KTTA

— FDA clearance allows Pasithea to advance PAS-004 for NF1-associated cNF, a condition affecting over 95% of people with NF1 and for which there are currently no FDA-approved systemic therapies . — MIAMI, Nov. 03, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation oral macrocyclic MEK inhibitor for the treatment of chronic diseases, including neurofibromatosis type 1 (NF1)-associated neurofibromas, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company's Investigational New Drug (IND) application for a randomized, placebo-controlled Phase 2 clinical trial for PAS-004 in patients with NF1 associated cutaneous neurofibromas (cNF).

MIAMI, Oct. 28, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, for the long-term treatment of chronic diseases including neurofibromatosis type 1 (NF1) associated neurofibromas, today announced that it will host a virtual key opinion leader (KOL) event, “Rethinking NF1 Treatment: KOL Perspectives on Cutaneous and Plexiform Neurofibromas,” on Wednesday, November 4, 2026, at 11:00 a.m. ET. The event will feature Rebecca M.

-- Prolonged Stable Disease: PAS-004 achieved prolonged stable disease in a heavily pre-treated population, with four patients on PAS-004 for more than 300 days, including two who continue on once daily PAS-004 for over 500 days despite recurrent, metastatic melanoma carrying the BRAF V600E mutation and prior progression on targeted combination therapy with dabrafenib and trametinib. -- Long-Term Tolerability: Overall, the safety profile of PAS-004 in the heavily pre-treated advanced cancer population appears favorable.

- Pasithea has been selected to present cutaneous neurofibromas (CN) clinical data in an oral presentation - Pasithea has been selected to present plexiform neurofibromas (PN) clinical data in a poster presentation - The European Neurofibromatosis Conference 2026 will take place in Vienna, Austria, from November 12–14, 2026 MIAMI, Sept. 14, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, for the long-term treatment of chronic diseases including neurofibromatosis type 1 (NF1)-associated neurofibromas, today announced it will present initial Part A clinical data from its ongoing Phase 1/1b trial of PAS-004 in adults with NF1.

-- Company will hold one-on-one investor meetings at the 12th Annual Cantor Global Healthcare Conference (September 9-11) and will present at the H.C. Wainwright 28th Annual Global Investment Conference (September 14-16) -- MIAMI, Sept.

-- Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of PAS-004, a Macrocyclic MEK Inhibitor, for the Treatment of Patients with MAPK Pathway Driven Advanced Solid Tumors will be presented Friday, October 23, 2026 -- Full abstract will be published on ESMO website per Congress' standard embargo schedule MIAMI, July 21, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) ("Pasithea" or the "Company"), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, for the long-term treatment of chronic diseases including the neurocutaneous manifestations of neurofibromatosis type 1 (NF1), today announced that an abstract detailing the Phase 1 dose-escalation study of PAS-004 in patients with MAPK pathway-driven advanced solid tumors has been accepted for poster presentation in the Developmental Therapeutics track at the European Society for Medical Oncology (ESMO) Congress 2026, taking place October 23-27, 2026, at the IFEMA Madrid Convention Center in Madrid, Spain. Details of the Poster Presentation: Title: Phase I Dose-Escalation Study of the Safety and Pharmacokinetics of PAS-004, a Macrocyclic MEK Inhibitor, for the Treatment of Patients with MAPK Pathway Driven Advanced Solid Tumors Presenter: Kartik Krishnan, Miami, Florida, United States Authors: Ildefonso I.

KTTA, NTRS, YEXT, AEHR and STT have been added to the Zacks Rank #1 (Strong Buy) List on July 20, 2026.

MIAMI, July 08, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor for the long-term treatment of chronic diseases including the neurocutaneous manifestations of neurofibromatosis type 1 (NF1), today announced management will participate in the Mind, Muscle & Vision Summit, hosted by B. Riley Securities, on July 16, 2026, at the InterContinental Boston in Boston, Massachusetts.

--  Favorable Safety Profile Supports Long-Term Chronic Dosing: PAS-004 has been well-tolerated, with all treatment-related adverse events (TRAEs) being Grade 1 or 2, no observed cardiac or retinal treatment-related events, and low rates of rash and gastrointestinal toxicities -- Protocol Amendment Extends Dose Escalation to Higher Levels: Continued dose escalation using tablet formulation to explore 18mg, 24mg, 30mg, 40mg, and up to 52mg dose levels to further characterize safety, pharmacokinetics (PK), and early efficacy signals at higher doses -- Potential Best-in-Class MEK Inhibitor Profile Emerging: Interim PK and safety data at pharmacologically active doses support PAS-004 as a differentiated candidate with potential for long-term chronic dosing with favorable tolerability -- Pilot Food Effect Study Initiated: An optional pilot food effect assessment has been introduced to evaluate the impact of fed vs. fasted administration on PAS-004 pharmacokinetics, to optimize long-term dosing strategy MIAMI, June 30, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic oral MEK inhibitor, for the long-term treatment of chronic diseases including the neurocutaneous manifestations of neurofibromatosis type 1 (NF1), today announced updated interim safety and clinical activity data from its ongoing first-in-human trial evaluating PAS-004 in patients with MAPK pathway-driven advanced solid tumors with a documented RAS, NF1 or RAF mutation, including patients who have failed prior BRAF/MEK inhibitor treatment (NCT06299839).

-- Remains on track to release interim NF1 data update in Q4 2026 -- -- Additional dose levels and longer treatment period added -- MIAMI, June 16, 2026 (GLOBE NEWSWIRE) -- Pasithea Therapeutics Corp. (NASDAQ: KTTA) (“Pasithea” or the “Company”), a clinical-stage biotechnology company developing PAS-004, a next-generation macrocyclic MEK inhibitor, today announced it has amended the clinical study protocol for the Phase 1/1b trial of PAS-004 in neurofibromatosis type 1 (NF1) patients with symptomatic inoperable, incompletely resected, or recurrent plexiform neurofibroma (PN). The amendments include an update to the dose escalation part of the study (Part A) to allow for the enrollment of additional participants at two additional higher dose levels (24mg and 32mg), the ability to backfill completed dose cohorts (4mg, 8mg, 12mg and 18mg) with up to two participants, and the evaluation of intermediate dose levels.