---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-079042"
form_type: "8-K"
ticker: "BTAI"
cik: "0001720893"
company_name: "BioXcel Therapeutics, Inc."
filed_at: "2025-08-15T23:59:59+00:00"
generated_at: "2026-05-17T12:27:12.464595+00:00"
event_type: "regulatory"
sentiment: "positive"
materiality_score: 0.7
calibrated_materiality_score: 0.7
confidence: "high"
source: SEC EDGAR
---

# BioXcel receives positive FDA preliminary comments ahead of pre-sNDA meeting

## Summary
- Positive preliminary FDA meeting comments received August 14, 2025.
- Pre-sNDA meeting scheduled for August 20, 2025 to align on sNDA submission format and content.
- Company evaluating feedback and plans to provide update next week.

## SEC filing metadata
- accession: 0001104659-25-079042
- form_type: 8-K
- ticker: BTAI
- cik: 0001720893
- company_name: BioXcel Therapeutics, Inc.
- filed_at: 2025-08-15T23:59:59+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/1720893/000110465925079042/0001104659-25-079042-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1720893/000110465925079042/tm2523368d3_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-079042
- JSON: https://secwatch.observer/filing/0001104659-25-079042.json
- Plain text: https://secwatch.observer/filing/0001104659-25-079042.txt

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