BioXcel Therapeutics submits pre-supplemental NDA meeting package for IGALMI

BioXcel Therapeutics (BTAI) announced the submission of a pre-supplemental New Drug Application meeting package to the U.S. Food and Drug Administration for IGALMI in support of a potential label expansion for outpatient use for the acute treatment of agitation associated with bipolar disorders or schizophrenia. The primary purpose of the pre-sNDA meeting, scheduled for August 20, 2025, is to gain alignment with the FDA regarding the content and format of the planned sNDA submission, which the Company is preparing. Additionally, the Company plans to reconfirm the understanding reached during the Type C meeting with the FDA on March 6, 2024, that FDA views the Company’s current development plans as a reasonable approach to support expanding the label to include at-home (outpatient) use of 120 mcg BXCL501 for the acute treatment of agitation associated with schizophrenia or bipolar disorders in the at-home setting.