BeiGene's US Application For BRUKINSA In A Type Of Lymphoma, Accepted For Review

The FDA has accepted for review BeiGene Ltd's (NASDAQ: BGNE) supplemental marketing application seeking approval for BRUKINSA (zanubrutinib) for the treatment of adult patients with Waldenström's Macroglobulinemia (WM), a type of blood cancer.
The target Action date is set for October 18.
In November 2019, BRUKINSA received accelerated approval in the U.S. to treat mantle cell lymphoma in adult patients who have received at least one prior therapy. In June 2020, BRUKINSA received conditional approval in China as a treatment for adult patients with chronic lymphocytic leukemia /small lymphocytic lymphoma who have received at least one prior therapy and as a treatment for adult patients with mantle cell lymphoma who have received at least one prior therapy.
Price Action: BGNE shares are down 0.55% at $381.83 on the last check Wednesday.