Pasithea Therapeutics Gets FDA Acceptance for PAS-004 IND Application

Dow Jones01-02

By Chris Wack

Pasithea Therapeutics said it has received Investigational New Drug Application clearance to proceed by the Federal Drug Administration to evaluate PAS-004 in cancer patients.

Pasithea stock was halted at $7.40 in premarket trading on the news.

PAS-004 is a macrocyclic MEK inhibitor for patients with advanced solid tumors with a documented mutation or patients who have failed BRAF/MEK inhibition.

Pasithea expects to dose the first patient in the first quarter of 2024.

The objectives of the dose escalation study are to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics as well as anti-tumor responses of PAS-004 as monotherapy in up to 36 advanced cancer patients, with preliminary early data expected as early as the third quarter of 2024.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

January 02, 2024 08:47 ET (13:47 GMT)

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