MIAMI, Florida — 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 that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to PAS-004 for the treatment of NF1-associated PN causing significant morbidity.
“We appreciate the FDA’s decision that PAS-004 meets the criteria for Fast Track designation for this indication,” said Dr. Tiago Reis Marques, Chief Executive Officer of Pasithea. “The ability to have early and frequent interactions with the FDA supports our goal to expeditiously develop PAS-004 for patients with NF1-associated PN causing significant morbidity.”
Fast Track designation includes the following opportunities to facilitate Fast Track product development:
- Frequent communications with the FDA review team throughout the product development process
- Rolling Review, which allows portions of a marketing application to be reviewed and assessed by the FDA before the company submits the complete application
- In addition, a Fast Track designation product may potentially be eligible for accelerated approval and/or priority review if relevant criteria are met. For more information, see the FDA’s website at
https://www.fda.gov/patients/fast-track-breakthrough-therapy-accelerated-approval-priority-review/fast-track
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).
About NF1- PN
Plexiform neurofibromas (PN) are tumors originating from the nerve sheath that grow through and around nerves and may involve multiple nerve branches. Thirty to fifty percent (30-50%) of patients with NF1 will harbor PNs, which can undergo malignant transformation. PN-related morbidities are primarily caused by the direct impact of the tumor on surrounding structures and can be life-threatening when they compress vital organs or when they become malignant.
About Pasithea Therapeutics Corp.
Pasithea is a clinical-stage biotechnology company primarily focused on the research and development of its lead drug candidate, PAS-004, a next-generation macrocyclic MEK inhibitor intended for the treatment of RASopathies, MAPK pathway-driven tumors, and other diseases. The Company is currently testing PAS-004 in a Phase 1 clinical trial in patients with advanced cancer (NCT06299839), and a Phase 1/1b clinical trial in patients with neurofibromatosis type 1 (NF1)-associated plexiform neurofibromas with symptomatic and inoperable, incompletely resected, or recurrent PN (NCT06961565). For more information please visit https://www.pasithea.com/ or follow the company on X.
Pasithea Therapeutics Contact
Patrick Gaynes
Investor Relations
[email protected]