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 a multi-year NIDA grant of approximately $3.3 million to fund a clinical study of BXCL501 for opioid withdrawal treatment. The grant will support a 160-patient Phase 2b trial comparing different doses of BXCL501 against placebo and Lucemyra™. This research responds to a significant health crisis, with over 142 million opioid prescriptions dispensed in the U.S. in 2020. Early trials indicated BXCL501 is well tolerated and may effectively reduce insomnia and anxiety in patients. Further funding of about $4.5 million will depend on achieving specific milestones.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) will release its second quarter 2022 financial results on August 9, 2022, before U.S. market opening. A conference call and webcast will take place at 8:30 AM ET to discuss the results and provide business updates. BioXcel utilizes artificial intelligence for drug re-innovation in neuroscience and immuno-oncology. Its product, IGALMI™, is approved for treating agitation in schizophrenia and bipolar disorders. The company is also pursuing treatments for Alzheimer's-related agitation and prostate cancer.
BioXcel Therapeutics (BTAI) announced the appointment of Michael P. Miller to its Board of Directors, effective July 1, 2022. Miller has nearly 40 years of experience in the pharmaceutical industry, previously serving as EVP, U.S. Commercial at Jazz Pharmaceuticals. His leadership is expected to enhance BioXcel's commercial capabilities as the company launches its product IGALMI, a sublingual film for treating agitation linked to Alzheimer's disease. Miller's extensive background in product launches and market access is viewed as crucial for the company's growth trajectory.
BioXcel Therapeutics (Nasdaq: BTAI) announced that CEO Vimal Mehta, Ph.D., will participate in fireside chats at the Jefferies Global Healthcare Conference on June 10, 2022, and the BofA Securities Napa Forum on June 22, 2022. Mehta will discuss the company’s neuroscience and immuno-oncology programs and its AI platform, which enhances drug discovery. The discussions will also cover the commercial readiness of IGALMI™ (dexmedetomidine) sublingual film, FDA-approved for treating agitation in adults.
BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced that CEO Vimal Mehta will participate in a fireside chat at the H.C. Wainwright Global Investment Conference on May 24 at 9:00 a.m. ET. The discussion will focus on the company's neuroscience and immuno-oncology programs, along with its AI platform for drug discovery and development. Dr. Mehta will also address the launch plans for IGALMI™ (dexmedetomidine) sublingual film, approved for treating agitation in patients with schizophrenia and bipolar disorders. A live webcast will be available for attendees.
BioXcel Therapeutics has received FDA approval for IGALMI™, a sublingual film for treating agitation in adults with schizophrenia or bipolar disorder. The expected cash runway extends to 2025, supported by a $260 million strategic financing. The company is optimizing its commercial launch efforts with a national salesforce beginning deployment on May 23, 2022. Clinical trials for BXCL501 are ongoing, with top-line results anticipated in Q4 2022.
BioXcel Therapeutics (Nasdaq: BTAI) announced that its CEO, Vimal Mehta, will speak at three investor conferences to showcase the company's neuroscience and immuno-oncology programs. The discussions will also highlight their artificial intelligence platform aimed at enhancing drug discovery. Key events include the BofA Securities 2022 Healthcare Conference on May 12, UBS Global Healthcare Conference on May 23, and H.C. Wainwright Global Investment Conference on May 25. The company’s product, IGALMI™, is FDA-approved for treating agitation in adults with schizophrenia or bipolar disorder.
BioXcel Therapeutics (BTAI) has dosed the first patient in the Phase 3 TRANQUILITY II trial of BXCL501 for treating agitation associated with Alzheimer’s disease. This pivotal study is part of a broader program that includes TRANQUILITY III, aiming to evaluate BXCL501’s safety and efficacy in patients aged 65 and older. The company plans to expand clinical sites and assesses both 40 and 60 mcg dosing regimens. BXCL501, recently FDA-approved for schizophrenia-related agitation, has shown promising results in reducing agitation in preliminary studies.
BioXcel Therapeutics (BTAI) will announce its first quarter 2022 financial results on May 9, 2022, before U.S. market opening. The management team will host a conference call at 8:30 AM ET to discuss the results and provide a business update. The call details, including domestic and international dial-in numbers, are provided. BioXcel leverages AI to develop medicines, with its product IGALMI™ approved for treating agitation in certain psychiatric disorders. For further information, the webcast and related materials will be available on their website.
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.
FAQ
What is the current stock price of Bioxcel Therapeutics (BTAI)?
What is the market cap of Bioxcel Therapeutics (BTAI)?
