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Neuren Secures FDA Meeting to Finalise Phase 3 Trial for Rare Syndrome

5:24pm on Sunday 1st of June, 2025 AEST Pharmaceuticals
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Neuren Secures FDA Meeting to Finalise Phase 3 Trial for Rare Syndrome

5:24pm on Sunday 1st of June, 2025 AEST
Key Points
  • FDA grants Type C Meeting for NNZ-2591 Phase 3 trial endpoint discussions
  • Previous Type B meeting aligned on other key trial design elements
  • Phase 3 trial planned to commence mid-2025 for Phelan-McDermid syndrome
  • NNZ-2591 shows promise across multiple neurodevelopmental disorders
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