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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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April 22, 2015
12:01 EDTSAGELigand earns milestone payment from Sage Therapeutics for SAGE-547
Ligand (LGND) announced that it has earned a $500,000 milestone payment from SAGE Therapeutics (SAGE) relating to the treatment of the first patient in SAGE’s Phase 3 open-label expanded access protocol, designated Study 302. Study 302 is designed to offer SAGE-547 to patients affected by super-refractory status epilepticus and to evaluate the safety of SAGE-547 in patients with SRSE. SAGE has reported that the results from this clinical trial, along with results from SAGE's planned Phase 3 placebo-controlled clinical trial - called the STATUS Trial – and other clinical data obtained from the SAGE-547 development program are intended to form the basis of a New Drug Application submission.
April 20, 2015
08:47 EDTSAGESage Therapeutics announces first patient treated under SAGE-547 Phase 3 trial
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07:18 EDTSAGEAmerican Academy of Neurology to hold annual meeting
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April 15, 2015
06:20 EDTSAGESage Therapeutics 2.29M share Secondary priced at $52.50
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April 13, 2015
16:37 EDTSAGESage Therapeutics files to sell $100M of common stock
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