Checkpoint Therapeutics Shares Halved After FDA Complete Response Letter

By Dean Seal

Shares of Checkpoint Therapeutics fell by more than half after federal regulators issued a complete response letter to a biologic license application for cosibelimab, its experimental treatment for a type of skin cancer.

The stock was down 53% at $1.55 in premarket trading. When the market closed Friday, shares had fallen by more than a third year-to-date.

The Waltham, Mass.-based company said Monday morning that the Food and Drug Administration's letter, which indicates that the agency can't approve the application in its current form, cites findings that arose during a multi-sponsor inspection of Checkpoint's third-party contract manufacturer.

Chief Executive James Oliviero said the company should be able to address the feedback in a resubmission, with the goal of getting marketing approval for cosibelimab next year.

Write to Dean Seal at dean.seal@wsj.com

(END) Dow Jones Newswires

December 18, 2023 09:25 ET (14:25 GMT)

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