The FDA decision on Alkermes plc’s (ALKS) New Drug Application seeking approval of ALKS 3831 for the treatment of schizophrenia and for the treatment of bipolar I disorder is anticipated on November 15, 2020. ALKS 3831 is composed of 10 mg of Samidorphan, a novel, new molecular entity, co-formulated with 5 mg, 10 mg, 15 mg, or 20 mg of Olanzapine, an established antipsychotic agent.On October 9, the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee jointly voted 16 to 1 that Samidorphan meaningfully mitigates Olanzapine-associated weight gain and voted 13 to 1, with 1 abstention that the safety profile of ALKS 3831 has been adequately characterized.The FDA usually follows the recommendations of its panels although it is not required to do so.If approved, analysts expect ALKS 3831 to achieve peak sales of *$364 million in 2026. (Source: GlobalData).ALKS closed Friday’s (Oct.23, 2020) trading at $16.39, up 0.43%.