FDA Declines To Approve Merck-Daiichi Sankyo Partnered Lung Cancer Drug
Portfolio Pulse from Vandana Singh
The FDA has issued a Complete Response Letter (CRL) for the Biologics License Application (BLA) of patritumab deruxtecan, a lung cancer drug developed by Daiichi Sankyo and Merck, due to issues at a third-party manufacturing facility. The CRL did not raise concerns about the drug's efficacy or safety. Merck's stock was down 1.04% following the news.
June 27, 2024 | 2:13 pm
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NEGATIVE IMPACT
The FDA issued a CRL for Merck's lung cancer drug, patritumab deruxtecan, due to manufacturing issues. The drug's efficacy and safety were not questioned. Merck's stock fell 1.04% following the news.
The CRL from the FDA is a significant regulatory setback for Merck, impacting investor sentiment negatively. Although the drug's efficacy and safety were not questioned, the delay in approval due to manufacturing issues has led to a short-term decline in Merck's stock price.
CONFIDENCE 90
IMPORTANCE 80
RELEVANCE 100