Bioxcel Therapeutics Soars 16.03% on Positive Clinical Trial Data

On August 27, 2025, Bioxcel Therapeutics' stock surged by 16.03% in pre-market trading, driven by significant developments in its clinical trials and upcoming investor communications.

Bioxcel Therapeutics is set to host a conference call and live webcast at 8 a.m. ET on August 27, 2025, to review the topline data from the SERENITY At-Home Pivotal Phase 3 trial. This trial is evaluating the safety of BXCL501, a proprietary sublingual film formulation of dexmedetomidine, as an acute treatment for agitation associated with bipolar disorders or schizophrenia in the at-home setting. The data will be presented during the investor call and webcast, providing insights into the efficacy and safety of BXCL501 in this specific patient population.

The SERENITY At-Home Phase 3 trial involved 200 patients with a history of agitation episodes despite being on stable treatment for their underlying bipolar or schizophrenia. Patients self-administered 120 mcg of BXCL501 or a placebo when they experienced agitation episodes over a 12-week period. The trial collected safety data and included a modified global impression of severity (mCGIs) as an exploratory endpoint to assess the experience in the outpatient setting.

BXCL501, outside of its approved indication by the U.S. Food and Drug Administration as IGALMI, is under investigation for the acute treatment of agitation associated with Alzheimer’s dementia and for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in the at-home setting. The drug has been granted Breakthrough Therapy designation by the FDA for the acute treatment of agitation associated with dementia and Fast Track designation for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.