BioXcel Therapeutics Announces Positive FDA Pre-sNDA Meeting Comments for sNDA Submission for BXCL501 in Agitation Associated with Bipolar Disorders or Schizophrenia
Achieved alignment with the FDA on sNDA package to expand the IGALMI label for the At-Home (Outpatient) setting
Related Questions
What is the expected timeline for FDA approval of the sNDA and how might that affect BXY's valuation?
How significant is the expansion of the IGALMI label to the At‑Home setting in terms of potential revenue growth?
What competitive threats exist for BXCL501 in the agitation treatment market for bipolar disorder and schizophrenia?