Neuren Pharmaceuticals enters trading halt ahead of FDA announcement

The news: Neuren Pharmaceuticals has entered a trading halt as it prepares an announcement on feedback by the US Food and Drug Administration (FDA) on its drug NNZ-2591 for Pitt Hopkins syndrome and hypoxic-ischemic encephalopathy (HIE).

The context: The FDA granted fast track designation for the treatment of NNZ-2591 in Angelman syndrome, Pitt Hopkins syndrome and Phelan-McDermid syndrome last year. The HIE program is currently in the pre-clinical development phase.

Neuren shares tanked 10% on Tuesday after the European Medicines Agency (EMA) gave the marketing authorisation application for Neuren's Rett syndrome treatment, trofinetide, a "negative trend vote".

The trading halt will remain in place until the earlier of the announcement or the start of trading on Friday.