US FDA declines to approve Checkpoint Therapeutics' skin cancer therapy (updated)

Checkpoint Therapeutics

18/12/2023 12:31

(Adds background on therapy throughout)
       Dec 18 (Reuters) - Checkpoint Therapeutics  CKPT.O  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)
 ((Mariam.ESunny@thomsonreuters.com;))