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) 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.
Intra-Cellular Therapies (Nasdaq: ITCI) has announced that its CEO, Sharon Mates, Ph.D., will present at the SVB Securities Global Biopharma Conference on February 15, 2023, at 10:40 a.m. ET. The conference aims to showcase innovations in biopharmaceuticals, with a focus on therapies for central nervous system disorders.
Participants can access the live and archived webcast through the Investor Relations section of the company's website. Intra-Cellular Therapies specializes in developing treatments for complex psychiatric and neurologic diseases, leveraging Nobel prize-winning research.
Intra-Cellular Therapies (Nasdaq: ITCI) will present at the 41st Annual J.P. Morgan Healthcare Conference on January 9, 2023, at 11:15 a.m. PT, according to a recent announcement. The presentation will be led by Sharon Mates, Ph.D., CEO and Chairman of the company. Interested attendees can access the live and archived webcast on the company's Investor Relations webpage. Intra-Cellular Therapies focuses on developing innovative treatments for central nervous system disorders, based on Nobel prize-winning research.
Intra-Cellular Therapies (Nasdaq: ITCI) presented new findings at the ACNP 61st Annual Meeting, showcasing the efficacy and safety of CAPLYTA (lumateperone) for treating bipolar I and II depression. The analysis involved over 1,200 patients, confirming CAPLYTA's favorable cardiometabolic profile with no significant weight gain. Efficacy results indicated significant improvement in depression symptoms compared to placebo. Additionally, CAPLYTA demonstrated a low incidence of treatment-emergent mania and extrapyramidal symptoms. CAPLYTA is approved for schizophrenia and bipolar depression treatment.
Intra-Cellular Therapies (Nasdaq: ITCI) will participate in two investor conferences, aimed at advancing its focus on treatments for central nervous system disorders. The J.P. Morgan Equity Opportunities Forum takes place from November 14-15, 2022, in Miami, FL. Following this, the company will be featured at the Evercore ISI 5th Annual HealthCONx Virtual Conference on November 29, 2022, at 12:35 PM ET. Interested investors can access a live webcast of the fireside chat by visiting the company's website.
Intra-Cellular Therapies reported net product revenues of $71.9 million for Q3 2022, a 233% increase from Q3 2021. Total revenues rose to $71.9 million from $22.2 million year-on-year. While total prescriptions for CAPLYTA surged 220% year-over-year, net loss narrowed to $53.5 million compared to $76.9 million in Q3 2021. Cash reserves stood at $630.5 million as of September 30, 2022, bolstered by a $460 million public offering in January 2022. CAPLYTA's expansion into bipolar depression is ongoing, supported by new dosage strengths.
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) will hold a conference call on November 3, 2022, at 8:30 a.m. ET to discuss its financial results for the quarter ending September 30, 2022. This call aims to provide a corporate update and invite stakeholders to participate via a registration link. Interested parties can access the live and archived webcast through the Investor Relations section of the company's website. Intra-Cellular Therapies specializes in developing treatments for central nervous system disorders, leveraging innovative insights from cellular research.
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