---
schema_version: "secwatch.filing_event.v1"
accession: "0001104659-25-083402"
form_type: "8-K"
ticker: "BTAI"
cik: "0001720893"
company_name: "BioXcel Therapeutics, Inc."
filed_at: "2025-08-27T23:59:59+00:00"
generated_at: "2026-05-17T09:44:21.130887+00:00"
event_type: "other_material"
sentiment: "positive"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# BioXcel Therapeutics' BXCL501 meets primary endpoint in SERENITY At-Home Phase 3 trial for agitation

## Summary
- Phase 3 SERENITY At-Home trial met primary safety endpoint; no drug-related SAEs, syncope, or falls in 2,437 episodes treated with 120 mcg BXCL501.
- No discontinuations due to tolerability in BXCL501 arm; adverse event profile consistent with approved IGALMI label.
- Company plans sNDA submission for label expansion to at-home setting in Q1 2026; market opportunity estimated at 57–77 million annual episodes in US.
- Exploratory efficacy data show greater percentage of patients achieved full agitation resolution with BXCL501 vs placebo, with consistent benefit across repeat dosing.

## SEC filing metadata
- accession: 0001104659-25-083402
- form_type: 8-K
- ticker: BTAI
- cik: 0001720893
- company_name: BioXcel Therapeutics, Inc.
- filed_at: 2025-08-27T23:59:59+00:00
- event_type: other_material
- sentiment: positive
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1720893/000110465925083402/0001104659-25-083402-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1720893/000110465925083402/tm2524474d1_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001104659-25-083402
- JSON: https://secwatch.observer/filing/0001104659-25-083402.json
- Plain text: https://secwatch.observer/filing/0001104659-25-083402.txt

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