Fortress Biotech Inc. filed SEC Form 8-K: Other Events
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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.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
Fortress Biotech, Inc. | ||
(Registrant) | ||
Date: December 16, 2024 | ||
| By: | /s/ David Jin |
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| David Jin |
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| Chief Financial Officer |