Pasithea Therapeutics (KTTA) Wins FDA Orphan Drug Status for ALS Candidate PAS-004

Pasithea Therapeutics Corp. (KTTA) announced on June 2, 2026, that the U.S. Food and Drug Administration granted orphan drug designation to PAS-004, its experimental treatment for amyotrophic lateral sclerosis (ALS). The designation affords the company seven years of U.S. market exclusivity upon approval, along with tax credits for clinical research and exemption from certain FDA fees. PAS-004 is a macrocyclic inhibitor in early-stage development, targeting both genetic and sporadic forms of the progressive neurodegenerative disease. ALS, also known as Lou Gehrig’s disease, affects roughly 30,000 people in the United States, with few approved therapies. The orphan status could accelerate Pasithea’s path to market while strengthening its rare-disease pipeline. Shares of the micro-cap biotech rose sharply in premarket trading following the news, as investors bet on potential long-term value from the regulatory milestone.