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FDA Fast Tracks Neuren’s NNZ-2591 for Phelan-McDermid Syndrome
9:37am on Monday 20th of October, 2025 AEDT
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Healthcare
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FDA Fast Tracks Neuren’s NNZ-2591 for Phelan-McDermid Syndrome
9:37am on Monday 20th of October, 2025 AEDT
Key Points
FDA grants Fast Track status to NNZ-2591 for Phelan-McDermid syndrome
Phase 3 Koala trial underway for children aged 3 to 12
No current FDA-approved treatments for Phelan-McDermid syndrome
NNZ-2591 also holds Fast Track for Angelman and Pitt Hopkins syndromes
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