Lumateperone 42 mg met the primary endpoint of change from baseline at Week 6 on the Montgomery-Åsberg Depression Rating Scale (MADRS) total score versus placebo (4.5 point reduction v. placebo; p<0.0001; Cohen's d effect size (ES)=0.56) Statistically significant efficacy was also seen in the Quick Inventory of Depressive Symptomatology SelfReport (QIDS-SR) scale, a patient self-reported measure of symptom severity of depression (p<0.0001) Supplemental NDA (sNDA) submission for the adjunctive treatment of m ...

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 ...

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 ...

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 ...

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 Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Commission File Number: 001-36274 _______________________ INTRA-CELLULAR THERAPIES, INC. (Exact name of registrant as specified in its charter) _______________________ Delaware 36-4742850 (State or other jurisdiction ...

Financial Performance - CAPLYTA Q1 2024 net product sales were $144.8 million, a 53% increase from $94.7 million in Q1 2023[1] - Total revenues for Q1 2024 were $144.9 million, compared to $95.3 million for the same period in 2023[2] - Net loss for Q1 2024 was $15.2 million, significantly improved from a net loss of $44.1 million in Q1 2023[2] - Total revenues for Q1 2024 reached $144.866 million, a 52% increase from $95.306 million in Q1 2023[30] - Product sales, net for Q1 2024 were $144.843 million, compared to $94.731 million in the same period last year, reflecting a significant growth[30] - The net loss for Q1 2024 was $15.247 million, a decrease from a net loss of $44.053 million in Q1 2023, indicating improved financial performance[30] - Basic and diluted net loss per common share for Q1 2024 was $0.16, compared to $0.46 in Q1 2023[30] Expenses - Selling, general and administrative (SG&A) expenses were $113.1 million in Q1 2024, up from $98.9 million in Q1 2023[4] - Research and development (R&D) expenses were $42.8 million in Q1 2024, compared to $38.0 million in Q1 2023[4] - Operating expenses for Q1 2024 totaled $165.818 million, up from $143.698 million in Q1 2023, primarily driven by increased selling, general and administrative expenses[30] - Full year 2024 SG&A expense guidance is set at $450 to $480 million, and R&D expense guidance is $215 to $240 million[4] Sales and Market Activity - CAPLYTA total prescriptions increased by 39% in Q1 2024 compared to the same period in 2023[1] - CAPLYTA 2024 net product sales guidance is reiterated at $645 - $675 million[1] Clinical Trials and Research - Positive Phase 3 results from Study 501 showed lumateperone significantly reduced depression scores compared to placebo (4.9 point reduction, p<0.0001)[3] - The company is focused on the commercialization of CAPLYTA and plans to conduct further clinical trials, with expectations of future revenues and expenses tied to these developments[26] Financial Position - Cash and cash equivalents as of March 31, 2024, were $139.819 million, down from $147.767 million at the end of 2023[32] - Total assets increased to $747.036 million as of March 31, 2024, compared to $728.295 million at the end of 2023[32] - The company reported an increase in accounts receivable, net, to $131.157 million from $114.018 million, indicating higher sales activity[32] - The accumulated deficit as of March 31, 2024, was $1.632 billion, up from $1.617 billion at the end of 2023[32] Capital Raising - The company completed a public offering resulting in net proceeds of approximately $543 million in April 2024[4]

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 ...