(Adds background on therapy throughout)
Dec 18 (Reuters) – Checkpoint Therapeutics said on Monday the U.S. Food and Drug Administration declined to approve its experimental therapy to treat a type of advanced skin cancer, citing issues related to a third-party contract manufacturer.
The company filed the marketing application for the drug, Cosibelimab, its lead therapy in development, earlier this year.
Shares of the Waltham, Massachusetts-based company were halted for trading premarket.
Checkpoint said the FDA did not state any concerns about the data or safety on the drug in its so-called complete response letter.
“We believe we can address the feedback in a resubmission to enable marketing approval in 2024,” said CEO James Oliviero said in a statement
The trial data showed the therapy helped reduce or clear cancerous tumors by 47.4%. (Reporting by Mariam Sunny and Puyaan Singh in Bengaluru; Editing by Sriraj Kalluvila)