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 Significan...
Pasithea Therapeutics Corp. (KTTA)
Company Research
Source: GlobeNewswire
MIAMI, April 01, 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 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
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News
- 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 Corp. (KTTA) Presents at Oppenheimer 36th Annual Healthcare Life Sciences Conference Transcript [Seeking Alpha]Seeking Alpha
- Pasithea Therapeutics to Present at the Oppenheimer 36th Annual Healthcare Life Sciences Conference [Yahoo! Finance]Yahoo! Finance
- Pasithea Therapeutics to Present at the Oppenheimer 36th Annual Healthcare Life Sciences ConferenceGlobeNewswire
- Pasithea Therapeutics (NASDAQ:KTTA) was upgraded by analysts at <a style="font-weight:bold" href="https://www.wallstreetzen.com/newsletters/zen-ratings?ticker=KTTA&utm_campaign=getratings&utm_medium=online&utm_source=MarketBeat">Wall StrMarketBeat
KTTA
Sec Filings
- 3/30/26 - Form 10-K
- 2/27/26 - Form SCHEDULE
- 2/20/26 - Form 8-K
- KTTA's page on the SEC website