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 pioneering clinical-stage biopharmaceutical company that harnesses the power of artificial intelligence (AI) to identify and develop the next generation of transformative medicines. Focusing on neuroscience and immuno-oncology, BioXcel re-innovates existing approved drugs and clinically validated candidates using proprietary machine learning algorithms and big data. This innovative approach allows the company to discover new therapeutic indications more efficiently.
BioXcel's two leading clinical programs are BXCL501 and BXCL701. BXCL501, marketed as IGALMI, is an FDA-approved sublingual film formulation of dexmedetomidine used for the acute treatment of agitation associated with schizophrenia or bipolar I and II disorder in adults. This product is undergoing further development to expand its use for agitation in dementia related to probable Alzheimer’s disease and for at-home use.
BXCL701 is an oral innate immune activator designed to inflame the tumor microenvironment, enhancing the efficacy of checkpoint inhibitors. It is currently being investigated for the treatment of rare forms of prostate cancer and pancreatic cancer. The company recently reported promising results from a Phase 2 trial of BXCL701 in combination with KEYTRUDA for metastatic pancreatic ductal adenocarcinoma (PDAC).
BioXcel also continues to strengthen its intellectual property portfolio, with over 100 patent applications in prosecution and multiple patents issued globally. The company's financial performance reflects a commitment to advancing its clinical pipeline; for example, net revenue from IGALMI increased significantly in the first quarter of 2024, driven by growing demand and new customer acquisitions.
The company maintains a strong focus on advancing its TRANQUILITY and SERENITY programs, designed to evaluate BXCL501 in treating agitation in various settings, including at home. Additionally, BioXcel's strategic collaborations with institutions like Georgetown University's Lombardi Comprehensive Cancer Center underline its dedication to innovative cancer therapies.
For ongoing updates, BioXcel engages with the investment community through regular conference calls and webcasts and actively participates in key industry conferences like the American Society of Clinical Oncology (ASCO) Annual Meeting. For more information and the latest news, please visit bioxceltherapeutics.com.
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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