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. This represents an acceleration of the planned PPD timelines. 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. 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. Get the latest Sage Therapeutics, Inc SAGE detailed stock quotes, stock data, Real-Time ECN.
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. View Sage Therapeutics, Inc SAGE investment & stock information. The Company is jointly developing zuranolone in the U.S.
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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. Food and Drug Administration in April 2022 seeking the approval of the Company’s product candidate zuranolone for the treatment of major depressive disorder. began a rolling submission of a new drug application to the U.S. Provides Zuranolone New Drug Application UpdateĪs previously announced, Sage Therapeutics, Inc.
The parties have agreed that as part of the settlement, if the settlement is approved, all of the claims asserted in the Derivative Action will be dismissed. The Court must approve the settlement of the Derivative Action. As part of the settlement, the Company is responsible for the payment of attorney’s fees in an amount that has not yet been determined. The settlement also provides for a release of claims related to the allegations in the Derivative Action with no admission of any wrongdoing.
Pursuant to the terms of the settlement agreement, the Company has implemented or agreed to implement and maintain certain changes to its director compensation policies and practices. (the “Company”) and certain of its directors entered into a settlement agreement with a stockholder of the Company to resolve an action brought derivatively on behalf of the Company in the Delaware Court of Chancery (the “Court”) challenging historical compensation practices for the Company’s non-employee directors (the “Derivative Action”).
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