records

Ideal customer profiles3 records

Technology focussed No

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature2 records

Partnerships

Nine partnerships are on record, tiered core.

• Axsome TherapeuticscoreStrategic or Co-development Partner · 1 November 2025Axsome acquired Baergic Bio (Avenue subsidiary) in November 2025. Baergic received $0.3 million upfront and is eligible for up to $2.5 million in milestone payments. Avenue (Fortress subsidiary) is eligible to receive approximately 74% of all future milestone and royalty payments including up to $79 million in sales milestones.
• Sun Pharma (Sun Pharmaceutical Industries)coreStrategic or Co-development Partner · 1 May 2025Sun Pharma acquired Checkpoint Therapeutics in May 2025 for approximately $355 million upfront plus ~$60 million CVR. Fortress received ~$28 million upfront with potential for additional $4.8 million CVR and 2.5% royalty on UNLOXCYT net sales. UNLOXCYT was approved by FDA in December 2024 and commercially launched in January 2026.
• Crystalys TherapeuticscoreStrategic or Co-development Partner · 1 July 2024Urica (Fortress majority-owned subsidiary) sold dotinurad to Crystalys in exchange for equity position and 3% royalty on future net sales. Crystalys raised $205 million Series A in Q3 2025 to advance dotinurad Phase 3 clinical trials. First patients dosed in October 2025.
• Sentynl TherapeuticscoreStrategic or Co-development Partner · 1 December 2023Sentynl assumed development and commercialization responsibility for ZYCUBO from Cyprium in December 2023. Sentynl acquired the PRV upon FDA approval of ZYCUBO in January 2026. Cyprium retains tiered royalties on net sales (3%-12.5%) and up to approximately $128-129 million in aggregate sales milestones. Fortress expects to receive over $100 million from the PRV sale.
• City of HopecoreStrategic or Co-development PartnerMustang Bio has exclusive worldwide licensing agreements with City of Hope on patents covering five novel CAR T cell therapies (MB-101 through MB-105). Helocyte has exclusive worldwide licensing agreements for Triplex and ConVax CMV immunotherapies.
• AstraZenecacoreStrategic or Co-development PartnerAstraZeneca acquired Caelum Biosciences in October 2021 for up to $500 million. Fortress received ~$56.9 million of upfront payment and is eligible for ~42% of proceeds from future milestone payments. AstraZeneca is developing CAEL-101 (anselamimab) for AL amyloidosis with regulatory submissions planned in EU and Japan.
• Nationwide Children's HospitalcoreStrategic or Co-development PartnerFortress entered into exclusive worldwide license agreement with Nationwide Children's Hospital in February 2019 to develop MB-108, an oncolytic virus (C134) for glioblastoma treatment, currently in development at Mustang Bio.
• Duke UniversitycoreStrategic or Co-development PartnerIn February 2026, Avenue (Fortress subsidiary) entered into exclusive worldwide license agreement with Duke University to acquire patent and know-how rights for ATX-04 (clenbuterol) for Pompe disease treatment.
• The University of Texas Health Science Center at HoustoncoreStrategic or Co-development PartnerFortress entered into exclusive worldwide license agreement in November 2016 for three programs for traumatic brain injury treatment, including CEVA-101 (pediatric and adult), CEVA-102, and CEVA-D bioreactor device. Programs in development at Cellvation.

Scale indicators8 records

Recent moves6 records

Expansion highlights6 records

Emerging players

• Aytu BioPharma: Small-cap specialty pharmaceutical company focused on commercializing prescription products for rare and underserved conditions. Comparable scale and approach to Fortress's specialty pharma operations through Journey Medical.
• Scilex Holding Company: Specialty pharmaceutical company focused on non-opioid pain management products with development pipeline. Comparable in therapeutic focus (pain management, specialty pharma) and small-cap structure similar to Fortress subsidiaries.

Broad incumbents

• Bausch Health Companies: Diversified specialty pharmaceutical company with complex subsidiary structure and a history of developing and commercializing branded specialty products across multiple therapeutic areas. Comparable corporate complexity and product portfolio breadth.
• Jazz Pharmaceuticals: Specialty biopharmaceutical company with diversified portfolio across CNS, oncology, and rare diseases, generating revenue from both marketed products and royalty streams. Larger-scale comparable to Fortress's specialty pharma approach.

Direct peers

• Supernus Pharmaceuticals: Specialty pharmaceutical company focused on CNS products (similar to Fortress's CNS programs including IV Tramadol and BAER-101) with both marketed products and a development pipeline. Comparable in therapeutic focus and mid-cap specialty pharma positioning.
• Ligand Pharmaceuticals: Royalty-driven biopharma holding company that acquires and develops therapeutic assets, generating revenue primarily through royalties, milestones, and equity stakes rather than direct commercialization. Closest comparable to Fortress's subsidiary and royalty model.
• Catalyst Pharmaceuticals: Specialty pharma focused on rare diseases with commercial-stage products. Similar profile to Fortress's rare disease focus (ZYCUBO for Menkes, CAEL-101 for AL amyloidosis) and small/mid-cap positioning with concentrated therapeutic areas.
• Royalty Pharma: Pure-play pharmaceutical royalty buyer that acquires royalty interests in biopharma products. Compares to Fortress's growing portfolio of royalty streams from approved products (UNLOXCYT, ZYCUBO, dotinurad, CAEL-101).
• Amneal Pharmaceuticals: Generic and specialty pharmaceutical company with diversified product portfolio across multiple therapeutic areas, including branded specialty products. Comparable to Fortress in the breadth of therapeutic areas and combination of branded and specialty products.
• ANI Pharmaceuticals: Specialty/generic pharmaceutical company that develops, manufactures, and markets branded and generic prescription products across multiple therapeutic areas. Comparable business model to Journey Medical's dermatology portfolio and Fortress's multi-product approach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks6 records

Key highlights7 records

Customer concentration

• Xx.com/fortressbio
• Facebookfacebook.com/fortressbiotech
• LinkedInlinkedin.com/company/fortress-biotech

Revenue estimate

Valuation estimate

Number of profiles

Profiles3 records

Subsidiaries8 records

Funding overview

Funding rounds14 records

Investors3 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Fortress Biotech