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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. (Nasdaq: BTAI) to host virtual Neuroscience R&D Day to discuss BXCL502, a potential treatment for chronic agitation in dementia, along with other emerging pipeline candidates. Dr. Jeffrey Cummings and Dr. Sandra Comer to discuss agitation relief in Alzheimer’s disease and BXCL501 as a potential treatment for opioid withdrawal.
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BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced plans to conduct Phase 3 trials of BXCL501 in the at-home setting for the TRANQUILITY program, targeting the acute treatment of agitation associated with dementia due to probable Alzheimer’s disease. The FDA's recommendation for a Phase 3 trial aligns with the Company's plans. The company also provided an update on strategic financing activities and reported its financial results for the third quarter of 2023.
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BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced positive overall survival (OS) data from its Phase 2 trial of BXCL701, the Company's investigational oral innate immune activator, in combination with KEYTRUDA® (pembrolizumab) in patients with metastatic castration-resistant prostate cancer (mCRPC) of adenocarcinoma phenotype. The median overall survival was 15.5 months with BXCL701 + KEYTRUDA, compared to 9.6 months with checkpoint inhibitor monotherapy, with a 59% one-year survival rate. Median progression-free survival was 4.2 months with BXCL701 + KEYTRUDA, compared to 2.1 months with checkpoint inhibitor monotherapy. The company plans to determine program development path following end of Phase 2 meeting with FDA scheduled for December.
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BioXcel Therapeutics provides an update on the NIDA-funded trial evaluating BXCL501 as a potential treatment for opioid use disorder. The trial aims to enroll 160 patients exposed to fentanyl and/or fentanyl adulterated with xylazine. Columbia University has been asked to add a fourth site to target trial completion in 2024. BioXcel Therapeutics plans to seek FDA feedback on potential registrational paths.
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BioXcel Therapeutics, Inc. will release its Q3 2023 financial results on November 14, 2023. The management team will host a conference call and webcast at 8:00 AM ET to discuss the results and provide a general business update.
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BioXcel Therapeutics announced that the Centers for Medicare & Medicaid Services (CMS) has issued a permanent and product-specific J-Code for IGALMI™ (dexmedetomidine) sublingual film, effective January 1, 2024. The J-code will simplify the reimbursement process and facilitate additional patient access to the treatment of agitation associated with schizophrenia or bipolar I or II disorder in adults.
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BioXcel Therapeutics announces positive findings from independent audit of TRANQUILITY II trial data
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BioXcel Therapeutics announces positive overall survival data from Phase 2 trial of BXCL701 in combination with KEYTRUDA® in patients with small cell neuroendocrine prostate cancer (SCNC)
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BioXcel Therapeutics provides update on late-stage clinical programs and patent portfolio for IGALMI™ (dexmedetomidine) sublingual film.
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BioXcel Therapeutics announces strategic reprioritization to focus on high-potential agitation-market opportunities and reduce operating expenses. Plans to develop BXCL501 for use in the at-home setting in the treatment of agitation in schizophrenia, bipolar disorders, and mild to moderate dementia due to probable Alzheimer’s disease.
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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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United States of America
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