NEW YORK, June 10, 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 that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the 45th Annual Goldman Sachs Global Healthcare Conference on Tuesday, June 11, 2024 at 10:00 a.m. ET in Miami, FL. The live and archived webcast can be accessed under "Events & ...

NEW YORK, May 29, 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 that Sharon Mates, Ph.D., Chief Executive Officer and Chairman, is scheduled to present at the Jefferies Global Healthcare Conference on Wednesday, June 5, 2024 at 11:00 a.m. ET in New York, NY. The live and archived webcast can be accessed under "Events & Presentations ...

NEW YORK, May 23, 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 highlights data presentations at the American Society of Clinical Psychopharmacology (ASCP) Annual Meeting being held in Miami, May 28 - 31, 2024. The analyses being presented provide important information about CAPLYTA’s efficacy, safety and tolerability profile in patients wit ...

Intra-Cellular Therapies, Inc. (ITCI) reported first-quarter 2024 loss of 16 cents per share, narrower than the Zacks Consensus Estimate of a loss of 31 cents, primarily due to higher product sales. The company had incurred a loss of 46 cents per share in the year-ago quarter. Total revenues, comprising product sales and grant revenues, came in at $144.9 million compared with $95.3 million reported in the year-ago period. The top line beat the Zacks Consensus Estimate of $141.9 million. Quarter in Detail Ca ...

NEW YORK, May 08, 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 that it will participate in two upcoming investor conferences: 2024 RBC Capital Markets Global Healthcare Conference Tuesday, May 14, 2024 at 10:00 a.m. ET in New York, NY Bank of America Healthcare Conference 2024 Thursday, May 16, 2024 at 9:20 a.m. PT (12:20 p.m. ET) ...

Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Q1 2024 Earnings Conference Call May 7, 2024 8:30 AM ET Company Participants Juan Sanchez - Vice President of Corporate Communications and Investor Relations Sharon Mates - Founder, Chairman and Chief Executive Officer Mark Neumann - Executive Vice President and Chief Commercial Officer Lawrence Hineline - Senior Vice President of Finance and Chief Financial Officer Suresh Durgam - Executive Vice President and Chief Medical Officer Conference Call Participants Je ...

Intra-Cellular Therapies (ITCI) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.31. This compares to loss of $0.46 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 48.39%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.44 per share when it actually produced a loss of $0.30, delivering a surprise of 31.82%. Over the last four quart ...

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 ...