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 biopharmaceutical company that uses artificial intelligence, big data, and proprietary machine learning algorithms to develop medicines in neuroscience. News about BioXcel Therapeutics often centers on its commercial product IGALMI (dexmedetomidine) sublingual film and its investigational program BXCL501 for the acute treatment of agitation associated with schizophrenia, bipolar disorders, and Alzheimer’s dementia.
Investors and clinicians following BTAI news can expect updates on late‑stage clinical programs such as the SERENITY At‑Home Pivotal Phase 3 trial, which evaluated the safety of a 120 mcg dose of BXCL501 for at‑home treatment of agitation in bipolar disorders or schizophrenia, and the TRANQUILITY In‑Care Phase 3 trial, designed to study agitation associated with Alzheimer’s dementia in care facilities. Company announcements have highlighted that SERENITY At‑Home met its primary safety endpoint and reported exploratory efficacy findings related to repeated dosing and symptom resolution across thousands of agitation episodes.
BioXcel Therapeutics’ news flow also includes regulatory and development milestones, such as plans to submit a supplemental New Drug Application (sNDA) seeking FDA approval for IGALMI use in the at‑home setting, positive correlation study results supporting the use of the modified CGI‑S scale, and presentations of clinical data at medical conferences. Corporate updates, including financing activities under an at‑the‑market equity program, Nasdaq listing compliance notices, and leadership or governance developments, are typically disclosed through SEC filings and press releases.
This news page aggregates these company‑specific developments so readers can review BioXcel Therapeutics’ clinical, regulatory, and corporate announcements over time. For those tracking BTAI, it provides a focused view of how the IGALMI and BXCL501 programs, as well as the broader pipeline through OnkosXcel Therapeutics in immuno‑oncology, progress through research, regulatory review, and commercialization efforts.
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.
BioXcel Therapeutics (BTAI) reported third quarter 2022 results, revealing a net revenue of $137,000 amidst heightened R&D expenses of $22.1 million, primarily linked to its BXCL501 clinical program. The company also posted a net loss of $41.8 million, up from $26.8 million year-on-year. Despite these losses, BioXcel is advancing its agitation-treatment market position with IGALMI™ and anticipates pivotal trial data for BXCL501 in Alzheimer’s-related agitation and bipolar disorders in 1H 2023. The firm maintains a cash balance of approximately $232.3 million as of September 30, 2022.
BioXcel Therapeutics (BTAI) has announced the release of its third quarter 2022 financial results set for November 10, 2022. The management team will hold a conference call at 8:30 AM ET to discuss these financial results and provide a business update. The financials are anticipated to cover performance metrics relevant to shareholders and the company’s AI-driven drug development in neuroscience and immuno-oncology.
BioXcel Therapeutics (Nasdaq: BTAI) has announced a Commercial Day presentation on October 18, 2022, to update on IGALMI™ (dexmedetomidine) sublingual film, a treatment for acute agitation linked to schizophrenia and bipolar disorders in adults. Key company leaders and healthcare experts will share insights on clinical applications and market strategies. IGALMI, approved by the FDA in April 2022, is administered under medical supervision due to potential serious side effects. Investors can RSVP for the event and access a live webcast via BioXcel's website.
BioXcel Therapeutics (Nasdaq: BTAI) announced that CEO Vimal Mehta and CCO Matt Wiley will participate in a fireside chat at the H.C. Wainwright 24th Annual Global Investment Conference on September 12, 2022, at 10:30 a.m. ET. The discussion will focus on the company’s neuroscience and immuno-oncology programs and its AI platform for drug discovery. They will also outline the commercial launch strategy for IGALMI™ (dexmedetomidine) sublingual film, approved for treating agitation in adults with schizophrenia or bipolar disorder. A live webcast will be accessible on the company's website.
BioXcel Therapeutics (BTAI) has commercially launched IGALMI™ (dexmedetomidine) for the acute treatment of agitation in bipolar I/II disorder and schizophrenia in adults. The company plans to initiate the SERENITY III pivotal trial for at-home use of BXCL501 in 2H 2022, following a positive FDA Type B meeting. They expect top-line data from the TRANQUILITY II trial for Alzheimer's-related agitation in 1H 2023. BioXcel reported a net loss of $37.7 million for Q2 2022, with cash reserves of approximately $233.5 million, ensuring funding into 2025.
BioXcel Therapeutics (Nasdaq: BTAI) announces participation in the Canaccord Genuity 42nd Annual Growth Conference on August 10, 2022, at 2:30 p.m. ET. CEO Vimal Mehta and CCO Matt Wiley will discuss the company's neuroscience and immuno-oncology programs, along with its AI-driven drug discovery platform. The event will also cover the commercial strategy for IGALMI™ (dexmedetomidine) sublingual film, approved for treating agitation in adults. A live webcast will be available on their website 15 minutes before the chat starts.
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