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clock Created with Sketch. 25/02/15
10:25
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Business progress since 1 January 2014:
Trofinetide proposed as International Nonproprietary Name (INN) for NNZ‐2566
Results from Phase 2 clinical trial in Rett syndrome successfully demonstrated clinical benefit from treatment with trofinetide
Application submitted to US Food and Drug Administration (FDA) for Breakthrough Therapy designation for trofinetide in Rett syndrome
Orphan Drug designation granted by FDA for trofinetide in Rett syndrome
Orphan Drug applications to the European Medicines Agency underway for both Rett syndrome and Fragile X syndrome
Fragile X syndrome Phase 2 trial commenced
Enrolment accelerated in moderate to severe traumatic brain injury Phase 2 trial (INTREPID)
Concussion phase 2 trial commenced
Grant award supporting Neuren’s brain injury collaboration with the US Army increased by approximately US$3 million and extended to 31 December 2015
Neuren leadership team strengthened in technical and manufacturing aspects of pharmaceutical development
(20min delay)