Pasithea Therapeutics Says FDA Clears IND Application For Randomized, Placebo-Controlled Phase 2 Clinical Trial For PAS-004 In Patients With NF1 Associated Cutaneous Neurofibromas

— FDA clearance allows Pasithea to advance PAS-004 for NF1-associated cNF, a condition affecting over 95% of people with NF1 and for which there are currently no FDA-approved systemic therapies. —

MIAMI, Nov. 03, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ:KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation oral macrocyclic MEK inhibitor for the treatment of chronic diseases, including neurofibromatosis type 1 (NF1)-associated neurofibromas, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for a randomized, placebo-controlled Phase 2 clinical trial for PAS-004 in patients with NF1 associated cutaneous neurofibromas (cNF). The Phase 2 study will be conducted under an active IND overseen by the FDA Division of Dermatology and Dentistry (DDD).