Pasithea Therapeutics Announces Grant of Rare Pediatric Disease Designation (RPDD) by FDA to PAS-004 for Treatment of Neurofibromatosis Type 1 (NF1)
Pasithea Therapeutics Corp. (KTTA)
Company Research
Source: GlobeNewswire
MIAMI, April 20, 2026 (GLOBE NEWSWIRE) -- 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 Rare Pediatric Disease Designation to PAS-004 for treatment of Neurofibromatosis type-1 (NF1). The FDA grants RPDD for serious or life-threatening diseases in which the serious or life-threatening manifestations primarily affect individuals aged from birth to 18 years and affect fewer than 200,000 people in the U.S. There are approximately 115,000 individuals in the U.S living with NF1. Under the FDA's Rare Pediatric Disease Priority Review Voucher program, a sponsor who receives an approval of a new drug application (NDA) or biologics license application (BLA) for a rare pediatric disease may be eligible for a Priority Review Voucher (“PRV”) which can be redeemed to obtain priority review
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News
- Pasithea Therapeutics (KTTA) had its "buy" rating reaffirmed by HC Wainwright. They now have a $3.00 price target on the stock.MarketBeat
- Pasithea Therapeutics Announces Grant of Rare Pediatric Disease Designation (RPDD) by FDA to PAS-004 for Treatment of Neurofibromatosis Type 1 (NF1) [Yahoo! Finance]Yahoo! Finance
- Pasithea Therapeutics (KTTA) was downgraded by Zacks Research from "hold" to "strong sell".MarketBeat
- 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 [TheStreet.com]TheStreet.com
- 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 MorbidityGlobeNewswire
KTTA
Analyst Actions
- 4/20/26 - HC Wainwright
KTTA
Sec Filings
- 4/22/26 - Form SCHEDULE
- 4/17/26 - Form 3
- 4/8/26 - Form SCHEDULE
- KTTA's page on the SEC website