Pasithea Therapeutics (KTTA) Surges 45.33% as Phase 1 Trial Clears 37mg Cohort, Advances to 45mg Dose Level

Pasithea Therapeutics (KTTA) surged 45.33% in pre-market trading on Nov. 25, 2025, driven by positive Phase 1 trial data for its lead candidate, PAS-004, a next-generation MEK inhibitor. The company reported no treatment-related adverse events in Cohort 7 (37mg capsules) during the dose-limiting toxicity (DLT) period, with safety, pharmacokinetic (PK), and pharmacodynamic (PD) data supporting progression to the next dose level (45mg capsules).

Pharmacokinetic results showed linear, dose-proportional behavior, with a Cmax/Cmin ratio below 2 and an area under the curve (AUC) of 6,690 ng·h/mL. PD data indicated sustained MAPK pathway suppression, with ~80% pERK inhibition near peak concentrations and >60% at trough levels, aligning with the drug’s potential for chronic dosing. The Safety Review Committee recommended advancing to Cohort 8, a key near-term milestone for the trial.

The absence of dose-limiting toxicities and consistent PD/PK profiles reinforce PAS-004’s safety and tolerability in advanced cancer patients. These findings address a critical unmet need in MEK inhibitors, which often face challenges with adverse events and inconsistent pathway inhibition. The escalation to 45mg capsules will provide further clarity on long-term efficacy and safety, potentially accelerating regulatory timelines.

Backtest assumptions suggest a momentum-driven strategy could capitalize on Pasithea’s recent volatility. Historical patterns indicate strong short-term gains following positive clinical readouts, with risk-reversal options or trailing stops potentially mitigating downside exposure. Investors may monitor Cohort 8 outcomes and upcoming PD data for confirmation of sustained efficacy.