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Intra-Cellular Therapies Inc. - ITCI STOCK NEWS

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

Rhea-AI Summary

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.

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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.

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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.

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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.

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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.

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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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Intra-Cellular Therapies reported a significant revenue growth of 178% in total revenues for Q2 2022, reaching $55.6 million, up from $20.0 million in Q2 2021. CAPLYTA net product revenues were $55.1 million, a 190% increase year-over-year and 58% over Q1 2022. Key metrics include a 225% rise in new prescriptions compared to Q2 2021. However, net loss escalated to $86.6 million from $68.7 million in the prior year. Cash reserves stood at $679.2 million as of June 30, 2022.

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Intra-Cellular Therapies (Nasdaq: ITCI) announced a conference call on August 9, 2022, at 8:30 a.m. ET to discuss the financial results for Q2 2022 and provide a corporate update. Interested parties can join the call by dialing 1-(877) 407-8291 or accessing the webcast on the company's website. Intra-Cellular Therapies focuses on developing therapeutics for CNS disorders, utilizing innovative research to create solutions for complex psychiatric and neurologic diseases.

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Intra-Cellular Therapies (ITCI) has presented new data regarding lumateperone (CAPLYTA) at the 2022 ISBD virtual conference. Key highlights include efficacy findings from Study 404, demonstrating significant improvements in depression scores (MADRS) and quality of life metrics in patients with bipolar depression. Lumateperone's favorable metabolic profile was also emphasized, showing stabilization of metabolic syndrome rates compared to placebo. Dr. Suresh Durgam expressed satisfaction with the positive feedback from the medical community regarding the drug's efficacy and safety.

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Intra-Cellular Therapies reported strong first-quarter 2022 results, highlighting a 120% revenue increase to $35 million compared to Q1 2021. CAPLYTA (lumateperone) saw a remarkable prescription growth, with new prescriptions up 300% post-approval for bipolar depression, and total prescriptions rising 63% from Q4 2021. Net product revenues for CAPLYTA reached $34.8 million, a 123% year-over-year increase. However, a net loss of $72.1 million was reported, up from $52.7 million in the prior year, alongside escalating R&D and SG&A expenses.

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FAQ

What is the current stock price of Intra-Cellular Therapies (ITCI)?

The current stock price of Intra-Cellular Therapies (ITCI) is $83.45 as of December 20, 2024.

What is the market cap of Intra-Cellular Therapies (ITCI)?

The market cap of Intra-Cellular Therapies (ITCI) is approximately 8.9B.

What does Intra-Cellular Therapies Inc. specialize in?

Intra-Cellular Therapies Inc. specializes in developing novel small-molecule drugs for treating central nervous system disorders, focusing on neuropsychiatric and neurological diseases.

What is CAPLYTA®?

CAPLYTA® (lumateperone) is an oral, once-daily atypical antipsychotic approved for treating schizophrenia and depressive episodes associated with bipolar I or II disorder.

How did Intra-Cellular Therapies perform financially in Q3 2023?

In Q3 2023, Intra-Cellular Therapies reported total revenues of $126.2 million, a 75% increase from the same period in 2022, with CAPLYTA's net product sales at $125.8 million.

What are the latest CAPLYTA sales figures?

For Q3 2023, CAPLYTA's net product sales were $125.8 million, representing a 75% increase from the same period in 2022.

What are the goals of Intra-Cellular Therapies' development programs?

Intra-Cellular Therapies aims to advance its pipeline, including additional lumateperone development programs, and expand CAPLYTA's label to become a drug of choice across mood disorders.

What is the forecast for CAPLYTA's net product sales in 2024?

The forecast for CAPLYTA's net product sales in 2024 is between $645 to $675 million.

What were the results of Study 501?

Study 501 showed positive Phase 3 results for lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disorder, demonstrating significant efficacy and safety.

What safety information is available for CAPLYTA?

CAPLYTA has a favorable safety profile with the most common adverse reactions being somnolence, dizziness, nausea, and dry mouth. It is contraindicated in patients with known hypersensitivity to lumateperone or any of its components.

Where is Intra-Cellular Therapies headquartered?

Intra-Cellular Therapies is headquartered at 3960 Broadway, New York, New York, United States.

What recent achievements has Intra-Cellular Therapies made?

Recent achievements include significant revenue growth, strong CAPLYTA sales, positive study results, and advancing development programs for treating major depressive disorder and other CNS conditions.

Intra-Cellular Therapies Inc.

Nasdaq:ITCI

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8.87B
101.92M
2.33%
96.38%
1.72%
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