The FDA will decide whether or not to approve Bristol-Myers Squibb Co.’s (BMY) CC-486, an investigational oral hypomethylating agent, on September 3, 2020.CC-486 is intended for the maintenance treatment of adult patients with acute myeloid leukemia, who achieved complete remission (i.e., showing no signs of cancer) after intensive chemotherapy.In clinical trials, CC-486 demonstrated a statistically significant improvement in overall survival compared with placebo when used as a maintenance therapy in the treatment of patients with newly diagnosed acute myeloid leukemia.If approved, CC-486 could become a new therapeutic standard for patients with AML in remission, according to Andrew Wei, a hematologist at the Alfred Hospital in Melbourne, Australia. BMY closed Wednesday’s (Aug.26, 2020) trading at $62.28, down 0.69%.