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Neuren Pharmaceuticals Ltd Receives Fast Track Designation For NNZ-2566 In Fragile X Syndrome

Thursday, 17 Oct 2013 07:17pm EDT 

Neuren Pharmaceuticals Ltd announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for Neuren’s programme to develop NNZ-2566 for Fragile X Syndrome. Fast Track designation is designed to expedite the development and review of important new medicines that are intended to treat serious diseases and meet unmet medical needs. Neuren intends to initiate the double-blind, placebo-controlled Phase II trial before the end of 2013. Enrolment is expected to be completed by the end of 2014 with top-line results announced in the first half of 2015. The study is designed to assess the safety, tolerability and efficacy of NNZ-2566 in treating symptoms of Fragile X Syndrome. 

Company Quote

-0.0010 -1.19%
24 Oct 2014