Pasithea Therapeutics Corp. (KTTA) on Monday said the U.S. Food and Drug Administration has granted Rare Pediatric Disease Designation to PAS-004 for the treatment of Neurofibromatosis Type 1 (NF1), a rare genetic disorder.
The designation makes the program eligible for a Priority Review Voucher if the drug is approved, which can be used for faster regulatory review of another product or sold to another company. Pasithea said recent voucher sales have ranged between $150 million and $205 million.
The company noted that a Phase 1/1b study of PAS-004 is currently underway in adult patients with symptomatic, inoperable or recurrent NF1-related plexiform neurofibromas.
Pasithea stock had closed at $0.7424 on Friday, up 0.87%.
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