Programs

A Diversified Pipeline Spanning Several Large Markets

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.

Our Current Programs1

Commercial

Candidate Indication Partnership2 Preclinical Phase 1 Phase 2 Phase 3 NDA/BLA Filed Marketed

48% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA/BLA Filed Phase complete
Marketed Phase in progress

Acne

48% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA/BLA Filed Phase complete
Marketed Phase in progress

Fungal Infections

48% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA/BLA Filed Phase complete
Marketed Phase in progress

Wounds

48% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA/BLA Filed Phase complete
Marketed Phase in progress

Recalcitrant Nodular Acne

48% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA/BLA Filed Phase complete
Marketed Phase in progress

48% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA/BLA Filed Phase complete
Marketed Phase in progress

48% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA/BLA Filed Phase complete
Marketed Phase in progress
  • 1. Portfolio includes product candidates in development at Fortress, at its majority-owned and majority-controlled partners, and partner companies that Fortress may otherwise have an economic interest in
  • 2. Column reflects approximate percentage ownership in Fortress partner company and corresponding direct product sales royalties owed to Fortress estimated as of June 30, 2023 or date of most recent public ownership filings for partner companies.

IMPORTANT SAFETY INFORMATION FOR ACCUTANE® (ISOTRETINOIN)

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.

Late Stage Product Candidates

Candidate Indication Partnership; Royalty2 Preclinical Phase 1 Phase 2 Phase 3 NDA/BLA Filed Marketed

Cosibelimab

Recurrent or Metastatic Cancers

8% Checkpoint; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA/BLA Filed Phase in progress
Marketed Phase not started

CUTX-101

Menkes Disease

75% of Cyprium; 3% - 12.5% royalty payable to Cyprium from partner Sentynl3 | 2.5% Annual Equity Dividend

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase in progress
NDA/BLA Filed Phase not started
Marketed Phase not started

IV Tramadol

Post-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.

7% Avenue; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA/BLA Filed Phase in progress
Marketed Phase not started

DFD-29

Rosacea

48% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase in progress
NDA/BLA Filed Phase not started
Marketed Phase not started

Olafertinib

Frontline NSCLC with EGFR Mutations

8% Checkpoint; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

CAEL-101 4

AL Amyloidosis

42% of future proceeds to Caelum from AstraZeneca

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase in progress
NDA/BLA Filed Phase not started
Marketed Phase not started

Triplex

Cytomegalovirus (CMV)

83% Helocyte; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase in progress
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started
  • 1. Portfolio includes product candidates in development at Fortress, at its majority-owned and majority-controlled partners, and partner companies that Fortress may otherwise have an economic interest in
  • 2. Column reflects approximate percentage ownership in Fortress partner company and corresponding direct product sales royalties owed to Fortress estimated as of June 30, 2023 or date of most recent public ownership filings for partner companies.
  • 4. AstraZeneca’s Alexion acquired Caelum Biosciences on 10/5/2021 for up to $500 million, including $150 million upfront and up to $350 million in future contingent milestone payments. FBIO received ~$56.9 million of such upfront amount and is eligible to receive ~42% of the proceeds from all future milestone payments.

Early Stage Product Candidates

Candidate Indication Partnership; Royalty2 Preclinical Phase 1 Phase 2 Phase 3 NDA/BLA Filed Marketed

MB-106

B-cell Non-Hodgkin Lymphoma and Chronic Lymphocytic Leukemia (CLL)

21% Mustang; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

Dotinurad

Gout and Chronic Kidney Disease

68% of Urica; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

AJ201

Spinal and Bulbar Muscular Atrophy (SBMA)

7% Avenue; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

Previously Transplanted X-Linked Severe Combined Immunodeficiency (XSCID)

21% Mustang; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

MB-101

Recurrent Glioblastoma (GBM)

21% Mustang; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

MB-108

Recurrent Glioblastoma (GBM)

21% Mustang; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

BAER-101

CNS Disorders

7% Avenue; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase complete
Phase 1 Phase in progress
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started
  • 1. Portfolio includes product candidates in development at Fortress, at its majority-owned and majority-controlled partners, and partner companies that Fortress may otherwise have an economic interest in
  • 2. Column reflects approximate percentage ownership in Fortress partner company and corresponding direct product sales royalties owed to Fortress estimated as of June 30, 2023 or date of most recent public ownership filings for partner companies.

Preclinical

Candidate Indication Partnership; Royalty2 Preclinical Phase 1 Phase 2 Phase 3 NDA/BLA Filed Marketed

MB-109

Recurrent GBM and Anaplastic Astrocytoma

21% Mustang 4.5% Royalty 2.5% Equity Dividend

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

In Vivo CAR T Technology

Hematologic and Solid Tumor Malignancies

21% Mustang; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

AAV.sFH

Complement-Mediated Diseases

Asset sold to 4DMT in April 2023 ~$140M in potential future milestone proceeds plus royalties4

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

AAV-ATP7A Gene Therapy

Menkes Disease

75% of Cyprium; 2.5% Annual Equity Dividend

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

CK-103

Multiple Solid Tumors

8% Checkpoint; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

CEVA-102

Traumatic Brain Injury (TBI)

79% of Cellvation; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

CK-302

Multiple Solid Tumors

8% Checkpoint; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

CK-303

Multiple Solid Tumors

8% Checkpoint; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started

CEVA-D

Traumatic Brain Injury (TBI)

79% Cellvation; 4.5% Royalty | 2.5% Equity Dividend

Preclinical Phase in progress
Phase 1 Phase not started
Phase 2 Phase not started
Phase 3 Phase not started
NDA/BLA Filed Phase not started
Marketed Phase not started
  • 1. Portfolio includes product candidates in development at Fortress, at its majority-owned and majority-controlled partners, and partner companies that Fortress may otherwise have an economic interest in
  • 2. Column reflects approximate percentage ownership in Fortress partner company and corresponding direct product sales royalties owed to Fortress estimated as of June 30, 2023 or date of most recent public ownership filings for partner companies.
  • 4. 4D Molecular Therapeutics acquired Aevitas’ short-form human factor H asset in April 2023 for up to ~$140 million in potential milestones and additional royalties on net sales.

Scientific Publications

We have a library of valuable content and resources that provide in-depth knowledge on our product candidates and various therapeutic areas of interest.

View Publications