---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-088800"
form_type: "8-K"
ticker: "BTAI"
cik: "0001720893"
company_name: "BioXcel Therapeutics, Inc."
filed_at: "2025-09-10T23:59:59+00:00"
generated_at: "2026-05-17T07:02:16.434116+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.88
calibrated_materiality_score: 0.88
confidence: "high"
source: SEC EDGAR
---

# BioXcel reports positive Phase 3 SERENITY At-Home data for BXCL501; agitation resolution significantly higher vs placebo

## Summary
- SERENITY At-Home trial: 246 patients randomized; BXCL501 showed significant mean reduction in mCGI-S score vs placebo at 2 hours (p<.05).
- Complete resolution of agitation in 50% of BXCL501 arm vs 33% placebo overall (p<.0001); severe episodes resolved 61% vs 18% (p<.0001).
- Efficacy maintained across repeated dosing and over 12-week duration; mean reduction of 1.2-1.4 in mCGI-S score.
- Company revises addressable market estimate to 57-77M agitation episodes annually (from prior 23M) based on trial and survey data.
- BXCL501 (IGALMI) is already FDA-approved for medically supervised settings; data supports potential label expansion for at-home use.

## SEC filing metadata
- accession: 0001104659-25-088800
- form_type: 8-K
- ticker: BTAI
- cik: 0001720893
- company_name: BioXcel Therapeutics, Inc.
- filed_at: 2025-09-10T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.88
- calibrated_materiality_score: 0.88
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1720893/000110465925088800/0001104659-25-088800-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1720893/000110465925088800/tm2525736d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-088800
- JSON: https://secwatch.observer/filing/0001104659-25-088800.json
- Plain text: https://secwatch.observer/filing/0001104659-25-088800.txt

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