(Reuters) -BioXcel Therapeutics plans to seek expanded approval for at-home use of its agitation drug after it met the main goal of a late-stage study in patients with bipolar disorder or schizophrenia, the company said on Wednesday.
Its shares were up nearly 10% in volatile trading before the bell.
The drug, BXCL501, met the main goal of being well-tolerated in the at-home treatment of agitation episodes in patients with bipolar disorders or schizophrenia, the company said.
Also known as dexmedetomidine, the drug is sold as Igalmi in the United States for acute treatment of agitation associated with schizophrenia or bipolar I or II disorder in medically supervised settings.
The company said it plans to submit the application for expanded approval in the first quarter of 2026.
BioXcel