According to the Complaint, Sage Therapeutics, Inc. is a biopharmaceutical company that develops and commercializes brain health medicines. The Company is developing, inter alia, zuranolone (SAGE-217/BIIB125), a neuroactive steroid for the treatment of PPD and MDD, in collaboration with Biogen; SAGE-718 (dalzanemdor), an oral, oxysterol-based positive allosteric modulator of the NMDA receptor for the treatment of, inter alia, MCI due to PD; and SAGE-324 (BIIB124), an oral investigational drug for the treatment of ET, also in collaboration with Biogen.

In May 2022, Sage announced that it had initiated a rolling submission of a New Drug Application to the U.S. Food and Drug Administration for zuranolone in the treatment of MDD. In June 2022, Sage announced that, rather than filing separate NDAs for zuranolone in the treatment of MDD and PPD, as originally intended, it would instead submit a single NDA seeking approval of zuranolone for the treatment of both MDD and PPD. In December 2022, Sage announced the completion of the rolling submission of the Zuranolone NDA to the FDA.

The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) zuranolone was less effective in treating 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 MCI due to 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 ET than Defendants had led investors to believe; (vi) accordingly, SAGE-324’s clinical, regulatory, and commercial prospects as a treatment for ET 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.