07:59 AM EDT, 08/27/2025 (MT Newswires) -- BioXcel Therapeutics ( BTAI ) said Wednesday that a phase 3 trial of BXCL501 met its primary endpoint of being well tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia.

The results showed no discontinuations due to tolerability in the BXCL501 arm, the company said.

The trial data will form the basis of the supplemental new drug application submission for label expansion of Igalmi in the at-home setting planned for Q1 2026.

BioXcel shares were up 1.5% in recent premarket activity.