secwatch.observer — SEC 8-K summary
======================================

Issuer:     BioXcel Therapeutics, Inc. (BTAI)
CIK:        0001720893
Form:       8-K
Filed at:   2025-10-30T23:59:59+00:00
Accession:  0001104659-25-104009
Event type: other_material
Sentiment:  positive
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

BioXcel expects to submit IGALMI at-home sNDA early Q1 2026
-----------------------------------------------------------

- Completed SERENITY At-Home Phase 3 safety trial in August 2025; positive topline data.
- Correlation study completed October 2025 with positive results supporting efficacy outcomes.
- sNDA submission for at-home label expansion now expected early Q1 2026 (previously no firm date).
- IGALMI currently approved only for acute agitation in bipolar/schizophrenia in supervised settings.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1720893/000110465925104009/0001104659-25-104009-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1720893/000110465925104009/tm2529774d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-104009

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer