2024-01-10 05:54:35 ET
Daiichi Sankyo ( OTCPK:DSNKY ) has reportedly filed for regulatory approval for a cancer treatment it is co-developing with AstraZeneca ( NASDAQ: AZN ).
According to a report by Citi analysts, the Japanese drugmaker confirmed during a recent investor event that it has submitted an application to the U.S. Food and Drug Administration seeking approval for datopotamab deruxtecan (Dato-DXd).
The company expects the application to be accepted by the end of the fiscal year, said Citi, adding that "confirmation that a filing has been made should reassure investors and prove somewhat positive for the shares."
Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2-directed antibody drug conjugate ( ADC ) being jointly developed by AstraZeneca ( AZN ) and Daiichi Sankyo ( OTCPK:DSNKY ).
In a late-stage trial, the therapy showed statistically significant and clinically meaningful improvement for the primary endpoint of progression-free survival in patients with HR-positive, HER2-low or negative breast cancer.
TSE-listed shares of Daiichi Sankyo jumped over 5% on the news
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Daiichi Sankyo rises on reported FDA filing for cancer drug developed with AstraZeneca