At Fortress Biotech, our diversified product pipeline includes over 20 candidates in various phases of pre-clinical and clinical development. These product candidates are developed in collaboration with our partner companies and span several large-market therapeutic areas, including oncology, rare diseases, gene therapy and more. In addition, Fortress has several marketed dermatology products.
UNLOXCYTTM was acquired by Sun Pharma in 2025; Fortress is eligible to receive a 2.5% royalty on net sales.
Recurrent or Metastatic Cancers
Cutaneous squamous cell carcinoma (cSCC)
Cutaneous squamous cell carcinoma (cSCC) is the second most common type of skin cancer in the United States. cSCC starts in squamous cells within the surface of the skin, and upon progression, can invade deeper layers of the skin or spread to lymph nodes or other parts of the body. Surgery is the first option for patients with cSCC. In advanced stages, some patients will be treated with radiation or systemic drug therapy; however, certain patients may not be able to be cured with surgery or radiation. It is estimated that 7,000 patients in the United States die each year from cSCC.
Acquired by Sun Pharma | 2.5% royalty to Fortress
Rosacea
Rosacea is a chronic, relapsing, diverse skin condition that most commonly presents with symptoms such as deep facial redness, spider veins (telangiectasia) and acne-like inflammatory lesions (papules and pustules). Based on research in the British Journal of Dermatology, it is estimated that 415 million people suffer with rosacea worldwide.1 Rosacea is most frequently seen in adults between 30 and 50 years of age. Surveys conducted by The National Rosacea Society report more than 90 percent of rosacea patients said their condition had lowered their self-confidence and self-esteem, and 41 percent reported that it had caused them to avoid public contact or cancel social engagements. Among rosacea patients with severe symptoms, 88 percent said the disorder had adversely affected their professional interactions, and 51 percent said they had missed work because of their condition.
1. Gether L, Overgaard LK, Egeberg A, Thyssen JP. Incidence and prevalence of rosacea: a systematic review and meta-analysis. Br J Dermatol 2018 Feb 25. doi: 10.1111/bjd.16481
37% Journey Medical Corporation
37% Journey Medical Corporation
Acne
37% Journey Medical Corporation
Fungal Infections
37% Journey Medical Corporation
Wounds
37% Journey Medical Corporation
Recalcitrant Nodular Acne
37% Journey Medical Corporation
37% Journey Medical Corporation
37% Journey Medical Corporation
CONTRAINDICATIONS AND WARNINGS
Accutane® must not be used by patients who are or may become pregnant. There is an extremely high risk that severe birth defects will result if pregnancy occurs while taking Accutane in any amount, even for short periods of time. Potentially any fetus exposed during pregnancy can be affected. There are no accurate means of determining whether an exposed fetus has been affected.
ZYCUBO® (CUTX-101) is a copper histidinate injection for the treatment of Menkes disease.
Learn More About ZYCUBO® (CUTX-101)Menkes Disease
Menkes disease is an X-linked genetic disorder of copper transport caused by mutations of the ATP7A gene. Copper is an essential trace element required for human development and health. In Menkes disease, patients are born without the ability to absorb copper from diet, leading to severe developmental delays and significant neurological symptoms. Without treatment, Menkes disease could lead to death by three years of age. There is currently no FDA-approved therapy for the treatment of Menkes disease.
74% of Cyprium; 3% - 12.5% royalty payable to Cyprium from partner Sentynl3 | 2.5% Annual Equity Dividend
Gout and Chronic Kidney Disease
Gout is a serious, progressive and debilitating inflammatory arthritis caused by deposits of uric acid crystal in and around the connective tissue of joints, tendons and the kidneys. There are nearly 20 million diagnosed patients with gout in the US, Europe and Canada as of 2021, and it is estimated that two to three million U.S. patients are unsatisfied with their urate-lowering therapy and their serum uric acid levels remain inadequately controlled.
70% of Urica; 3% Royalty to Urica | 2.5% Equity Dividend
CAEL-101 is a 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.
