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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
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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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