bgfoto/E+ via Getty Images Intra-Cellular's Caplyta Shows Promise in Major Depressive Disorder In a November article, I wrote about Intra-Cellular's (NASDAQ:ITCI) Caplyta (lumateperone), a drug approved to treat schizophrenia and bipolar depression. The article was particularly focused on the drug's potential for Major Depressive Disorder (MDD). I had high expectations for important Phase 3 readouts. (...) lumateperone’s innovative pharmacological profile, its potential to meet the unmet needs of MDD pa ...

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]

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 & ...

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 ...

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 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 ...

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 quarter ...