Neurotech Seeks FDA Orphan Status for Rare Disorder Drug

Neurotech International Ltd. (AU:NTI) has released an update.

Neurotech International Ltd has filed for orphan drug designation with the FDA for NTI164, aimed at treating the rare neurological disorders PANDAS and PANS, which are currently without approved therapies. Orphan drug status could provide the company with benefits such as tax credits, fee exemptions, and exclusive marketing rights for seven years post-approval. The market potential for PANDAS/PANS treatments is estimated at US$1.2 billion, with FDA’s decision expected within three months.

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