Checkpoint Therapeutics shares are trading lower after the FDA issued a complete response letter for the cosibelimab biologic license application due to inspection findings at a third-party manufacturer.
Portfolio Pulse from Benzinga Newsdesk
Checkpoint Therapeutics' stock is trading lower following the FDA's issuance of a complete response letter for the biologic license application of cosibelimab, which was impacted by inspection findings at a third-party manufacturer.
December 18, 2023 | 4:29 pm
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NEGATIVE IMPACT
Checkpoint Therapeutics' shares are down after the FDA's complete response letter regarding cosibelimab, linked to third-party manufacturing issues.
The FDA's complete response letter is a significant regulatory setback for Checkpoint Therapeutics, indicating that the approval process for cosibelimab will be delayed until the issues at the third-party manufacturer are resolved. This news is likely to negatively impact investor sentiment and the stock price in the short term, as it directly pertains to the company's ability to bring a key product to market.
CONFIDENCE 85
IMPORTANCE 90
RELEVANCE 100