BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia
Provided By GlobeNewswire
Last update: Aug 18, 2025
Achieved alignment with the FDA on sNDA package to expand the IGALMI label for the At-Home (Outpatient) setting
sNDA submission on track for Q1 2026
Read more at globenewswire.com4.05
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