The filed complaint alleges that defendants made false statements and/or concealed that: (i) Zuranolone, a neuroactive steroid for the treatment of postpartum depression, was less effective in treating Major Depressive Disorder (MDD) than defendants had led investors to believe; (ii) accordingly, the FDA was unlikely to approve the Zuranolone NDA for the treatment of MDD in its present form, and Zuranolone’s clinical results for MDD, as well as its overall regulatory and commercial prospects, were overstated; (iii) SAGE-718 was less effective in treating Mild Cognitive Impairment (MCI) due to Parkinson’s Disease (PD) than defendants had led investors to believe; (iv) accordingly, SAGE-718’s clinical, regulatory, and commercial prospects as a treatment for MCI due to PD were overstated; (v) SAGE-324 was less effective in treating essential tremor than defendants had led investors to believe; (vi) accordingly, SAGE-324’s clinical, regulatory, and commercial prospects as a treatment for essential tremor were overstated; and (vii) as a result of all the foregoing, the Company’s public statements were materially false and misleading at all relevant times.