BioXcel Therapeutics (BTAI) Misses Q3 EPS by 45c

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Go back to BioXcel Therapeutics (BTAI) Misses Q3 EPS by 45c

BioXcel Therapeutics Aligns with FDA Recommendation for Phase 3 Trial for TRANQUILITY Program, Provides Update on Strategic Financing, and Reports Third Quarter 2023 Financial Results

November 14, 2023 7:01 AM EST

Company plans to conduct Phase 3 trial of BXCL501 in the at-home setting for TRANQUILITY program to support potential sNDA for acute treatment of agitation associated with dementia due to probable Alzheimers disease

Potential market opportunity for BXCL501 to include acute treatment of agitation across full spectrum of Alzheimers-related dementia and agitation severity across all care settings

Based on FDA feedback, Company plans to conduct Phase 3 trial with 120 mcg (IGALMI approved dose) in the at-home setting for SERENITY III program for acute treatment of agitation in bipolar disorders or... More