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Last $54.62 USD
Change Today +1.28 / 2.40%
Volume 309.4K
As of 8:10 PM 09/4/15 All times are local (Market data is delayed by at least 15 minutes).

sage therapeutics inc (SAGE) Snapshot

Open
$52.90
Previous Close
$53.34
Day High
$55.24
Day Low
$52.81
52 Week High
06/9/15 - $89.04
52 Week Low
09/16/14 - $26.27
Market Cap
1.6B
Average Volume 10 Days
460.0K
EPS TTM
$-2.43
Shares Outstanding
28.8M
EX-Date
--
P/E TM
--
Dividend
--
Dividend Yield
--
Current Stock Chart for SAGE THERAPEUTICS INC (SAGE)

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sage therapeutics inc (SAGE) Details

Sage Therapeutics, Inc., a biopharmaceutical company, develops and commercializes novel medicines to treat life-threatening and rare central nervous system disorders. The company’s lead product candidate includes SAGE-547, an intravenous (IV) agent that is in Phase I/II clinical development as an adjunctive therapy for the treatment of super-refractory status epilepticus (SRSE). Its pipeline also includes second-generation molecules, such as SAGE-217, an oral therapy for orphan genetic epilepsies; and SAGE-689, an adjunctive intravenous second-line therapy for the treatment of refractory status epilepticus. The company was formerly known as Sterogen Biopharma, Inc. and changed its name to Sage Therapeutics, Inc. in September 2011. Sage Therapeutics, Inc. was founded in 2010 and is based in Cambridge, Massachusetts.

35 Employees
Last Reported Date: 08/12/15
Founded in 2010

sage therapeutics inc (SAGE) Top Compensated Officers

Chief Executive Officer, President, Director ...
Total Annual Compensation: $550.0K
Chief Medical Officer
Total Annual Compensation: $390.0K
Chief Scientific Officer
Total Annual Compensation: $300.0K
Compensation as of Fiscal Year 2014.

sage therapeutics inc (SAGE) Key Developments

SAGE Therapeutics Announces Results from Exploratory Trial in Essential Tremor

SAGE Therapeutics announced results from a exploratory clinical trial of SAGE-547 to evaluate the GABAA mechanism of action as a treatment for essential tremor, a debilitating neurological disorder that causes involuntary, rhythmic shaking with no known cause that is estimated to affect more than 10 million people in the United States. In a randomized, double-blind, placebo-controlled, crossover trial of 25 patients affected by essential tremor, where patients were exposed to the target steady state dose for only two hours, several clinician-rated and accelerometer-rated measures showed significant reductions in tremor. These changes included a significant reduction in accelerometer-measured upper limb kinetic tremor (p=0.046) which is one of the major manifestations of tremor impacting morbidity. Overall clinician ratings of large tremor motions, as well as smaller movements such as writing and spiral drawing, also showed improvement (p=0.056). In addition, SAGE-547 demonstrated a clinically meaningful reduction of tremor amplitude as measured by accelerometer (at least a 30% reduction from baseline) in 33% of patients, compared with 16% of patients in the placebo arm. Seventeen of these patients were exposed to higher doses of SAGE-547 in an open-label extension with 44% demonstrating at least a 30% reduction in tremor amplitude from baseline. The most common adverse events at higher doses were fatigue and dizziness. Hypotension led to discontinuation of one patient. No serious adverse events were observed on therapy or during the 30-day follow-up period. Trial Design: The trial was designed as a signal-finding study to evaluate the safety, tolerability, pharmacokinetics and efficacy of the GABAA mechanism in patients with essential tremor. The study was powered at 80% for p=0.05. he goals of the study were to evaluate the feasibility of using the GABAA mechanism and, if positive activity signals were obtained, inform the clinical pathway and design of a second-generation SAGE molecule for the chronic treatment of this disorder. Patients (n=25) received either blinded SAGE-547 or placebo in two crossover treatment periods. SAGE-547 was administered as a step-up infusion to a steady state dosage. Seventeen of the 25 patients volunteered to participate in an open-label, dose-escalation extension to study the range of pharmacodynamic effects of the GABAA modulator mechanism in conscious patients. Patients were monitored for up to 30 days following treatment. The study was designed to enroll patients with moderate to severe essential tremor as assessed by a clinician rating scale, The Essential Tremor Rating Scale (TETRAS). Tremor outcome was measured during the trial by TETRAS and accelerometry, a direct physical measure of tremor amplitude and frequency. Patients enrolled in the trial were required to have had diagnosed essential tremor for at least two years and to be off medication, or on a stable dose of medication for their tremor, for at least 28 days prior to screening. Trial Results: A clear reduction in tremor amplitude, as measured by accelerometer, was observed when comparing administration of SAGE-547 to placebo. Anti-tremor activity of SAGE-547 was observed at non-sedating doses, and peak anti-tremor activity correlated with steady state SAGE-547 levels. The time points showing the reductions in tremor corresponded to peak plasma measurements. In an open-label, higher dose administration of SAGE-547, a dose-related anti-tremor activity was observed with some sedative effect characterized as sleepiness and fatigue. Tolerance to the sedative effects was noted during drug administration with patients becoming less sedated in the hours they were administered SAGE-547. These data suggest that the anti-tremor effect may be uncoupled from sedation and that tolerance to sedation may occur quickly. These findings are consistent with the extrasynaptic activity of SAGE-547 and are observations that are encouraging for the utility of a second-generation compound. Of the 25 patients enrolled, three patients reported at least one adverse event on blinded SAGE-547, compared to five patients reporting at least one adverse event while on placebo. Of the 17 patients in the open-label, higher dose SAGE-547 portion, eight patients reported at least one adverse event. The only adverse events reported more than once across all SAGE-547 treatment periods were fatigue and dizziness, predominantly at the higher dose of SAGE-547. There was one discontinuation in the higher dose SAGE-547 portion due to hypotension, with recovery following drug discontinuation. There were no reports of serious adverse events.

