BioXcel Therapeutics, Inc. (BTAI) announced plans to submit an sNDA this month seeking FDA approval for at-home use of IGALMI in the acute treatment of agitation associated with bipolar disorder or schizophrenia. Agitation is a common and disruptive symptom in patients with serious mental health conditions, often requiring urgent intervention. Currently, there are no FDA-approved options for managing agitation in the at-home setting, leaving patients and caregivers with limited choices. IGALMI (dexmedetomidine) is a sublingual film formulation of a selective alpha-2 adrenergic receptor agonist, designed to provide rapid relief of agitation. Already approved for use under healthcare supervision, the new sNDA aims to expand its availability for administration in the home environment. Net revenue from IGALMI was $98 thousand for the third quarter of 2025, compared to $214 thousand for the same period in 2024. The sNDA submission follows progress in BioXcel's SERENITY and TRANQUILITY programs, which are evaluating IGALMI and its investigational counterpart BXCL501 across neuropsychiatric indications. BXCL501 has received Breakthrough Therapy designation for agitation associated with dementia. BioXcel's CEO, Vimal Mehta, said the company is focused on launch planning and anticipates that IGALMI could be approved for at-home use as early as 2026. This milestone would mark a significant expansion of IGALMI's role in neuropsychiatry, potentially transforming how agitation is managed outside of clinical settings. BTAI has traded between $1.17 and $9.26 over the past year. The stock is currently trading in the pre-market at $1.81, up 4.02%.
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May 01, 2026 15:54 ET Central banks dominated the economics news flow this week with almost all major ones announcing their latest policy decisions and many boosted expectations for a rate hike in June. In other news, several countries released the preliminary data for first quarter economic growth. In the U.S., comments by Fed Chair Jerome Powell were also in focus as his term ends this month.