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(RTTNews) - Pasithea Therapeutics Corp. (KTTA) Tuesday announced that FDA has accepted its Investigational New Drug Application or IND clearance to evaluate PAS-004 in patients with MAPK pathway-driven advanced solid tumors.

In the pre-market session, shares are gaining more than 6 percent on the Nasdaq.

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

PAS-004 is a macrocyclic MEK 1/2 inhibitor. The study targets patients with documented RAS, RAF or NF1 mutation or patients who have failed BRAF/MEK inhibition.

PAS-004 is the first macrocyclic MEK inhibitor to enter human clinical trials and is expected to be an oral, once-day or less frequent dose.

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