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) will release its fourth quarter and fiscal year 2021 financial results on March 10, 2022, before U.S. market open. A conference call will follow at 8:30 AM ET for a discussion of the results and business updates. The company specializes in AI-driven therapeutics in neuroscience and immuno-oncology, focusing on BXCL501 and BXCL701 for psychiatric disorders and advanced prostate cancer, respectively. Webcast details will be available on their website.
BioXcel Therapeutics (BTAI) announced positive results from the Phase 3 SERENITY II trial for BXCL501, a treatment for agitation associated with bipolar disorder. The study revealed statistically significant improvements in agitation scores at two hours post-treatment compared to placebo. Notable findings include a 90.5% response rate in the 180 mcg group, with adverse events reported in 35.7% of patients. BXCL501 is set for PDUFA review by the FDA on April 5, 2022, following its Breakthrough Therapy designation for agitation treatments.
BioXcel Therapeutics (BTAI) announced promising interim results from its Phase 2 trial of BXCL701, an oral innate immunity activator, in combination with KEYTRUDA in patients with metastatic castration-resistant prostate cancer (mCRPC). In the small cell neuroendocrine carcinoma cohort, the composite response rate was 33%, and in adenocarcinoma, it was 21%. Despite some serious adverse events reported, the data suggests potential to enhance treatment efficacy in difficult-to-treat mCRPC types. The company plans to expand trials based on these findings.
BioXcel Therapeutics (BTAI) announced that CEO Vimal Mehta will present at the SVB Leerink 11th Annual Global Healthcare Conference on February 16 at 2:20 p.m. ET. The presentation will focus on the company's neuroscience and immuno-oncology programs, highlighting their AI platform that enhances drug discovery and development. Additionally, Mehta will discuss commercial and launch plans for BXCL501, a treatment for agitation linked to psychiatric and neurological disorders. Visit their website for a live webcast and materials from the conference.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced the appointment of Matt Wiley as Senior Vice President and Chief Commercial Officer. Wiley brings over 25 years of experience in commercial strategy, particularly in neuroscience product launches. His role is critical as the company prepares for the anticipated approval and commercial launch of BXCL501 for treating agitation linked to schizophrenia and bipolar disorders. Wiley previously led significant marketing efforts for products generating up to $1.4 billion in revenue.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced that CEO Vimal Mehta, Ph.D., will present corporate updates at the 40th Annual J.P. Morgan Healthcare Conference on January 13, 2022, at 9:45 a.m. ET. The event will be held virtually, and interested parties can access the webcast on the company's website. BioXcel specializes in utilizing artificial intelligence to innovate medicines in neuroscience and immuno-oncology, focusing on its lead programs, BXCL501 and BXCL701, aimed at treating agitation and aggressive prostate cancer, respectively.
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.
