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 develops AI-enabled biopharmaceutical programs in neuroscience and, through its wholly owned OnkosXcel Therapeutics subsidiary, immuno-oncology. Its news centers on IGALMI, the FDA-approved sublingual film formulation of dexmedetomidine for acute agitation associated with schizophrenia or bipolar I or II disorder in adults, and on BXCL501 development across additional neuropsychiatric settings.
Recurring updates include FDA interactions and label-expansion activity for IGALMI, commercial planning for broader use settings, financial results, and capital-raising transactions. Company announcements also cover investigator-led and funded studies of BXCL501 in areas such as acute agitation in Alzheimer’s dementia, opioid withdrawal, and acute stress reactions, alongside disclosures tied to its drug re-innovation approach using big data and machine learning.
On April 19, 2022, BioXcel Therapeutics (Nasdaq: BTAI) announced the formation of its subsidiary, OnkosXcel Therapeutics, to advance therapies targeting challenging cancers with high unmet needs. The lead asset, BXCL701, is currently in Phase 2 trials for aggressive prostate cancer and has shown promising data. OnkosXcel aims to optimize the oncology franchise and leverage AI for drug development. BXCL701, designed to activate innate immunity, has received Orphan Drug Designation in four indications, suggesting significant potential in treating both 'cold' and 'hot' tumors.
BioXcel Therapeutics (BTAI) announced strategic financing agreements with Oaktree Capital Management and Qatar Investment Authority, providing up to $260 million to support the U.S. commercial launch of IGALMI™ and clinical development of BXCL501. This financing includes a credit agreement of up to $135 million, revenue interest financing of up to $120 million, and a potential equity investment of up to $5 million. The arrangements are expected to extend the company’s cash runway into 2025 and support a pivotal Phase 3 program for treating agitation in Alzheimer’s patients.
BioXcel Therapeutics has announced the FDA approval of IGALMI (dexmedetomidine), the first orally dissolving sublingual film for treating agitation in adults with schizophrenia or bipolar I/II disorder. The approval is significant as it provides a self-administered option with a rapid onset of action, showing effects as early as 20 minutes. The company aims for a Q2 2022 launch, targeting up to 25 million agitation episodes annually in the U.S. This milestone positions IGALMI as an innovative solution in a field long challenged by conventional treatments.
BioXcel Therapeutics (Nasdaq: BTAI) announced significant progress in its clinical initiatives, nearing FDA approval for BXCL501 by the April 5, 2022 PDUFA date. The company launched pivotal Phase 3 trials for BXCL501 in treating agitation in Alzheimer’s patients and submitted an IND for its use in major depressive disorder. Encouraging Phase 2 data for BXCL701 in prostate cancer patients was presented, enhancing its immuno-oncology portfolio. Despite increased R&D and administrative expenses, cash reserves stand at $233 million. A conference call will discuss Q4 and full year 2021 financial results.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced that CEO Vimal Mehta, Ph.D., will present at the Barclays Global Healthcare Conference on March 15 at 3:50 p.m. ET. The presentation will focus on the Company’s neuroscience and immuno-oncology programs, as well as its artificial intelligence platform designed for drug discovery. Additionally, the event will cover commercial readiness for its product candidate, BXCL501, which targets agitation in psychiatric and neurological disorders. The presentation can be accessed via the Company’s website.
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.