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BioXcel Therapeutics develops AI-enabled biopharmaceutical programs in neuroscience and, through its wholly owned OnkosXcel Therapeutics subsidiary, immuno-oncology. Its news centers on IGALMI, the FDA-approved sublingual film formulation of dexmedetomidine for acute agitation associated with schizophrenia or bipolar I or II disorder in adults, and on BXCL501 development across additional neuropsychiatric settings.
Recurring updates include FDA interactions and label-expansion activity for IGALMI, commercial planning for broader use settings, financial results, and capital-raising transactions. Company announcements also cover investigator-led and funded studies of BXCL501 in areas such as acute agitation in Alzheimer’s dementia, opioid withdrawal, and acute stress reactions, alongside disclosures tied to its drug re-innovation approach using big data and machine learning.
BioXcel Therapeutics (BTAI) provided updates on its BXCL501 dementia program, reporting that the 30 mcg dose achieved statistical significance in the TRANQUILITY Phase 1b/2 study. A 40 mcg dose cohort study has been initiated to further inform the development strategy. The end of Phase 2 meeting with the FDA is scheduled for Q2 2021, with a pivotal Phase 3 program expected in H2 2021. BXCL501 aims to address dementia-related agitation, a condition lacking FDA-approved treatments.
BioXcel Therapeutics (Nasdaq: BTAI) announced the appointment of June Bray to its Board of Directors, bringing over 40 years of global regulatory experience in the healthcare sector. Previously a Senior VP at Allergan, Bray has overseen the approval of 32 New Drug Applications (NDAs) in the U.S. Her expertise is expected to assist BioXcel as it prepares to submit its first NDA for BXCL501 this month, signaling the company's transition to a commercial neuroscience-focused organization. Bray aims to leverage her knowledge to enhance treatment options for patients experiencing agitation.
BioXcel Therapeutics (Nasdaq: BTAI) has initiated the Phase 2 PLACIDITY trial for BXCL501, an investigational treatment targeting delirium-related agitation, with topline results expected in Q1 2022. This multicenter, randomized, double-blind study aims to evaluate the safety and efficacy of BXCL501 in ICU patients, including those with COVID-19, by testing ascending doses. The primary endpoint is a reduction in agitation as measured by the Richmond Agitation Sedation Scale. BXCL501 addresses a significant unmet medical need, as no FDA-approved therapies exist for this condition.
BioXcel Therapeutics (BTAI) has appointed Javier Rodriguez as Senior Vice President, Chief Legal Officer, and Corporate Secretary. This decision aligns with the company's transition towards commercialization, particularly in neuroscience. Rodriguez brings over 20 years of legal experience from leading firms, including Indivior PLC. His expertise in biopharmaceuticals and knowledge of proprietary technologies are expected to enhance BioXcel’s strategic direction as it progresses towards filing for FDA approval of its first candidate, BXCL501, targeting neuropsychiatric disorders.
BioXcel Therapeutics (BTAI) will host a virtual Key Opinion Leader (KOL) event on February 19, 2021, from 11:00 am ET to 2:00 pm ET, focusing on BXCL501, an investigational treatment for neuropsychiatric conditions. Experts in schizophrenia, dementia, and opioid withdrawal will discuss the unmet medical needs and the potential impact of BXCL501, which has received Fast Track Designation from the FDA. The event will be accessible via the Company's website, with an archive available for 30 days post-event.
BioXcel Therapeutics (BTAI) has announced an update regarding its Phase 1b/2 trial of BXCL701, an investigational oral innate immunity activator for aggressive prostate cancer. The update will be presented at the virtual 2021 ASCO Genitourinary Cancers Symposium from February 11 to 13, 2021. The poster, titled BXCL701 combined with pembrolizumab in men with metastatic castration-resistant prostate cancer, will be available starting February 11 at 8:00 a.m. ET. BXCL701 aims to convert 'cold' tumors into 'hot' tumors, enhancing immune response against cancer.
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.