Checkpoint Therapeutics (NASDAQ:CKPT) shares plummeted 48% to $1.72 in midday trading on Monday after the US Food and Drug Administration (FDA) failed to approve its drug development candidate Cosibelimab, the clinical-stage immunotherapy and targeted oncology company’s experimental therapy to treat a type of advanced skin cancer.
In its complete response letter (CRL), the FDA cited issues related to a third-party contract manufacturer as the reason for its decision.
"As the only deficiencies relate to the FDA’s inspection of our third-party contract manufacturing organization, we believe we can address the feedback in a resubmission to enable marketing approval in 2024," Checkpoint Therapeutics (NASDAQ:CKPT) CEO James Oliviero said in a statement.
Checkpoint noted the FDA did not state any concerns about the data or safety on the drug.
Trial data showed the therapy helped reduce or clear cancerous tumors by 47.4%.
Checkpoint filed the marketing application for Cosibelimab earlier this year.