The FDA Has Issued A Complete Response Letter To Checkpoint Therapeutics' Cosibelimab Biologic License Application For Metastatic Or Locally Advanced Cutaneous Squamous Cell Carcinoma Who Are Not Candidates For Curative Surgery Or Radiation
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The FDA issued a Complete Response Letter (CRL) to Checkpoint Therapeutics for their Cosibelimab application for treating metastatic or locally advanced cutaneous squamous cell carcinoma. The CRL relates to issues found during an inspection of a third-party contract manufacturing organization used by Checkpoint.
December 18, 2023 | 12:03 pm
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Checkpoint Therapeutics received a CRL from the FDA for their Cosibelimab application, which may delay the drug's approval process and affect the company's stock price negatively in the short term.
The issuance of a CRL by the FDA typically indicates significant regulatory hurdles that a company must overcome before its product can be approved. This can lead to delays in product launch, potential additional costs, and a negative perception among investors, all of which can adversely affect the stock price in the short term.
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