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Neurotech Secures FDA Orphan Drug Status for Rett Syndrome Therapy NTI164
7:03pm on Monday 2nd of June, 2025 AEST
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Biotechnology
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Neurotech Secures FDA Orphan Drug Status for Rett Syndrome Therapy NTI164
7:03pm on Monday 2nd of June, 2025 AEST
Key Points
FDA grants orphan drug designation for NTI164 in Rett Syndrome
Positive genomic and proteomic data reinforce NTI164’s immune modulation in PANDAS/PANS
Over 50 ASD patients continue long-term NTI164 treatment with no safety concerns
Pre-clinical toxicology and human pharmacokinetic studies progressing toward FDA IND
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