BeiGene down 9% as FDA extends action date for Brukinsa supplemental approval

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• The U.S. FDA has extended the action date by three months to Jan. 20, 2023 Beigene's (NASDAQ:BGNE) supplemental New Drug Application for Brukinsa (zanubrutinib) for chronic lymphocytic leukemia or small lymphocytic lymphoma.
• Shares are down 9%.
• The extension is to review additional data provided by the company, which is considered a major amendment to the application.
• That data, released by Beigene (BGNE) in April, was an initial response analysis from a trial that showing Brukinsa's superiority versus (Imbruvica) ibrutinib in overall response rate.