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NEW HAVEN - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a clinical-stage biopharmaceutical company with a current market capitalization of $52 million, announced Wednesday positive exploratory efficacy results from its SERENITY At-Home Phase 3 trial evaluating BXCL501, a sublingual film formulation of dexmedetomidine, for treating agitation in bipolar disorders or schizophrenia in the outpatient setting. According to InvestingPro data, the company’s stock has shown significant volatility, with prices ranging from $1.17 to $13.36 over the past 52 weeks.
The trial showed BXCL501 demonstrated a significant mean reduction in modified Clinical Global Impression-Severity scores compared to placebo at two hours across 2,433 treated episodes. Complete resolution of agitation was significantly higher with BXCL501 compared to placebo across all severity levels of agitation episodes.
Data indicated consistent benefits with repeat dosing, with similar reductions in agitation symptoms maintained throughout the 12-week trial period and across multiple treated episodes.
The trial enrolled 246 patients with bipolar disorders (45%) or schizophrenia (55%), collecting data on 2,628 agitation episodes. Patients were able to self-administer the treatment, with 81% completing the full 12-week trial.
"These positive results, along with the safety and tolerability data previously announced, reinforce BXCL501’s potential in the at-home setting where there is substantial unmet need with no FDA-approved options currently available," said Vimal Mehta, CEO of BioXcel Therapeutics, according to the press release. Despite current losses of $50.95 million over the last twelve months, two analysts have recently revised their earnings estimates upward for the upcoming period, with price targets ranging widely from $1 to $66, reflecting diverse views on the company’s potential.
BXCL501, marketed as IGALMI, is currently FDA-approved for acute treatment of agitation associated with bipolar disorders or schizophrenia in medically supervised settings. Based on these results, BioXcel plans to submit a supplemental New Drug Application in the first quarter of 2026 seeking label expansion for at-home use.
The company estimates the total addressable market at 57-77 million agitation episodes annually, significantly higher than previous estimates of 23 million episodes per year. While the market opportunity appears substantial, InvestingPro analysis shows the company generated revenue of just $0.87 million in the last twelve months, with analysts anticipating a slight sales decline in the current year. For deeper insights into BioXcel’s financial health and growth potential, investors can access the comprehensive Pro Research Report, available exclusively on InvestingPro, which covers over 1,400 US stocks with detailed analysis and actionable intelligence.
In other recent news, BioXcel Therapeutics announced that its SERENITY At-Home Phase 3 trial for BXCL501 met its primary safety endpoint. This trial evaluated the sublingual film formulation of dexmedetomidine for at-home treatment of agitation in patients with bipolar disorders or schizophrenia. The 120 mcg dose was well-tolerated with no discontinuations due to tolerability issues, maintaining a consistent safety profile throughout the 12-week study period. BioXcel plans to submit a supplemental New Drug Application in the first quarter of 2026 to expand IGALMI’s usage to outpatient settings without healthcare provider supervision. The trial’s database lock has been completed, and the company expects to release topline results later this month, having collected data from over 2,600 agitation episodes across more than 200 patients. BioXcel has also scheduled an investor call to present these topline data. The trial results support a planned label expansion for IGALMI, aiming to broaden its application beyond medically supervised settings.
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