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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 that CEO Sharon Mates, Ph.D., will present at the 11th Annual SVB Leerink Global Healthcare Conference on February 17, 2022, at 8:40 am ET. Attendees can access the live and archived webcast through the Investor Relations section of the company's website. Intra-Cellular Therapies focuses on innovative treatments for central nervous system disorders, leveraging Nobel prize-winning research to understand cellular impacts of therapies. For more details, visit www.intracellulartherapies.com.
Intra-Cellular Therapies (Nasdaq: ITCI) has successfully completed a public offering of 9,523,810 shares at $42.00 each, raising approximately $460 million in gross proceeds. The underwriters fully exercised their option for an additional 1,428,571 shares. After deductions, the net proceeds amount to around $433.7 million. The offering was conducted under a shelf registration statement with the SEC. This infusion of capital aims to support the company's ongoing development of therapeutics for central nervous system disorders.
Intra-Cellular Therapies (ITCI) announced the pricing of a public offering of 9,523,810 shares at $42.00 each, totaling $400 million in gross proceeds. The offering will close on January 7, 2022, subject to customary conditions. Underwriters have a 30-day option to purchase an additional 1,428,571 shares. This is part of a shelf registration statement filed with the SEC. The funds raised will support ongoing development of CNS therapeutics, enhancing the company's financial position and growth prospects.
Intra-Cellular Therapies (Nasdaq: ITCI) has initiated a public offering of $400 million in shares of its common stock, with underwriters given a 30-day option to purchase an additional 15% of the shares. The offering is part of a shelf registration statement effective with the SEC. J.P. Morgan, SVB Leerink, and others are acting as joint book-running managers. The offering is subject to market conditions, with no assurance on completion or terms.
Intra-Cellular Therapies (ITCI), a biopharmaceutical company focused on treatments for central nervous system disorders, announced that CEO Sharon Mates, Ph.D., will present at the 40th Annual J.P. Morgan Healthcare Conference. The presentation is scheduled for January 10, 2022, at 7:30 AM ET. Investors can access the live and archived webcast through the company's website under the 'Events & Presentations' section. Intra-Cellular Therapies develops innovative therapies based on groundbreaking research to treat complex psychiatric and neurologic conditions.
Intra-Cellular Therapies announced FDA approval for CAPLYTA, the first treatment for depressive episodes associated with bipolar I and II disorder. CAPLYTA is approved as both monotherapy and adjunctive therapy with lithium or valproate. This approval is based on two positive Phase 3 studies showing significant improvements over placebo. Bipolar disorder affects about 11 million adults in the U.S., highlighting a significant unmet medical need. CAPLYTA offers a favorable safety and tolerability profile, making it a crucial treatment option for patients.
Intra-Cellular Therapies (Nasdaq:ITCI) announces the passing of Director Richard Lerner, MD, who contributed significantly to science and medicine. Dr. Lerner served on the board since 2002 and was influential in the company's mission to develop therapies for CNS disorders. His accolades include the Wolf Prize and membership in prestigious scientific academies. The company's leadership, including CEO Sharon Mates, expressed deep sadness and condolences to his family. Intra-Cellular Therapies focuses on innovative treatments for complex psychiatric and neurologic diseases, founded on Nobel Prize-winning research.
Intra-Cellular Therapies reported a remarkable 200% increase in total revenues for Q3 2021, totaling $22.2 million, driven by strong sales of CAPLYTA, which achieved $21.6 million in net product revenues. The company has completed its sales force expansion in preparation for the bipolar depression launch, pending FDA approval with a target date of December 17, 2021. Additionally, CAPLYTA's total prescriptions rose by 15% over the previous quarter. However, the net loss for Q3 grew to $76.9 million compared to $55.2 million a year ago.
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) will host a conference call on November 9, 2021, at 8:30 a.m. ET to discuss its financial results for Q3 2021 and provide a corporate update. Investors can access the call via phone or through a live webcast available on the company’s investor relations website. Intra-Cellular Therapies focuses on developing treatments for central nervous system disorders using innovative, research-backed methods.
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.