By Josh Beckerman
Shares of Checkpoint Therapeutics rose 4.6% to $3.84 in post-market trading after the Food and Drug Administration approved Unloxcyt (cosibelimab-ipdl) for advanced cutaneous squamous cell carcinoma, the first-ever approval for the company.
Checkpoint said in July the FDA accepted for review its resubmission of the Biologics License Application and set a Prescription Drug User Fee Act goal date of Dec. 28.
The agency issued a Complete Response Letter for the application in December 2023. The letter cited findings that arose during a multi-sponsor inspection of Checkpoint's third-party contract manufacturer. The letter didn't state any concerns about the clinical data package, safety, or labeling for the approvability of cosibelimab, the company said at the time.
Checkpoint said it believes Unloxcyt offers a differentiated treatment option versus available therapies by binding to PD-L1, rather than PD-1, to release the inhibitory effects of PD-L1 as part of the anti-tumor immune response.
The approval provides an opportunity to compete in a U.S. market estimated to exceed $1 billion annually, the company said.
Write to Josh Beckerman at josh.beckerman@wsj.com
(END) Dow Jones Newswires
December 13, 2024 19:09 ET (00:09 GMT)
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