Checkpoint Therapeutics Inc CKPT shares are trading lower by 52.7% to $1.57 Monday morning after the company received a complete response letter (CRL) from the FDA regarding their application for cosibelimab, a treatment for certain types of skin cancer.
The letter pointed out issues related to a third-party manufacturer's inspection, not concerns about the treatment's effectiveness or safety.
The CRL did not state any concerns about the clinical data package, safety or labeling for the approvability of cosibelimab.
Checkpoint says the company is confident in addressing these concerns for a resubmission and aims to bring cosibelimab to market in 2024, focusing on collaboration with the manufacturer and the FDA.
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According to data from Benzinga Pro, CKPT has a 52-week high of $8.15 and a 52-week low of $1.30.
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