Sage Therapeutics: EMA grants Orphan Drug Designation to SAGE-718

Sage Therapeutics announced the European Medicines Agency granted Orphan Drug Designation to SAGE-718 for the treatment of Huntington’s disease. SAGE-718 is in development as a potential oral therapy for cognitive disorders associated with NMDA receptor dysfunction. Multiple clinical studies are ongoing with SAGE-718 across several disease areas, including two placebo-controlled Phase 2 studies and a Phase 3 open-label safety study in the lead indication of HD-related cognitive impairment, and additionally Phase 2 placebo-controlled studies in mild cognitive impairment associated with Parkinson’s disease and MCI and mild dementia due to Alzheimer’s disease