Reported Earlier, FDA Issues Complete Response Letter for Daiichi Sankyo and Merck's Lung Cancer Treatment, Patritumab Deruxtecan Approval Delayed by FDA Due to Third-Party Manufacturing Concerns
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The FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of Daiichi Sankyo and Merck's lung cancer treatment, patritumab deruxtecan, due to third-party manufacturing concerns. The CRL did not identify any issues with the efficacy or safety data submitted.
June 27, 2024 | 7:13 am
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The FDA has delayed the approval of Merck's lung cancer treatment, patritumab deruxtecan, due to third-party manufacturing concerns. This could impact Merck's short-term stock performance negatively.
The delay in approval due to manufacturing concerns could lead to a negative short-term impact on Merck's stock as investors may react to the regulatory setback.
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