As previously announced, Sage Therapeutics, Inc. began a rolling submission of a new drug application to the U.S. Food and Drug Administration in April 2022 seeking the approval of the Company's product candidate zuranolone for the treatment of major depressive disorder. The Company also previously announced its expectation that it would complete the NDA submission for MDD in the second half of 2022 and make an associated but separate NDA filing seeking the approval of zuranolone for the treatment of postpartum depression in early 2023, pending the completion and results of its SKYLARK Study, a Phase 3 placebo-controlled clinical trial evaluating the efficacy and safety of a two-week course of zuranolone 50 mg compared to placebo in women with severe PPD. The Company is jointly developing zuranolone in the U.S. with Biogen MA Inc. and Biogen International GmbH.

The Company is reporting that, in lieu of separate NDA filings, the Company and Biogen have decided to submit a single NDA seeking approval of zuranolone for the treatment of both MDD and PPD. The Company has informed the FDA of this update, and the FDA raised no objections and stated it looked forward to continuing discussions with the Company. The Company and Biogen expect to complete the submission of this single NDA in the second half of 2022, and to seek priority review of the filing.

This represents an acceleration of the planned PPD timelines. If the Company meets its planned filing timelines and the NDA receives priority review, the Company expects the PDUFA target action date for zuranolone to be in the third quarter of 2023.