Sage Therapeutics and Biogen Announce Plans to Submit a New Drug Application (NDA) for Zuranolone to the U.S. Food & Drug Administration in the Second Half of 2022 with Rolling Submission ...
Sage Therapeutics, Inc. (SAGE)
Last sage therapeutics, inc. earnings: 2/27 06:30 am
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Source: Business Wire
Following the pre-NDA meeting, the companies confirmed the current efficacy and safety databases are expected to be adequate for filing with confirmed pathways for MDD and PPDThe planned initial submission package will be for the treatment of MDD with an anticipated PPD filing thereafter CAMBRIDGE, Mass.--(BUSINESS WIRE)--Sage Therapeutics, Inc. (Nasdaq: SAGE) and Biogen Inc. (Nasdaq: BIIB) today announced their plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for zuranolone, an investigational two-week, once-daily therapeutic in the second half of 2022. The planned initial submission package will seek approval of zuranolone for the treatment of major depressive disorder (MDD) and an additional filing for postpartum depression (PPD) is anticipated in the first half of 2023. The decision to submit the application follows recent discussions with the FDA, including a pre-NDA meeting held this fall. Data from completed studies in the LANDSCAPE
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SAGE
News
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SAGE
Earnings
- 2/14/24 - Beat
SAGE
Sec Filings
- 3/27/24 - Form SC
- 3/26/24 - Form 8-K
- 2/21/24 - Form SC
- SAGE's page on the SEC website