BXY News

BioXcel Therapeutics Announces Database Lock in SERENITY At-Home Pivotal Phase 3 Safety Trial for Acute Treatment of Agitation Associated with Bipolar Disorders or Schizophrenia

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Data from more than 2,600 agitation episodes collected

BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia

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Achieved alignment with the FDA on sNDA package to expand the IGALMI label for the At-Home (Outpatient) setting

BioXcel Therapeutics Reports Second Quarter 2025 Financial Results and Recent Business Updates

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Topline data from SERENITY At-Home Phase 3 trial for acute treatment of agitation associated with bipolar disorders or schizophrenia expected in August

August 12, 2025Earnings
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