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
12-18-23 0925ET