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 pioneering biopharmaceutical company headquartered at 3960 Broadway, New York, New York, United States. The company is dedicated to developing novel, small-molecule drugs to treat diseases of the central nervous system (CNS), focusing on neuropsychiatric and neurological disorders.
Core Business and Products:
Intra-Cellular Therapies leverages proprietary chemistry platforms to create innovative treatments for complex psychiatric and neurologic conditions. Its flagship product, CAPLYTA® (lumateperone), is approved for the treatment of schizophrenia and depressive episodes associated with bipolar I or II disorder. CAPLYTA's efficacy is believed to stem from its dual action on serotonin 5-HT2A receptors and dopamine D2 receptors.
Recent Achievements:
- Q3 2023 Financial Performance: The company reported a significant revenue increase to $126.2 million, a 75% rise from the same period in 2022.
- CAPLYTA Sales Growth: CAPLYTA's net product sales surged by 75% in Q3 2023, reaching $125.8 million, demonstrating strong prescription uptake.
- 2023 Net Product Sales Guidance: The company raised its CAPLYTA net product sales guidance to $460-470 million.
- Positive Study Results: At the American College of Neuropsychopharmacology (ACNP) Annual Meeting, the company presented positive results for CAPLYTA in patients with major depressive disorder (MDD) and bipolar disorder with anxious distress and mixed features.
- Phase 3 Study Success: In April 2024, Intra-Cellular Therapies announced robust positive Phase 3 results from Study 501, evaluating lumateperone as an adjunctive therapy for MDD.
Financial Condition and Outlook:
Intra-Cellular Therapies continues to show strong financial performance. For the full year 2023, the company reported total revenues of $464.4 million, up from $250.3 million in 2022. CAPLYTA's net product sales for 2023 were $462.2 million, an 86% year-over-year growth. The company has provided a 2024 net product sales guidance of $645 to $675 million.
Partnerships and Future Projects:
Intra-Cellular Therapies has strategic partnerships with several leading financial institutions, including J.P. Morgan, Leerink Partners, BofA Securities, Morgan Stanley, and RBC Capital Markets, to support its growth and financing strategies. The company is also advancing its pipeline, with upcoming CAPLYTA Phase 3 readouts in adjunctive MDD and additional lumateperone development programs.
Commitment to Safety:
Intra-Cellular Therapies emphasizes the safety and tolerability of its products. CAPLYTA has a favorable safety profile, with the most common adverse reactions being somnolence, dizziness, nausea, and dry mouth. The company remains vigilant in monitoring and communicating any potential risks associated with its therapies.
For more detailed information, please visit the company's official website: www.intracellulartherapies.com
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.
Intra-Cellular Therapies announced the acceptance of supplemental new drug applications (sNDAs) for CAPLYTA for treating bipolar depression, with a PDUFA action date of December 17, 2021. In Q1 2021, total revenues surged to $15.9 million, with net product revenues from CAPLYTA at $15.6 million, compared to $1.1 million and $0.9 million in Q1 2020, respectively. The company introduced ITI-1284 ODT-SL, a new deuterated form of lumateperone. R&D expenses slightly decreased to $15.1 million, while SG&A expenses increased to $52.6 million. The net loss for Q1 was $52.7 million.
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