BioXcel receives positive FDA pre-sNDA comments for BXCL501 at-home use; sNDA on track for Q1 2026

BioXcel Therapeutics, Inc.

FDA provided positive written feedback on August 14, 2025 for BXCL501 sNDA in agitation associated with bipolar disorders or schizophrenia for outpatient setting.
Pre-sNDA meeting originally scheduled for August 20, 2025 is cancelled as objectives accomplished based on FDA written responses.
Company believes sNDA regulatory package will be sufficient; submission remains on track for first quarter of 2026.
This expands potential use of BXCL501 (IGALMI) from inpatient to at-home treatment for acute agitation.

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