Pasithea Therapeutics provides updated clinical trial timelines

Pasithea Therapeutics Corp. (NASDAQ: KTTA) announced updated timelines for its ongoing clinical trials of PAS-004, an oral macrocyclic MEK inhibitor being developed for neurofibromatosis type 1 associated plexiform neurofibromas and advanced cancer patients.

The company has completed enrollment of 12 patients through the first four dose cohorts in Part A of its Phase 1/1b clinical trial in adult patients with NF1-PN. Pasithea plans to present data from this study in the second half of 2026, including efficacy data through the six-month timepoint for both plexiform and cutaneous neurofibromas, along with safety, tolerability and pharmacokinetic data.

For its Phase 1 clinical trial in advanced cancer patients, the company expects to present longer-term follow-up data from patients in Cohort 4 through Cohort 8 in the second quarter of 2026.

"In November 2025, we announced encouraging results in patients previously treated with a MEK inhibitor, including a partial response and an initial disease control rate of 71.4% among efficacy evaluable patients with BRAF-mutated tumors," said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea.

In December 2025, the company raised $60 million in gross proceeds through a public offering, which it stated will support operations through at least the first half of 2028.

Pasithea is currently testing PAS-004 in two clinical trials: NCT06299839 for advanced cancer patients and NCT06961565 for adult patients with neurofibromatosis type 1-associated plexiform neurofibromas.

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