Pasithea Therapeutics Corp. (NASDAQ:KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to PAS-004 for the treatment of Amyotrophic Lateral Sclerosis (ALS).

The FDA grants Orphan Drug Designation to therapies intended for the treatment, prevention, or diagnosis of diseases or conditions affecting fewer than 200,000 people in the United States. Orphan Drug Designation provides several potential benefits to drug developers, including eligibility for tax credits for qualified clinical trials, exemption from certain FDA fees, and the potential for seven years of market exclusivity following approval.