Bioxcel Therapeutics Inc Stock Price, News & Analysis

BioXcel Therapeutics (Nasdaq: BTAI) ringed the Nasdaq closing bell on February 21, 2023, celebrating its achievements, including the FDA approval of IGALMI™ for treating agitation in adults with schizophrenia or bipolar disorder. CEO Vimal Mehta highlighted the positive Phase 2 data for BXCL701, targeting aggressive prostate cancer, and the upcoming pivotal study readouts for BXCL501 in neuropsychiatric conditions in 2023. This event underscores BioXcel's commitment to AI-driven drug development and market expansion opportunities.

BioXcel Therapeutics (BTAI) announced promising results from its Phase 2a trial of BXCL701 in combination with KEYTRUDA® (pembrolizumab) for treating small cell neuroendocrine variant metastatic castration-resistant prostate cancer (mCRPC). In a cohort of 28 evaluable patients, a composite response rate of 25% was achieved. Additionally, the disease control rate was 48% with a median response duration exceeding 6 months. Despite 18% of patients experiencing serious adverse events, the trial's outcomes support further investigation in a Phase 2b trial. BioXcel plans to initiate a randomized study comparing BXCL701 plus pembrolizumab versus BXCL701 monotherapy in the second half of 2023.

BioXcel Therapeutics (Nasdaq: BTAI) announced a Key Opinion Leader (KOL) Day on February 21, 2023, focusing on its immuno-oncology program BXCL701 aimed at treating small cell neuroendocrine prostate cancer (SCNC). The event will feature insights from experts presenting Phase 2 data at the ASCO GU Symposium. SCNC is an aggressive form of prostate cancer, with projections of approximately 10,740 new cases. BXCL701 is an investigational oral innate immune activator showing promise in enhancing immune responses against tumors. Interested investors can RSVP for the event and access a live webcast.

BioXcel Therapeutics, Inc. (BTAI) announced promising top-line results from its Phase 2 trial of BXCL701, an oral innate immune activator, combined with KEYTRUDA® (pembrolizumab) for treating small cell neuroendocrine metastatic castration-resistant prostate cancer (SCNC). The trial showed encouraging response rates in this underserved patient population, which had 10,740 SCNC cases in 2022. Full data will be presented at the 2023 ASCO Genitourinary Cancers Symposium in February. BXCL701 aims to activate the immune response in 'cold' tumors to facilitate effective immunotherapy.

BioXcel Therapeutics (Nasdaq: BTAI) announced that CEO Vimal Mehta will present corporate updates and 2023 milestones at the 41^st Annual J.P. Morgan Healthcare Conference on January 11, 2023, at 9:45 a.m. PST. The presentation will be accessible via a live webcast on the company's website. BioXcel leverages artificial intelligence to develop transformative drugs, including its product IGALMI™, approved for treating agitation in schizophrenia and bipolar disorders. The company also explores additional therapies under development for various neuropsychiatric conditions.

BioXcel Therapeutics (BTAI) announced the initiation of the pivotal Phase 3 TRANQUILITY III trial for BXCL501, targeting agitation in Alzheimer’s patients residing in nursing homes. This trial is part of the broader TRANQUILITY program, which aims to address the needs of Alzheimer’s patients experiencing agitation, an issue expected to grow as the aging population increases.

With around 100 million agitation episodes occurring annually in the U.S. due to Alzheimer’s, the market opportunity for BXCL501 could potentially expand over six-fold. Top-line results from TRANQUILITY II are anticipated in the first half of 2023.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced that Vimal Mehta, Ph.D., CEO, and Matt Wiley, CCO, will participate in a virtual fireside chat at the Bank of America 2022 Biotech SMID Cap Conference on December 7, 2022, at 1:45 PM ET. They will discuss the company's neuroscience and immuno-oncology programs, along with its AI platform for drug discovery. Additionally, they will detail the ongoing launch strategy for IGALMI™ (dexmedetomidine) sublingual film, which treats agitation in specific psychiatric disorders.

BioXcel Therapeutics (BTAI) announced the initiation of Part 1 in its pivotal Phase 3 SERENITY III trial, assessing BXCL501, a sublingual film for at-home treatment of agitation associated with bipolar disorder and schizophrenia. The trial involves 200 patients across 20 sites in the U.S., aiming for top-line data in 1H 2023. Notably, there are 23 million agitation episodes annually occurring outside institutions, significantly expanding the potential market for BXCL501. The drug has received Breakthrough Therapy and Fast Track designations, highlighting its anticipated importance in addressing significant patient needs.

BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced participation in investor conferences, featuring CEO Vimal Mehta and CCO Matt Wiley. They will discuss the company's neuroscience and immuno-oncology programs, highlighting their AI platform aimed at enhancing drug discovery. Key events include the Guggenheim 4th Annual Immunology and Neurology Day on November 14, 2022, at 3:20 PM ET in New York City, and the Jefferies 2022 London Healthcare Conference on November 16, 2022, at 11:30 AM GMT. Webcasts can be accessed on the company's website.