Checkpoint Therapeutics (CKPT.O) said on Monday the U.S. Food and Drug Administration had declined to approve its experimental therapy to treat a form of skin cancer following an inspection at a contract manufacturer, sending its shares down nearly 50%.
Shares of the Waltham, Massachusetts-based company were down 47.3%, to $1.7 in premarket trade, among the worse performing stocks across U.S. stock exchanges.
Checkpoint filed the marketing application for cosibelimab, its lead therapy in development, earlier this year.
The company said the FDA did not state any concerns about the data or safety of the therapy in its so-called complete response letter.
“We believe we can address the feedback in a resubmission to enable marketing approval in 2024,” CEO James Oliviero said in a statement
According to the company, cutaneous squamous cell carcinoma is the second most common type of skin cancer in the United States, with around 1 million cases every year.
The trial data showed the therapy helped reduce or clear cancerous tumors by 47.4%.
Checkpoint also said about 40,000 cases become advanced and it estimates around 15,000 people die of the disease annually.
Source : Reuters