Welcome to our dedicated page for Bioxcel Therapeutics news (Ticker: BTAI), a resource for investors and traders seeking the latest updates and insights on Bioxcel Therapeutics stock.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) is a biopharmaceutical company that uses artificial intelligence, big data, and proprietary machine learning algorithms to develop medicines in neuroscience. News about BioXcel Therapeutics often centers on its commercial product IGALMI (dexmedetomidine) sublingual film and its investigational program BXCL501 for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and Alzheimer’s dementia.
Investors and clinicians following BTAI news can expect updates on late‑stage clinical programs such as the SERENITY At‑Home Pivotal Phase 3 trial, which evaluated the safety of a 120 mcg dose of BXCL501 for at‑home treatment of agitation in bipolar disorders or schizophrenia, and the TRANQUILITY In‑Care Phase 3 trial, designed to study agitation associated with Alzheimer’s dementia in care facilities. Company announcements have highlighted that SERENITY At‑Home met its primary safety endpoint and reported exploratory efficacy findings related to repeated dosing and symptom resolution across thousands of agitation episodes.
BioXcel Therapeutics’ news flow also includes regulatory and development milestones, such as plans to submit a supplemental New Drug Application (sNDA) seeking FDA approval for IGALMI use in the at‑home setting, positive correlation study results supporting the use of the modified CGI‑S scale, and presentations of clinical data at medical conferences. Corporate updates, including financing activities under an at‑the‑market equity program, Nasdaq listing compliance notices, and leadership or governance developments, are typically disclosed through SEC filings and press releases.
This news page aggregates these company‑specific developments so readers can review BioXcel Therapeutics’ clinical, regulatory, and corporate announcements over time. For those tracking BTAI, it provides a focused view of how the IGALMI and BXCL501 programs, as well as the broader pipeline through OnkosXcel Therapeutics in immuno‑oncology, progress through research, regulatory review, and commercialization efforts.
BioXcel Therapeutics (Nasdaq: BTAI), an AI-driven biopharmaceutical company focused on neuroscience, has announced its participation in the upcoming H.C. Wainwright 27th Annual Global Investment Conference.
CEO Vimal Mehta, Ph.D. will deliver a company overview presentation on Monday, September 8, 2025, at 4:30 p.m. Eastern Time. Investors can access the presentation through a live webcast, which will also be archived and available on the company's website under the Events & Presentations section.
BioXcel Therapeutics (Nasdaq: BTAI) announced positive results from its SERENITY At-Home Pivotal Phase 3 safety trial for BXCL501 (IGALMI®) in treating agitation episodes for bipolar disorders or schizophrenia patients at home. The trial met its primary endpoint, demonstrating favorable tolerability with no discontinuations in the treatment arm.
The study treated 2,437 agitation episodes across 208 patients, with 81% completing the full 12-week trial. The safety profile remained consistent with the approved IGALMI® label, showing no drug-related serious adverse events. Based on these results, BioXcel plans to submit a supplemental New Drug Application (sNDA) in Q1 2026 for label expansion to include at-home use without healthcare provider supervision.
The company estimates a significantly larger market opportunity of 57-77 million annual agitation episodes in the U.S., notably higher than previously reported 23 million episodes.
BioXcel Therapeutics (Nasdaq: BTAI) has scheduled an investor call and webcast for August 27, 2025, at 8:00 AM ET to present topline data from its SERENITY At-Home Pivotal Phase 3 safety trial. The study evaluates BXCL501, the company's proprietary sublingual film formulation of dexmedetomidine, for treating acute agitation in patients with bipolar disorders or schizophrenia in at-home settings.
The results will be released via press release before the call, which can be accessed through a webcast link or by dialing in. Presentation materials will be available on the company's website, with a replay accessible until November 26, 2025.
BioXcel Therapeutics (Nasdaq: BTAI) has announced the completion of database lock for its SERENITY At-Home pivotal Phase 3 safety trial, evaluating BXCL501 for acute treatment of agitation in bipolar disorders or schizophrenia patients. The study, conducted across 22 sites nationwide, enrolled over 200 patients and collected data from more than 2,600 agitation episodes.
