BTAI News & Events

Reports Q1 revenue $206,000, consensus $381,490. "The first quarter was marked by tremendous progress, achieving a major regulatory milestone and developing the IGALMI commercial launch plan for the at-home setting," said Vimal Mehta, CEO of BioXcel Therapeutics. "We are very pleased with the recent approval of another product in Alzheimer's agitation, in an area adjacent to our focus on the acute treatment of agitation in Alzheimer's dementia with BXCL501. Our first-in-class mechanism has the potential to make a transformative impact on the lives of a large patient population in this disease area. We are actively pursuing strategic options to maximize shareholder value for the IGALMI franchise."

BioXcel Therapeutics announced the enrollment of the first patients in a U.S. Department of War-funded Phase 2a clinical trial evaluating BXCL501 for the treatment of acute stress reactions, also known as acute stress disorder. The trial is being led by the University of North Carolina at Chapel Hill Institute of Trauma Recovery and marks a significant milestone in the collaboration between BioXcel Therapeutics and UNC.

BioXcel Therapeutics announced that the FDA has accepted its supplemental new drug application, or sNDA, for approval of Igalmi for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. The FDA has assigned a Prescription Drug User Fee Act target action date of November 14.