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Neuren Secures FDA Nod on Phase 3 Endpoints for PMS Drug NNZ-2591

2:39am on Monday 2nd of June, 2025 AEST Healthcare
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Neuren Secures FDA Nod on Phase 3 Endpoints for PMS Drug NNZ-2591

2:39am on Monday 2nd of June, 2025 AEST
Key Points
  • FDA confirms co-primary endpoints for NNZ-2591 Phase 3 trial
  • Endpoints focus on VABS-3 Receptive Communication and PMSA-C scores
  • Phase 2 results showed clinically meaningful improvements in 16 of 18 children
  • Phase 3 trial expected to start mid-2025, no additional funding needed
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