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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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October 9, 2015
20:30 EDTSAGESAGE Therapeutics management to meet with William Blair
Meeting to be held in San Francisco on October 15 hosted by William Blair.
October 6, 2015
06:32 EDTSAGESAGE Therapeutics announces initiation of Phase 1 and first dosing of SAGE-217
Sage Therapeutics announced it has initiated dosing in a Phase 1 single ascending dose trial evaluating SAGE-217 in healthy volunteers. Initial top-line results from the study are expected in the first half of 2016. SAGE-217 is a next generation positive allosteric modulator that has been optimized for greater selectivity of GABAA receptors and a pharmacokinetic profile intended to support once-daily oral dosing. SAGE is developing SAGE-217 for high frequency seizures associated with select neurological disorders, including orphan epilepsies, and other GABAA dysfunction-related disorders, such as essential tremor. In preclinical development, SAGE-217 demonstrated anti-seizure and anxiolytic activity in multiple animal models, including potent activity in seizure models such as Dravet and Fragile X syndromes. The Phase 1 single ascending dose study of SAGE-217 is a double-blind, placebo-controlled trial to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamic effects of SAGE-217 administered orally in approximately 80 healthy adult volunteers.
October 5, 2015
09:42 EDTSAGESAGE Therapeutics has a conference call hosted by JPMorgan
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September 30, 2015
07:11 EDTSAGELeerink to hold a roundtable
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September 29, 2015
09:02 EDTSAGELigand expands Captisol license, supply agreements with SAGE Therapeutics
Ligand Pharmaceuticals (LGND) announces it has expanded its global license and supply agreements with SAGE Therapeutics (SAGE) to now also cover the use of Captisol in the development and commercialization of SAGE-689. Under the terms of the license, Ligand received a licensing fee and will be eligible to receive potential milestone payments, tiered royalties on future net sales and revenue from Captisol material sales. SAGE will be responsible for all costs related to the program.

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