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How FDA Feedback Shapes Neuren’s NNZ-2591 Trials for Rare Brain Disorders

7:02pm on Wednesday 4th of February, 2026 AEDT Healthcare
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How FDA Feedback Shapes Neuren’s NNZ-2591 Trials for Rare Brain Disorders

7:02pm on Wednesday 4th of February, 2026 AEDT
Key Points
  • FDA provided written feedback on NNZ-2591 clinical plans for HIE and Pitt Hopkins syndrome
  • Additional juvenile animal data required before HIE trial initiation
  • Pitt Hopkins trial design to include specific clinical global impression scale with functional outcome measure
  • Neuren remains financially well-positioned to advance programs
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