Bioxcel Therapeutics shares rise 3.17% premarket after submitting pre-sNDA meeting package for IGALMI® label expansion.

Bioxcel Therapeutics, Inc. rose 3.17% in premarket trading, with the company submitting a pre-supplemental New Drug Application (pre-sNDA) meeting package to the FDA for IGALMI®. The purpose of the meeting, scheduled for August 20, 2025, is to gain alignment with the FDA regarding the content and format of the planned sNDA submission for potential label expansion for outpatient use for the acute treatment of agitation associated with bipolar disorders or schizophrenia.