Pasithea Therapeutics' PAS-004 Gains FDA Orphan Drug Status for ALS and PLS

Pasithea Therapeutics Corp. (NASDAQ: KTTA) announced on June 2, 2026, that the U.S. Food and Drug Administration granted orphan drug designation to its experimental therapy PAS-004 for the treatment of amyotrophic lateral sclerosis and primary lateral sclerosis. The designation provides financial incentives, including tax credits and a potential seven-year market exclusivity period upon approval. PAS-004 is a macrocyclic MEK inhibitor designed to target neuroinflammation in motor neuron diseases. The company previously completed a Phase 1 trial in healthy volunteers and plans to initiate a Phase 2 study in ALS patients later this year. Under the Orphan Drug Act, the FDA designates therapies for rare diseases affecting fewer than 200,000 people in the U.S. ALS, often called Lou Gehrig's disease, has limited treatment options, while primary lateral sclerosis is a rare progressive neurodegenerative disorder.