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 nominated Sir Michael Rawlins as a new independent director and Joel S. Marcus for re-election to its Board of Directors for the 2021 annual meeting on June 21, 2021. Sir Michael, former chairman of MHRA, brings extensive regulatory experience to aid in the anticipated approval of CAPLYTA for bipolar depression. The current board member, Dr. Christopher Alafi, will complete his term at this meeting. This strategic move underscores the company’s commitment to growth and effective governance.
Intra-Cellular Therapies (Nasdaq: ITCI) presented promising preclinical results on its PDE1 inhibitor, lenrispodun, at the AACR 2021 Virtual Annual Meeting. The studies indicate its potential to enhance anti-tumor effects when combined with PD-1 checkpoint inhibitors in colorectal cancer. Key findings revealed that lenrispodun decreased tumor-associated macrophages and increased natural killer cells, leading to reduced tumor volumes and improved survival rates in mouse models. The company is exploring lenrispodun for conditions like Parkinson's disease and heart failure, highlighting its broad therapeutic potential.
Intra-Cellular Therapies reported Q4 2020 net product revenues for CAPLYTA at $12.4 million, up 77% from Q3. Full year 2020 revenues reached $22.5 million, with a net loss of $227.0 million or $3.23 per share. R&D expenses decreased by 26% to $65.8 million, while SG&A expenses surged to $186.4 million. The company submitted supplemental new drug applications for CAPLYTA to treat bipolar depression and initiated pivotal studies for major depressive disorder. Total cash and investments were $658.8 million at year-end, signaling strong liquidity.
Intra-Cellular Therapies (Nasdaq: ITCI) announced the expansion of its pipeline with ITI-1284, a deuterated form of lumateperone, delivered as an orally disintegrating tablet (ODT-SL) for sublingual administration. Phase 1 studies in healthy volunteers, including those over 65, showed safety and rapid absorption. The company plans to develop ITI-1284 ODT-SL for treating behavioral disturbances in dementia and certain depressive disorders in the elderly. No serious adverse events were reported, with mild effects observed in the elderly cohort.
Intra-Cellular Therapies (ITCI) has submitted Supplemental New Drug Applications (sNDAs) to the FDA for CAPLYTA (lumateperone) targeting bipolar I and II depressive episodes. This treatment could potentially be the first FDA-approved option for bipolar depression as both monotherapy and adjunctive therapy. Positive results from two Phase 3 studies indicate a favorable safety profile with low rates of adverse events. The FDA's decision is anticipated in the second half of 2021, addressing a significant need in a market of approximately 11 million affected adults in the U.S.
Intra-Cellular Therapies (Nasdaq: ITCI) has announced that Sharon Mates, Ph.D., CEO and Chairman, will present at the SVB Leerink 10th Annual Global Healthcare Conference on February 26, 2021, at 10:00 am ET. The event can be accessed live and recorded via the company's Investor Relations page. Intra-Cellular Therapies focuses on developing therapeutics for central nervous system disorders, drawing on Nobel Prize-winning research to create innovative treatments for psychiatric and neurologic diseases.
Intra-Cellular Therapies (Nasdaq: ITCI) announced a conference call on February 25, 2021, at 8:30 a.m. ET to discuss its financial results for the quarter and year ending December 31, 2020. Investors can access the call by dialing 1-(844) 835-6563 (U.S.) or 1-(970) 315-3916 (international), using conference ID 8499868. The call will also be available as a live and archived webcast on the company's website under the Investor Relations section.
Intra-Cellular Therapies (Nasdaq: ITCI) published positive results from the CAPLYTA clinical trial (ITI-007-303) in patients with stable schizophrenia. The 6-week study demonstrated that CAPLYTA, administered at 42 mg, was well-tolerated with minimal metabolic and extrapyramidal symptoms. Patients experienced stability in schizophrenia symptoms, with low adverse events such as somnolence (6.6%) and headache (5.3%). Notably, mean cholesterol and weight levels decreased during treatment. The findings support CAPLYTA's safety and efficacy, offering valuable insights for clinicians in managing schizophrenia.
Intra-Cellular Therapies (Nasdaq:ITCI) announced that CEO Sharon Mates, Ph.D., will present at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 9:10 AM ET. The conference will be accessible via a live and archived webcast on the company's website, requiring registration 5-10 minutes prior to the event.
Intra-Cellular Therapies focuses on developing therapeutics for central nervous system disorders, leveraging Nobel prize-winning research to create innovative treatments for complex psychiatric and neurologic diseases.
Intra-Cellular Therapies has initiated clinical programs for its long-acting injectable formulation of lumateperone and the novel compound ITI-333 for opioid use disorder.
The LLAI formulation is designed for once monthly administration to maintain therapeutic levels in patients with schizophrenia. The Phase 1 study will assess its pharmacokinetics and safety.
ITI-333 aims to treat opioid use disorder with a unique mechanism, showing promise without the safety concerns associated with traditional opioids.
FAQ
What is the current stock price of Intra-Cellular Therapies (ITCI)?
What is the market cap of Intra-Cellular Therapies (ITCI)?
What does Intra-Cellular Therapies Inc. specialize in?
What is CAPLYTA®?
How did Intra-Cellular Therapies perform financially in Q3 2023?
What are the latest CAPLYTA sales figures?
What are the goals of Intra-Cellular Therapies' development programs?
What is the forecast for CAPLYTA's net product sales in 2024?
What were the results of Study 501?
What safety information is available for CAPLYTA?
Where is Intra-Cellular Therapies headquartered?
What recent achievements has Intra-Cellular Therapies made?
