An FDA panel will scrutinize Alkermes plc’s (ALKS) oral atypical antipsychotic drug candidate ALKS 3831, proposed for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, on October 9, 2020.ALKS 3831 is composed of Samidorphan, a novel, new molecular entity, co-formulated with the established antipsychotic agent, Olanzapine, in a single bilayer tablet.The efficacy, safety, and benefit-risk profile of ALKS 3831 for the proposed indications, the clinical meaningfulness in reducing Olanzapine-associated weight gain, and its impact on laboratory-based metabolic parameters are expected to be reviewed by the advisory committee panel.The final decision on ALKS 3831 is expected on November 15, 2020.If approved, analysts expect ALKS 3831 to achieve peak sales of *$364 million in 2026. (Source: GlobalData)ALKS closed Friday’s (Sep.25, 2020) trading at $16.74, up 1.27%.