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. (BTAI) is a clinical-stage biopharmaceutical company pioneering AI-driven drug re-innovation in neuroscience and immuno-oncology. This page serves as the definitive source for official updates including clinical trial progress, regulatory milestones, and strategic initiatives.
Investors and industry observers will find curated press releases detailing advancements in BXCL501 development for neuropsychiatric conditions, immuno-oncology research through subsidiary OnkosXcel, and financial disclosures. Our news collection enables stakeholders to track how machine learning accelerates therapeutic discovery while managing development risks.
Content is organized to highlight essential updates: clinical trial results, regulatory filings, research collaborations, and financial performance. Each update reflects BioXcel's unique approach combining big data analytics with established clinical science to address unmet medical needs.
Bookmark this page for direct access to verified information about BioXcel's innovative pipeline and corporate developments. Check regularly for updates on how artificial intelligence continues to reshape therapeutic discovery in high-need medical specialties.
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.
BioXcel Therapeutics (NASDAQ: BTAI) has submitted a pre-supplemental New Drug Application (pre-sNDA) meeting package to the FDA for IGALMI®, seeking potential label expansion for outpatient use in treating acute agitation associated with bipolar disorders or schizophrenia.
The company has scheduled a pre-sNDA meeting with the FDA for August 20, 2025, following a previous Type C meeting on March 6, 2024. BioXcel is nearing completion of the SERENITY At-Home Pivotal Phase 3 trial, with top-line results expected this quarter. The development addresses a significant unmet need, as approximately 23 million annual episodes of agitation occur in the at-home setting in the U.S., with no current FDA-approved therapies available.
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