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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 announced positive topline results from Study 502, which evaluated lumateperone 42 mg as adjunctive therapy for Major Depressive Disorder (MDD).

The drug achieved significant and clinically meaningful results in primary and key secondary endpoints. Lumateperone 42 mg showed a 4.5-point reduction on the MADRS total score compared to placebo (p<0.0001; ES=0.56) and a significant reduction in the CGI-S score (p<0.0001; ES=0.51).

Statistically significant results were also observed on the QIDS-SR scale (p<0.0001). The safety profile was generally favorable and consistent with prior studies. An sNDA submission is anticipated in the second half of 2024.

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Intra-Cellular Therapies (Nasdaq: ITCI), a biopharmaceutical company focusing on CNS disorder therapeutics, announced that its CEO, Sharon Mates, Ph.D., will present at the 45th Annual Goldman Sachs Global Healthcare Conference. The presentation is scheduled for June 11, 2024, at 10:00 a.m. ET in Miami, FL. The live and archived webcast will be available under the 'Events & Presentations' section of the company's website. Attendees are advised to log in 5-10 minutes prior to the event to register and install any necessary software.

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Intra-Cellular Therapies (Nasdaq: ITCI), a biopharmaceutical company specializing in treatments for central nervous system (CNS) disorders, announced that its CEO, Sharon Mates, Ph.D., will present at the Jefferies Global Healthcare Conference. This event is scheduled for June 5, 2024, at 11:00 a.m. ET in New York, NY. A live and archived webcast will be available on the company's website under the Investor Relations section. Viewers are advised to log in 5-10 minutes early to register and install necessary software.

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Intra-Cellular Therapies (Nasdaq: ITCI) presented data at the American Society of Clinical Psychopharmacology Annual Meeting, held in Miami from May 28-31, 2024. The data focused on CAPLYTA’s efficacy, safety, and tolerability profiles in treating bipolar I and II disorders, and major depressive disorder (MDD) with mixed features. Key presentations included:

Poster W49: Lumateperone for MDD and Bipolar Disorder with Anxious Distress and Mixed Features.

Poster T40: Lumateperone for MDD and Bipolar Depression with Mixed Features: Symptomatic Efficacy.

Poster T41: Lumateperone for Major Depressive Episodes in MDD and Bipolar Disorders.

CAPLYTA is indicated for schizophrenia and depressive episodes associated with bipolar I or II disorder as monotherapy or adjunctive therapy. The safety profile includes risks such as increased mortality in elderly patients with dementia-related psychosis, suicidal thoughts in young patients, and metabolic changes.

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Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) will participate in two investor conferences: 2024 RBC Capital Markets Global Healthcare Conference on May 14, 2024, and Bank of America Healthcare Conference 2024 on May 16, 2024. The webcasts will be available on the company's website.

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Intra-Cellular Therapies reported strong financial results in Q1 2024 with CAPLYTA net product sales of $144.8 million, a 53% increase from the previous year. The company reiterated its 2024 net sales guidance at $645 - $675 million and announced positive Phase 3 results for lumateperone as an adjunctive therapy for major depressive disorder.

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Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) will host a conference call and webcast on May 7, 2024, to discuss the financial results for the first quarter of 2024. The company focuses on CNS disorder therapeutics. Participants can register online to join the call and access the webcast through the Investor Relations section on the company's website.

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Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) announced the successful completion of a public offering, including the full exercise of underwriters' option to purchase additional shares, resulting in gross proceeds of approximately $575 million. The offering involved the sale of 1,027,397 shares of common stock at $73.00 per share, following the initial offering of 6,849,316 shares. The underwriters included J.P. Morgan, Leerink Partners, BofA Securities, Morgan Stanley, and RBC Capital Markets. The offering was made under a shelf registration statement on Form S-3 and the final prospectus supplement is available on the SEC's website.
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Intra-Cellular Therapies, Inc. announced the pricing of its underwritten public offering of 6,849,316 shares of common stock at $73.00 per share, expecting gross proceeds of $500.0 million. The offering includes an option for additional shares, managed by top financial institutions. The public offering is made under a shelf registration statement on Form S-3, with the closing date set for April 22, 2024.
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Intra-Cellular Therapies, Inc. announces a proposed public offering of $500 million of common stock, with the underwriters having a 30-day option to purchase additional shares. The offering is led by J.P. Morgan, Leerink Partners, BofA Securities, Morgan Stanley, and RBC Capital Markets. The company filed a shelf registration statement with the SEC and will provide a preliminary prospectus supplement for the offering.
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FAQ

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

ITCI Rankings

ITCI Stock Data

8.25B
105.58M
2.32%
89.66%
3.53%
Pharmaceutical Preparation Manufacturing
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