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, 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.
FAQ
What is the current stock price of BioXcel Therapeutics (BTAI)?
What is the market cap of BioXcel Therapeutics (BTAI)?
What does BioXcel Therapeutics, Inc. specialize in?
What are the company's leading products?
What is IGALMI?
What is BXCL701 used for?
How does BioXcel use artificial intelligence?
What recent achievements has BioXcel reported?
What is the TRANQUILITY program?
What patents does BioXcel hold?
How can I stay updated on BioXcel's developments?
What collaborations is BioXcel involved in?