View Clinical Trial View Clinical Trial View Clinical TrialAL Amyloidosis
AL amyloidosis is a rare systemic disorder caused by an abnormality of plasma cells in the bone marrow. Misfolded amyloid proteins produced by plasma cells cause buildup in and around tissues, nerves and organs, gradually affecting their function. This can cause progressive and widespread organ damage and high mortality rates.
42% of future proceeds to Caelum from AstraZeneca
Triplex is a universal, multi-antigen T-cell immunotherapeutic vaccine for controlling cytomegalovirus (CMV) in stem cell and solid organ transplant recipients.
View Clinical Trial View Clinical Trial View Clinical Trial View Clinical Trial View Clinical Trial View Clinical Trial View Clinical Trial View Clinical Trial View Clinical Trial View Clinical Trial View Clinical Trial View Clinical TrialCytomegalovirus (CMV), Cancer and Human Immunodeficiency Virus (HIV)
CMV is a common virus that is typically asymptomatic in healthy individuals but can cause life-threatening disease in those with weakened or uneducated immune systems. Patients undergoing allogeneic stem cell and solid organ transplantation are at particularly high risk of experiencing complications associated with CMV.
CMV can be transmitted to seronegative transplant recipients through infected donor grafts or reactivated in seropositive transplant recipients (particularly those with low baseline immunity) as a result of their immune-suppressed condition. In either instance, CMV can cause severe and life-threatening complications, including pneumonia, gastroenteritis and retinitis.
A novel bispecific CMV/HIV CAR T cell therapy (optionally for use in combination with Triplex), is currently the subject of a Phase 1 trial in adults living with HIV-1
Additionally, Triplex in combination with a bi-specific CMV/CD19 Chimeric Antigen Receptor (CAR) T cell is being evaluated for the treatment of non-Hodgkin lymphoma.
83% Helocyte; 4.5% Royalty | 2.5% Equity Dividend
IV Tramadol is intended for the management of moderate to moderately severe postoperative pain.
View Clinical Trial View Clinical Trial View Clinical TrialPost-Operative Acute Pain Management
Many patients who undergo surgical procedures experience severe postoperative pain. IV Tramadol is being developed as a potential treatment for pain management following surgery, including abdominoplasty and bunionectomy.
Abdominoplasty, or more commonly referred to as a “tummy tuck,” is a cosmetic surgical procedure in which excess skin and fat is removed from the abdomen, resulting in a smoother and firmer abdomen. A bunionectomy is a surgical procedure to remove a bunion from a patient’s foot. Depending on the complexity of these surgeries, some patients will experience severe postoperative pain.
10% Avenue; 4.5% Royalty | 2.5% Equity Dividend
MB-101 is a chimeric antigen receptor (CAR) T therapy for glioblastoma (GBM).
View Clinical Trial View Clinical TrialRecurrent Glioblastoma (GBM)
GBM is the most common brain and central nervous system (CNS) cancer, accounting for 45.2% of malignant primary brain and CNS tumors, 54% of all gliomas, and 16% of all primary brain and CNS tumors. There were an estimated 12,390 new GBM cases predicted in 2017 in the U.S. Malignant brain tumors are the most common cause of cancer-related deaths in adolescents and young adults aged 15-39 and the most common cancer occurring among 15-19-year-olds in the U.S. Although GBM is a rare disease (2-3 cases per 100,000 persons per year in the US and EU), it is quite lethal, with five-year survival rates historically under 10%. Standard of care therapy consists of maximal surgical resection, radiation and chemotherapy with temozolomide, which, while rarely curative, is shown to extend median overall survival from 4.5 to 15 months. GBM remains difficult to treat due to the inherent resistance of the tumor to conventional therapies.
4% Mustang; 4.5% Royalty | 2.5% Equity Dividend
MB-108 is a next-generation oncolytic virus (C134) that can replicate in tumor cells, but not in normal cells. Replication of MB-108 in the tumor itself not only kills the infected tumor cells but also causes the tumor cell to act as a factory to produce new virus.
