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) announced a strategic shift, prioritizing late-stage clinical programs for BXCL501 in bipolar disorders, schizophrenia, and Alzheimer's disease while deprioritizing sales efforts for its approved drug IGALMI™. The company has initiated the SERENITY At-Home pivotal Phase 3 trial for agitation in bipolar disorders or schizophrenia and submitted a protocol to the FDA for the TRANQUILITY In-Care pivotal Phase 3 trial for Alzheimer's dementia-related agitation. BioXcel will maintain IGALMI in the market without its current commercial infrastructure, focusing resources on developing BXCL501 for potential new markets. This strategic move aims to optimize resource allocation and advance the company's lead neuroscience asset into promising growth opportunities.
BioXcel Therapeutics (Nasdaq: BTAI) has initiated patient enrollment in its SERENITY At-Home pivotal Phase 3 trial. The study will evaluate the safety of BXCL501, an investigational orally dissolving film formulation of dexmedetomidine, for the acute treatment of agitation associated with bipolar disorders or schizophrenia in the at-home setting. The trial is expected to last 9-12 months and will enroll approximately 200 patients. Participants will self-administer 120 mcg of BXCL501 or placebo during agitation episodes over a 12-week period. The primary objective is safety, with an exploratory endpoint using a modified clinical global impression of change (mCGI-C) to evaluate patient and caregiver impressions. This trial addresses a significant unmet need, as there are currently no FDA-approved therapies for at-home treatment of agitation in these conditions.
BioXcel Therapeutics (Nasdaq: BTAI), a biopharmaceutical company focusing on AI-driven neuroscience and immuno-oncology medicines, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference. The event will take place in Boston on August 13, 2024.
CEO Vimal Mehta, Ph.D., will engage in a fireside chat at 1 p.m. ET, accompanied by Vincent J. O'Neill, M.D., Executive VP and Chief of Product Development and Medical Officer. Interested parties can access a live webcast of the discussion through the company's website. The replay will be available for 90 days post-event.
BioXcel Therapeutics (Nasdaq: BTAI) reported its Q2 2024 financial results, highlighting progress in key clinical programs. The company is preparing to initiate the SERENITY At-Home pivotal Phase 3 trial for BXCL501 in acute agitation associated with bipolar disorders or schizophrenia. Plans for the TRANQUILITY In-Care pivotal Phase 3 trial for agitation in Alzheimer's dementia are advancing. Positive topline results were reported from the IGALMI™ post-marketing requirement study.
Financial highlights include:
- IGALMI™ net revenue grew 90% in Q2 2024 over Q1 2024
- Net revenue was $1.1 million, up 141% year-over-year
- R&D expenses decreased to $8.0 million from $27.0 million in Q2 2023
- SG&A expenses reduced to $9.5 million from $25.9 million in Q2 2023
- Net loss narrowed to $8.3 million from $53.5 million in Q2 2023
- Cash and cash equivalents totaled $56.3 million as of June 30, 2024
BioXcel Therapeutics (Nasdaq: BTAI), a biopharmaceutical company focused on AI-driven medicine development in neuroscience and immuno-oncology, has announced its plan to release second quarter 2024 financial results on August 6, 2024, before U.S. financial markets open. The company will host a conference call and webcast at 8:00 AM ET on the same day to discuss the results and provide a business update.
Investors and interested parties can access the webcast link under the 'News/Events' section of BioXcel's website. For those unable to attend live, a replay will be available for 90 days following the event. This announcement highlights BioXcel's commitment to transparency and shareholder communication.
BioXcel Therapeutics (Nasdaq: BTAI) reported preliminary estimated unaudited net revenue of approximately $1.1 million from sales of IGALMI™ (dexmedetomidine) sublingual film for Q2 2024. This represents a 90% increase from the previous quarter and a 141% increase from Q2 2023. The growth was driven by increased contracting with psychiatric care clinics and behavioral health facilities using a small commercial team.
CEO Vimal Mehta expressed satisfaction with the positive feedback received from physicians, caregivers, and patients about IGALMI™ for acute agitation treatment in schizophrenia or bipolar disorders. The company's focused market-access strategy aims to build IGALMI brand equity in the institutional setting, with potential expansion into the at-home market pending successful development and approval of BXCL501.
BioXcel Therapeutics has announced positive topline results from a post-marketing requirement study on IGALMI™ (dexmedetomidine) sublingual film for treating agitation in bipolar disorder or schizophrenia. The study observed no signs of tachyphylaxis, tolerance, or withdrawal at the 180 mcg dose over seven days. All 28 inpatient participants, who experienced agitation episodes, showed symptom improvement as per the Positive and Negative Syndrome Scale-Excitatory Component (PEC) and the Clinical Global Impressions – Improvement (CGI-I) Scale. The 180 mcg dose was well-tolerated, with no serious adverse events reported. These findings support the ongoing Phase 3 SERENITY and TRANQUILITY trials.
BioXcel Therapeutics (Nasdaq: BTAI) announced that its CEO, Vimal Mehta, Ph.D., will present at the Jefferies Global Healthcare Conference on June 5, 2024, in New York City.
The presentation will cover the company's late-stage clinical programs with BXCL501, aimed at treating agitation in Alzheimer's dementia, bipolar disorders, and schizophrenia. Dr. Mehta will be joined by Vincent J. O’Neill, M.D., the Chief of Product Development and Medical Officer.
Investors and stakeholders can access a live webcast and presentation materials via the company's website. The webcast will be available for replay for 90 days.
BioXcel Therapeutics (Nasdaq: BTAI) has announced that Dr. Rob Risinger will present both oral and poster presentations at the 2024 American Society of Clinical Psychopharmacology (ASCP) Annual Meeting from May 28 to 31 in Miami Beach, FL. The presentations will focus on the comparison of sublingual Dexmedetomidine with Quetiapine in elderly subjects, a study on BXCL501 with anti-depressants in healthy volunteers, and a dose-finding study of BXCL501 for agitation linked to dementia.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) reported strong financial results for Q1 2024, with plans to advance the TRANQUILITY and SERENITY programs. The company secured two new patents for BXCL501, completed a $25 million offering, and saw a 55% revenue increase. Additionally, the IGALMI™ PMR study and OnkosXcel Therapeutics' abstract presentation were highlighted.
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