Pasithea Therapeutics Reports Positive Early Trial Results for PAS-004 in Neurofibromatosis

Pasithea Therapeutics (KTTA) reported tumor shrinkage in all 15 patients treated with PAS-004 in a Phase 1/1b NF1 trial, with a median 41% reduction in skin tumors. Two patients showed partial responses in nerve-associated tumors. The drug was well-tolerated. KTTA plans a Phase 2 study and stock rose 11.41% in pre-market trading.

Pasithea Therapeutics (KTTA) reported positive Phase 1/1b trial results for PAS-004 in neurofibromatosis type 1. All participants showed tumor reductions, with median reductions of 41% and 46% across all and Phase 2 doses, respectively. No serious adverse events were reported. The FDA cleared a Phase 2 trial for PAS-004.

Pasithea Therapeutics (KTTA) reported positive Phase 1/1b results for PAS-004, showing median 41% reduction in target cNF surface area. All 15 participants had reductions, with deeper reductions at higher doses. FDA cleared Phase 2 trial. No serious adverse events reported. Webcast scheduled for November 13, 2026.

Pasithea Therapeutics (KTTA) received FDA clearance for its IND application to study PAS-004 in treating NF1-related skin tumors. The Phase 2 trial will assess the oral drug's efficacy and safety. PAS-004 is designed for chronic dosing and has shown early treatment-response signals in ongoing studies. KTTA stock rose 8.67% to $0.39.

Pasithea Therapeutics (KTTA) received FDA clearance for a Phase 2 trial of PAS-004 in NF1 skin tumors. The study is placebo-controlled and will evaluate the oral MEK inhibitor. No FDA-approved systemic treatments exist for this condition, and Pasithea estimates 80,000 U.S. patients have moderate to severe cases.

Pasithea Therapeutics (KTTA) reported Phase 1 trial data for PAS-004, an oral MEK inhibitor, showing stable disease in advanced solid tumor patients. Four patients remained on treatment for over 300 days, with two over 500 days. No dose-limiting toxicities were observed. The data was presented at ESMO Congress 2026.