USFDAJun 2, 2026, 07:03 AM
Pasithea Therapeutics' PAS-004 Gets FDA Orphan Drug Designation for ALS
AI Summary
Pasithea Therapeutics Corp. announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to its lead drug candidate, PAS-004, for the treatment of Amyotrophic Lateral Sclerosis (ALS). This designation provides potential benefits including tax credits for clinical trials, exemption from certain FDA fees, and seven years of market exclusivity upon approval. The company previously received a $1 million grant from the ALS Association to study PAS-004 for ALS.
Key Highlights
- FDA granted Orphan Drug Designation to PAS-004 for Amyotrophic Lateral Sclerosis (ALS).
- Orphan Drug Designation offers tax credits, FDA fee exemption, and potential 7 years of market exclusivity.
- ALS affects fewer than 200,000 people in the United States.
- Pasithea previously received a $1 million grant from the ALS Association in November 2025.
- PAS-004 is a next-generation macrocyclic MEK inhibitor.
- PAS-004 is currently in Phase 1 trials for advanced cancer and NF1-associated plexiform neurofibromas.
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