View Clinical TrialRecurrent Glioblastoma (GBM)
GBM is the most common brain and central nervous system (CNS) cancer, accounting for 45.2% of malignant primary brain and CNS tumors, 54% of all gliomas and 16% of all primary brain and CNS tumors. There were an estimated 12,390 new GBM cases predicted in 2017 in the U.S. Malignant brain tumors are the most common cause of cancer-related deaths in adolescents and young adults aged 15-39 and the most common cancer occurring among 15-19-year-olds in the U.S. Although GBM is a rare disease (2-3 cases per 100,000 persons per year in the US and EU), it is quite lethal, with five-year survival rates historically under 10%. Standard of care therapy consists of maximal surgical resection, radiation and chemotherapy with temozolomide, which, while rarely curative, is shown to extend median overall survival from 4.5 to 15 months. GBM remains difficult to treat due to the inherent resistance of the tumor to conventional therapies.
4% Mustang; 4.5% Royalty | 2.5% Equity Dividend
MB-109 combines MB-101 (IL13Rα2-targeted CAR-T cells) CAR T cell therapy with MB-108 (C134 oncolytic virus). The combination is designed to leverage MB-108 to make cold glioblastoma tumors “hot,” and thereby may improve the efficacy of MB-101 CAR-T cell therapy. Clinical data from separate trials, together with results from the in vivo combination studies currently underway, will support the first ever industry-sponsored trial of an oncolytic virus with a CAR-T for the treatment of cancer patients.
Recurrent GBM and Anaplastic Astrocytoma
4% Mustang 4.5% Royalty 2.5% Equity Dividend
FB-606 is a small molecule in development for the treatment of Duchenne Muscular Dystrophy.
Duchenne Muscular Dystrophy
FB-606 is a small molecule in development for the treatment of Duchenne Muscular Dystrophy.
Internally Sourced Program Preclinical
AAV.sFH is an adeno-associated virus (AAV) gene therapy that restores lasting production of regulatory proteins, potentially providing a curative treatment for diseases with high unmet need.
Complement-Mediated Diseases
Asset sold to 4DMT in April 2023 ~$140M in potential future milestone proceeds plus royalties4
Adeno-associated virus (AAV)-based ATP7A is a gene therapy intended for use in combination with CUTX-101 for the treatment of Menkes disease and related copper transport disorders.
Menkes Disease
Menkes disease is an X-linked genetic disorder of copper transport caused by mutations of the ATP7A gene. Copper is an essential trace element required for human development and health. In Menkes disease, patients are born without the ability to absorb copper from diet, leading to severe developmental delays and significant neurological symptoms. Without treatment, Menkes disease could lead to death by three years of age. Currently, there is no FDA-approved therapy for treatment of Menkes disease.
74% of Cyprium; 2.5% Annual Equity Dividend
CEVA-102 is the first cell product produced by CEVA-D and is being developed for the treatment of severe traumatic brain injury (TBI) in adults and children.
Traumatic Brain Injury (TBI)
TBIs are associated with 33% of all trauma-related deaths. There are no effective therapies to treat secondary brain injury and the post-injury response of central nervous system apoptosis and neuroinflammation.
80% of Cellvation; 4.5% Royalty | 2.5% Equity Dividend
CEVA-D is a novel bioreactor device that enhances the anti-inflammatory potency of bone marrow-derived cells without genetic manipulation, using wall shear stress (WSS) to suppress tumor necrosis factor-a (TNF-a) production by activated immune cells.
Traumatic Brain Injury (TBI)
TBIs are associated with 33% of all trauma-related deaths. There are no effective therapies to treat secondary brain injury and the post-injury response of central nervous system apoptosis and neuroinflammation.
80% Cellvation; 4.5% Royalty | 2.5% Equity Dividend
We have a library of valuable content and resources that provide in-depth knowledge on our product candidates and various therapeutic areas of interest.
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