Sage Therapeutics, Inc. - Special Call

To discuss the results of the essential tremor exploratory clinical trial

SAGE Therapeutics Announces First Patient Treated in Phase 3 Status Trial of SAGE-547 in Super-Refractory Status Epilepticus

SAGE Therapeutics announced that it has treated the first patient enrolled in the STATUS Trial (SAGE-547 Treatment as Adjunctive Therapy Utilized in Status Epilepticus), a global, Phase 3, randomized, double-blind, placebo-controlled clinical trial to evaluate SAGE-547 as a treatment for patients with super-refractory status epilepticus (SRSE). SRSE is a rare, life-threatening condition of persistent, unremitting seizure, for which there are no approved therapies. The STATUS Trial is designed to assess the efficacy and safety of SAGE-547 in approximately 126 patients with SRSE, aged two years or older, and will be conducted in the U.S., Canada and Europe. Patients will be randomized 1:1 to receive either SAGE-547 or placebo in addition to standard-of-care third-line anti-seizure agents for six days. The planned primary endpoint of the Phase 3 clinical trial will be successful resolution of status epilepticus (SE) after weaning the patient off all third-line agents, and SAGE-547 or placebo, without resumption of SE within 24 hours after completion of blinded SAGE-547 or placebo administration. SAGE recently announced that agreement has been reached with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment on the trial design, endpoints and statistical approach of the Phase 3 clinical trial. The SPA provides agreement from the FDA that the Phase 3 STATUS Trial can adequately address objectives in support of a U.S. regulatory submission for approval of SAGE-547 for the treatment of patients with SRSE. SAGE's Phase 3 open-label expanded access protocol, designated Study 302, was initiated in April 2015 and continues its enrollment. Study 302 is designed to make SAGE-547 available to patients in the U.S. who are affected by SRSE and who have not been admitted to, nor can be transferred to, a planned STATUS Trial clinical site. In a completed Phase 1/2 open-label clinical trial, SAGE-547 demonstrated robust activity, with a 77% response rate in 22 evaluable patients with SRSE, and also a favorable tolerability profile. Independent of treatment response, six patient deaths occurred within the trial period, all driven by underlying conditions. Although 64% of patients reported serious adverse events, none were drug-related as determined by the Safety Review Committee.

 

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