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 (Nasdaq: BTAI) announced the initiation of a rolling submission for its New Drug Application (NDA) with the FDA for BXCL501, aimed at treating agitation in patients with schizophrenia and bipolar disorders. Following a pre-NDA meeting, the FDA provided feedback which the company believes supports its data package for submission. BXCL501, which has Fast Track designation, demonstrated statistical superiority over placebo in Phase 3 trials. The full NDA submission is anticipated in Q1 2021.
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BioXcel Therapeutics, Inc. (Nasdaq: BTAI) announced a conference call on November 12, 2020, at 8:30 AM ET to discuss its Q3 2020 financial and operational results. The conference will include a webcast accessible via the company's website. BioXcel is focused on drug development using AI to enhance therapies in neuroscience and immuno-oncology, with advanced programs like BXCL501 for neuropsychiatric agitation and BXCL701 targeting rare prostate cancer and pancreatic cancer. The call aims to provide insights into recent developments and future outlook.
BioXcel Therapeutics (BTAI) announced FDA clearance for its IND application for BXCL501, a sublingual film formulation of dexmedetomidine, aimed at treating agitation associated with delirium. This marks the fifth potential indication for BXCL501. A Phase 2 trial will commence soon, targeting ICU patients, including those with COVID-19. The trial aims to assess safety and efficacy, with a primary endpoint of a 2-point drop in the Richmond Agitation Sedation Scale at two hours post-administration. The move highlights BioXcel's commitment to addressing unmet medical needs in critical care.
BioXcel Therapeutics (BTAI) announced positive results from its Phase 3 SERENITY trials for BXCL501, targeting acute agitation in schizophrenia and bipolar disorder. The company plans to submit a New Drug Application (NDA) to the FDA by Q1 2021. Additionally, they launched a 90 mcg cohort in the TRANQUILITY trial for dementia patients and expanded the BXCL701 trial for castrate-resistant prostate cancer. Financially, BTAI raised approximately $200 million through a follow-on offering, enhancing its cash position for future clinical and commercial activities.
BioXcel Therapeutics (BTAI) has announced an underwritten public offering of 4,000,000 shares of common stock at $50.00 per share, aiming to raise approximately $200 million in gross proceeds. Additionally, underwriters have a 30-day option to purchase up to 600,000 additional shares. Proceeds will not benefit the company directly from any shares sold by stockholders. The offering is set to close around July 31, 2020, following customary conditions. This offering was filed under a registration statement with the SEC, and details will be available in a final prospectus supplement.
BioXcel Therapeutics (BTAI) announced a public offering of $200 million in common stock on July 27, 2020, with an additional $30 million option for underwriters. The net proceeds are earmarked for funding ongoing clinical trials, preparation for commercialization, and general corporate purposes. The offering is managed by BofA Securities, Goldman Sachs, Jefferies, Guggenheim Securities, and SunTrust Robinson Humphrey, amid variable market conditions. This offering is facilitated through an automatic shelf registration statement with the SEC.
BioXcel Therapeutics (BTAI) reported positive results from its SERENITY I and II trials for BXCL501, a sublingual thin film of dexmedetomidine. The trials showed significant improvements in the Positive and Negative Syndrome Scale, Excitatory Component (PEC) score, with reductions occurring as early as 20 minutes post-treatment (p<0.0001). BXCL501 was well tolerated, with no serious adverse events. The company plans to submit a New Drug Application (NDA) to the FDA in Q1 2021, aiming to address acute agitation in schizophrenia and bipolar disorder.
BioXcel Therapeutics (BTAI) announced it received a Notice of Allowance from the U.S. Patent Office for patent application No. 16/453,679 for BXCL501, its sublingual thin-film formulation of dexmedetomidine. The patent strengthens intellectual property for BXCL501, seen as a potential treatment for agitation. This move is important as the company prepares to report topline data from its SERENITY trials aimed at acute agitation in schizophrenia and bipolar disorder. The patent's term extends until at least 2039, and BioXcel plans to list it with FDA drug evaluations.
BioXcel Therapeutics, Inc. (BTAI) announced the appointment of Dr. Reina Benabou as Senior Vice President and Chief Development Officer. With over 20 years of experience in drug development, her expertise is expected to enhance the company’s capabilities in neuroscience product commercialization. The firm aims to leverage her skills as they report topline results from their SERENITY trials and pursue multiple indications for BXCL501, their lead candidate. BXCL501 targets acute agitation in various disorders and has received Fast Track Designation from the FDA.
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