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FDA grants Fast Track status to Pasithea's PAS-004 for treating NF1-associated plexiform neurofibromas.

Market News
01 Apr 2026
GlobeNewsWire
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Bullish
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Pasithea Therapeutics announced that the FDA has granted Fast Track designation to its drug PAS-004, aimed at treating plexiform neurofibromas (PN) associated with neurofibromatosis type 1 (NF1). This designation helps expedite the development and review process for PAS-004, which is currently in Phase 1/1b clinical trials for patients with symptomatic, inoperable, or recurrent NF1-PN. Fast Track status allows for more frequent FDA interactions and rolling review of marketing applications, potentially speeding up approval. This is significant as NF1-PN tumors cause serious health issues and currently lack effective treatments.

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