Welcome to our dedicated page for Pasithea Therapeutics news (Ticker: KTTA), a resource for investors and traders seeking the latest updates and insights on Pasithea Therapeutics stock.
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 (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.
Pasithea Therapeutics (NASDAQ: KTTA) announced that the FDA has granted Orphan Drug Designation to PAS-004, a next-generation macrocyclic MEK inhibitor, for treating Amyotrophic Lateral Sclerosis (ALS).
The designation offers potential tax credits, certain FDA fee exemptions, and up to seven years of market exclusivity after approval. Pasithea previously received a $1 million ALS Association grant in November 2025 to study PAS-004 in ALS.
Pasithea Therapeutics (NASDAQ: KTTA) appointed Kartik Krishnan, M.D., Ph.D. as Chief Medical Officer, effective May 1, 2026. Dr. Krishnan will lead clinical development and medical strategy for PAS-004, a macrocyclic MEK inhibitor in development for NF1-associated plexiform and cutaneous neurofibromas.
He brings over 20 years of clinical development experience and prior roles at Genentech, Amgen, BioMarin, and others, including work on cobimetinib (approved MEK inhibitor) and pediatric clinical training.
Pasithea Therapeutics (NASDAQ: KTTA) announced the U.S. FDA granted Rare Pediatric Disease Designation to PAS-004 for treatment of Neurofibromatosis type 1 (NF1) on April 20, 2026. The designation could make Pasithea eligible for a Priority Review Voucher (PRV); disclosed PRV sales have ranged from $150–$205 million in the last 12 months.
PAS-004 already holds Orphan Drug and Fast Track designations and is in a Phase 1/1b multicenter dose-escalation trial (NCT06961565) in adults with symptomatic NF1 plexiform neurofibromas.