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BioXcel Therapeutics Submits Supplemental New Drug Application to U.S. Food and Drug Administration for IGALMI® Label Expansion in the At-Home Setting

BioXcel (BTAI)BioXcelFDA / regulatory

sNDA submission supports the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home (outpatient) setting with IGALMI ® Submission timeline supports potential approval of IGALMI ® label expansion as early as year-end 2026 NEW HAVEN, Conn., Jan.

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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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