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 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) announced significant advancements regarding BXCL501, which received FDA Breakthrough Therapy designation for treating agitation related to dementia. The registrational program is expected to commence in the second half of 2021. The company submitted a New Drug Application (NDA) for BXCL501 aimed at agitation in schizophrenia and bipolar disorders. Commercial preparations are ramping up, alongside plans to file a Marketing Authorization Application (MAA) with the EMA. First quarter financials revealed a net loss of $26.4 million and R&D expenses increased to $14.7 million, reflecting growth in personnel and consulting needs.
BioXcel Therapeutics (Nasdaq: BTAI) announced that Dr. Vimal Mehta, CEO and Founder, will speak at two virtual healthcare investor conferences. The first is the BofA Securities 2021 Virtual Health Care Conference on May 11, 2021, at 8:45 AM ET, followed by the UBS Global Healthcare Virtual Conference on May 25, 2021, at 2:00 PM ET. Live webcasts and presentation materials will be available on the company's website. BioXcel focuses on developing transformative medicines using artificial intelligence in neuroscience and immuno-oncology.
BioXcel Therapeutics (BTAI) announced a conference call scheduled for May 10, 2021, at 8:30 AM ET to discuss Q1 2021 financial results. The call will provide insights into the company's financial performance, particularly regarding its leading investigational drugs, BXCL501 for agitation and opioid withdrawal, and BXCL701 for aggressive prostate cancer treatment. Investors and interested parties can access the call via a domestic number or through a webcast on the company's website, with replay options available until May 24, 2021.
BioXcel Therapeutics has launched the "Boiling Point" Campaign during Mental Health Awareness Month to educate healthcare professionals about the management of agitation related to schizophrenia and bipolar disorders. This initiative targets emergency medical providers by offering an interactive website with educational resources on identifying and managing agitation symptoms. Notably, agitation affects over 3 million individuals in the U.S. annually, with severe cases often resulting in coercive restraint. The campaign aims to promote early intervention and cooperative treatment strategies among healthcare providers.
BioXcel Therapeutics (Nasdaq: BTAI) announced that data from its pivotal Phase 3 trials, SERENITY I & II, for BXCL501 will be presented at the American Psychiatric Association Annual Meeting from May 1-3, 2021. These trials explored the treatment of agitation in patients with schizophrenia and bipolar disorders. The results aim to demonstrate how BXCL501, an orally dissolving film, effectively alleviates acute agitation. With approximately 9 million U.S. adults suffering from these conditions, effective management of agitation is crucial to prevent escalation.
BioXcel Therapeutics (BTAI) announced positive topline results from its Phase 1b/2 RELEASE study of BXCL501, an orally dissolving formulation for treating opioid withdrawal. The study achieved its primary safety endpoint with no severe adverse events reported, and demonstrated improved retention rates in multiple dosing cohorts: 42% and 52% for 120 mcg and 180 mcg doses at Day 6, compared to 24% for placebo. Despite these findings, the results regarding severity of withdrawal symptoms were inconclusive, potentially due to the high prevalence of fentanyl among participants. Further analysis is ongoing.
BioXcel Therapeutics (Nasdaq: BTAI) announced that the U.S. FDA has granted Breakthrough Therapy designation for its investigational drug BXCL501, aimed at treating agitation related to dementia. This designation accelerates development and regulatory review for serious conditions. CEO Vimal Mehta emphasized the urgent need for effective treatments in this area, highlighting that current options lack FDA approval and have safety warnings. Positive data from the Phase 1b/2 TRANQUILITY trial supports BXCL501's potential effectiveness.
BioXcel Therapeutics (BTAI) submitted an NDA to the FDA for BXCL501, targeting acute treatment of schizophrenia and bipolar disorder-related agitation. The TRANQUILITY trial met both primary and secondary endpoints, showing significant agitation reduction. Topline results from ongoing BXCL701 trials in aggressive prostate cancer are expected in mid-2021. The company reported a net loss of $21.1 million in Q4 2020, up from $8.3 million in Q4 2019, attributed to increased R&D and operational costs. Cash reserves stood at $213.1 million as of December 31, 2020, facilitating continued clinical advancement.
BioXcel Therapeutics has announced the successful completion of the rolling submission of its New Drug Application (NDA) for BXCL501 to the FDA. This investigational drug targets agitation associated with schizophrenia and bipolar disorders. The NDA submission is a significant milestone, having progressed from first-in-human trials to NDA submission in over two years. BXCL501 is an orally dissolving film of dexmedetomidine, showing promising clinical results in Phase 3 trials. If approved, it could provide an essential treatment option for patients facing agitation.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced a conference call and webcast scheduled for March 11, 2021, at 8:30 AM ET to discuss its fourth quarter and full year 2020 operating and financial results. The company is focused on developing innovative medicines in neuroscience and immuno-oncology through AI techniques. Key projects include BXCL501, targeting agitation and opioid withdrawal, and BXCL701 for aggressive prostate cancer treatment. Further details are available on the company’s website.