Pasithea Therapeutics Corp. priced a public offering of 80 million shares of common stock (or pre‑funded warrants) at $0.75 per share, generating approximately $60 million in gross proceeds. The financing is expected to extend the company’s cash runway through at least the first half of 2028, providing critical liquidity for its Phase 1 and Phase 1/1b trials of the lead candidate PAS‑004.
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Pasithea Therapeutics Corp. received a $1 million Hoffman ALS Clinical Trial Award from the ALS Association, a non‑dilutive grant that will fund the company’s first Phase 1 study of its macrocyclic MEK inhibitor PAS‑004 in amyotrophic lateral sclerosis (ALS). The award, announced on November 25, 2025, will support enrollment of twelve patients across three sequential dose cohorts and a 28‑week follow‑up period, with safety, tolerability, ALS Functional Rating Scale–Revised scores and neurofilament light chain levels as primary readouts.
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Pasithea Therapeutics Corp. reported that Cohort 7 of its first‑in‑human Phase 1 study of the macrocyclic MEK inhibitor PAS‑004 has been completed. The 37 mg capsule cohort enrolled 12 patients and recorded no treatment‑related adverse events during the dose‑limiting toxicity period, a key safety milestone that supports the drug’s tolerability profile.
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Pasithea Therapeutics disclosed that its next‑generation macrocyclic MEK inhibitor, PAS‑004, achieved dose‑proportional tablet exposure in a Phase 1/1b study of adults with neurofibromatosis type 1. The 4 mg and 8 mg tablets produced roughly three‑fold higher area‑under‑the‑curve and peak concentrations than the 22 mg capsule, while keeping the peak‑to‑trough ratio below two at steady state. The data also show reduced inter‑patient variability and a similar time to maximum concentration, indicating a more predictable and potentially more convenient dosing schedule.
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Pasithea Therapeutics Corp. disclosed interim data from its first‑in‑human Phase 1 study of the macrocyclic MEK inhibitor PAS‑004, with a data cutoff of November 10, 2025. The study enrolled patients with MAPK‑driven advanced solid tumors and is the first clinical assessment of the drug’s safety, pharmacokinetics, and early anti‑tumor activity.
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