FDA grants accelerated review status for Sage Therapeutics' SAGE-217 for MDD [Seeking Alpha]
Sage Therapeutics, Inc. (SAGE)
Last sage therapeutics, inc. earnings: 2/27 06:30 am
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Source: Seeking Alpha
FDA grants accelerated review status for Sage Therapeutics' SAGE-217 for MDDThe FDAdesignates Sage Therapeutics' (NASDAQ:SAGE) Phase 3-stage SAGE-217 a Breakthrough Therapy for the treatment of major depressive disorder (MDD).Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.SAGE-217, a neuroactive steroid, is next-generation GABA modulator. The GABA system, the major inhibitory signaling pathway in the brain and central nervous system (CNS), plays a key role in regulating CNS function.Previously:Sage Therapeutics' SAGE-217 successful in mid-stage MDD study; shares ahead 52% premarket (Dec. 7, 2017)Click to subscribe to real-time analytics on SAGENow read:Marinus Pharma's Ganaxolone: If At First You Don't Succeed... »
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SAGE
News
- Sage Therapeutics, Inc. (NASDAQ: SAGE) was downgraded by analysts at Bank of America Co. from a "neutral" rating to an "underperform" rating. They now have a $14.00 price target on the stock, down previously from $24.00.MarketBeat
- Neurodegenerative Disorder-Focused Sage Therapeutics Stock Falls On Disappointing Parkinson's Data [Yahoo! Finance]Yahoo! Finance
- Sage Therapeutics scraps Parkinson's drug development after treatment fails mid-stage study [Reuters]Reuters
- Sage Therapeutics Announces Topline Results from Phase 2 PRECEDENT Study of Dalzanemdor (SAGE-718) in the Treatment of Mild Cognitive Impairment in Parkinson's Disease [Yahoo! Finance]Yahoo! Finance
- Sage Therapeutics Announces Topline Results from Phase 2 PRECEDENT Study of Dalzanemdor (SAGE-718) in the Treatment of Mild Cognitive Impairment in Parkinson’s DiseaseBusiness Wire
SAGE
Earnings
- 2/14/24 - Beat
SAGE
Sec Filings
- 4/17/24 - Form 8-K
- 3/27/24 - Form SC
- 3/26/24 - Form 8-K
- SAGE's page on the SEC website