文章核心观点 - Intra-Cellular是一家专注于神经精神疾病和神经系统疾病的商业阶段生物技术公司[1] - 公司主要产品Caplyta(lumateperone 42mg)已获批用于治疗成人精神分裂症和双相抑郁症[2][3] - Caplyta销售额持续增长,2023年第一季度同比增长53%,处方量增长85%[4] - 公司正在评估Caplyta用于治疗其他适应症,如抑郁症,预计将在2024年下半年提交补充新药申请[6][7][8] - 公司还在开发其他神经系统疾病和癌症领域的候选药物,现金储备充足[10][11][12] - 但公司依赖单一产品的风险较高,面临监管环境趋严和竞争加剧的挑战[13][14][15] 公司概况 - Intra-Cellular是一家专注于神经精神疾病和神经系统疾病的商业阶段生物技术公司[1] - 公司主要产品Caplyta(lumateperone 42mg)已获批用于治疗成人精神分裂症和双相抑郁症[2][3] - 公司正在评估Caplyta用于治疗其他适应症,如抑郁症,预计将在2024年下半年提交补充新药申请[6][7][8] - 公司还在开发其他神经系统疾病和癌症领域的候选药物,现金储备充足[10][11][12] 产品表现 - Caplyta销售额持续增长,2023年第一季度同比增长53%,处方量增长85%[4] - 公司预计Caplyta未来销售将进一步提高[5] 挑战与风险 - 公司依赖单一产品的风险较高[13] - 面临监管环境趋严和竞争加剧的挑战[14][15]

Intra-Cellular Therapies (ITCI) announced positive top-line results from Study 502, the second late-stage study that evaluated lumateperone 42 mg for the treatment of major depressive disorder (MDD). Intra-Cellular also reported that the key secondary endpoint was also achieved by demonstrating a statistically significant and clinically meaningful reduction in the Clinical Global Impression Scale score, which is a measure of severity of illness compared with placebo at week six. Additionally, feedback from ...

Intra-Cellular Therapies (ITCI) shares rallied 9.6% in the last trading session to close at $75.48. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 5.4% gain over the past four weeks. This biopharmaceutical company is expected to post quarterly loss of $0.20 per share in its upcoming report, which represents a year-over-year change of +55.6%. Revenues are expected to be $157.59 million, up 42.2% from the year ...

文章核心观点 - 公司宣布其新药物lumateperone 42 mg作为抗抑郁药物的辅助治疗在两项III期临床试验中取得积极成果 [1][2][3] - 该药物在主要终点和次要终点指标上均显示出显著的疗效和临床意义,并且安全性良好 [1][2][3][4][5][10] - 公司计划于2024年下半年向FDA提交补充新药申请,以获得该适应症的批准 [1][7] 根据目录分别总结 临床试验结果 - 在MADRS总评分和CGI-S量表上,lumateperone 42 mg组与安慰剂组相比均显示出显著的疗效改善 [1][2][3][10] - 在QIDS-SR-16自评量表上,lumateperone 42 mg组也显示出了显著的改善抑郁症状的效果 [4] - 该药物的安全性和耐受性总体良好,常见不良反应包括眩晕、嗜睡、口干等 [5][10] 公司计划 - 公司计划于2024年下半年向FDA提交补充新药申请,以获得该适应症的批准 [1][7] - 公司对该药物在治疗抑郁症方面的潜力表示信心,认为其有望成为该领域的领先选择 [2] 抑郁症概况 - 抑郁症是美国常见的情绪障碍,每年约有2100万成人受其影响,是全球主要致残原因之一 [11] - 约三分之二的抑郁症患者无法通过一线治疗获得缓解 [7][11]

The live and archived webcast can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at www.intracellulartherapies.com. Please log in approximately 5-10 minutes prior to the event to register and to download and install any necessary software. Burns McClellan, Inc. Cameron Radinovic cradinovic@burnsmc.com 646-930-4406 Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies af ...

It has been about a month since the last earnings report for Intra-Cellular Therapies (ITCI) . Shares have added about 1.2% in that time frame, underperforming the S&P 500. Will the recent positive trend continue leading up to its next earnings release, or is Intra-Cellular due for a pullback? Before we dive into how investors and analysts have reacted as of late, let's take a quick look at the most recent earnings report in order to get a better handle on the important drivers. Intra-Cellular Q1 Loss Narro ...

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 ...

The analyses being presented provide important information about CAPLYTA's efficacy, safety and tolerability profile in patients with bipolar I and II disorder and in patients with major depressive disorder (MDD) suffering from a major depressive episode and exhibiting mixed features. ASCP Presentations: CAPLYTA® (lumateperone) is indicated in adults for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive thera ...

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 DetailCaply ...

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 ConferenceTuesday, May 14, 2024 at 10:00 a.m. ET in New York, NY Bank of America Healthcare Conference 2024Thursday, May 16, 2024 at 9:20 a.m. PT (12:20 p.m. ET) in ...