Fortress Biotech Reports Record 2022 Financial Results and Recent Corporate High… – Press Release


Fortress expects to file a total of three new drug applications in 2023

Record consolidated net revenue of $75.7 million for full-year 2022

FDA accepted for filing the Biologics License Application for cosibelimab in patients with metastatic or locally advanced cutaneous squamous cell carcinoma; PDUFA goal date of January 3, 2024

Rolling NDA submission for CUTX-101 for the treatment of Menkes disease is expected to be completed in 2023

Topline results from the Phase 3 clinical program of DFD-29 to treat papulopustular rosacea expected in the first half of 2023; NDA submission expected in the second half of 2023

MIAMI, March 30, 2023 (GLOBE NEWSWIRE) — Fortress Biotech, Inc. FBIO (“Fortress”), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, today announced financial results and recent corporate highlights for the full-year ended December 31, 2022.

Lindsay A. Rosenwald, M.D., Fortress’ Chairman, President and Chief Executive Officer, said, “In 2022, we continued to advance our extensive portfolio of multiple clinical-stage programs, several of which are late-stage and pivotal. We also generated record consolidated net revenues of $75.7 million, much of which came from the sales of our eight marketed dermatology products. Our growth continues in 2023, as the U.S. Food and Drug Administration (“FDA”) accepted for filing the Biologics License Application (“BLA”) for cosibelimab earlier this month and we expect to have two New Drug Applications (“NDA”) submitted to the FDA for CUTX-101 for Menkes disease and DFD-29 for rosacea this year. We also anticipate multiple clinical trial initiations, data readouts and regulatory filings across our other development-stage programs. Fortress has also established 25 acquisition companies with expert opinion leaders in multiple therapeutic areas over the past year. These expert opinion leaders will continue to…