Programs

A Diversified Pipeline Spanning Several Large Markets

At Fortress Biotech, our diversified product pipeline includes over 25 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 Market

58% Journey Medical Corporation

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

Acne

58% Journey Medical Corporation

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

Acne

58% Journey Medical Corporation

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

Fungal Infections

58% Journey Medical Corporation

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

Wounds

58% Journey Medical Corporation

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

Recalcitrant Nodular Acne

58% Journey Medical Corporation

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

58% Journey Medical Corporation

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

58% Journey Medical Corporation

Preclinical Phase complete
Phase 1 Phase complete
Phase 2 Phase complete
Phase 3 Phase complete
NDA/BLA Filed Phase complete
Market 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 as of 9/30/2022

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 Market

Cosibelimab

cSCC

19% 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
Market Phase not started

CUTX-101

Menkes Disease

71% Cyprium; 4.5% Royalty | 2.5% Equity Dividend

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

IV Tramadol

Post-Surgical Acute Pain

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.

11% Avenue³; 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
Market Phase not started

DFD-29

Rosacea

58% Journey Medical Corporation⁵

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

MB-107

Newly Diagnosed X-Linked Severe Combined Immunodeficiency (XSCID)

19% Mustang; 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
Market Phase not started

MB-207

Previously Transplanted X-Linked Severe Combined Immunodeficiency (XSCID)

19% Mustang; 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
Market Phase not started

Olafertinib

Frontline NSCLC with EGFR Mutations

19% 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
Market 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
Market Phase not started

Triplex

Cytomegalovirus (CMV)

82% 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
Market Phase not started

CEVA 101 Pediatric

Traumatic Brain Injury (TBI)

78% Cellvation; 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
Market Phase not started

CEVA 101 Adult

Traumatic Brain Injury (TBI)

78% Cellvation; 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
Market 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 as of 9/30/2022
  • 3. FBIO ownership percentage estimate of Avenue as of Sep 30, 2022, does not account for dilution from Avenue’s public offering on Oct 11, 2022
  • 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
  • 5. Fortress currently owns 58% of Journey Medical Corporation on an issued and outstanding basis as of 12/31/2021

Early Stage Product Candidates

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

MB-106

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

19% 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
Market Phase not started

Dotinurad

Rheumatology

65% 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
Market Phase not started

AJ201

Spinal and Bulbar Muscular Atrophy (SBMA)

11% Avenue³; 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
Market Phase not started

MB-102

AML, BPDCN, and hrMDS

19% 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
Market Phase not started

MB-101

Glioblastoma (GBM)

19% 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
Market Phase not started

MB-104

Multiple Myeloma (MM)

19% 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
Market Phase not started

MB-103

GBM and Metastatic Breast Cancer to Brain

19% 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
Market Phase not started

MB-108

Glioblastoma (GBM)

19% 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
Market Phase not started

MB-105

Prostate, Pancreatic, Gastric and Bladder Cancers

19% 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
Market Phase not started

BAER-101

CNS Disorders

11% of Avenue³; 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
Market Phase not started

MB-110

RAG1-SCID

19% 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
Market 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 as of 9/30/2022
  • 3. FBIO ownership percentage estimate of Avenue as of Sep 30, 2022, does not account for dilution from Avenue’s public offering on Oct 11, 2022

Preclinical

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

MB-109

Recurrent GBM and Anaplastic Astrocytoma

19% 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
Market Phase not started

In Vivo CAR T Technology

Hematologic and Solid Tumor Malignancies

19% 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
Market Phase not started

AVTS-001

AMD, PNH, and aHUS

54% of Aevitas; 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
Market Phase not started

AAV-ATP7A Gene Therapy

Menkes Disease

71% Cyprium; 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
Market Phase not started

CK-103

Multiple Solid Tumors

19% 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
Market Phase not started

CEVA-102

Traumatic Brain Injury (TBI)

78% 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
Market Phase not started

CK-302

Multiple Solid Tumors

19% 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
Market Phase not started

CK-303

Multiple Solid Tumors

19% 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
Market Phase not started

ConVax

Cytomegalovirus Prevention and Control

82% of Helocyte; 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
Market Phase not started

CEVA-D

Traumatic Brain Injury (TBI)

78% 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
Market Phase not started

ONCOlogues

Genetically Driven Cancers & Coronaviruses

75% Oncogenuity; 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
Market 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 as of 9/30/2022

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