Checkpoint Therapeutics Says FDA Accepted For Review Its Resubmission Of Its Biologics License Application For Cosibelimab
Portfolio Pulse from Benzinga Newsdesk
Checkpoint Therapeutics announced that the FDA has accepted for review its resubmission of the Biologics License Application for Cosibelimab, an anti-PD-L1 antibody for treating metastatic or locally advanced cutaneous squamous cell carcinoma. The FDA has set a PDUFA goal date of December 28, 2024.
July 25, 2024 | 11:33 am
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Checkpoint Therapeutics' resubmission of its Biologics License Application for Cosibelimab has been accepted by the FDA, with a PDUFA goal date of December 28, 2024. This is a significant step forward for the company in bringing its anti-PD-L1 antibody to market for treating cSCC.
The acceptance of the resubmission by the FDA is a positive regulatory milestone for Checkpoint Therapeutics. It indicates progress in the approval process for Cosibelimab, which could potentially lead to market entry and revenue generation if approved. The set PDUFA date provides a clear timeline for investors.
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