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

Core Insights - BioXcel Therapeutics has achieved alignment with the FDA on the supplemental New Drug Application (sNDA) package to expand the IGALMI label for at-home use, with submission expected in Q1 2026 [1][2][3] Group 1: FDA Interaction and Regulatory Progress - The company received positive feedback from the FDA during a pre-sNDA meeting, confirming that the planned regulatory package is sufficient for submission [2][4] - The objectives of the pre-sNDA meeting were accomplished, leading to the cancellation of the originally scheduled meeting [3] - The acceptance of the sNDA will depend on the FDA's review of the complete filing [3] Group 2: Clinical Trials and Product Details - The SERENITY At-Home Phase 3 trial is designed to evaluate the safety of a 120 mcg dose of BXCL501 for treating agitation associated with bipolar disorders or schizophrenia in an at-home setting [6] - The trial involves 200 patients and is a double-blind, placebo-controlled study, with topline data expected soon [4][6] - IGALMI is currently FDA-approved for acute treatment of agitation in medically supervised settings, available in 120 mcg and 180 mcg doses [4][9] Group 3: Market Potential and Designation - BXCL501 has received Fast Track Designation for the acute treatment of agitation associated with bipolar disorders and schizophrenia, with no FDA-approved therapies for at-home treatment currently available [5][8] - The company aims to address the urgent needs of patients suffering from bipolar disorder or schizophrenia, potentially transforming the treatment paradigm [4][5]