BRIEF-Cynapsus receives fda fast track designation for APL-130277

Mon Aug 29, 2016 6:36am EDT
 
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Aug 29 (Reuters) - Cynapsus Receives FDA fast track designation for apl

* 130277 for the treatment of off episodes in patients with Parkinson's disease

* Cynapsus receives FDA fast track designation for APL-130277 for the treatment of off episodes in patients with Parkinson's disease

* Says we plan to submit a new drug application (NDA) to FDA in first half of 2017

* Post dose titration phase, top line data for phase 3 efficacy trial CTH-300 is expected in mid-to-late Q4 of 2016

* CTH-201 phase 2 thorough QT study, is expected to commence in Q4 of 2016, and is planned to be completed in first half of 2017 Source text for Eikon: Further company coverage: