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BioXcel Therapeutics, Inc. - BTAI STOCK NEWS

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.

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BioXcel Therapeutics, Inc. (BTAI) secures European Patent for BXCL501 to treat agitation in individuals with dementia, expanding its intellectual property portfolio and commercialization potential globally.
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BioXcel Therapeutics, Inc. provides updates on late-stage clinical programs for BXCL501, focusing on treating agitation associated with Alzheimer’s dementia, bipolar disorders, and schizophrenia. The company plans to expand data for TRANQUILITY and SERENITY programs, emphasizing safety and efficacy. Financially, the company reported increased net revenue from IGALMI, reduced R&D and SG&A expenses, and a net loss for the fourth quarter and full year 2023. The company's cash and cash equivalents are estimated to fund operations through mid-2024.
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BioXcel Therapeutics, Inc. (BTAI) will release its Q4 and full year 2023 financial results on March 12, 2024. The company uses AI for neuroscience and immuno-oncology drugs. A conference call and webcast will discuss the results and business updates.
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BioXcel Therapeutics, Inc. terminates a $60.0 million public offering due to unfavorable market conditions. The company shifts focus to FDA meeting for Phase 3 trial of BXCL501 in treating agitation associated with dementia.
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BioXcel Therapeutics, Inc. receives FDA Fast Track designation for BXCL701 in combination with a checkpoint inhibitor for treating metastatic small cell neuroendocrine prostate cancer. The company plans to discuss the registration path with the FDA, highlighting the potential of BXCL701 in addressing unmet medical needs in SCNC patients.
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BioXcel Therapeutics, Inc. has announced an underwritten public offering of $60.0 million of shares of its common stock, with an option to purchase additional shares. The net proceeds will be used to fund ongoing and planned clinical trials, commercialization, and general corporate purposes. The offering is being made pursuant to a shelf registration statement on Form S-3 filed with the SEC. BofA Securities and Truist Securities are acting as joint book-running managers for the proposed public offering.
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BioXcel Therapeutics, Inc. announced the completion of patient enrollment in the safety lead-in portion of the Phase 2 trial of BXCL701 in combination with KEYTRUDA in pancreatic cancer. Initial study data is expected in 2024. The trial is evaluating BXCL701, an oral innate immune activator, and is expected to begin the human proof of concept portion in H1 2024. The company aims to address the significant unmet medical need in treating advanced pancreatic cancer, which has a low survival rate. Preclinical studies have shown encouraging results, and the company is optimistic about the potential of BXCL701 in combination with KEYTRUDA for this indication.
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BioXcel Therapeutics, Inc. announces the issuance of a new patent for the treatment of agitation in patients with Alzheimer’s disease using the oromucosal administration of 60 mcg of dexmedetomidine in a water-soluble dosage form. This strengthens the company's strategic focus on bringing to market BXCL501 for potential acute treatment of agitation for Alzheimer’s patients. The patent is expected to have an expiration date of Dec. 29, 2037, subject to patent term adjustment, patent term extension, and terminal disclaimers. Additionally, the company has received an issue notification for another patent related to the treatment of agitation associated with schizophrenia or bipolar disorder through oromucosal administration.
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BioXcel Therapeutics, Inc. (Nasdaq: BTAI) to host virtual Neuroscience R&D Day to review BXCL502 and other potential emerging pipeline candidates. Dr. Jeffrey Cummings and Dr. Sandra Comer to discuss BXCL502 as a potential treatment for chronic agitation relief in Alzheimer’s disease and BXCL501 as a potential treatment for opioid withdrawal.
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BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announces the promotion of Vincent J. O’Neill, M.D., to Executive Vice President, Chief of Product Development and Medical Officer, and the appointment of Rajiv Patni, M.D., as Strategic Clinical Advisor to the CEO and Board of Directors. The company emphasizes a strategic reprioritization focused on advancing late-stage clinical programs and emerging pipeline candidates. O’Neill's promotion and Patni's appointment aim to strengthen clinical leadership in line with the prioritization of late-stage TRANQUILITY and SERENITY III programs for BXCL501’s potential use to treat Alzheimer’s, bipolar disorder, and schizophrenia-related agitation.
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FAQ

What is the current stock price of BioXcel Therapeutics (BTAI)?

The current stock price of BioXcel Therapeutics (BTAI) is $0.5706 as of November 21, 2024.

What is the market cap of BioXcel Therapeutics (BTAI)?

The market cap of BioXcel Therapeutics (BTAI) is approximately 24.4M.

What does BioXcel Therapeutics, Inc. specialize in?

BioXcel Therapeutics specializes in drug development using artificial intelligence to identify new therapeutic indications in neuroscience and immuno-oncology.

What are the company's leading products?

The leading products are BXCL501, an FDA-approved sublingual film for acute agitation treatment, and BXCL701, an oral immune activator for cancer treatment.

What is IGALMI?

IGALMI is the commercial name for BXCL501, approved by the FDA for treating acute agitation in adults with schizophrenia or bipolar disorder.

What is BXCL701 used for?

BXCL701 is being investigated for treating rare forms of prostate cancer and pancreatic cancer by enhancing the efficacy of checkpoint inhibitors.

How does BioXcel use artificial intelligence?

BioXcel uses AI and proprietary machine learning algorithms to re-innovate existing approved drugs and clinically validated candidates, identifying new therapeutic indications.

What recent achievements has BioXcel reported?

BioXcel recently reported a significant increase in net revenue from IGALMI and promising results from a Phase 2 trial of BXCL701 for metastatic pancreatic cancer.

What is the TRANQUILITY program?

The TRANQUILITY program evaluates BXCL501 for treating agitation associated with Alzheimer’s dementia, aiming to expand its use for at-home care.

What patents does BioXcel hold?

BioXcel holds over 100 patent applications in prosecution and several issued patents globally, strengthening its intellectual property portfolio.

How can I stay updated on BioXcel's developments?

You can stay updated through the company's website, conference calls, webcasts, and participation in industry conferences like ASCO.

What collaborations is BioXcel involved in?

BioXcel collaborates with institutions like Georgetown University's Lombardi Comprehensive Cancer Center to advance innovative cancer therapies.

BioXcel Therapeutics, Inc.

Nasdaq:BTAI

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24.38M
34.45M
20.06%
8.76%
0.85%
Biotechnology
Pharmaceutical Preparations
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