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Benzinga
Benzinga
Business
Vandana Singh

BioXcel Seeks FDA Label Expansion For Schizophrenia Treatment

FDA Schizophrenia BTAI Bipolar Disorder
Richmond,,Virginia,,Usa,-,9,May,2019:,Illustrative,Editorial,Of

BioXcel Therapeutics Inc. (NASDAQ:BTAI) announced that its SERENITY At-Home Phase 3 trial of BXCL501—its sublingual dexmedetomidine film for acute agitation in bipolar disorder or schizophrenia—met its primary endpoint.

The results show consistent symptom reduction across 2,400+ episodes. It will now support an FDA supplemental filing to expand Igalmi's label for at-home use in Q1 2026.

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