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 (BTAI) is sponsoring a virtual roundtable on Dec. 8, 2025 at 10:00 a.m. EST focused on treating acute agitation linked to bipolar disorder and schizophrenia.
Hosted by journalist Anjalee Khemlani, the one-hour event features Drs. Leslie Citrome, Marc Milano, and Leon Ravin discussing the potential for safe, self‑administered at‑home treatments and shifting care outside emergency and inpatient settings. The release cites an estimated 57–77 million annual at‑home agitation episodes in the U.S. Pre-registration is available and a recording will be posted to the BioXcel Therapeutics website.
BioXcel Therapeutics (Nasdaq: BTAI) reported Q3 2025 results and late-stage program updates for BXCL501/IGALMI. The company plans an sNDA submission in early Q1 2026 seeking FDA approval for at-home use based on positive SERENITY At-Home Phase 3 safety data.
SERENITY enrolled 246 patients (2,628 episodes); no drug-related SAEs, syncopes, or falls; tolerability consistent with approved IGALMI label. TRANQUILITY In-Care Phase 3 for Alzheimer’s agitation is being prepared after FDA protocol feedback. Company cites a revised U.S. TAM of 57–77M agitation episodes annually.
Q3 financials: IGALMI revenue $98k; R&D $8.7M; operating loss $14.2M; net loss $30.9M; cash $37.3M as of Sept 30, 2025.
BioXcel Therapeutics (Nasdaq: BTAI) reported positive correlation results supporting exploratory efficacy outcomes from the SERENITY At-Home program and plans to include the data in a supplemental New Drug Application (sNDA) targeted for Q1 2026.
In a prospective, open‑label in‑clinic study of 33 patients, the modified CGI‑S (mCGI‑S) scored by patients and caregivers strongly correlated with clinician PEC scores: ρ=0.89, p<0.0001 for patients and ρ=0.88, p<0.0001 for informants. No serious adverse events were reported and safety remained consistent with the IGALMI label. Company plans to include these findings in the sNDA and present additional data at upcoming medical meetings.
BioXcel Therapeutics (Nasdaq: BTAI) will ring the Nasdaq Closing Bell on October 14, 2025 to commemorate a milestone in its neuroscience program.
CEO Vimal Mehta and company representatives will mark the event following the successful completion of the SERENITY At-Home pivotal trial for IGALMI®, highlighting the company’s focus on treating agitation associated with bipolar disorder and schizophrenia. The ceremony begins at 3:45 PM ET at Nasdaq MarketSite and will be streamed live.
BioXcel Therapeutics (Nasdaq: BTAI), an AI-focused biopharmaceutical company, has successfully regained compliance with Nasdaq's market value of listed securities (MVLS) requirements. The company had previously received a non-compliance notice on March 20, 2025, for failing to maintain an MVLS above $35.0 million for 30 consecutive business days.
Following a hearing before the Nasdaq Hearing Panel on May 1, 2025, BioXcel was granted an exception period to regain compliance. On September 17, 2025, Nasdaq confirmed the company's return to compliance with all Capital Market listing requirements, officially closing the matter.
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.