Pasithea Therapeutics Stock Price, News & Analysis

Pasithea Therapeutics Corp. (Nasdaq: KTTA, KTTAW) is a clinical-stage biotechnology company focused on the research and development of its lead drug candidate PAS-004, a next-generation macrocyclic oral MEK inhibitor. According to the company’s public disclosures, PAS-004 is being developed for the treatment of neurofibromatosis type 1-associated plexiform neurofibromas (NF1-PN), MAPK pathway-driven advanced solid tumors, RASopathies and other diseases, and is also being advanced into clinical evaluation for amyotrophic lateral sclerosis (ALS).

Core focus and lead program PAS-004

Pasithea describes PAS-004 as a macrocyclic MEK inhibitor intended for indications where the MAPK pathway plays a central role, including NF1-PN and tumors driven by RAS, NF1 or RAF mutations. The company reports that PAS-004 is already in human clinical trials, with a Phase 1 trial in advanced cancer patients (NCT06299839) and a Phase 1/1b trial in adult NF1 patients with symptomatic and inoperable, incompletely resected or recurrent plexiform neurofibromas (NCT06961565). In its communications, Pasithea highlights pharmacokinetic (PK) properties such as dose-proportional exposure, a relatively flat PK curve with a Cmax/Cmin ratio below 2, and a long half-life, which it believes are relevant for chronic dosing in diseases requiring sustained MAPK pathway suppression.

Clinical development in NF1-associated plexiform neurofibromas

The Phase 1/1b NF1-PN study in adults is designed to evaluate the safety, tolerability, PK and pharmacodynamics (PD) of PAS-004, as well as preliminary efficacy on plexiform and cutaneous neurofibromas and quality-of-life measures. Pasithea reports that the trial is being conducted in two parts: a dose-escalation Part A using tablet doses of 4 mg, 8 mg, 12 mg and 18 mg in a modified 3+3 design to identify a recommended Part B dose, followed by an expansion Part B in which participants receive PAS-004 tablets at the recommended dose and a lower dose over multiple 28‑day treatment cycles. The company has disclosed activation of clinical trial sites in Australia, South Korea and the United States, including the University of Alabama at Birmingham and two South Korean centers, and has noted completion of enrollment through multiple tablet dose cohorts in Part A.

Advanced cancer program and MAPK pathway-driven tumors

In advanced cancer, Pasithea is conducting a first-in-human Phase 1 trial of PAS-004 in patients with MAPK pathway-driven solid tumors, including those with documented RAS, NF1 or RAF mutations or prior exposure to BRAF/MEK inhibition. Interim data released by the company describe early signals of monotherapy clinical activity, including a partial response in a BRAF V600E melanoma patient previously treated with MEK plus BRAF inhibitor therapy, and a reported disease control rate among efficacy-evaluable patients with BRAF-mutated tumors. Across multiple dose cohorts, the company has emphasized that PAS-004 has been dosed once daily and, based on its reports, has shown dose-proportional PK, a Cmax/Cmin ratio below 2 and a long half-life, with treatment-related adverse events characterized as Grade 1 or 2 in the data disclosed to date.

Emerging ALS clinical work

Pasithea has announced that the ALS Association awarded a Hoffman ALS Clinical Trial Award grant to support a Phase 1 study of PAS-004 in ALS patients. The company states that this study is intended to evaluate the efficacy, safety and tolerability of PAS-004 in individuals living with ALS, with endpoints that include safety, ALS Functional Rating Scale–Revised scores and neurofilament light chain levels to explore potential early signals of clinical activity. In its description of the rationale, Pasithea points to the role of MEK and related kinases in TDP‑43–related neurodegeneration and neuroinflammation as the scientific basis for targeting ALS.

Pipeline context and disease areas

In addition to the detailed PAS-004 program, Pasithea’s prior pipeline description has referenced discovery and development efforts for central nervous system (CNS) disorders and other diseases, including RASopathies and certain cancers. The company has identified indications of interest such as Neurofibromatosis Type 1, Amyotrophic Lateral Sclerosis (ALS), Multiple Sclerosis (MS) and Schizophrenia, and has cited earlier-stage candidates described as PAS-003 (a monoclonal antibody) and PAS-001 (a small molecule). Available information indicates that PAS-004 is the primary clinical-stage asset, with the other candidates referenced as part of a broader development pipeline.

Corporate and capital markets information

Pasithea Therapeutics Corp. is incorporated in the United States and, based on its SEC filings, maintains its principal offices in Miami Beach, Florida. Its common stock trades on The Nasdaq Capital Market under the symbol KTTA, and its publicly listed warrants trade under the symbol KTTAW. The company has identified itself in SEC filings as an emerging growth company. In its public offering and at-the-market program disclosures, Pasithea has described the use of proceeds for general corporate purposes, including ongoing research and pre-clinical studies, clinical trials, development of biological and pharmaceutical technologies, licensing activities and potential investments or acquisitions that are synergistic or complementary to its technologies.

Regulatory and governance disclosures

Through proxy statements and current reports on Form 8‑K, Pasithea has outlined various corporate governance and capital structure matters, including amendments to its stock incentive plan, the potential implementation of a reverse stock split within a specified ratio range at the discretion of its board of directors, and an at-the-market offering agreement for its common stock. The company has also disclosed receipt of a Nasdaq notice regarding non-compliance with the minimum bid price requirement and has indicated that it is considering options, including a potential reverse split, to regain compliance. These regulatory filings provide additional context on the company’s capital markets strategy and listing status, but do not alter the clinical-stage nature of its business.

Position within pharmaceutical preparation manufacturing

Within the broader pharmaceutical preparation manufacturing sector, Pasithea positions itself as a biotechnology company focused on MEK inhibition and MAPK pathway biology, with an emphasis on NF1-associated plexiform neurofibromas, advanced cancers and ALS. Its disclosures highlight the importance of chronic dosing, sustained pathway inhibition and tolerability in indications where long-term treatment may be required. Investors and observers reviewing KTTA and KTTAW can use Pasithea’s clinical trial updates, pharmacokinetic and pharmacodynamic data, and regulatory filings to assess the progress and risk profile of its development programs.