BioXcel Seeks FDA Approval for At-Home Use of IGALMI in Bipolar and Schizophrenia Agitation

BioXcel Therapeutics plans to submit an sNDA to the FDA this month for at-home use of IGALMI in treating agitation associated with bipolar disorder or schizophrenia. IGALMI is a sublingual film formulation that provides rapid relief of agitation. The company aims to expand its availability for administration in the home environment. Net revenue from IGALMI was $98 thousand in Q3 2025, compared to $214 thousand in the same period in 2024. The sNDA follows progress in BioXcel's SERENITY and TRANQUILITY programs.