Fortress Biotech, Inc. announced its financial results and recent corporate highlights for the third quarter ended September 30, 2024, on November 14, 2024. The company highlighted the U.S. Food and Drug Administration (FDA) approval for Emrosi™ on November 4, a treatment for inflammatory lesions of rosacea in adults, developed by its partner company, Journey Medical Corporation.
Another significant update was the Prescription Drug User Fee Act (PDUFA) goal date of December 28, 2024, for cosibelimab, an anti-PD-L1 antibody, for the potential approval to treat metastatic or locally advanced cutaneous squamous cell carcinoma (cSCC). This product is from Fortress-founded Checkpoint Therapeutics.
Fortress's Chairman, President, and CEO, Lindsay A. Rosenwald, M.D., emphasized that Emrosi's approval marks the first FDA approval across the Fortress portfolio, demonstrating the company's ability to advance clinical-stage programs through commercialization. The company anticipates up to two more U.S. FDA approvals within the next nine months, underscoring an exciting late-stage pipeline with multiple upcoming value creation opportunities.
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