Key Highlights

  • Pasithea Therapeutics (NASDAQ:KTTA) traded at USD 0.56 intraday on November 13, 2026, up 7.66%, on about 1.17 million shares, nearly twice its average volume, with a Market Value of about USD 18.7 million.
  • Initial Phase 1/1b data for PAS-004 in neurofibromatosis type 1 showed tumour reductions in all 15 evaluable patients with cutaneous neurofibromas, with a median best reduction of 41%.
  • At the planned Phase 2 doses, the median reduction was 46%, and all 18 evaluable patients with plexiform neurofibromas also showed reductions.
  • No treatment-related serious adverse events or discontinuations were reported, and the FDA has cleared a randomised Phase 2 trial in about 200 adults.

Positive Early Data Drive the Gain

Pasithea Therapeutics presented initial data from its Phase 1/1b trial of PAS-004 on November 13, 2026 at a European neurofibromatosis conference, and the shares rose 7.66% to USD 0.56. PAS-004 is an oral MEK inhibitor designed for neurofibromatosis type 1, a genetic disorder that causes tumours to grow along nerves. The trial had enrolled 19 participants as of September 15. Among the 15 patients who could be evaluated for cutaneous neurofibromas, the skin tumours that are a visible burden for many adults with NF1, every patient saw a reduction, with a median best reduction of 41% across doses and 46% at the 4, 8 and 12 milligram doses planned for Phase 2. In the 4 milligram group, median reductions reached 49% at cycle 12 and 71% at cycle 15, which suggests the effect deepens with time. All 18 patients evaluable for plexiform neurofibromas, which are larger internal tumours, also showed reductions, with two meeting the threshold for a partial response and a third pending confirmation.

Safety and the Path to Phase 2

Safety is critical for MEK inhibitors, which as a class can cause skin, gut and muscle side effects that limit long-term use. In this trial there were no treatment-related serious adverse events and no discontinuations due to side effects. Two patients had grade 3 increases in a muscle enzyme that resolved after a one-week pause in dosing. At the planned Phase 2 doses, rash occurred in 33% of patients and diarrhoea in 11%. The Food and Drug Administration has cleared an investigational new drug application for a randomised, double-blind, placebo-controlled Phase 2 trial in about 200 adults with NF1-related cutaneous neurofibromas. There is currently no approved drug for cutaneous neurofibromas in adults, so a well tolerated oral treatment could address a large unmet need. Pasithea, based in Miami Beach, Florida, is a clinical stage company with PAS-004 as its lead candidate.

Funding Is the Next Question

The data are early and come from an open-label study with a small number of patients, so they need confirmation in the controlled Phase 2 trial. A trial of about 200 patients is expensive, and Pasithea Therapeutics (NASDAQ:KTTA) has a market value of under USD 20 million, which means it will likely need new Capital or a partner to run it. Its cash position was not confirmed in this review. The 52-week range of USD 0.38 to USD 2.06 shows that the shares have been weak, and the price below USD 1.00 could bring Nasdaq listing pressure. Investors should watch for financing, Partnership talks and the start of the Phase 2 study. A partnership with a larger drug company would reduce the need for dilutive Equity and would also validate the data, so any licensing news would be significant for the shares.

Where Things Stand

Pasithea Therapeutics rose 7.66% to USD 0.56 on November 13, 2026 after PAS-004 showed a median 41% reduction in cutaneous neurofibromas with no serious treatment-related side effects. The FDA has cleared a 200-patient Phase 2 trial. Funding that trial is the key next step.