Biotech News

BioXcel Therapeutics Reports Fourth Quarter and Full-Year 2025 Financial Results as Company Prepares for Potential IGALMI® Approval in Outpatient Setting

BioXcel (BTAI)BioXcel2026-03-27 11:00 ESTFDA / regulatory

sNDA submitted seeking approval of IGALMI ® in the at-home (outpatient) setting for the treatment of acute agitation associated with bipolar disorders or schizophrenia sNDA submission timeline supports potential approval as early as year-end 2026 Advancing commercial and launch plans based on

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BioXcel

BioXcel Therapeutics is a neuroscience and immuno-oncology company focused on using artificial intelligence to identify therapeutic candidates. Its story combines data-driven discovery with development-stage biotech execution.

Recent company news

BTAIBioXcel2026-05-28 11:00 EST

BioXcel Therapeutics Presents New Data from SERENITY At-Home Phase 3 Trial for Agitation Associated with Bipolar Disorders or Schizophrenia at 2026 ASCP Annual Meeting

BTAIBioXcel2026-05-15 11:00 EST

BioXcel Therapeutics Provides Business Update and Reports First Quarter 2026 Financial Results

BTAIBioXcel2026-04-17 11:00 EST

BioXcel Therapeutics Announces Virtual Event to Discuss Commercial Launch Plan Based on Market Opportunity Assessment for IGALMI® in the At-Home Setting

BTAIBioXcel2026-04-08 11:00 EST

BioXcel Therapeutics Announces Enrollment of First Patients in U.S. Department of War-Funded Study of BXCL501 (Sublingual Dexmedetomidine) for Treatment of Acute Stress Reactions

BTAIBioXcel2026-04-01 11:00 EST

BioXcel Therapeutics Announces Food & Drug Administration Acceptance of Supplemental New Drug Application for Use of IGALMI® in the At-Home Setting

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