Fast track granted by FDA for NNZ-2591 in Phelan-McDermid syndrome

Neuren Pharmaceuticals

20 October 2025 - Neuren Pharmaceuticals today announced that the US FDA has granted fast track designation for NNZ-2591 for the treatment of Phelan-McDermid syndrome. 

Currently there are no FDA approved treatments for Phelan-McDermid syndrome.

Read Neuren Pharmaceuticals press release

Michael Wonder

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Michael Wonder

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Medicine , US , Fast track