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 (BTAI) has announced an underwritten public offering of 4,000,000 shares of common stock at $50.00 per share, aiming to raise approximately $200 million in gross proceeds. Additionally, underwriters have a 30-day option to purchase up to 600,000 additional shares. Proceeds will not benefit the company directly from any shares sold by stockholders. The offering is set to close around July 31, 2020, following customary conditions. This offering was filed under a registration statement with the SEC, and details will be available in a final prospectus supplement.
BioXcel Therapeutics (BTAI) announced a public offering of $200 million in common stock on July 27, 2020, with an additional $30 million option for underwriters. The net proceeds are earmarked for funding ongoing clinical trials, preparation for commercialization, and general corporate purposes. The offering is managed by BofA Securities, Goldman Sachs, Jefferies, Guggenheim Securities, and SunTrust Robinson Humphrey, amid variable market conditions. This offering is facilitated through an automatic shelf registration statement with the SEC.
BioXcel Therapeutics (BTAI) reported positive results from its SERENITY I and II trials for BXCL501, a sublingual thin film of dexmedetomidine. The trials showed significant improvements in the Positive and Negative Syndrome Scale, Excitatory Component (PEC) score, with reductions occurring as early as 20 minutes post-treatment (p<0.0001). BXCL501 was well tolerated, with no serious adverse events. The company plans to submit a New Drug Application (NDA) to the FDA in Q1 2021, aiming to address acute agitation in schizophrenia and bipolar disorder.
BioXcel Therapeutics (BTAI) announced it received a Notice of Allowance from the U.S. Patent Office for patent application No. 16/453,679 for BXCL501, its sublingual thin-film formulation of dexmedetomidine. The patent strengthens intellectual property for BXCL501, seen as a potential treatment for agitation. This move is important as the company prepares to report topline data from its SERENITY trials aimed at acute agitation in schizophrenia and bipolar disorder. The patent's term extends until at least 2039, and BioXcel plans to list it with FDA drug evaluations.
BioXcel Therapeutics, Inc. (BTAI) announced the appointment of Dr. Reina Benabou as Senior Vice President and Chief Development Officer. With over 20 years of experience in drug development, her expertise is expected to enhance the company’s capabilities in neuroscience product commercialization. The firm aims to leverage her skills as they report topline results from their SERENITY trials and pursue multiple indications for BXCL501, their lead candidate. BXCL501 targets acute agitation in various disorders and has received Fast Track Designation from the FDA.
BioXcel Therapeutics (BTAI) has appointed Will Kane as Executive Vice President and Chief Commercial Officer. With over 30 years of experience, Kane previously led Allergan's U.S. General Medicine unit, overseeing significant sales and numerous successful drug launches. His expertise will support BTI's transition from a research-focused company to a commercial entity, particularly in advancing BXCL501, a treatment for acute agitation linked to neuropsychological disorders. The pivotal SERENITY trials are imminent, with potential positive outcomes that could enhance the company's market position.
BioXcel Therapeutics, Inc. (BTAI) announced that Dr. Vimal Mehta will participate in fireside chats at two virtual investor conferences. The first event, the BMO 2020 Prescriptions for Success Healthcare Conference, will take place on June 23, 2020, at 8:30 AM ET. The second event, the BofA Securities Napa Biopharma Conference, is scheduled for June 24, 2020, at 7:30 AM PT (10:30 AM ET). Live webcasts will be available on the company’s website, with archives accessible for at least 30 days.
BioXcel Therapeutics (BTAI) has enrolled the first patient in the Phase 1b/2 RELEASE trial evaluating BXCL501, a sublingual formulation of dexmedetomidine designed to treat opioid withdrawal symptoms. This trial signifies a key advancement in BTI's neuroscience program, targeting a major health crisis exacerbated by the COVID-19 pandemic. The multicenter study aims to assess BXCL501's safety and efficacy in about 125 participants over 10 days. Preliminary data from prior studies show promise, with topline results expected in Q1 2021.
BioXcel Therapeutics, Inc. (BTAI) announced that Dr. Vimal Mehta, the Founder and CEO, will present at the Jefferies Virtual Healthcare Conference on June 4, 2020, at 3:30 PM ET. The event will showcase the company's innovative use of artificial intelligence in developing therapies aimed at neuroscience and immuno-oncology. A live webcast of the presentation will be available on the company's website, with an archive accessible for 30 days post-event. BioXcel is known for its drug re-innovation approach, focusing on advanced clinical programs like BXCL501 and BXCL701.
BioXcel Therapeutics (BTAI) announced a conference call scheduled for May 12, 2020, at 8:30 AM ET, to discuss its Q1 2020 operating and financial results. The call will provide insights into the company’s performance in the clinical-stage biopharmaceutical sector, focusing on AI-driven therapy development in neuroscience and immuno-oncology. The company is known for its advanced programs, including BXCL501 for neuropsychiatric agitation and BXCL701 for rare prostate cancer and pancreatic cancer treatments.
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?
