BeiGene's Brukinsa Applications Under FDA, European Review For Leukemia

The European Medicines Agency (EMA) has accepted for review two new indication applications for BeiGene Ltd's BGNE Brukinsa (zanubrutinib) for chronic lymphocytic leukemia (CLL) and marginal zone lymphoma (MZL).

• In November 2021, Brukinsa received its first approval in the European Union (EU) for Waldenström's macroglobulinemia (WM), who have received at least one prior therapy or for the first-line treatment of patients unsuitable for chemo-immunotherapy.
• Additionally, the FDA has also accepted for review BeiGene's supplemental marketing application for Brukinsa for chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). CLL is the most common form of adult leukemia. 
• The Prescription Drug User Fee Act (PDUFA) target action date is October 22.
• Price Action: BGNE shares are down 2.82% at $207.00 during the market session on the last check Tuesday.