BioXcel to host investor call on SERENITY At-Home trial results

NEW HAVEN, Conn. - BioXcel Therapeutics, Inc. (NASDAQ:BTAI), whose stock has surged nearly 187% over the past six months despite showing high price volatility, will host an investor call and webcast on Wednesday, August 27, 2025, at 8 a.m. ET to present topline data from its SERENITY At-Home Pivotal Phase 3 trial, the company announced Tuesday. According to InvestingPro data, the company’s market capitalization stands at $75.6 million, with the stock currently trading near its Fair Value.

The trial evaluated the safety of BXCL501, a proprietary sublingual film formulation of dexmedetomidine, for treating acute agitation associated with bipolar disorders or schizophrenia in at-home settings. With current revenue of just $870,000 in the last twelve months and significant R&D investments, InvestingPro analysis indicates the company faces near-term profitability challenges, with analysts not expecting positive earnings this year.

The SERENITY At-Home study involved 200 patients with histories of agitation episodes despite stable treatment for their underlying conditions. Participants self-administered either 120 mcg of BXCL501 or placebo during agitation episodes over a 12-week period, with safety data collected throughout the trial.

BXCL501 is currently approved by the FDA under the brand name IGALMI for acute treatment of agitation associated with schizophrenia and bipolar disorders in adults when administered under healthcare provider supervision. The drug has received Breakthrough Therapy designation for agitation associated with dementia and Fast Track designation for acute treatment of agitation associated with schizophrenia, bipolar disorders, and dementia.

Common side effects of IGALMI in clinical studies include drowsiness, mouth numbness or tingling, dizziness, dry mouth, and low blood pressure.

BioXcel Therapeutics describes itself as a biopharmaceutical company using artificial intelligence to develop neuroscience medicines. The company’s approach involves leveraging existing approved drugs and clinical candidates with data analytics to identify new therapeutic applications.

The information in this article is based on a company press release statement.

In other recent news, BioXcel Therapeutics has completed the database lock for its pivotal Phase 3 SERENITY At-Home trial, which evaluates BXCL501 for treating agitation in bipolar disorder or schizophrenia patients. The company anticipates releasing the study’s topline results later this month. Additionally, BioXcel has filed a prospectus supplement for an $80 million at-the-market equity offering, with Canaccord Genuity LLC designated as the sales agent. H.C. Wainwright has raised its price target on BioXcel Therapeutics to $10 from $8, maintaining a Buy rating in anticipation of the upcoming clinical trial data. The company also received positive feedback from the FDA concerning the potential expansion of BXCL501 for at-home use, which supports its planned sNDA submission set for the first quarter of 2026. Moreover, BioXcel has received FDA alignment for IGALMI’s use in at-home settings, further solidifying its regulatory plans. These developments highlight BioXcel’s ongoing efforts to advance its treatment options and secure regulatory approvals.

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