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. (BTAI) is a clinical-stage biopharmaceutical company pioneering AI-driven drug re-innovation in neuroscience and immuno-oncology. This page serves as the definitive source for official updates including clinical trial progress, regulatory milestones, and strategic initiatives.
Investors and industry observers will find curated press releases detailing advancements in BXCL501 development for neuropsychiatric conditions, immuno-oncology research through subsidiary OnkosXcel, and financial disclosures. Our news collection enables stakeholders to track how machine learning accelerates therapeutic discovery while managing development risks.
Content is organized to highlight essential updates: clinical trial results, regulatory filings, research collaborations, and financial performance. Each update reflects BioXcel's unique approach combining big data analytics with established clinical science to address unmet medical needs.
Bookmark this page for direct access to verified information about BioXcel's innovative pipeline and corporate developments. Check regularly for updates on how artificial intelligence continues to reshape therapeutic discovery in high-need medical specialties.
BioXcel Therapeutics, a clinical-stage biopharmaceutical company (Nasdaq: BTAI), has initiated a public offering of $100 million in common stock. Additionally, a related stockholder may grant underwriters a 30-day option for an extra $15 million. Proceeds will be allocated for ongoing clinical trials, commercialization preparations, and general corporate purposes. The offering is subject to market conditions, with no assurance on timing or actual terms. This is being conducted under an existing SEC registration statement.
BioXcel Therapeutics (Nasdaq: BTAI) has scheduled a virtual Commercial Day on June 25, 2021, from 12:00 PM ET to 1:30 PM ET. This event aims to update stakeholders on the launch readiness for BXCL501, an investigational treatment for agitation associated with schizophrenia and bipolar disorders. Attendees will include CEO Vimal Mehta and industry experts, offering insights into BXCL501’s market potential. The event will be available via live webcast on the company’s website and archived for 30 days.
BioXcel Therapeutics (Nasdaq: BTAI) announced that Dr. Vimal Mehta, CEO, will participate in three upcoming virtual healthcare investor conferences. These include the Jefferies Virtual Healthcare Conference on June 2, Goldman Sachs 42nd Annual Global Healthcare Conference on June 9, and BofA Securities Napa Biopharma Conference on June 14. The live webcasts will be accessible on the Company's website and archived for 30 days post-event. BioXcel focuses on utilizing artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology.
BioXcel Therapeutics has announced the FDA's acceptance of their New Drug Application for BXCL501, an investigational treatment for acute agitation associated with schizophrenia and bipolar disorders. The FDA has set a PDUFA action date for January 5, 2022. BXCL501, if approved, would be a significant advancement in treating agitation, a common and challenging symptom affecting nearly 3 million adults in the U.S. annually. The NDA is supported by positive results from two Phase 3 studies demonstrating BXCL501's efficacy and safety.
BioXcel Therapeutics (BTAI) announced the selection of four abstracts for presentation at the ISBD 2021 Global Annual Conference from May 13-15, 2021. Key topics include the pivotal SERENITY program results on BXCL501's efficacy in treating acute agitation in bipolar disorder. The company has also submitted a New Drug Application for BXCL501 to the FDA. This innovative formulation targets agitation mechanisms and has received breakthrough designations, emphasizing its potential in neuropsychiatric treatment.
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.
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