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 (Nasdaq: BTAI) announced its Q1 2023 financial results will be released on May 8, 2023, before U.S. markets open. The company will host a conference call at 8:00 AM ET to discuss the results and provide a business update. BioXcel specializes in using artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology. Their flagship product, IGALMI™, is a sublingual film approved for treating agitation associated with schizophrenia and bipolar disorders. The company is also evaluating several pipeline candidates for various indications. The press release includes forward-looking statements about anticipated outcomes and risks associated with the company’s operations.
On March 14, 2023, OnkosXcel Therapeutics announced the confidential submission of a draft registration statement on Form S-1 with the SEC for a proposed initial public offering (IPO) of its common stock. The number of shares and price range of the offering have yet to be determined, with the IPO anticipated to follow the SEC's review, contingent on market conditions. OnkosXcel operates as a subsidiary of BioXcel Therapeutics (Nasdaq: BTAI). This announcement complies with Rule 135 of the Securities Act of 1933, and does not constitute an offer to sell or solicit offers to buy any securities.
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.
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