Data to support potential sNDA submission for label expansion of IGALMI® in the home setting Topline data expected in second half of 2025 NEW HAVEN, Conn., March 07, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced it has reached 33% enrollment in its 200-patient SERENITY At-Home trial. The pivotal Phase 3 trial is designed to evaluate the safety of BXCL501, t ...

Data to support potential sNDA submission for label expansion of IGALMI® in the home setting Topline data expected in second half of 2025 NEW HAVEN, Conn., March 07, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced it has reached 33% enrollment in its 200-patient SERENITY At-Home trial. The pivotal Phase 3 trial is designed to evaluate the safety of BXCL501, th ...

文章核心观点 - 生物制药公司BioXcel Therapeutics完成400万股普通股及附带认股权证的注册直接发行，总收益约1400万美元 [1] 公司信息 - BioXcel Therapeutics是利用人工智能开发神经科学变革性药物的生物制药公司，其全资子公司OnkosXcel Therapeutics专注于免疫肿瘤学药物开发，公司采用药物再创新方法，利用现有获批药物和临床验证候选产品结合大数据和专有机器学习算法确定新治疗适应症 [5] 发行情况 - 公司完成400万股普通股（面值每股0.001美元）及附带认股权证的注册直接发行，组合发行价为每股3.50美元，总收益约1400万美元，附带认股权证行使价为每股4.20美元，发行日起可随时行使，受一定所有权限制，发行日起五年到期 [1] - 公司授予购买者选择权，发行结束后两周内可随时额外购买最多400万股股票及附带认股权证，组合发行价为每股3.50美元 [1] - Rodman & Renshaw LLC担任此次发行的独家配售代理，发行于2025年3月4日结束 [2] 发行依据 - 上述证券（包括额外证券购买选择权行使时可发行的证券）依据2023年11月13日美国证券交易委员会宣布生效的S - 3表格上架注册声明发售，发售仅通过构成有效注册声明一部分的招股说明书补充文件进行 [3] 联系方式 - 公司企业/投资者联系人为Erik Kopp，电话1.203.494.7062；媒体联系人为Russo Partners的David Schull，电话1.858.717.2310 [8]

The market expects BioXcel Therapeutics, Inc. (BTAI) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended December 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the other han ...

NEW HAVEN, Conn., March 03, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (the "Company") (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it has entered into a securities purchase agreement with certain institutional investors for the purchase and sale in a registered direct offering of 4,000,000 shares (the "Shares") of common stock, par value $0.001 per share ("Common Stock") (or common stock equiv ...

FDA concludes site inspection is closed under 21 C.F.R.20.64(d)(3); Voluntary Action Indicated Company believes this further supports reliability of data from TRANQUILITY II trial of BXCL501 NEW HAVEN, Conn., March 03, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that the U.S. Food and Drug Administration (FDA) has concluded that the inspection of a single ...

FDA concludes site inspection is closed under 21 C.F.R.20.64(d)(3); Voluntary Action Indicated Company believes this further supports reliability of data from TRANQUILITY II trial of BXCL501 NEW HAVEN, Conn., March 03, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (Nasdaq: BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that the U.S. Food and Drug Administration (FDA) has concluded that the inspection of a single ...

NEW HAVEN, Conn., Feb. 28, 2025 (GLOBE NEWSWIRE) -- BioXcel Therapeutics, Inc. (NASDAQ:BTAI), a biopharmaceutical company utilizing artificial intelligence to develop transformative medicines in neuroscience, today announced that it has received written notice from the Listing Qualifications Department of The Nasdaq Stock Market LLC ("Nasdaq") that the Company has regained compliance with the minimum closing bid price requirement under Nasdaq Listing Rule 5550(a)(2). As previously disclosed, on September 16 ...

文章核心观点 生物制药公司BioXcel Therapeutics宣布将进行1比16的反向股票分割，以重新符合纳斯达克资本市场的最低出价要求 [1][2] 反向股票分割信息 - 生效时间为2025年2月7日下午5点，2月10日开始以调整后基础交易 [1] - 交易市场为纳斯达克资本市场，股票代码“BTAI”，新CUSIP编号09075P204 [2] - 不发行零碎股份，有权获得零碎股份的股东将获得现金支付 [3] - 对公司已发行股票期权和股权奖励计划进行相应调整 [4] - 经2025年1月28日股东大会批准，董事会决定以1比16的比例进行分割 [5] 公司简介 - 利用人工智能开发神经科学变革性药物，子公司OnkosXcel Therapeutics专注免疫肿瘤学药物开发 [6] - 采用药物再创新方法，利用现有获批药物和临床验证候选产品结合大数据和专有机器学习算法确定新治疗适应症 [6] 联系方式 - 公司/投资者联系人为Erik Kopp，电话1.203.494.7062 [9] - 媒体联系人为David Schull，电话1.858.717.2310 [9]

文章核心观点 公司更新了神经科学主要资产BXCL501后期临床项目进展，采取措施增强运营和财务灵活性、强化董事会领导，旨在为患者带来新治疗选择并为利益相关者创造价值 [1][2] 各部分总结 BXCL501关键3期试验 - SERENITY居家试验多数试验点已开放，患者入组进展顺利，用于双相情感障碍或精神分裂症相关急性激越治疗 [6] - 制定了TRANQUILITY护理试验计划，用于阿尔茨海默病痴呆相关激越治疗 [6] IGALMI市场情况 - 公司计划通过现有分销渠道继续向现有和未来客户供应IGALMI，无商业支持 [3] BXCL502研发情况 - 继续深入研究BXCL502作用机制，以支持其用于治疗慢性阿尔茨海默病相关激越的开发，2024年12月在会议上展示了相关海报 [4] 公司更新 战略融资 - 2024年11月25日宣布修订现有信贷协议，增强运营和财务灵活性 - 2024年11月25日完成股权融资，总收益700万美元 [7] 董事会新任命 - 公司加强董事会力量，新增具有临床、财务和法律专业知识人员 - 拉吉夫·帕特尼博士有广泛全球产品开发经验，现任Judo Bio首席执行官，曾在多家制药公司任职 [5] - 大卫·麦克有25年以上律师、董事和投资者经验，为多家公司提供财务和法律领导 [8] 产品信息 IGALMI - 是一种处方药物，用于成人精神分裂症和双相I或II型障碍相关急性激越治疗，首次给药24小时后的安全性和有效性未研究，儿童使用安全性和有效性未知 [9] BXCL501 - 除作为IGALMI获批适应症外，是一种研究性专有口服溶膜制剂，正在研究用于阿尔茨海默病痴呆和双相I或II型障碍或精神分裂症居家环境下急性激越治疗，相关安全性和有效性未确立，已获FDA突破性疗法和快速通道指定 [16] 公司概况 - 是一家利用人工智能开发神经科学变革性药物的生物制药公司，其全资子公司OnkosXcel Therapeutics专注于免疫肿瘤学药物开发，采用药物再创新方法识别新治疗适应症 [17]