Neuren shares buoyed by fast track FDA review

The news: Shares in Neuren Pharmaceuticals gained more than 5% after the Melbourne-based biotech received fast track designation from the US Food and Drug Administration (FDA) for a trial-phase treatment for Pitt Hopkins syndrome.

The numbers: Neuren shares were up 5.4% to $13.77 at 2:25pm AEDT, after dropping by a third over the last 12 months.

The context: The FDA's fast track process is designed to facilitate the development and expedite the review of drugs to treat serious conditions.

There are currently no approved treatments for Pitt Hopkins syndrome, a neurodevelopmental condition that impacts between 1 in 34,000 and 1 in 41,000 people.