UPDATE -- BioXcel Therapeutics Announces SERENITY At-Home Pivotal Phase 3 Safety Trial Met its Primary Endpoint in Support of sNDA Submission for Label Expansion of IGALMI®

Core Insights - BioXcel Therapeutics announced that BXCL501 achieved the primary endpoint of being well tolerated in the SERENITY At-Home trial for treating agitation episodes in patients with bipolar disorders or schizophrenia [1][2][3] - The company plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 for expanded usage of BXCL501 in outpatient settings without healthcare provider supervision [1][2][3] - The SERENITY At-Home trial treated over 2400 episodes of agitation, indicating a larger potential market opportunity for BXCL501 [1][2][3] Company Overview - BioXcel Therapeutics is a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience [2][30] - BXCL501 is a proprietary sublingual film formulation of dexmedetomidine, currently FDA-approved for use in medically supervised settings [2][23][24] - The SERENITY At-Home trial is a pivotal Phase 3 study designed to evaluate the safety of BXCL501 for acute treatment of agitation in the home setting [2][22] Trial Results - The SERENITY At-Home trial was a double-blind, placebo-controlled study involving 246 patients, with 168 patients (81%) completing the full 12-week trial [6][22] - The 120 mcg dose of BXCL501 was well-tolerated, with no discontinuations due to tolerability issues [5][13] - Adverse events were consistent with the approved IGALMI label, with no new or unexpected treatment-emergent adverse events reported [13][19] Market Insights - Previous estimates indicated 23 million annual episodes of agitation, but new data suggests the total addressable market could be significantly higher, with estimates ranging from 57 million to 77 million episodes annually in the U.S. [19] - The majority of agitation episodes are believed to be moderate or severe, highlighting a significant unmet medical need for effective at-home treatments [19][26] - Physicians report underdiagnosis and undertreatment of agitation episodes in community settings, with only a third of patients receiving prescription drugs [19]