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) reported its 2022 financial results, revealing a net revenue of approximately $238,000 for Q4 and $375,000 for the full year, attributed to limited market access. The company's net loss for Q4 was $54.8 million, with a full-year loss of $165.8 million. IGALMI™ (dexmedetomidine) is now commercially launched, with strong interest in market access and an expanded field team of 70 representatives. Upcoming pivotal data readouts for BXCL501 are expected in Q2 2023, targeting significant agitation episodes. Strategic options for OnkosXcel are under exploration, while a conference call is planned for updates.
BioXcel Therapeutics (Nasdaq: BTAI) will release its fourth quarter and full year 2022 financial results on March 9, 2023, before the market opens. The management team will host a conference call at 8:30 AM ET to discuss the results and provide a business update. Known for its AI-driven approach to developing treatments in neuroscience and immuno-oncology, BioXcel's commercial product, IGALMI™, targets agitation associated with psychiatric disorders. The company continues to explore new indications for its products, including BXCL501 for Alzheimer's agitation and BXCL701 for aggressive prostate cancer.
BioXcel Therapeutics (Nasdaq: BTAI) ringed the Nasdaq closing bell on February 21, 2023, celebrating its achievements, including the FDA approval of IGALMI™ for treating agitation in adults with schizophrenia or bipolar disorder. CEO Vimal Mehta highlighted the positive Phase 2 data for BXCL701, targeting aggressive prostate cancer, and the upcoming pivotal study readouts for BXCL501 in neuropsychiatric conditions in 2023. This event underscores BioXcel's commitment to AI-driven drug development and market expansion opportunities.
BioXcel Therapeutics (BTAI) announced promising results from its Phase 2a trial of BXCL701 in combination with KEYTRUDA® (pembrolizumab) for treating small cell neuroendocrine variant metastatic castration-resistant prostate cancer (mCRPC). In a cohort of 28 evaluable patients, a composite response rate of 25% was achieved. Additionally, the disease control rate was 48% with a median response duration exceeding 6 months. Despite 18% of patients experiencing serious adverse events, the trial's outcomes support further investigation in a Phase 2b trial. BioXcel plans to initiate a randomized study comparing BXCL701 plus pembrolizumab versus BXCL701 monotherapy in the second half of 2023.
BioXcel Therapeutics (Nasdaq: BTAI) announced a Key Opinion Leader (KOL) Day on February 21, 2023, focusing on its immuno-oncology program BXCL701 aimed at treating small cell neuroendocrine prostate cancer (SCNC). The event will feature insights from experts presenting Phase 2 data at the ASCO GU Symposium. SCNC is an aggressive form of prostate cancer, with projections of approximately 10,740 new cases. BXCL701 is an investigational oral innate immune activator showing promise in enhancing immune responses against tumors. Interested investors can RSVP for the event and access a live webcast.
BioXcel Therapeutics, Inc. (BTAI) announced promising top-line results from its Phase 2 trial of BXCL701, an oral innate immune activator, combined with KEYTRUDA® (pembrolizumab) for treating small cell neuroendocrine metastatic castration-resistant prostate cancer (SCNC). The trial showed encouraging response rates in this underserved patient population, which had 10,740 SCNC cases in 2022. Full data will be presented at the 2023 ASCO Genitourinary Cancers Symposium in February. BXCL701 aims to activate the immune response in 'cold' tumors to facilitate effective immunotherapy.
BioXcel Therapeutics (Nasdaq: BTAI) announced that CEO Vimal Mehta will present corporate updates and 2023 milestones at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023, at 9:45 a.m. PST. The presentation will be accessible via a live webcast on the company's website. BioXcel leverages artificial intelligence to develop transformative drugs, including its product IGALMI™, approved for treating agitation in schizophrenia and bipolar disorders. The company also explores additional therapies under development for various neuropsychiatric conditions.
BioXcel Therapeutics (BTAI) announced the initiation of the pivotal Phase 3 TRANQUILITY III trial for BXCL501, targeting agitation in Alzheimer’s patients residing in nursing homes. This trial is part of the broader TRANQUILITY program, which aims to address the needs of Alzheimer’s patients experiencing agitation, an issue expected to grow as the aging population increases.
With around 100 million agitation episodes occurring annually in the U.S. due to Alzheimer’s, the market opportunity for BXCL501 could potentially expand over six-fold. Top-line results from TRANQUILITY II are anticipated in the first half of 2023.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced that Vimal Mehta, Ph.D., CEO, and Matt Wiley, CCO, will participate in a virtual fireside chat at the Bank of America 2022 Biotech SMID Cap Conference on December 7, 2022, at 1:45 PM ET. They will discuss the company's neuroscience and immuno-oncology programs, along with its AI platform for drug discovery. Additionally, they will detail the ongoing launch strategy for IGALMI™ (dexmedetomidine) sublingual film, which treats agitation in specific psychiatric disorders.
BioXcel Therapeutics (BTAI) announced the initiation of Part 1 in its pivotal Phase 3 SERENITY III trial, assessing BXCL501, a sublingual film for at-home treatment of agitation associated with bipolar disorder and schizophrenia. The trial involves 200 patients across 20 sites in the U.S., aiming for top-line data in 1H 2023. Notably, there are 23 million agitation episodes annually occurring outside institutions, significantly expanding the potential market for BXCL501. The drug has received Breakthrough Therapy and Fast Track designations, highlighting its anticipated importance in addressing significant patient needs.
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