Pasithea Therapeutics Corp Stock Price, News & Analysis

Pasithea Therapeutics (Nasdaq: KTTA) reported positive tablet pharmacokinetic (PK) data from its ongoing Phase 1/1b study of PAS-004 in adult NF1 patients on Nov 21, 2025. Key findings: linear, dose-proportional PK across 4mg and 8mg tablets; steady‑state Cmax/Cmin <2 with Cmax and Cmin above the cellular IC50; and a long half‑life (~57 hours). Cohort PK: 4mg AUC 1,120 ng·h/mL, Cmax 58.1 ng/mL, Cmin 37.6 ng/mL; 8mg AUC 2,290 ng·h/mL, Cmax 118 ng/mL, Cmin 75.4 ng/mL. Tablet exposures were ~3x higher (dose‑normalized) than capsule, with the 8mg tablet AUC/Cmax slightly exceeding the 22mg capsule and showing reduced interpatient variability and similar Tmax.

Pasithea Therapeutics (Nasdaq: KTTA) reported positive interim Phase 1 data for oral MEK inhibitor PAS-004 in MAPK-driven advanced solid tumors, disclosed through a data cutoff of Nov 10, 2025. Key findings include an unconfirmed monotherapy partial response (–31.9%) in a BRAF V600E melanoma patient on Cohort 4A (15mg) who remains on study >11 months, and a second BRAF V600E patient with durable stable disease >6 months (Cohort 6, 30mg).

Other highlights: initial Disease Control Rate of 71.4% in BRAF-mutated tumors (5 of 7), overall 42.8% DCR in 21 evaluable patients, favorable safety with no DLTs or discontinuations, and pharmacokinetics showing dose-proportionality and AUC ~5,480 ng·h/mL at 30mg.

Pasithea Therapeutics (Nasdaq: KTTA) activated a new U.S. clinical trial site at the University of Alabama at Birmingham (UAB) for its ongoing Phase 1/1b open-label study of PAS-004 in adults with neurofibromatosis type 1 (NF1) who have symptomatic, inoperable, incompletely resected, or recurrent plexiform neurofibromas.

The global Phase 1/1b trial is designed to assess safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of PAS-004; enrollment at the UAB site is expected to begin immediately following activation (announced Nov 4, 2025). Pasithea will also serve as Platinum Sponsor of the NF Caregivers Symposium hosted at UAB on Nov 8, 2025.

Pasithea Therapeutics (NASDAQ: KTTA) has announced the activation of two major clinical trial sites in South Korea for its Phase 1/1b study of PAS-004, a next-generation macrocyclic MEK inhibitor. The trial will evaluate the drug's safety, tolerability, and pharmacokinetics in adult patients with neurofibromatosis type 1 (NF1) who have symptomatic and inoperable plexiform neurofibromas.

The activated sites include ASAN Medical Centre and Severance Hospital, which together have access to an estimated 10,000 NF1 patients in South Korea. Professor Lee Beom-Hee from ASAN Medical Center, which has the largest NF1 caseload in South Korea, will lead the trial at their facility. The drug PAS-004 has shown a distinct pharmacokinetic profile and offers a more convenient dosing regimen compared to existing treatments.

Pasithea Therapeutics (NASDAQ: KTTA) has received approval to advance to Cohort 2 in its Phase 1/1b clinical trial of PAS-004, a next-generation macrocyclic MEK inhibitor for neurofibromatosis type 1 (NF1) patients. The external Safety Review Committee's recommendation follows a successful safety review of Cohort 1, where no dose limiting toxicities were observed in the initial three patients.

The trial will now proceed with Cohort 2, testing an 8mg tablet dosage. The company has already enrolled the first three patients in this cohort, noting strong enrollment demand. Initial interim clinical data from the first two cohorts is expected in Q1 2026.

Pasithea Therapeutics (NASDAQ: KTTA), a clinical-stage biotech company developing PAS-004 (a next-generation macrocyclic MEK inhibitor), has updated its presentation time at the upcoming H.C. Wainwright 27th Annual Global Investment Conference.

CEO Dr. Tiago Reis Marques will deliver the company presentation on Monday, September 8, 2025, at 5:00 PM ET at the Lotte New York Palace Hotel. Management will also be available for one-on-one meetings during the conference, which runs from September 8-10, 2025 in New York City.

Pasithea Therapeutics (NASDAQ: KTTA), a clinical-stage biotech company, will participate in the upcoming H.C. Wainwright 27th Annual Global Investment Conference. The company's CEO, Dr. Tiago Reis Marques, will deliver a presentation on September 10, 2025, at 2:30 PM ET at the Lotte New York Palace Hotel.

Pasithea is currently developing PAS-004, a next-generation macrocyclic MEK inhibitor. Management will be available for one-on-one meetings throughout the conference, which runs from September 8-10, 2025.

Pasithea Therapeutics (NASDAQ: KTTA) has achieved a significant milestone in its clinical development program by completing enrollment and initial dosing of three subjects in Cohort 1 of its Phase 1/1b trial for PAS-004. The trial evaluates a novel once-daily macrocyclic MEK inhibitor in adult patients with neurofibromatosis type 1 (NF1) who have symptomatic and inoperable plexiform neurofibromas.

The company expects to present initial interim safety, tolerability, biomarker, and preliminary efficacy data in Q1 2026. PAS-004 aims to differentiate itself from current FDA-approved therapies that require twice-daily dosing, potentially offering better patient compliance and tolerability advantages.

Pasithea Therapeutics (NASDAQ: KTTA) has appointed Dr. James Lee, a renowned expert from the Francis Crick Institute, to its Scientific Advisory Board. Dr. Lee, who authored a significant 2024 Nature publication identifying ETS2 as a key regulator of inflammation in IBD, will guide the development of PAS-004, the company's next-generation macrocyclic MEK inhibitor. The appointment aims to expand PAS-004's applications beyond NF1 to treat various ETS2-driven inflammatory diseases, including IBD, ulcerative colitis, Crohn's disease, primary sclerosing cholangitis, and ankylosing spondylitis. The company plans to fund this expansion through non-dilutive financing, including grants and strategic collaborations. Dr. Lee, who trained at Oxford, Cambridge, and Harvard, currently serves as a Clinician Scientist Group Leader and Honorary Consultant Gastroenterologist, bringing extensive expertise in IBD research and treatment.