Pasithea (KTTA) Surges 45.33% on Positive Phase 1 Trial Data, Advances to Next Dose Cohort

Pasithea (Nasdaq: KTTA) surged 45.33% in pre-market trading on November 25, 2025, following positive Phase 1 trial data for its lead candidate, PAS-004.

The biotech firm reported no treatment-related adverse events in Cohort 7 (37mg capsules) of its trial, with pharmacokinetic (PK) data showing linear dose proportionality and a Cmax/Cmin ratio below 2. Pharmacodynamic (PD) results indicated sustained MAPK pathway suppression, with ~80% pERK inhibition at peak concentrations and >60% at trough levels. The Safety Review Committee approved advancement to Cohort 8 (45mg capsules), signaling a key milestone for dose escalation.

The CEO highlighted the balanced safety and efficacy profile, emphasizing potential for long-term chronic dosing in MAPK-driven diseases. Investors are now monitoring tolerability at higher doses and PD confirmation in the next cohort, which could reinforce the drug’s therapeutic potential.

Backtest assumption: A strategy buying on the 45% pre-market pop and holding through a 10-day window would require a stop-loss below 20% to mitigate volatility. Position sizing should reflect the stock’s high beta and clinical trial risk profile.