BioXcel Therapeutics Reports Positive Phase 3 Results for IGALMI At-Home Use

Reuters10-30

BioXcel <a href="https://laohu8.com/S/LENZ">Therapeutics</a> Reports Positive Phase 3 Results for IGALMI At-Home Use

BioXcel Therapeutics Inc. announced the completion of the SERENITY At-Home Pivotal Phase 3 Safety Trial for IGALMI®, which is approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings. The company reported positive topline safety and exploratory efficacy data from the trial in August 2025. Additionally, in October 2025, BioXcel completed a correlation study that supported the exploratory efficacy outcomes of the SERENITY At-Home trial and announced positive results. The data from these studies will be included in a planned Supplemental New Drug Application (sNDA) to the FDA, seeking to expand the label for IGALMI® to include at-home use. The company expects to complete the sNDA submission in the first quarter of 2026.

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 EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001104659-25-104009), on October 30, 2025, and is solely responsible for the information contained therein.

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