The trial evaluated a 120 mcg dose of BXCL501 in a double-blind, placebo-controlled study. The company implemented robust oversight controls, including patient eligibility reviews and DSMB reviews. BXCL501 has received Fast Track Designation, addressing an unmet need as there are currently no FDA-approved therapies for acute agitation treatment in at-home settings. Topline results are expected in August.
BioXcel Therapeutics (NASDAQ: BTAI) has received positive pre-sNDA meeting feedback from the FDA regarding the potential expansion of IGALMI's (BXCL501) label for at-home use in treating agitation associated with bipolar disorders or schizophrenia. The company plans to submit the sNDA in Q1 2026.
The FDA's feedback confirms agreement on the content and format of the planned submission, including clinical, nonclinical, and CMC requirements. The regulatory package will include data from the Phase 3 SERENITY At-Home trial, a 12-week study evaluating the safety of 120 mcg BXCL501 dose. IGALMI is currently approved for use in medically supervised settings and is available in 120 mcg and 180 mcg doses.
Notably, BXCL501 has received Fast Track Designation, and there are currently no FDA-approved therapies for acute agitation treatment in the at-home setting.
BioXcel Therapeutics (Nasdaq: BTAI), an AI-driven biopharmaceutical company focused on neuroscience, has announced its participation in the H.C. Wainwright & Co. "HCW@Home" series. CEO Vimal Mehta, Ph.D. will engage in a virtual fireside chat on Thursday, August 14, 2025, at 1:00 p.m. ET.
The company, which leverages artificial intelligence to develop innovative medicines, will provide insights into its operations and developments during this virtual event.
BioXcel Therapeutics (Nasdaq: BTAI) reported Q2 2025 financial results and provided key updates on its clinical programs. The company completed its SERENITY At-Home Phase 3 trial for treating agitation in bipolar disorders and schizophrenia patients, with topline results expected in August. The trial enrolled over 200 patients across 22 sites, collecting data from more than 2,200 agitation episodes.
Financial results showed IGALMI® revenue of $120,000 in Q2 2025, down from $1.1M in Q2 2024. The company reported an operating loss of $15.9M and a net loss of $19.2M. Cash position stood at $18.6M as of June 30, 2025, with additional post-quarter funding of $15.1M through ATM sales and warrant exercises.
BioXcel Therapeutics (NASDAQ: BTAI), an AI-driven biopharmaceutical company focused on neuroscience, has announced its participation in the Canaccord Genuity 45th Annual Growth Conference. CEO Vimal Mehta will engage in a fireside chat on August 12, 2025, at 12 p.m. ET in Boston.
Investors can access the presentation through a webcast on the company's website under the Events & Presentations page, with the replay available for 90 days.
BioXcel Therapeutics (Nasdaq: BTAI) announced the publication of a study in Frontiers in Pharmacology demonstrating significant effects of dexmedetomidine, the active ingredient in BXCL501, in reducing stress-induced behaviors. The research supports potential applications beyond its current FDA approval as IGALMI™ for acute agitation in bipolar and schizophrenia patients.
The study revealed that dexmedetomidine showed superior potency compared to other alpha2-adrenergic receptor agonists, effectively mitigated both acute and chronic stress responses, and demonstrated favorable attributes for daily administration. Notably, the compound showed no negative impacts on motor function or cognition and positively affected sleep patterns.
BioXcel Therapeutics (Nasdaq: BTAI) has completed the last patient visit in its pivotal Phase 3 SERENITY At-Home clinical trial, evaluating IGALMI® (dexmedetomidine) for treating agitation in bipolar disorders or schizophrenia patients at home. The study collected data from over 2,200 agitation episodes across more than 200 patients at 22 sites nationwide.
The double-blind, placebo-controlled trial tested a 120 mcg dose of BXCL501 and aims to support a supplemental New Drug Application (sNDA) to expand IGALMI's label for outpatient use. Topline data is expected this month. If approved, IGALMI would become the first FDA-approved therapy for the estimated 23 million annual episodes of bipolar or schizophrenia-related agitation occurring at home in the U.S.
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