Pasithea Therapeutics announces grant of fast track designation by FDA to PAS-004 for treatment of neurofibromatosis type 1 associated plexiform neurofibromas causing significant morbidity

Pasithea Therapeutics

1 April 2026 - Pasithea Therapeutics today announced that the US FDA has granted fast track designation to PAS-004 for the treatment of neurofibromatosis type 1 associated plexiform neurofibromas causing significant morbidity.

The Company is currently conducting a Phase 1/1b multi-centre, open-label, dose escalation trial of PAS-004 in adult participants with symptomatic, inoperable, incompletely resected, or recurrent neurofibromatosis type 1 associated plexiform neurofibromas.

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Michael Wonder

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Michael Wonder

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Medicine , US , Fast track