---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-069149"
form_type: "8-K"
ticker: "BTAI"
cik: "0001720893"
company_name: "BioXcel Therapeutics, Inc."
filed_at: "2025-07-21T23:59:59+00:00"
generated_at: "2026-05-18T05:09:30.694841+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# BioXcel submits pre-sNDA package to FDA for IGALMI outpatient label expansion

## Summary
- Pre-sNDA meeting package submitted July 21, 2025 for IGALMI (BXCL501) outpatient use.
- FDA meeting scheduled for August 20, 2025 to align on sNDA content and format.
- Expansion targets acute agitation in schizophrenia or bipolar disorders at-home setting.
- Plans to reconfirm prior Type C meeting (March 6, 2024) support for 120 mcg dose development.
- sNDA submission preparation ongoing; no guarantee of FDA approval.

## SEC filing metadata
- accession: 0001104659-25-069149
- form_type: 8-K
- ticker: BTAI
- cik: 0001720893
- company_name: BioXcel Therapeutics, Inc.
- filed_at: 2025-07-21T23:59:59+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/1720893/000110465925069149/0001104659-25-069149-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1720893/000110465925069149/tm2521267d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-069149
- JSON: https://secwatch.observer/filing/0001104659-25-069149.json
- Plain text: https://secwatch.observer/filing/0001104659-25-069149.txt

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