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, Inc. (BTAI) announced that the FDA has extended the PDUFA date for the New Drug Application (NDA) of BXCL501 to April 5, 2022. This extension follows a meeting with the FDA on November 30, where no additional data was requested. BXCL501 aims to treat agitation linked to schizophrenia and bipolar disorders. The company is optimistic about the therapy's potential benefits for millions affected by these conditions.
BioXcel Therapeutics (BTAI) announced participation in a fireside chat at the 12th Annual Jefferies Global Healthcare Conference on November 17, 2021, at 4:20 p.m. GMT. CEO Vimal Mehta and CSO Frank Yocca will discuss the company's neuroscience and immune-oncology programs, focusing on their AI platform for drug discovery and development, as well as plans for BXCL501's launch. Interested investors can access the live webcast via the company's website, with a replay available for 90 days post-event.
BioXcel Therapeutics (Nasdaq: BTAI) reported progress in commercial readiness for BXCL501, an orally dissolving film targeting agitation in schizophrenia and bipolar disorders ahead of its January 5, 2022 PDUFA date. The company is set to initiate a Phase 3 program for BXCL501 in Alzheimer's patients. Financially, R&D expenses dropped to $11.9 million, while general and administrative expenses rose to $14.9 million, leading to a net loss of $26.8 million for Q3 2021. Strong pipeline advancements, including BXCL502 and promising interim results from BXCL701, were highlighted.
BioXcel Therapeutics (BTAI) announced the release of its Q3 2021 financial results on November 10, 2021, before U.S. markets open. The management team will conduct a conference call and webcast at 8:30 AM ET to discuss these results and provide a business update. The company focuses on leveraging artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology, with key projects including BXCL501 for psychiatric agitation and BXCL701 for aggressive prostate cancer.
BioXcel Therapeutics (BTAI) announced a successful expansion of its Phase 1b/2 trial for BXCL701, an investigational drug for small-cell neuroendocrine prostate cancer (SCNC). The trial met its efficacy threshold, showing three composite responses among ten evaluable patients, leading to cohort expansion. As SCNC currently lacks FDA-approved treatments, the study signifies a crucial step forward. Data from the trial, including the expanded cohort's findings, is expected by Q1 2022, with hopes for BXCL701 to generate immune responses in 'cold' tumors.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) hosted a virtual R&D Day on September 23, 2021, to showcase its AI-driven drug development initiatives, particularly focusing on neuropsychiatric disorders. The company introduced its new program, BXCL502, and discussed the expansion of BXCL501, which targets agitation associated with various neuropsychiatric disorders. BXCL501 has received Breakthrough Therapy designation and Fast Track designation for several indications. The event featured insights from leading neuroscience experts and emphasized the role of AI in building a sustainable pipeline for transformative medicines.
BioXcel Therapeutics (BTAI) reported promising data from its ongoing Phase 1b/2 trial of BXCL701, an oral innate immunity activator, in metastatic castration-resistant prostate carcinoma (mCRPC) patients at the ESMO Congress. The trial showed a 26% composite response rate among adenocarcinoma patients, with all responders experiencing a decrease in tumor size. The treatment exhibited a favorable safety profile, with low-grade adverse events. BXCL701 aims to enhance the efficacy of immunotherapies, representing a potential breakthrough in treating mCRPC.
BioXcel Therapeutics (Nasdaq: BTAI) announced updates from its Phase 1b/2 trial of BXCL701, an investigational oral innate immunity activator for aggressive prostate cancer. The findings will be presented at the ESMO Congress, taking place September 16-21, 2021. The poster, titled 'BXCL701—1st-in-class oral activator of systemic innate immunity—combined with pembrolizumab in men with mCRPC: Phase 2 results,' will be available from September 15 at 6:05 PM EST. BXCL701 aims to convert 'cold' tumors into 'hot' ones, enhancing immune response against mCRPC and other solid tumors.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) will host a virtual R&D Day on September 23, 2021, from 12:00 PM to 2:00 PM ET, titled Revolutionizing Drug Discovery and Development Through AI. The event will showcase BioXcel’s AI platform and emerging neuroscience pipeline, highlighting updates on its lead program, BXCL501. Key executives, including CEO Vimal Mehta and CSO Frank Yocca, will present, alongside Dr. Maurizio Fava from Massachusetts General Hospital. BXCL501 targets agitation in psychiatric disorders and has received Breakthrough Therapy and Fast Track designations.
BioXcel Therapeutics (BTAI) reported financial results for Q2 2021, including a net loss of $27.6 million. The company raised approximately $100 million through a stock offering in June, supporting ongoing clinical studies and commercialization efforts. BXCL501, aimed at treating agitation in schizophrenia and bipolar disorders, has received an FDA PDUFA date of January 5, 2022. The Phase 3 program for dementia-related agitation is anticipated to begin in Q4 2021. R&D expenses decreased to $13.5 million, while G&A expenses rose sharply to $14.1 million due to increased team expansion costs.
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