Bioxcel Stock Shoots Up 3% Pre-Market After Company Announces Positive Efficacy Data For Agitation Drug In Study

BioXcel Therapeutics, Inc. (BTAI) announced on Wednesday that its BXCL501 demonstrated continued effects and consistent benefit with repeat dosing in the treatment of agitation associated with bipolar disorders or schizophrenia in a late-stage trial.

BXCL501 is an investigational, orally dissolving film formulation of Dexmedetomidine, marketed by the company as Igalmi. While the primary objective of the trial was to ascertain the safety of the formulation in an at-home setting, the continued effects and consistent benefits observed with repeat dosing in the trial further support the potential of BXCL501 for use in the outpatient setting, the company said.

Shares of the company rose 3% in the pre-market session. On Stocktwits, retail sentiment around BTAI stock rose from 'extremely bearish' to 'bearish' territory over the past 24 hours, while message volume stayed at 'extremely low' levels.

BioXcel reported late last month that the drug was well-tolerated in the study. The company said that the data from the study will form the basis of a submission to the U.S. Food and Drug Administration (FDA) slated for the first quarter of 2026 and aimed at expanding the label for Dexmedetomidine in the at-home setting.

“These positive results, along with the safety and tolerability data previously announced, reinforce BXCL501's potential in the at-home setting where there is substantial unmet need with no FDA-approved options currently available,” said BioXcel CEO Vimal Mehta.

The company said that a total of 246 patients were part of the trial, and 2,437 agitation episodes in 208 patients were treated. All patients were able to successfully self-administer the film, and an average of 11.7 agitation episodes were recorded per treated patient.

Igalmi is already approved for the acute treatment of agitation associated with bipolar I or II disorder or schizophrenia in medically supervised settings.

BTAI stock is down by 40% this year and by 59% over the past 12 months.

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