Checkpoint Therapeutics Resubmits BLA for Cosibelimab to FDA for Advanced Skin Cancer Treatment
Portfolio Pulse from Benzinga Newsdesk
Checkpoint Therapeutics has resubmitted its Biologics License Application (BLA) for cosibelimab to the FDA for the treatment of advanced skin cancer. The resubmission addresses issues raised in a previous complete response letter, which were related to manufacturing and not clinical data. The BLA is supported by positive safety and efficacy results from pivotal studies.
July 02, 2024 | 11:11 am
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Checkpoint Therapeutics has resubmitted its BLA for cosibelimab to the FDA, addressing previous manufacturing issues. The resubmission is supported by positive clinical data, which could lead to FDA approval and potential market entry.
The resubmission of the BLA for cosibelimab addresses the FDA's previous concerns related to manufacturing, not clinical data. Positive clinical results and alignment with the FDA on the resubmission strategy increase the likelihood of approval, which could positively impact CKPT's stock price.
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