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) reported financial results for Q2 2021, including a net loss of $27.6 million. The company raised approximately $100 million through a stock offering in June, supporting ongoing clinical studies and commercialization efforts. BXCL501, aimed at treating agitation in schizophrenia and bipolar disorders, has received an FDA PDUFA date of January 5, 2022. The Phase 3 program for dementia-related agitation is anticipated to begin in Q4 2021. R&D expenses decreased to $13.5 million, while G&A expenses rose sharply to $14.1 million due to increased team expansion costs.
BioXcel Therapeutics, Inc. (BTAI) announced the release of its second quarter 2021 financial results scheduled for August 10, 2021, before U.S. market opening. A conference call will follow at 8:30 AM EDT to discuss the results and provide a business update. The company focuses on utilizing artificial intelligence to develop innovative treatments in neuroscience and immuno-oncology, with notable clinical advancements in BXCL501 and BXCL701, aimed at addressing agitation and aggressive prostate cancer, respectively.
BioXcel Therapeutics (BTAI) will participate in the Canaccord Genuity 41st Annual Growth Conference on August 12, 2021, at 9:30 a.m. Eastern Time. The event will feature Dr. Vimal Mehta, the CEO and Founder of BioXcel. Investors and interested parties can access the live webcast on the Company’s website under the “Events” section. A replay will be available for 30 days post-event. BioXcel focuses on utilizing artificial intelligence to develop innovative medicines, including therapies for agitation and advanced prostate cancer.
BioXcel Therapeutics (BTAI) has priced an underwritten public offering of 3,155,000 shares at $31.70 each, aiming for gross proceeds of approximately $100 million. A related party, BioXcel LLC, has granted underwriters a 30-day option to purchase up to 473,250 additional shares. The offering is set to close around June 25, 2021, and is being managed by BofA Securities under a previously filed registration statement with the SEC. The company will not receive any proceeds from shares sold by BioXcel LLC.
BioXcel Therapeutics, a clinical-stage biopharmaceutical company (Nasdaq: BTAI), has initiated a public offering of $100 million in common stock. Additionally, a related stockholder may grant underwriters a 30-day option for an extra $15 million. Proceeds will be allocated for ongoing clinical trials, commercialization preparations, and general corporate purposes. The offering is subject to market conditions, with no assurance on timing or actual terms. This is being conducted under an existing SEC registration statement.
BioXcel Therapeutics (Nasdaq: BTAI) has scheduled a virtual Commercial Day on June 25, 2021, from 12:00 PM ET to 1:30 PM ET. This event aims to update stakeholders on the launch readiness for BXCL501, an investigational treatment for agitation associated with schizophrenia and bipolar disorders. Attendees will include CEO Vimal Mehta and industry experts, offering insights into BXCL501’s market potential. The event will be available via live webcast on the company’s website and archived for 30 days.
BioXcel Therapeutics (Nasdaq: BTAI) announced that Dr. Vimal Mehta, CEO, will participate in three upcoming virtual healthcare investor conferences. These include the Jefferies Virtual Healthcare Conference on June 2, Goldman Sachs 42nd Annual Global Healthcare Conference on June 9, and BofA Securities Napa Biopharma Conference on June 14. The live webcasts will be accessible on the Company's website and archived for 30 days post-event. BioXcel focuses on utilizing artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology.
BioXcel Therapeutics has announced the FDA's acceptance of their New Drug Application for BXCL501, an investigational treatment for acute agitation associated with schizophrenia and bipolar disorders. The FDA has set a PDUFA action date for January 5, 2022. BXCL501, if approved, would be a significant advancement in treating agitation, a common and challenging symptom affecting nearly 3 million adults in the U.S. annually. The NDA is supported by positive results from two Phase 3 studies demonstrating BXCL501's efficacy and safety.
BioXcel Therapeutics (BTAI) announced the selection of four abstracts for presentation at the ISBD 2021 Global Annual Conference from May 13-15, 2021. Key topics include the pivotal SERENITY program results on BXCL501's efficacy in treating acute agitation in bipolar disorder. The company has also submitted a New Drug Application for BXCL501 to the FDA. This innovative formulation targets agitation mechanisms and has received breakthrough designations, emphasizing its potential in neuropsychiatric treatment.
BioXcel Therapeutics (BTAI) announced significant advancements regarding BXCL501, which received FDA Breakthrough Therapy designation for treating agitation related to dementia. The registrational program is expected to commence in the second half of 2021. The company submitted a New Drug Application (NDA) for BXCL501 aimed at agitation in schizophrenia and bipolar disorders. Commercial preparations are ramping up, alongside plans to file a Marketing Authorization Application (MAA) with the EMA. First quarter financials revealed a net loss of $26.4 million and R&D expenses increased to $14.7 million, reflecting growth in personnel and consulting needs.
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