CKPT - Checkpoint stock plunges 50% on FDA rejection of skin cancer drug

2023-12-18 10:28:27 ET

Shares of Checkpoint Therapeutics ( NASDAQ: CKPT ) plunged 50% in morning trading Monday after the company said the FDA had declined to approve its drug cosibelimab for the treatment of advanced cutaneous squamous cell carcinoma, a common type of skin cancer.

Checkpoint said the FDA issued the company a Complete Response Letter for its market application for the drug, citing issues with an inspection involving its contract manufacturer for the product. The agency didn’t cite any concerns about the data package, safety or labeling affecting approvability of the drug.

“As the only deficiencies relate to the FDA’s inspection of our third-party contract manufacturing organization, we believe we can address the feedback in a resubmission to enable marketing approval in 2024,” Checkpoint CEO James Oliviero said in a statement.

More on Checkpoint Therapeutics

• Seeking Alpha’s Quant Rating on Checkpoint Therapeutics
• Historical earnings data for Checkpoint Therapeutics
• Financial information for Checkpoint Therapeutics

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