Material Event Form 8 K

Item 8.01. Other Events.

​

On December 13, 2024, Checkpoint Therapeutics ("Checkpoint"), a majority-controlled subsidiary of Fortress Biotech, Inc. (the "Company" or "Fortress"), announced that the U.S. Food and Drug Administration (the "FDA") approved UNLOXCYT™ (cosibelimab-ipdl) for the treatment of adults with metastatic or locally advanced cutaneous squamous cell carcinoma ("cSCC") who are not candidates for curative surgery or curative radiation. UNLOXCYT is the first and only programmed death ligand-1 (PD-L1) blocking antibody to receive FDA marketing approval for this indication.

​

The FDA approval for UNLOXCYT was granted based on clinically meaningful objective response rates and duration of response data, as assessed by an independent central review committee, from Study CK-301-101 (NCT03212404), a multicenter, multicohort, open-label study of UNLOXCYT in adults with advanced solid tumor cancers, including cSCC.

​

​