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July 22, 2014
06:41 EDTSAGESage Therapeutics receives fast track designation for SAGE-547
SAGE Therapeutics announced that the FDA has granted fast track designation to the SAGE-547 development program. SAGE-547 is an allosteric modulator of GABAA receptors in development for the treatment of adult patients with refractory status epilepticus who have not responded to standard regimens. SAGE is currently evaluating SAGE-547 in a Phase 1/2 clinical trial for the treatment of SRSE. Preliminary data indicate that the first four patients enrolled in the clinical trial met the key efficacy endpoint, in that each was successfully weaned off his or her anesthetic agent while SAGE-547 was being administered. There have also been no reported drug-related serious adverse events in these four patients to date.
News For SAGE From The Last 14 Days
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November 12, 2014
08:02 EDTSAGECredit Suisse to hold a conference
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November 11, 2014
06:31 EDTSAGESage Therapeutics reports Q3 EPS (50c), consensus (40c)
Reports Q3 revenue $0.
November 10, 2014
09:20 EDTSAGEOn The Fly: Pre-market Movers
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07:58 EDTSAGESage Therapeutics price target raised to $58 from $40 at Canaccord
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06:38 EDTSAGESage Therapeutics reports postive top-line Phase 2 data of SAGE-547
SAGE Therapeutics announced that in a Phase 1/2 clinical trial of SAGE-547, an allosteric modulator of both synaptic and extra-synaptic GABAA receptors, all primary and secondary endpoint targets were achieved in patients with super-refractory status epilepticus ), a critical condition in which the brain is in a state of persistent seizure. In 73%of patients, treatment with SAGE-547 allowed for patients to be successfully weaned off their anesthetic agent. Top-line data reported from 12 patients, eight males and four females with a mean age of 54, enrolled in the study show that all 12 patients met the primary endpoint, safety and tolerability. Of the 11 patients evaluable for efficacy, eight patients met the key efficacy endpoint of being successfully weaned off their anesthetic agents while SAGE-547 was being administered, and eight patients were successfully weaned off SAGE-547 without recurrence of SRSE. With an overall response rate of 73%, SAGE-547 was generally well tolerated and no drug-related serious adverse events, as determined by the Safety Review Committee, were reported in treated patients. Mean exposure levels of SAGE-547 were approximately 200nm. In addition to the top-line Phase 1/2 trial results, SAGE reported that seven patients, four males and three females with a mean age of 12.5, have been treated with SAGE-547 by independent centers under emergency-use Investigational New Drug Applications. Five of these patients treated with SAGE-547 achieved resolution of SRSE either during the course of or soon after SAGE-547 treatment. The overall response rate was 71 percent, similar to the observed response rate in the Phase 1/2 clinical trial.
06:29 EDTSAGESage drug helped patients with severe epilepsy, TheStreet reports
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