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 develops AI-enabled biopharmaceutical programs in neuroscience and, through its wholly owned OnkosXcel Therapeutics subsidiary, immuno-oncology. Its news centers on IGALMI, the FDA-approved sublingual film formulation of dexmedetomidine for acute agitation associated with schizophrenia or bipolar I or II disorder in adults, and on BXCL501 development across additional neuropsychiatric settings.
Recurring updates include FDA interactions and label-expansion activity for IGALMI, commercial planning for broader use settings, financial results, and capital-raising transactions. Company announcements also cover investigator-led and funded studies of BXCL501 in areas such as acute agitation in Alzheimer’s dementia, opioid withdrawal, and acute stress reactions, alongside disclosures tied to its drug re-innovation approach using big data and machine learning.
BioXcel Therapeutics (NASDAQ: BTAI) announced positive topline exploratory efficacy data from its SERENITY At-Home Pivotal Phase 3 safety trial for BXCL501 (IGALMI®), evaluating the treatment of agitation in bipolar disorders or schizophrenia patients. The trial demonstrated significant efficacy across 2,433 treated episodes, with BXCL501 showing higher complete resolution rates compared to placebo (50% vs 33%, p.0001).Key findings include consistent benefits with repeat dosing and maintained efficacy throughout the 12-week trial period. For severe agitation episodes, 61% fully resolved with BXCL501 versus 18% with placebo. The company plans to submit a sNDA in Q1 2026 for expanded usage in outpatient settings, targeting a substantial market of 57-77M annual agitation episodes.
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.