---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-019531"
form_type: "8-K"
ticker: "BTAI"
cik: "0001720893"
company_name: "BioXcel Therapeutics, Inc."
filed_at: "2025-03-03T23:59:59+00:00"
generated_at: "2026-05-25T19:05:06.560323+00:00"
event_type: "other_material"
sentiment: "negative"
materiality_score: 0.65
calibrated_materiality_score: 0.65
confidence: "high"
source: SEC EDGAR
---

# BioXcel: FDA inspection closed with VAI; SERENITY trial enrolling; Nasdaq compliance regained; CMO resigns

## Summary
- FDA closed TRANQUILITY II site inspection with 'Voluntary Action Indicated'; no regulatory action taken.
- SERENITY At-Home Phase 3 trial: 23 sites open, enrolling; topline data expected H2 2025 for sNDA.
- Regained compliance with Nasdaq minimum bid price rule; notice received Feb 28, 2025.
- Vincent J. O'Neill, M.D. resigned as EVP, Chief of Product Development and Medical Officer.

## SEC filing metadata
- accession: 0001104659-25-019531
- form_type: 8-K
- ticker: BTAI
- cik: 0001720893
- company_name: BioXcel Therapeutics, Inc.
- filed_at: 2025-03-03T23:59:59+00:00
- event_type: other_material
- sentiment: negative
- materiality_score: 0.65
- calibrated_materiality_score: 0.65
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1720893/000110465925019531/0001104659-25-019531-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1720893/000110465925019531/tm258055d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-019531
- JSON: https://secwatch.observer/filing/0001104659-25-019531.json
- Plain text: https://secwatch.observer/filing/0001104659-25-019531.txt

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