Sage Therapeutics Submits New Drug Application to U.S. FDA for Intravenous Brexanolone in the Treatment of Postpartum Depression
Sage Therapeutics, Inc. (SAGE)
Last sage therapeutics, inc. earnings: 2/27 06:30 am
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Source: Business Wire
Brexanolone IV submission is the Company’s first New Drug Application CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced the Company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for its lead product candidate, an intravenous formulation of brexanolone (SAGE-547), for the treatment of postpartum depression (PPD). Brexanolone IV received Breakthrough Therapy Designation in September 2016, underscoring the significant unmet need in women with PPD. Breakthrough Therapy Designation is intended to offer a potentially expedited development path and review for promising drug candidates intended to treat serious conditions, including increased interaction and guidance from the FDA. T
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SAGE
News
- Sage Therapeutics, Inc. (NASDAQ: SAGE) was downgraded by analysts at StockNews.com from a "hold" rating to a "sell" rating.MarketBeat
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- Sage Therapeutics, Inc. (SAGE) May Report Negative Earnings: Know the Trend Ahead of Next Week's Release [Yahoo! Finance]Yahoo! Finance
- Sage Therapeutics, Inc. (NASDAQ: SAGE) had its price target lowered by analysts at Scotiabank from $34.00 to $19.00. They now have a "sector outperform" rating on the stock.MarketBeat
- Sage Therapeutics, Inc. (NASDAQ: SAGE) had its price target lowered by analysts at Oppenheimer Holdings Inc. from $25.00 to $17.00. They now have a "market perform" rating on the stock.MarketBeat
SAGE
Earnings
- 2/14/24 - Beat
SAGE
Sec Filings
- 4/19/24 - Form 8-K
- 4/17/24 - Form 8-K
- 3/27/24 - Form SC
- SAGE's page on the SEC website