Neuren Pharmaceuticals (ASX:NEU) Receives FDA Fast Track for NNZ-2591 in Pitt Hopkins Syndrome
Regulatory Update
Neuren Pharmaceuticals (ASX:NEU) announced that the US Food and Drug Administration (FDA) has granted Fast Track designation to NNZ-2591 for the treatment of Pitt Hopkins syndrome (PTHS). Fast Track is intended to expedite the development and review process for drugs addressing serious conditions with unmet medical needs.
Clinical Trial Results
In Neuren’s Phase 2 clinical trial of NNZ-2591 for children with PTHS, 82% of participants exhibited improvements in communication, social interaction, cognition, and motor abilities.
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