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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
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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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