BioXcel expects to submit IGALMI at-home sNDA early Q1 2026

BioXcel Therapeutics, Inc.

Completed SERENITY At-Home Phase 3 safety trial in August 2025; positive topline data.
Correlation study completed October 2025 with positive results supporting efficacy outcomes.
sNDA submission for at-home label expansion now expected early Q1 2026 (previously no firm date).
IGALMI currently approved only for acute agitation in bipolar/schizophrenia in supervised settings.

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