---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-104009"
form_type: "8-K"
ticker: "BTAI"
cik: "0001720893"
company_name: "BioXcel Therapeutics, Inc."
filed_at: "2025-10-30T23:59:59+00:00"
generated_at: "2026-05-17T01:23:00.018257+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

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

## Summary
- 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.

## SEC filing metadata
- accession: 0001104659-25-104009
- form_type: 8-K
- ticker: BTAI
- cik: 0001720893
- company_name: BioXcel Therapeutics, Inc.
- filed_at: 2025-10-30T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1720893/000110465925104009/0001104659-25-104009-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1720893/000110465925104009/tm2529774d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-104009
- JSON: https://secwatch.observer/filing/0001104659-25-104009.json
- Plain text: https://secwatch.observer/filing/0001104659-25-104009.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.