BXYRegulatoryglobenewswire

BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia

Sentiment:Positive (75)

Summary

Achieved alignment with the FDA on sNDA package to expand the IGALMI label for the At-Home (Outpatient) setting

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Article published on August 18, 2025 by globenewswire