---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-26-038174"
form_type: "8-K"
ticker: "BTAI"
cik: "0001720893"
company_name: "BioXcel Therapeutics, Inc."
filed_at: "2026-04-01T23:59:59+00:00"
generated_at: "2026-05-15T07:59:20.365957+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# BioXcel announces FDA acceptance of sNDA for IGALMI in at-home agitation; PDUFA Nov 14, 2026

## Summary
- FDA accepted supplemental New Drug Application for IGALMI (dexmedetomidine) for acute agitation in bipolar disorders or schizophrenia in outpatient setting.
- PDUFA target action date is November 14, 2026.
- If approved, IGALMI would be the first sublingual film for at-home agitation treatment.

## SEC filing metadata
- accession: 0001104659-26-038174
- form_type: 8-K
- ticker: BTAI
- cik: 0001720893
- company_name: BioXcel Therapeutics, Inc.
- filed_at: 2026-04-01T23:59:59+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1720893/000110465926038174/0001104659-26-038174-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1720893/000110465926038174/tm2610820d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-26-038174
- JSON: https://secwatch.observer/filing/0001104659-26-038174.json
- Plain text: https://secwatch.observer/filing/0001104659-26-038174.txt

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