Pasithea says FDA grants orphan drug designation for PAS-004 in ALS

Pasithea Therapeutics Corp.

Pasithea Therapeutics Corp.

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  • Pasithea Therapeutics received FDA Orphan Drug Designation for PAS-004 to treat amyotrophic lateral sclerosis.
  • Designation could support development via tax credits, fee waivers, potential seven-year U.S. market exclusivity on approval.
  • ALS Association awarded a USD 1 million grant in November 2025 to study PAS-004 in ALS.


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