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BioXcel Therapeutics develops AI-enabled biopharmaceutical programs in neuroscience and, through its wholly owned OnkosXcel Therapeutics subsidiary, immuno-oncology. Its news centers on IGALMI, the FDA-approved sublingual film formulation of dexmedetomidine for acute agitation associated with schizophrenia or bipolar I or II disorder in adults, and on BXCL501 development across additional neuropsychiatric settings.
Recurring updates include FDA interactions and label-expansion activity for IGALMI, commercial planning for broader use settings, financial results, and capital-raising transactions. Company announcements also cover investigator-led and funded studies of BXCL501 in areas such as acute agitation in Alzheimer’s dementia, opioid withdrawal, and acute stress reactions, alongside disclosures tied to its drug re-innovation approach using big data and machine learning.
BioXcel Therapeutics (BTAI) announced substantial progress in the development of BXCL501 for treating agitation in schizophrenia and bipolar disorders, with NDA submission on track for Q1 2021. Third quarter 2020 financial results showed a net loss of $24.8 million, up from $9.0 million in Q3 2019, due to increased R&D expenses of $16.3 million. Strong cash reserves of $233 million are set to fund key milestones into 2022. Promising data from ongoing clinical trials for BXCL701 in combination with KEYTRUDA® were also highlighted.
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 (p0.0001). 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.