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SAGE Therapeutics Inc (SAGE.OQ)

SAGE.OQ on NASDAQ Stock Exchange Global Market

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Latest Key Developments (Source: Significant Developments)

Sage Therapeutics Receives Notification Of PDUFA Extension For Zulresso Injection
Tuesday, 20 Nov 2018 

Nov 20 (Reuters) - SAGE Therapeutics Inc ::SAGE THERAPEUTICS RECEIVES NOTIFICATION OF PDUFA EXTENSION FOR ZULRESSO (BREXANOLONE) INJECTION.SAGE THERAPEUTICS INC - PDUFA GOAL DATE EXTENDED TO MARCH 19, 2019 TO FINALIZE REMS.SAGE THERAPEUTICS INC - NO ADDITIONAL CLINICAL DATA OR INFORMATION REQUESTED BY FDA.SAGE THERAPEUTICS INC - PREPARATIONS CONTINUE FOR A POTENTIAL U.S. COMMERCIAL LAUNCH OF ZULRESSO NOW PLANNED FOR JUNE 2019.  Full Article

Sage Therapeutics Announces FDA Acceptance Of NDA Filing
Wednesday, 30 May 2018 

May 30 (Reuters) - SAGE Therapeutics Inc ::SAGE THERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF NDA FILING AND GRANT OF PRIORITY REVIEW FOR BREXANOLONE IV IN THE TREATMENT OF POSTPARTUM DEPRESSION.SAGE THERAPEUTICS ANNOUNCES FDA ACCEPTANCE OF NDA FILING AND GRANT OF PRIORITY REVIEW FOR BREXANOLONE IV IN THE TREATMENT OF POSTPARTUM DEPRESSION.SAGE THERAPEUTICS INC - PRIORITY REVIEW STATUS EXPECTED TO ACCELERATE REVIEW PERIOD; PDUFA DATE SET FOR DECEMBER 19, 2018 FOR BREXANOLONE IV.SAGE THERAPEUTICS INC - FDA IS CURRENTLY PLANNING TO HOLD AN ADVISORY COMMITTEE MEETING TO DISCUSS BREXANOLONE IV APPLICATION.  Full Article

Sage Therapeutics Submits New Drug Application To U.S. FDA For Intravenous Brexanolone In The Treatment Of Postpartum Depression
Monday, 23 Apr 2018 

April 23 (Reuters) - SAGE Therapeutics Inc ::SAGE THERAPEUTICS SUBMITS NEW DRUG APPLICATION TO U.S. FDA FOR INTRAVENOUS BREXANOLONE IN THE TREATMENT OF POSTPARTUM DEPRESSION.SAGE THERAPEUTICS SUBMITS NEW DRUG APPLICATION TO U.S. FDA FOR INTRAVENOUS BREXANOLONE IN THE TREATMENT OF POSTPARTUM DEPRESSION.SAGE THERAPEUTICS - NDA SUBMISSION SUPPORTED BY DATA FROM HUMMINGBIRD PROGRAM.  Full Article

Sage Therapeutics Reports Positive Results From Phase 2 Placebo-Controlled Trial Of Sage-217 In Major Depressive Disorder
Thursday, 7 Dec 2017 

Dec 7 (Reuters) - Sage Therapeutics Inc ::SAGE THERAPEUTICS REPORTS POSITIVE TOP-LINE RESULTS FROM PHASE 2 PLACEBO-CONTROLLED TRIAL OF SAGE-217 IN MAJOR DEPRESSIVE DISORDER.SAGE THERAPEUTICS - SAGE-217 MET PRIMARY ENDPOINT AND PROVIDED RAPID, DURABLE EFFECTS THROUGH 2-WEEK TREATMENT PERIOD AND ADDITIONAL 4-WEEK FOLLOW-UP.SAGE THERAPEUTICS - PHASE 2 TRIAL OF SAGE-217​ ‍WELL-TOLERATED.SAGE THERAPEUTICS INC - DATA FROM PHASE 2 STUDY SUPPORT FURTHER DEVELOPMENT OF SAGE-217 FOR MDD AND RELATED DISORDERS.SAGE THERAPEUTICS - SAGE-217 DEMONSTRATED HIGHLY STATISTICALLY SIGNIFICANT MEAN REDUCTION IN HAM-D SCORE COMPARED TO PLACEBO AT 15 DAYS​.SAGE THERAPEUTICS INC - SAGE-217 HAD NO SERIOUS OR SEVERE ADVERSE EVENTS IN PHASE 2 STUDY.SAGE THERAPEUTICS - ALL SECONDARY ENDPOINTS WERE CONSISTENT WITH PRIMARY ENDPOINTS AT DAY 15 OF TRIAL OF SAGE-217.  Full Article

Sage Therapeutics prices public offering of 3.53 mln common shares at $85/share
Wednesday, 15 Nov 2017 

Nov 14 (Reuters) - Sage Therapeutics Inc -:SAGE THERAPEUTICS PRICES PUBLIC OFFERING OF COMMON STOCK.SAYS PUBLIC OFFERING OF 3.53 MILLION COMMON SHARES PRICED AT $85.00PER SHARE.  Full Article

Sage Therapeutics announces proposed public offering of common stock
Monday, 13 Nov 2017 

Nov 13 (Reuters) - Sage Therapeutics Inc :Sage Therapeutics announces proposed public offering of common stock.Sage Therapeutics Inc - ‍has commenced an underwritten public offering of $300.0 million of its common stock​.  Full Article

Sage Therapeutics announces Brexanolone achieves primary endpoints
Thursday, 9 Nov 2017 

Nov 9 (Reuters) - Sage Therapeutics Inc ::Announces Brexanolone achieves primary endpoints in both phase 3 clinical trials in postpartum depression.Statistically significant mean reduction in HAM-D score compared to placebo at 60 hours demonstrated in both trials​.Brexanolone was generally well tolerated and showed a similar safety profile as seen in earlier studies​.Brexanolone achieved primary endpoint in both trials​.In each trial, 1 patient experienced serious adverse event; neither required hospitalization, 1 deemed not to be study-drug related​.Sage plans to file a New Drug Application (NDA) with U.S. Food and Drug Administration in 2018 for Brexanolone​.  Full Article

Sage Therapeutics announces qtrly loss per share $1.97‍​
Thursday, 2 Nov 2017 

Nov 2 (Reuters) - Sage Therapeutics Inc :Sage Therapeutics announces third quarter 2017 financial results and provides pipeline update.Qtrly loss per share $1.97‍​.  Full Article

Sage Therapeutics advances SAGE-217
Monday, 13 Feb 2017 

Sage Therapeutics Inc - : Sage Therapeutics advances SAGE-217 into placebo-controlled phase 2 clinical trial in major depressive disorder . SAGE-217 was found to be generally well-tolerated with no serious adverse events or discontinuations reported .Statistically significant mean change from baseline was observed by day 2 of study.  Full Article

UPDATE 2-FDA panel recommends Sage's postpartum depression treatment

Nov 2 An advisory panel to the U.S. Food and Drug Administration on Friday recommended Sage Therapeutics Inc's experimental treatment for postpartum depression, saying the benefits of the drug outweighed risks.