AstraZeneca and Daiichi Sankyo Withdraw Drug Application in EU

In a report, AstraZeneca and Daiichi Sankyo have voluntarily pulled their marketing authorization application for datopotamab deruxtecan in the EU, despite a commitment to its future availability for lung cancer patients. The decision follows feedback from EU regulators.

Date: 24-12-2024

AI Rating: 5

This report highlights a significant development regarding AstraZeneca Plc and Daiichi Sankyo's drug application for datopotamab deruxtecan. The voluntary withdrawal of their marketing authorisation application (MAA) in the European Union for the treatment of non-small cell lung cancer indicates regulatory hurdles that could potentially impact the companies' stock prices.

While the withdrawal of a drug application can often be perceived negatively, AstraZeneca and Daiichi Sankyo have expressed their commitment to continuing the development of datopotamab deruxtecan. Their determination to make the drug available to lung cancer patients suggests an ongoing pipeline and potential future revenue from other applications. Additionally, their clinical development program includes seven pivotal trials, implying a robust plan for future approval and market entry.

Furthermore, it is worth noting that their application for datopotamab deruxtecan pertaining to metastatic breast cancer remains under review by the EU, which may provide some stabilization for investor sentiment.

Overall, while this news may lead to short-term volatility due to the withdrawal, the companies' ongoing commitment to clinical trials could mitigate long-term negative perceptions. Investors will need to monitor subsequent announcements regarding the status of their trials and EU approval processes.

Stocks: AZN DSKYF