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 has announced the FDA approval of IGALMI (dexmedetomidine), the first orally dissolving sublingual film for treating agitation in adults with schizophrenia or bipolar I/II disorder. The approval is significant as it provides a self-administered option with a rapid onset of action, showing effects as early as 20 minutes. The company aims for a Q2 2022 launch, targeting up to 25 million agitation episodes annually in the U.S. This milestone positions IGALMI as an innovative solution in a field long challenged by conventional treatments.
BioXcel Therapeutics (Nasdaq: BTAI) announced significant progress in its clinical initiatives, nearing FDA approval for BXCL501 by the April 5, 2022 PDUFA date. The company launched pivotal Phase 3 trials for BXCL501 in treating agitation in Alzheimer’s patients and submitted an IND for its use in major depressive disorder. Encouraging Phase 2 data for BXCL701 in prostate cancer patients was presented, enhancing its immuno-oncology portfolio. Despite increased R&D and administrative expenses, cash reserves stand at $233 million. A conference call will discuss Q4 and full year 2021 financial results.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced that CEO Vimal Mehta, Ph.D., will present at the Barclays Global Healthcare Conference on March 15 at 3:50 p.m. ET. The presentation will focus on the Company’s neuroscience and immuno-oncology programs, as well as its artificial intelligence platform designed for drug discovery. Additionally, the event will cover commercial readiness for its product candidate, BXCL501, which targets agitation in psychiatric and neurological disorders. The presentation can be accessed via the Company’s website.
BioXcel Therapeutics (BTAI) will release its fourth quarter and fiscal year 2021 financial results on March 10, 2022, before U.S. market open. A conference call will follow at 8:30 AM ET for a discussion of the results and business updates. The company specializes in AI-driven therapeutics in neuroscience and immuno-oncology, focusing on BXCL501 and BXCL701 for psychiatric disorders and advanced prostate cancer, respectively. Webcast details will be available on their website.
BioXcel Therapeutics (BTAI) announced positive results from the Phase 3 SERENITY II trial for BXCL501, a treatment for agitation associated with bipolar disorder. The study revealed statistically significant improvements in agitation scores at two hours post-treatment compared to placebo. Notable findings include a 90.5% response rate in the 180 mcg group, with adverse events reported in 35.7% of patients. BXCL501 is set for PDUFA review by the FDA on April 5, 2022, following its Breakthrough Therapy designation for agitation treatments.
BioXcel Therapeutics (BTAI) announced promising interim results from its Phase 2 trial of BXCL701, an oral innate immunity activator, in combination with KEYTRUDA in patients with metastatic castration-resistant prostate cancer (mCRPC). In the small cell neuroendocrine carcinoma cohort, the composite response rate was 33%, and in adenocarcinoma, it was 21%. Despite some serious adverse events reported, the data suggests potential to enhance treatment efficacy in difficult-to-treat mCRPC types. The company plans to expand trials based on these findings.
BioXcel Therapeutics (BTAI) announced that CEO Vimal Mehta will present at the SVB Leerink 11th Annual Global Healthcare Conference on February 16 at 2:20 p.m. ET. The presentation will focus on the company's neuroscience and immuno-oncology programs, highlighting their AI platform that enhances drug discovery and development. Additionally, Mehta will discuss commercial and launch plans for BXCL501, a treatment for agitation linked to psychiatric and neurological disorders. Visit their website for a live webcast and materials from the conference.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced the appointment of Matt Wiley as Senior Vice President and Chief Commercial Officer. Wiley brings over 25 years of experience in commercial strategy, particularly in neuroscience product launches. His role is critical as the company prepares for the anticipated approval and commercial launch of BXCL501 for treating agitation linked to schizophrenia and bipolar disorders. Wiley previously led significant marketing efforts for products generating up to $1.4 billion in revenue.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced that CEO Vimal Mehta, Ph.D., will present corporate updates at the 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022, at 9:45 a.m. ET. The event will be held virtually, and interested parties can access the webcast on the company's website. BioXcel specializes in utilizing artificial intelligence to innovate medicines in neuroscience and immuno-oncology, focusing on its lead programs, BXCL501 and BXCL701, aimed at treating agitation and aggressive prostate cancer, respectively.
BioXcel Therapeutics (BTAI) has initiated its pivotal Phase 3 program for BXCL501 to treat agitation in Alzheimer’s disease patients, following FDA breakthrough therapy designation. This program includes two studies, TRANQUILITY II and TRANQUILITY III, enrolling 300 patients aged 65 and older from assisted living and nursing homes. The studies will evaluate the safety and efficacy of BXCL501, aiming to address agitation, which affects up to 70% of Alzheimer’s patients, with no current FDA-approved treatments available. Results are anticipated to have significant implications for the company's market position.
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