---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-079459"
form_type: "8-K"
ticker: "BTAI"
cik: "0001720893"
company_name: "BioXcel Therapeutics, Inc."
filed_at: "2025-08-18T23:59:59+00:00"
generated_at: "2026-05-17T11:58:01.298898+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# BioXcel receives positive FDA pre-sNDA comments for BXCL501 at-home use; sNDA on track for Q1 2026

## Summary
- FDA provided positive written feedback on August 14, 2025 for BXCL501 sNDA in agitation associated with bipolar disorders or schizophrenia for outpatient setting.
- Pre-sNDA meeting originally scheduled for August 20, 2025 is cancelled as objectives accomplished based on FDA written responses.
- Company believes sNDA regulatory package will be sufficient; submission remains on track for first quarter of 2026.
- This expands potential use of BXCL501 (IGALMI) from inpatient to at-home treatment for acute agitation.

## SEC filing metadata
- accession: 0001104659-25-079459
- form_type: 8-K
- ticker: BTAI
- cik: 0001720893
- company_name: BioXcel Therapeutics, Inc.
- filed_at: 2025-08-18T23:59:59+00:00
- event_type: regulatory
- 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/1720893/000110465925079459/0001104659-25-079459-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1720893/000110465925079459/tm2523368d4_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-079459
- JSON: https://secwatch.observer/filing/0001104659-25-079459.json
- Plain text: https://secwatch.observer/filing/0001104659-25-079459.txt

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