BTAI News & Events

BioXcel Therapeutics announced the completion of an updated market opportunity assessment for Igalmi for acute agitation associated with bipolar disorders or schizophrenia in the at-home setting, informed by results from the SERENITY At-Home clinical study. The assessment represents a key milestone in the Company's commercial preparation initiatives for Igalmi, with findings intended to inform launch planning activities. A comprehensive launch plan for Igalmi in the at-home setting is in development. The Company submitted a supplemental New Drug Application last month seeking the FDA's approval of Igalmi for at-home use in the acute treatment of agitation associated with bipolar disorders or schizophrenia. "This assessment further validates Igalmi's commercial opportunity in the at-home setting," said Mark Pavao, Interim Chief Commercial Officer of BioXcel Therapeutics. "The strong prescriber and patient interest, as well as positive payer feedback on potential formulary coverage, reinforce our confidence in launch planning and represent a critical step as we advance our commercial strategy. We will build on these insights as we develop and finalize a comprehensive launch plan."

BioXcel Therapeutics announced it submitted a supplemental New Drug Application, sNDA, to the U.S. Food and Drug Administration, FDA, for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting with Igalmi. The sNDA was submitted on January 14, 2026. "We are pleased with the successful submission of this sNDA for IGALMI, which represents an important milestone in expanding access to patients who are experiencing acute agitation episodes in the at-home setting," said Vimal Mehta, Ph.D., Chief Executive Officer of BioXcel Therapeutics. "The submission is supported by results from the Phase 3 SERENITY At-Home safety trial, fulfilling a clear unmet medical need in the at-home setting where agitation often originates. This supports the Company's mission of driving a broader and more convenient access to a critical treatment option across care-settings."