Welcome to our dedicated page for Intra-Cellular Therapies news (Ticker: ITCI), a resource for investors and traders seeking the latest updates and insights on Intra-Cellular Therapies stock.
Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) is a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. Company communications emphasize that it is founded on Nobel Prize-winning research into intracellular mechanisms and that this science underpins its work on complex psychiatric and neurologic diseases. News about ITCI often centers on its approved product CAPLYTA (lumateperone) and its expanding clinical pipeline.
Investors and observers following ITCI news will see updates on CAPLYTA, an oral, once-daily atypical antipsychotic approved in adults for the treatment of schizophrenia and for depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. Recent company announcements have highlighted financial results driven by CAPLYTA net product sales, as well as clinical and regulatory milestones such as a supplemental New Drug Application (sNDA) submitted to the U.S. Food and Drug Administration for adjunctive treatment of major depressive disorder (MDD).
ITCI news flow also includes detailed clinical trial readouts and conference presentations. The company has reported positive Phase 3 data from Studies 501 and 502 evaluating lumateperone as adjunctive therapy in MDD, Phase 3 results in the prevention of relapse in schizophrenia, and multiple late-stage trials in bipolar disorder, pediatric populations, and other CNS indications. Additional updates cover progress in the ITI-1284-ODT-SL program in generalized anxiety disorder and Alzheimer’s disease-related psychosis and agitation, the PDE1 inhibitor program with lenrispodun (ITI-214) in Parkinson’s disease and ITI-1020 in oncology, and the ITI-1500 non-hallucinogenic neuroplastogen program.
Another important category of ITCI news involves corporate and strategic developments. Intra-Cellular Therapies and Johnson & Johnson have announced a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies, with the transaction subject to regulatory and stockholder approvals. Legal and intellectual property news, including a settlement of CAPLYTA patent litigation with Sandoz, also features in company disclosures. For investors tracking ITCI, this news page aggregates earnings announcements, clinical data, regulatory submissions, patent settlements, and acquisition-related updates in one place.
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) announced a Virtual Event on October 20, 2021, from 1:00 p.m. to 4:00 p.m. ET, focusing on its development programs for lumateperone, ITI-1284, PDE1 inhibitors, and ITI-333. The event will be accessible via a webcast on the company's Investor Relations page. Intra-Cellular Therapies specializes in therapeutics for CNS disorders, leveraging Nobel prize-winning research to develop innovative treatments for psychiatric and neurologic diseases.
Intra-Cellular Therapies (Nasdaq: ITCI) will host a virtual event on October 20, 2021, from 12:30 to 3:30 p.m. ET. The event will focus on the company’s pipeline, including lumateperone, ITI-1284, PDE1 inhibitors, and ITI-333. Presentations will be made by management and key opinion leaders. Interested parties can access the live and archived webcast via the Investor Relations section of the company's website. This event aims to provide insights into the innovative treatments being developed for CNS disorders.
Intra-Cellular Therapies announced positive results from its Phase 3 trial for lumateperone (42 mg) in treating major depressive episodes linked to bipolar I and II disorders. The study, involving 381 patients, indicated a significant reduction in depressive symptoms compared to placebo (MADRS score difference -4.6, P<0.0001). Lumateperone demonstrated a favorable safety profile, with adverse events similar to placebo. These findings support the drug's supplemental NDA currently under FDA review, with a target action date of December 17, 2021, positioning lumateperone as a potential new treatment for bipolar depression.
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) announced that CEO Sharon Mates, Ph.D., will present at the 2021 Cantor Virtual Global Healthcare Conference on September 28, 2021, at 10:40 am ET. Investors can access the live and archived webcast in the Investor Relations section of the company's website. Intra-Cellular Therapies focuses on developing therapeutics for central nervous system disorders, leveraging groundbreaking research to create innovative treatments for complex psychiatric and neurologic diseases.
Intra-Cellular Therapies highlights favorable findings from recent studies on lenrispodun (ITI-214), a PDE1 inhibitor, published in several medical journals. These studies indicate lenrispodun is well-tolerated in heart failure patients, enhances cardiac contractility, and improves vascular function in aging models. The research suggests lenrispodun may offer a safer alternative for heart failure treatment by increasing cAMP and cGMP levels. Its potential spans various diseases, including Parkinson's. The promising results could be significant for future clinical applications and therapies.
Intra-Cellular Therapies, a biopharmaceutical company focused on CNS disorders, announced that CEO Sharon Mates, Ph.D., will present at the Canaccord Genuity 41st Annual Growth Conference on August 12, 2021, at 2:30 pm PT. The event will be available via live and archived webcast on the company's website. Intra-Cellular Therapies is known for its innovative approaches in developing treatments for psychiatric and neurologic diseases rooted in Nobel prize-winning research.
Intra-Cellular Therapies (ITCI) reported strong second-quarter results, achieving total revenues of $20 million, a significant increase from $1.9 million year-over-year. Net product revenues for CAPLYTA rose to $19 million, up 22% from the prior quarter. The company is awaiting FDA action on its supplemental new drug applications (sNDAs) for bipolar depression, with a target date of December 17, 2021. The enrollment for the Phase 3 clinical trial of lumateperone as an adjunctive treatment for major depressive disorder has begun. However, the net loss for the quarter was $68.7 million.
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) will host a conference call on August 9, 2021, at 8:30 a.m. ET to discuss its financial results for Q2 2021. The call can be accessed via phone or online, with a specific conference ID provided. The company specializes in developing treatments for CNS disorders based on Nobel Prize-winning research.
Intra-Cellular Therapies (Nasdaq: ITCI) announced the publication of a pooled analysis evaluating the safety and tolerability of lumateperone (42 mg), a treatment for schizophrenia. The analysis included 1,073 patients across three randomized, double-blind, placebo-controlled trials. Findings indicate that lumateperone's safety profile is comparable to placebo, with treatment-emergent adverse events (TEAEs) similar in incidence. Notable outcomes include low discontinuation rates due to TEAEs (0.5%) and minimal changes in weight and metabolic parameters. The publication highlights lumateperone as a favorable treatment for schizophrenia.
Intra-Cellular Therapies, a biopharmaceutical company focused on CNS disorders, announced that Dr. Sharon Mates, CEO and Chairman, will present at two investor conferences. The first is the Jefferies Virtual Healthcare Conference on June 2 at 11:30 am ET, followed by the Goldman Sachs 42nd Annual Global Healthcare Conference on June 10 at 1:20 pm ET. Live and archived webcasts will be available on the company’s website. Intra-Cellular leverages Nobel prize-winning research to develop treatments for complex psychiatric and neurologic diseases.
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