UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
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FORM
CURRENT REPORT
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Item 8.01. Other Events.
On July 25, 2024, Checkpoint Therapeutics, Inc. issued a press release to announce that the U.S. Food and Drug Administration (“FDA”) accepted Checkpoint’s resubmission of its Biologics License Application for cosibelimab, its anti-programmed death ligand-1 antibody, as a potential new treatment for adults with metastatic or locally advanced cutaneous squamous cell carcinoma who are not candidates for curative surgery or curative radiation. The FDA has set a Prescription Drug User Fee Act goal date of December 28, 2024.
A copy of such press release is being furnished as Exhibit 99.1 to this report.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
The following exhibit is furnished herewith:
| Exhibit Number |
Description | |
| 99.1 | Press release issued by Checkpoint Therapeutics, Inc., dated July 25, 2024. | |
| 104 | Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Date: July 25, 2024 | Checkpoint Therapeutics, Inc. | |
| (Registrant) | ||
| By | /s/ James F. Oliviero | |
| James F. Oliviero | ||
| President and Chief Executive Officer | ||