CAPLYTA Q2 2024 net product sales were $161.3 million, compared to $110.1 million for the same period in 2023, representing a 46% increase CAPLYTA's strong prescription uptake continues: Q2 2024 CAPLYTA total prescriptions increased 36%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance raised to $650 to $680 million Announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disor ...

CAPLYTA Q2 2024 net product sales were $161.3 million, compared to $110.1 million for the same period in 2023, representing a 46% increase CAPLYTA’s strong prescription uptake continues: Q2 2024 CAPLYTA total prescriptions increased 36%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance raised to $650 to $680 million Announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disor ...

NEW YORK, July 24, 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 Wednesday, August 7, 2024, to provide a corporate update and discuss details of the Company's financial results for the quarter ended June 30, 2024. To attend the live conference ca ...

NEW YORK, July 24, 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 Wednesday, August 7, 2024, to provide a corporate update and discuss details of the Company's financial results for the quarter ended June 30, 2024. To attend the live conference c ...

Shares of Intra-Cellular Therapies (ITCI) have gained 3.6% over the past four weeks to close the last trading session at $71.56, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $93.13 indicates a potential upside of 30.1%.The mean estimate comprises 15 short-term price targets with a standard deviation of $14.69. While the lowest estimate of $65 indicates a 9.2% decline from the ...

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). The second phase III study evaluating lumateperone 42 mg, given once daily as an adjunctive therapy to antidepressants for MDD, met the primary endpoint. A statistically significant and clinically meaningful reduction in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score was observed compared wit ...

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. The sudden soaring of the stock price was observed after the company announced achieving statistically significant and clinically meaningful results in both the primary and the key secondary endpoints of the second late-stage st ...

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 patien ...

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]