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BioXcel Therapeutics posts new Phase 3 SERENITY At-Home data for BXCL501 in agitation linked to bipolar disorder, schizophrenia

PUBT·05/28/2026 11:01:40
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BioXcel Therapeutics posts new Phase 3 SERENITY At-Home data for BXCL501 in agitation linked to bipolar disorder, schizophrenia
  • BioXcel Therapeutics presented new analyses from its Phase 3 SERENITY At-Home trial at the 2026 ASCP Annual Meeting; primary results were disclosed earlier.
  • The exploratory readout showed BXCL501 reduced agitation versus placebo across baseline severity levels, with the strongest effect in severe episodes.
  • Benefits held up with repeat self-dosing over the 12-week study, supporting use outside supervised care settings.
  • The FDA set a Nov. 14, 2026 PDUFA date for the sNDA seeking at-home use of IGALMI for acute agitation in bipolar disorder or schizophrenia.


Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. BioXcel Therapeutics Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: 202605280700PRIMZONEFULLFEED9727896) on May 28, 2026, and is solely responsible for the information contained therein.