FDA grants fast track to local drug

Posted 22 October 2025 PM

ASX-listed Neuren Pharmaceuticals is out to prove it's no one-hit-wonder, receiving a Fast Track designation from the FDA.

The Melbourne-headquartered pharma was granted the designation for NNZ-2591, in the indication of Phelan-McDermid syndrome. Currently, there are no FDA-approved treatments for Phelan-McDermid syndrome.

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