Pasithea Therapeutics Corp. reports news centered on PAS-004, its next-generation macrocyclic MEK inhibitor, and the company’s clinical-stage biotechnology operations. Recurring updates cover NF1-associated plexiform and cutaneous neurofibromas, advanced cancer, ALS-related research, FDA designations, clinical development strategy and medical leadership.
Company news also includes capital actions, investor conference presentations and public-company matters tied to common stock and warrant securities. Pasithea’s releases frame the business around drug-development progress, regulatory designations and financing activity supporting research, preclinical work and clinical trials.
Pasithea Therapeutics (Nasdaq: KTTA) received FDA clearance to study PAS-004 in a Phase 2 trial for NF1-associated cutaneous neurofibromas.
The randomized, placebo-controlled trial will evaluate the oral drug candidate in patients with skin tumors associated with neurofibromatosis type 1 (NF1). The active investigational new drug application permits clinical development in these patients in the United States, under the FDA Division of Dermatology and Dentistry.
Pasithea intends to seek regulatory approval for this second indication. There are currently no FDA-approved systemic therapies for NF1-associated cutaneous neurofibromas. The application was supported by nonclinical safety data and clinical safety, tolerability, drug-exposure data and early treatment-response signals from ongoing studies in adults with NF1-associated plexiform neurofibromas and advanced cancer.
Pasithea Therapeutics (KTTA) will host a virtual expert event on NF1 treatment on November 4, 2026, at 11:00 a.m. ET. Rebecca M. Brown and Kavita Sarin will join management to discuss unmet needs and treatments for NF1-associated cutaneous and plexiform neurofibromas. The program will cover PAS-004 and review Phase 1 solid tumor data presented at the ESMO Congress 2026.
Pasithea Therapeutics (Nasdaq: KTTA) reported updated Phase 1 PAS-004 cancer study data showing prolonged stable disease and preliminary safety findings. Results presented at ESMO Congress 2026 reflect 37 patients across 10 dose cohorts as of September 15, 2026, in an ongoing dose-escalation study of advanced solid tumors.
Four patients had received PAS-004 for more than 300 days; two remained on treatment beyond 500 days with prolonged stable disease. Treatment-related adverse events affected 45.9% (17 of 37), all Grade 1 or 2. No dose-limiting toxicities, treatment-related discontinuations, or MEK inhibitor-associated heart or retinal toxicities were observed. The maximum tolerated dose had not been reached. Estimated half-life was approximately 58 hours, with a peak-to-trough drug concentration ratio below 1.5 at steady state; the company said this supports long-term, once-daily dosing.
Pasithea Therapeutics (KTTA) will present initial Part A clinical data from its ongoing Phase 1/1b trial of PAS-004 in adults with neurofibromatosis type 1 (NF1) at the 2026 European Neurofibromatosis Conference in Vienna, Austria, from November 12–14, 2026.
PAS-004 is described as a next-generation macrocyclic oral MEK inhibitor being developed for long-term treatment of chronic diseases including NF1-associated neurofibromas. The conference presentations will mark the first public disclosure of clinical data from Part A of the PAS-004 trial. Cutaneous neurofibromas (CN) data will be delivered in an oral presentation, and plexiform neurofibromas (PN) data will be shared in a poster session.
The oral presentation, by Rebecca Brown, MD of the University of Alabama at Birmingham, is scheduled in “Clinical Session 3: Visible Manifestations in Neurofibromatosis” on Friday, November 13, 2026, from 08:00–09:30 (CET) in Lecture Hall 1 at the Hyatt Regency Vienna. The PN-focused poster will be presented by Pasithea’s Chief Executive Officer, Tiago Reis Marques, during the Thursday, November 12 poster session. The company plans a follow-up press release with detailed clinical results at the time of presentation.
Pasithea Therapeutics (KTTA) will participate in two investor conferences in September 2026 to engage with investors and present its business.
Management will hold one-on-one meetings at the 12th Annual Cantor Global Healthcare Conference in New York, NY, from September 9-11, 2026. Management will also present at the H.C. Wainwright 28th Annual Global Investment Conference, held September 14-16, 2026, with the company’s presentation scheduled for Monday, September 14, 2026, at 2:30 PM ET. Pasithea is a clinical-stage biotech developing PAS-004, a next-generation macrocyclic oral MEK inhibitor for chronic diseases including neurocutaneous manifestations of NF1.
Pasithea Therapeutics (NASDAQ: KTTA) will present Phase I dose-escalation data for PAS-004, a next-generation oral macrocyclic MEK inhibitor, in MAPK pathway-driven advanced solid tumors at the ESMO Congress 2026 in Madrid. The poster (Abstract 1050P) is scheduled for Friday, October 23, 2026, 15:15–16:00 CEST, in the Developmental Therapeutics track. According to Pasithea Therapeutics, the full abstract will appear on the ESMO website under the congress embargo, with a detailed data release planned at presentation.
Pasithea Therapeutics (NASDAQ: KTTA) will participate in the B. Riley Securities Mind, Muscle & Vision Summit on July 16, 2026, at the InterContinental Boston.
The clinical-stage biotech, developing PAS-004 for chronic diseases including NF1-related neurocutaneous manifestations, will hold one-on-one investor meetings and join event discussions.
Pasithea Therapeutics (Nasdaq: KTTA) reported positive interim Phase 1 data for PAS-004, an oral MEK inhibitor in advanced MAPK pathway-driven solid tumors, including MEK/BRAF-pretreated patients.
Among 34 heavily pretreated patients, PAS-004 showed a favorable safety profile, durable disease stabilization beyond six months in several cases, and pharmacokinetics supporting once-daily chronic dosing. A protocol amendment extends dose escalation with a tablet formulation up to 52mg and adds a pilot food-effect study.
Pasithea Therapeutics (NASDAQ:KTTA) amended the clinical protocol for its Phase 1/1b PAS-004 trial in NF1 patients with symptomatic inoperable, incompletely resected or recurrent plexiform neurofibroma.
Changes add higher dose levels (24mg, 32mg), allow longer treatment up to 18 months, expand imaging and CN measurements, and support a planned interim NF1 data update in Q4 2026.
Pasithea Therapeutics (NASDAQ:KTTA) will exhibit at the Children's Tumor Foundation 2026 NF Conference, held June 26-30, 2026 in Denver, Colorado.
The company plans to engage with the NF1 clinical and academic community following recent FDA Fast Track and Rare Pediatric Disease designations for its lead NF1 candidate PAS-004.