• All participants showed cutaneous neurofibroma (cNF) reductions: All 15 evaluable participants had reductions in target cNF surface area, with a median best reduction of 41% across all doses and 46% at doses planned for Phase 2
• cNF reductions deepened with continued treatment: The median reduction in target cNF surface area reached 49% at Cycle 12 among participants followed through 12 cycles and 71% at Cycle 15 in the 4mg cohort
• Favorable safety and tolerability profile: No treatment related serious adverse events, treatment related discontinuations, retinopathy or adverse event of decreased left ventricular ejection fraction (LVEF)
• IND cleared for Phase 2 in cNF: The FDA's Division of Dermatology and Dentistry has cleared the IND for a Phase 2 trial of PAS-004 in adults with NF1-associated cNF
• Early activity in plexiform neurofibromas (PN): Reductions in target PN volume observed in all 18 evaluable participants, including two with reductions ≥20%, one achieving a 22.5% reduction at the first on-treatment MRI (Cycle 4)
• PAS-004 Clinical Data Webcast: Pasithea will post a webcast on Friday, November 13, 2026, at 7:00 a.m. EST to discuss the data presented at the European Neurofibromatosis Conference
   

Disclaimer:This article represents the opinion of the author only. It does not represent the opinion of Webull, nor should it be viewed as an indication that Webull either agrees with or confirms the truthfulness or accuracy of the information. It should not be considered as investment advice from Webull or anyone else, nor should it be used as the basis of any investment decision.