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%
https://finance.yahoo.com/news/1-us-fda-declines-approve-123118673.html
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.