Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 _______________________ FORM 10-Q _______________________ (Mark One) x QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 or o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from_________to_________ Commission File Number: 001-36274 _______________________ INTRA-CELLULAR ...

公司产品 - 公司是一家专注于发现、临床开发和商业化创新小分子药物的生物制药公司，主要针对神经精神疾病和神经系统疾病中未满足的医疗需求，通过靶向中枢神经系统内部信号传导机制来解决[1] - CAPLYTA® (lumateperone)已获得FDA批准，用于成人精神分裂症的治疗，公司于2020年3月开始了CAPLYTA的商业推出[1] - 在2021年12月，CAPLYTA获得FDA批准，用于成人双相抑郁症的治疗，公司于2021年12月开始了CAPLYTA用于双相抑郁症的商业推出[1] - FDA批准了CAPLYTA的两种额外剂量，10.5毫克和21毫克胶囊，以提供给同时服用强或中度CYP3A4抑制剂的患者的剂量建议，以及给予中度或严重肝功能受损患者（Child-Pugh B或C级）的21毫克剂量[1] Lumateperone临床试验 - Lumateperone 42毫克作为抗抑郁药物的辅助疗法，满足了研究501的主要终点，显示出与安慰剂相比在第6周的Montgomery Asberg抑郁评定量表（MADRS）总分上的显著和临床意义的减少[3] - Lumateperone 42毫克在研究中显示出显著的疗效，早期时间点（第1周）就有统计学显著性，并在整个研究中保持在主要和关键次要终点上[3] - Lumateperone 42毫克在研究中显著改善了患者报告的抑郁症状，通过Quick Inventory of Depressive Symptomatology Self Report（QIDS-SR-16）测量[3] - Lumateperone在研究中表现出良好的安全性和耐受性，最常见的不良事件是口干（10.8%）、疲劳（9.5%）和震颤（5.0%）[3] 未来展望 - 公司正在进行全球第3期临床试验，评估Lumateperone 42毫克作为抗抑郁药物的辅助疗法，研究505旨在作为支持Lumateperone作为抗抑郁药物的辅助疗法的补充新药申请的潜在额外注册试验[5] - 公司正在进行研究，评估Lumateperone用于预防精神分裂症患者复发，该研究包括五个阶段，包括筛选阶段、6周的开放标签适应期、12周的开放标签稳定期、26周的双盲治疗期和2周的安全随访期[8] 财务状况 - 我公司预计2024年第一季度CAPLYTA净产品销售额约为1.448亿美元[22] - 我公司截至2024年3月31日的现金、现金等价物、投资证券和受限现金约为4.77亿美元[22]

CAPLYTA Q1 2024 net product sales were $144.8 million, compared to $94.7 million for the same period in 2023, representing a 53% increase CAPLYTA's strong prescription uptake continues: Q1 2024 CAPLYTA total prescriptions increased 39%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance reiterated at $645 - $675 million Announced robust positive Phase 3 results from Study 501 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disorder (M ...

NEW YORK, April 30, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Tuesday, May 7, 2024, to provide a corporate update and discuss details of the Company's financial results for the quarter ended March 31, 2024. To attend the live conference call ...

公开发行详情 - Intra-Cellular Therapies完成了公开发行1,027,397股普通股，募集资金约为575百万美元[1] - J.P. Morgan, Leerink Partners, BofA Securities, Morgan Stanley和RBC Capital Markets担任了此次发行的联席主承销商[3] - 公开发行是根据之前向证券交易委员会（SEC）提交的Form S-3注册声明进行的[4]

生物科技股票投资 - 生物科技股票投资具有高风险高回报的特点[1] - 降低利率将刺激生物科技领域的投资[2] 热门生物科技股票 - IntraCellular Therapies (ITCI)是市场上最热门的生物科技股票之一，其股价在过去六个月内增长超过45%[3] - Viking Therapeutics (VKTX)是另一只表现出色的生物科技股票，过去六个月上涨超过528%[6] 重量级生物科技公司 - Novo Nordisk (NVO)是生物科技行业的重量级选手，拥有超过一个世纪的历史，具有庞大的创新药物管道[11]

NEW YORK, April 17, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) ("Intra-Cellular Therapies"), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced the pricing of its previously announced underwritten public offering of 6,849,316 shares of its common stock at a public offering price of $73.00 per share. All of the shares in the offering will be sold by Intra-Cellular Therapies, with g ...

Intra-Cellular Therapies, Inc. (ITCI) announced positive top-line results from its late-stage study evaluating lumateperone 42 mg for the treatment of major depressive disorder (MDD). The stock climbed 23.3% on Apr 16 following the encouraging news. The stock hit a new 52-week high on Tuesday, driven by the significant pipeline development.The phase III study, called Study 501, evaluating lumateperone 42 mg given once daily as an adjunctive therapy to antidepressants for MDD, met the primary endpoint. A sta ...

公司股价表现 - Intra-Cellular Therapies (ITCI)股价在最近一个交易日上涨了23.3%，收盘价为$79.84，这一动向可以归因于交易量的增加，交易的股票数量比一般交易日要多[1] - 公司宣布其III期研究501号研究评估lumateperone 42毫克作为辅助治疗抑郁症的主要和关键次要终点，股价突然飙升[2] 财务预测 - Intra-Cellular预计在即将发布的财报中每股亏损$0.33，同比增长+28.3%，预计营收为1.403亿美元，同比增长47.2%[3]

NEW YORK, April 16, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) ("Intra-Cellular Therapies"), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that it has commenced an underwritten public offering of $500 million of shares of its common stock. In connection with the offering, Intra-Cellular Therapies intends to grant the underwriters a 30-day option to purchase up to an additiona ...