Pasithea Therapeutics Corp Stock Price, News & Analysis

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.

Pasithea Therapeutics has presented updated interim data from its Phase 1 study of PAS-004, a next-generation macrocyclic MEK inhibitor, at ASCO 2025. The study enrolled 21 patients with MAPK pathway-driven advanced solid tumors across six dosing cohorts. Key findings show PAS-004 demonstrating preliminary clinical activity in heavily pre-treated patients, with notable results in cohort 4A (15mg capsule). A stage 4 BRAF-mutated melanoma patient achieved stable disease with -14.9% tumor reduction after 5+ months. The drug showed favorable pharmacokinetics with a half-life exceeding 60 hours and maintained good tolerability with only grade 1 or 2 adverse events. Of 16 evaluable patients, 10 achieved stable disease, with progression-free survival up to 159 days and overall survival up to 253 days. The results suggest PAS-004's potential as a best-in-class MEK inhibitor for various MAPK pathway-driven tumors.

Pasithea Therapeutics (NASDAQ: KTTA) has announced promising preclinical data for its drug candidate PAS-004, a next-generation macrocyclic MEK inhibitor. The study, conducted at the Francis Crick Institute, demonstrated that PAS-004 outperforms FDA-approved MEK inhibitor selumetinib in inhibiting ETS2-driven inflammatory responses in IBD models. Key findings show PAS-004 achieved: - Superior suppression of ETS2 signaling across all tested doses - Significant reduction in ETS2-dependent functions - Higher normalized enrichment score (-3.96 vs -3.56) compared to selumetinib - Greater statistical significance (1.2 x 10⁻²⁵⁰ vs 3.7 x 10⁻⁷⁴) The results suggest PAS-004's potential as a treatment for inflammatory diseases like IBD and ankylosing spondylitis, with the ability to affect multiple cytokines including TNFα, IL-23, and IL-1β. The company reports favorable safety data from its Phase 1 clinical trial in advanced cancer patients.

Pasithea Therapeutics (NASDAQ: KTTA) has initiated a Phase 1/1b open-label study for PAS-004, their next-generation macrocyclic MEK inhibitor, in adult patients with neurofibromatosis type 1 (NF1). The trial will begin at Royal North Shore Hospital in Sydney, Australia, with patient dosing expected in Q2 2025. The study will evaluate safety, tolerability, pharmacokinetics, and preliminary efficacy of PAS-004 in treating both plexiform and cutaneous neurofibromas, starting with a 4mg daily tablet dosage. The company plans to expand to additional sites in Australia, South Korea, and the U.S. Notably, Pasithea expects to receive up to 48.5% cash refund on eligible R&D activities through Australian tax incentives. The company is now funded to produce initial interim patient data, with PAS-004 showing promising safety profiles in previous cancer trials.