Pasithea Therapeutics Advances CNS Treatment with FDA Guidance on PAS-004 Clinical Development
Portfolio Pulse from Benzinga Newsdesk
Pasithea Therapeutics Corp. (NASDAQ:KTTA) has received positive feedback from the FDA on its clinical development plan for PAS-004, a treatment for CNS disorders. The FDA recommended starting dosing in patients rather than healthy volunteers. PAS-004 has orphan drug designation for NF1 treatment since November 2020.

November 29, 2023 | 1:00 pm
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POSITIVE IMPACT
Pasithea Therapeutics received FDA guidance to start patient dosing for PAS-004, which is positive for the company's CNS treatment pipeline.
The FDA's positive feedback is a significant milestone for Pasithea Therapeutics, as it allows the company to proceed with patient dosing in its clinical trials for PAS-004. This step is crucial for advancing the treatment through the regulatory pathway and potentially bringing it to market. The orphan drug designation also adds to the positive outlook, as it provides certain benefits that can accelerate development. Investors may view this news as a strong indicator of progress and potential, likely leading to a positive short-term impact on KTTA's stock price.
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