BioXcel submits pre-sNDA package to FDA for IGALMI outpatient label expansion

BioXcel Therapeutics, Inc.

Pre-sNDA meeting package submitted July 21, 2025 for IGALMI (BXCL501) outpatient use.
FDA meeting scheduled for August 20, 2025 to align on sNDA content and format.
Expansion targets acute agitation in schizophrenia or bipolar disorders at-home setting.
Plans to reconfirm prior Type C meeting (March 6, 2024) support for 120 mcg dose development.
sNDA submission preparation ongoing; no guarantee of FDA approval.

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