GlobeNewswire·Apr 1, 2026, 7:01 AM ET

Pasithea Therapeutics Announces Grant of Fast Track Designation by FDA to PAS-004 for Treatment of Neurofibromatosis Type 1 (NF1) Associated Plexiform Neurofibromas (PN) Causing Significant Morbidity

Pasithea Therapeutics Corp. (NASDAQ: KTTA) announced that the U.S. FDA granted Fast Track designation to its drug candidate PAS-004 for treating NF1-associated plexiform neurofibromas (PN) causing significant morbidity.
Fast Track designation enables frequent communications with the FDA review team & rolling review of marketing application portions before complete submission.
Products with Fast Track designation may potentially qualify for accelerated approval &/or priority review if relevant criteria are met.
The Company is currently conducting a Phase 1/1b multicenter, open-label, dose escalation trial of PAS-004 in adult participants with symptomatic, inoperable, incompletely resected, or recurrent NF1-PN (NCT06961565).
Plexiform neurofibromas are tumors originating from nerve sheaths that grow through & around nerves, affecting 30-50% of NF1 patients & posing risks of malignant transformation or compression of vital organs.
PAS-004 is a next-generation macrocyclic MEK inhibitor intended for RASopathies, MAPK pathway-driven tumors, & other diseases.
Pasithea is also testing PAS-004 in a Phase 1 clinical trial for patients with advanced cancer (NCT06299839).
The press release includes forward-looking statements regarding clinical trial results, safety, efficacy, & regulatory timelines that are subject to risks & uncertainties.