secwatch.observer — SEC 8-K summary
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Issuer:     BioXcel Therapeutics, Inc. (BTAI)
CIK:        0001720893
Form:       8-K
Filed at:   2026-01-20T23:59:59+00:00
Accession:  0001104659-26-004787
Event type: regulatory
Sentiment:  positive
Materiality: 0.70
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

BioXcel submits sNDA for at-home use of IGALMI for agitation in bipolar/schizophrenia
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- Submitted sNDA to FDA on January 14, 2026 for IGALMI in the at-home setting.
- IGALMI currently approved only under healthcare provider supervision since April 2022.
- No FDA-approved at-home options exist for acute agitation in bipolar disorders or schizophrenia.
- Seeking to expand IGALMI's label to cover broader at-home patient population.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1720893/000110465926004787/0001104659-26-004787-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1720893/000110465926004787/tm263511d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-004787

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