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 announced that BXCL501, its investigational treatment for agitation in dementia, achieved significant results in the TRANQUILITY trial. The 60 mcg dose met primary and secondary endpoints, showing rapid reductions in agitation. Most patients reported mild adverse effects, with no severe events noted. The trial supports advancement towards pivotal studies, a crucial step for addressing a major unmet need for effective therapies in dementia-related agitation, currently affecting 4 million patients in the U.S.
BioXcel Therapeutics (BTAI) announced a corporate update presentation at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021. CEO Dr. Vimal Mehta will share insights about the company’s strategic plans for 2021, including the filing of their first New Drug Application with the FDA for BXCL501 and reporting topline results from the TRANQUILITY and RELEASE studies, expected in mid-January. BXCL501 targets agitation in various neuropsychiatric disorders and has received FDA Fast Track Designation.
BioXcel Therapeutics, Inc. (BTAI) announced a collaboration with the VA Connecticut Healthcare System and Yale University Medical School, funded by the U.S. Department of Defense. The grant aims to study BXCL501 in patients with post-traumatic stress disorder (PTSD) related to alcohol and substance abuse disorders. This marks the first evaluation of BXCL501 as a chronic treatment. The study involves self-administration of BXCL501 over a 28-day period. The initiative is expected to enhance understanding of BXCL501’s potential benefits in addressing PTSD symptoms.
BioXcel Therapeutics (BTAI) announced that Dr. Vimal Mehta, its CEO, will participate in a fireside chat at the Jefferies Virtual London Healthcare Conference on November 19, 2020, at 7:20 PM GMT/2:20 PM ET. The event will be available via live webcast on the company's website, with an archive accessible for at least 30 days afterward. BioXcel is focused on drug development using artificial intelligence to enhance therapies in neuroscience and immuno-oncology, notably through its advanced programs BXCL501 and BXCL701.
BioXcel Therapeutics (BTAI) announced substantial progress in the development of BXCL501 for treating agitation in schizophrenia and bipolar disorders, with NDA submission on track for Q1 2021. Third quarter 2020 financial results showed a net loss of $24.8 million, up from $9.0 million in Q3 2019, due to increased R&D expenses of $16.3 million. Strong cash reserves of $233 million are set to fund key milestones into 2022. Promising data from ongoing clinical trials for BXCL701 in combination with KEYTRUDA® were also highlighted.
BioXcel Therapeutics (Nasdaq: BTAI) announced the initiation of a rolling submission for its New Drug Application (NDA) with the FDA for BXCL501, aimed at treating agitation in patients with schizophrenia and bipolar disorders. Following a pre-NDA meeting, the FDA provided feedback which the company believes supports its data package for submission. BXCL501, which has Fast Track designation, demonstrated statistical superiority over placebo in Phase 3 trials. The full NDA submission is anticipated in Q1 2021.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced a conference call on November 12, 2020, at 8:30 AM ET to discuss its Q3 2020 financial and operational results. The conference will include a webcast accessible via the company's website. BioXcel is focused on drug development using AI to enhance therapies in neuroscience and immuno-oncology, with advanced programs like BXCL501 for neuropsychiatric agitation and BXCL701 targeting rare prostate cancer and pancreatic cancer. The call aims to provide insights into recent developments and future outlook.
BioXcel Therapeutics (BTAI) announced FDA clearance for its IND application for BXCL501, a sublingual film formulation of dexmedetomidine, aimed at treating agitation associated with delirium. This marks the fifth potential indication for BXCL501. A Phase 2 trial will commence soon, targeting ICU patients, including those with COVID-19. The trial aims to assess safety and efficacy, with a primary endpoint of a 2-point drop in the Richmond Agitation Sedation Scale at two hours post-administration. The move highlights BioXcel's commitment to addressing unmet medical needs in critical care.
BioXcel Therapeutics (BTAI) announced positive results from its Phase 3 SERENITY trials for BXCL501, targeting acute agitation in schizophrenia and bipolar disorder. The company plans to submit a New Drug Application (NDA) to the FDA by Q1 2021. Additionally, they launched a 90 mcg cohort in the TRANQUILITY trial for dementia patients and expanded the BXCL701 trial for castrate-resistant prostate cancer. Financially, BTAI raised approximately $200 million through a follow-on offering, enhancing its cash position for future clinical and commercial activities.
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