secwatch.observer — SEC 8-K summary
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Issuer:     BioXcel Therapeutics, Inc. (BTAI)
CIK:        0001720893
Form:       8-K
Filed at:   2025-10-14T23:59:59+00:00
Accession:  0001104659-25-098992
Event type: regulatory
Sentiment:  positive
Materiality: 0.75
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

BioXcel Therapeutics reports strong correlation between clinician & caregiver agitation scales; sNDA planned Q1 2026
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- Correlation study (N=33) shows ρ=0.89 (patient) and ρ=0.88 (informant) between PEC and mCGI-S scales, p<0.0001.
- No serious adverse events; safety profile consistent with IGALMI label.
- Results to be included in sNDA submission for BXCL501 planned for Q1 2026.
- mCGI-S scale developed with FDA for at-home efficacy assessment of acute agitation.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1720893/000110465925098992/0001104659-25-098992-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1720893/000110465925098992/tm2528636d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-25-098992

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