---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-004787"
form_type: "8-K"
ticker: "BTAI"
cik: "0001720893"
company_name: "BioXcel Therapeutics, Inc."
filed_at: "2026-01-20T23:59:59+00:00"
generated_at: "2026-05-16T09:34:11.788992+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# BioXcel submits sNDA for at-home use of IGALMI for agitation in bipolar/schizophrenia

## Summary
- Submitted sNDA to FDA on January 14, 2026 for IGALMI in the at-home setting.
- IGALMI currently approved only under healthcare provider supervision since April 2022.
- No FDA-approved at-home options exist for acute agitation in bipolar disorders or schizophrenia.
- Seeking to expand IGALMI's label to cover broader at-home patient population.

## SEC filing metadata
- accession: 0001104659-26-004787
- form_type: 8-K
- ticker: BTAI
- cik: 0001720893
- company_name: BioXcel Therapeutics, Inc.
- filed_at: 2026-01-20T23:59:59+00:00
- event_type: regulatory
- sentiment: positive
- materiality_score: 0.7
- calibrated_materiality_score: 0.7
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1720893/000110465926004787/0001104659-26-004787-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1720893/000110465926004787/tm263511d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-004787
- JSON: https://secwatch.observer/filing/0001104659-26-004787.json
- Plain text: https://secwatch.observer/filing/0001104659-26-004787.txt

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