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. (BTAI) is a clinical-stage biopharmaceutical company pioneering AI-driven drug re-innovation in neuroscience and immuno-oncology. This page serves as the definitive source for official updates including clinical trial progress, regulatory milestones, and strategic initiatives.
Investors and industry observers will find curated press releases detailing advancements in BXCL501 development for neuropsychiatric conditions, immuno-oncology research through subsidiary OnkosXcel, and financial disclosures. Our news collection enables stakeholders to track how machine learning accelerates therapeutic discovery while managing development risks.
Content is organized to highlight essential updates: clinical trial results, regulatory filings, research collaborations, and financial performance. Each update reflects BioXcel's unique approach combining big data analytics with established clinical science to address unmet medical needs.
Bookmark this page for direct access to verified information about BioXcel's innovative pipeline and corporate developments. Check regularly for updates on how artificial intelligence continues to reshape therapeutic discovery in high-need medical specialties.
BioXcel Therapeutics (BTAI) has initiated its pivotal Phase 3 program for BXCL501 to treat agitation in Alzheimer’s disease patients, following FDA breakthrough therapy designation. This program includes two studies, TRANQUILITY II and TRANQUILITY III, enrolling 300 patients aged 65 and older from assisted living and nursing homes. The studies will evaluate the safety and efficacy of BXCL501, aiming to address agitation, which affects up to 70% of Alzheimer’s patients, with no current FDA-approved treatments available. Results are anticipated to have significant implications for the company's market position.
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.
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