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) announced a conference call on May 4, 2023, at 8:30 a.m. ET to discuss its financial results for Q1 2023. The company focuses on therapeutics for central nervous system disorders, leveraging Nobel prize-winning research to develop innovative treatments for complex psychiatric and neurologic diseases.
The call will provide a corporate update and delve into the financial performance for the quarter ended March 31, 2023. Participants must register in advance via a provided link, and both live and archived webcasts will be accessible on the company's website.
Intra-Cellular Therapies (Nasdaq: ITCI) has announced that its CEO, Sharon Mates, Ph.D., will present at the 22nd Annual Needham Virtual Healthcare Conference on April 18, 2023, at 11:45 a.m. ET. This event will be available as a live and archived webcast, accessible via the Events & Presentations section of their website. Attendees are advised to log in 5-10 minutes early to register and install any necessary software.
Founded on Nobel prize-winning research, Intra-Cellular Therapies focuses on developing therapeutics for complex psychiatric and neurologic diseases. Their innovative approach targets the inner workings of cells to create effective treatments. For more details, visit www.intracellulartherapies.com.
Intra-Cellular Therapies (ITCI) announced positive topline results from Study 403 for lumateperone 42mg, showing significant efficacy in reducing symptoms of major depressive episodes in patients with mixed features of major depressive disorder (MDD) and bipolar depression. Lumateperone demonstrated a 5.7-5.9 point reduction in scores on the Montgomery Asberg Depression Rating Scale (MADRS) compared to placebo (p<0.0001). Key secondary endpoints also showed significant improvement on the Global Impression of Severity Scale (CGI-S). The treatment was well tolerated with consistent safety profiles. A conference call is scheduled to discuss results and next steps with the FDA.
Intra-Cellular Therapies (Nasdaq: ITCI) reported a remarkable financial performance for full year 2022, with total revenues of $250.3 million, a significant increase from $83.8 million in 2021. CAPLYTA’s fourth quarter net product sales surged to $87.4 million, marking a 243% year-over-year growth. The company anticipates CAPLYTA 2023 net product sales between $430 million and $455 million. Despite substantial growth, the net loss for 2022 was $256.3 million, down from $284.1 million in 2021, highlighting the company's ongoing investments in commercialization and R&D.
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) announced a conference call on March 1, 2023, at 8:30 a.m. ET to discuss its financial results for the quarter and year ending December 31, 2022. The call will provide a corporate update and details of the company’s performance. Participants must register in advance through a provided link to access the live call, with an archived webcast available on the company's Investor Relations website. Intra-Cellular Therapies focuses on developing therapeutics for central nervous system disorders, leveraging innovative research methodologies.
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