secwatch.observer — SEC 8-K summary
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Issuer:     BioXcel Therapeutics, Inc. (BTAI)
CIK:        0001720893
Form:       8-K
Filed at:   2026-04-01T23:59:59+00:00
Accession:  0001104659-26-038174
Event type: regulatory
Sentiment:  neutral
Materiality: 0.65
Item codes: 8.01
LLM model:  deepseek-v4-flash:cloud@v2

BioXcel announces FDA acceptance of sNDA for IGALMI in at-home agitation; PDUFA Nov 14, 2026
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- FDA accepted supplemental New Drug Application for IGALMI (dexmedetomidine) for acute agitation in bipolar disorders or schizophrenia in outpatient setting.
- PDUFA target action date is November 14, 2026.
- If approved, IGALMI would be the first sublingual film for at-home agitation treatment.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1720893/000110465926038174/0001104659-26-038174-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1720893/000110465926038174/tm2610820d1_8k.htm
  HTML page:      https://secwatch.observer/filing/0001104659-26-038174

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