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.
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BioXcel Therapeutics (Nasdaq: BTAI) announced its Q1 2023 financial results will be released on May 8, 2023, before U.S. markets open. The company will host a conference call at 8:00 AM ET to discuss the results and provide a business update. BioXcel specializes in using artificial intelligence to develop innovative medicines in neuroscience and immuno-oncology. Their flagship product, IGALMI™, is a sublingual film approved for treating agitation associated with schizophrenia and bipolar disorders. The company is also evaluating several pipeline candidates for various indications. The press release includes forward-looking statements about anticipated outcomes and risks associated with the company’s operations.
On March 14, 2023, OnkosXcel Therapeutics announced the confidential submission of a draft registration statement on Form S-1 with the SEC for a proposed initial public offering (IPO) of its common stock. The number of shares and price range of the offering have yet to be determined, with the IPO anticipated to follow the SEC's review, contingent on market conditions. OnkosXcel operates as a subsidiary of BioXcel Therapeutics (Nasdaq: BTAI). This announcement complies with Rule 135 of the Securities Act of 1933, and does not constitute an offer to sell or solicit offers to buy any securities.
BioXcel Therapeutics (BTAI) reported its 2022 financial results, revealing a net revenue of approximately $238,000 for Q4 and $375,000 for the full year, attributed to limited market access. The company's net loss for Q4 was $54.8 million, with a full-year loss of $165.8 million. IGALMI™ (dexmedetomidine) is now commercially launched, with strong interest in market access and an expanded field team of 70 representatives. Upcoming pivotal data readouts for BXCL501 are expected in Q2 2023, targeting significant agitation episodes. Strategic options for OnkosXcel are under exploration, while a conference call is planned for updates.
BioXcel Therapeutics (Nasdaq: BTAI) will release its fourth quarter and full year 2022 financial results on March 9, 2023, before the market opens. The management team will host a conference call at 8:30 AM ET to discuss the results and provide a business update. Known for its AI-driven approach to developing treatments in neuroscience and immuno-oncology, BioXcel's commercial product, IGALMI™, targets agitation associated with psychiatric disorders. The company continues to explore new indications for its products, including BXCL501 for Alzheimer's agitation and BXCL701 for aggressive prostate cancer.
BioXcel Therapeutics (Nasdaq: BTAI) ringed the Nasdaq closing bell on February 21, 2023, celebrating its achievements, including the FDA approval of IGALMI™ for treating agitation in adults with schizophrenia or bipolar disorder. CEO Vimal Mehta highlighted the positive Phase 2 data for BXCL701, targeting aggressive prostate cancer, and the upcoming pivotal study readouts for BXCL501 in neuropsychiatric conditions in 2023. This event underscores BioXcel's commitment to AI-driven drug development and market expansion opportunities.
BioXcel Therapeutics (BTAI) announced promising results from its Phase 2a trial of BXCL701 in combination with KEYTRUDA® (pembrolizumab) for treating small cell neuroendocrine variant metastatic castration-resistant prostate cancer (mCRPC). In a cohort of 28 evaluable patients, a composite response rate of 25% was achieved. Additionally, the disease control rate was 48% with a median response duration exceeding 6 months. Despite 18% of patients experiencing serious adverse events, the trial's outcomes support further investigation in a Phase 2b trial. BioXcel plans to initiate a randomized study comparing BXCL701 plus pembrolizumab versus BXCL701 monotherapy in the second half of 2023.
BioXcel Therapeutics (Nasdaq: BTAI) announced a Key Opinion Leader (KOL) Day on February 21, 2023, focusing on its immuno-oncology program BXCL701 aimed at treating small cell neuroendocrine prostate cancer (SCNC). The event will feature insights from experts presenting Phase 2 data at the ASCO GU Symposium. SCNC is an aggressive form of prostate cancer, with projections of approximately 10,740 new cases. BXCL701 is an investigational oral innate immune activator showing promise in enhancing immune responses against tumors. Interested investors can RSVP for the event and access a live webcast.
BioXcel Therapeutics, Inc. (BTAI) announced promising top-line results from its Phase 2 trial of BXCL701, an oral innate immune activator, combined with KEYTRUDA® (pembrolizumab) for treating small cell neuroendocrine metastatic castration-resistant prostate cancer (SCNC). The trial showed encouraging response rates in this underserved patient population, which had 10,740 SCNC cases in 2022. Full data will be presented at the 2023 ASCO Genitourinary Cancers Symposium in February. BXCL701 aims to activate the immune response in 'cold' tumors to facilitate effective immunotherapy.
BioXcel Therapeutics (Nasdaq: BTAI) announced that CEO Vimal Mehta will present corporate updates and 2023 milestones at the 41st Annual J.P. Morgan Healthcare Conference on January 11, 2023, at 9:45 a.m. PST. The presentation will be accessible via a live webcast on the company's website. BioXcel leverages artificial intelligence to develop transformative drugs, including its product IGALMI™, approved for treating agitation in schizophrenia and bipolar disorders. The company also explores additional therapies under development for various neuropsychiatric conditions.
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