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Checkpoint Therapeutics, Inc.

Company NameCheckpoint Therapeutics, Inc.
Stock SymbolCKPT

On December 18, 2023, Checkpoint disclosed that the U.S. Food and Drug Administration (“FDA”) had not approved the Biologics License Application (“BLA”) that the Company had submitted for its metastatic cutaneous squamous cell carcinoma (“cSCC”) treatment, cosibelimab. Specifically, the Company stated that the FDA had issued a complete response letter which “cites findings that arose during a multi-sponsor inspection of Checkpoint’s third-party [CMO] as approvability issues to address in a resubmission.”

On this news, Checkpoint’s stock price fell $1.49, or 44.9%, to close at $1.83 per share on December 18, 2023, thereby injuring investors. 

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