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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 presented data from its Phase 3 program for CAPLYTA (lumateperone) as adjunctive therapy for Major Depressive Disorder (MDD) at the American College of Neuropsychopharmacology Annual Meeting. The data from Studies 501 and 502 showed significant improvements in remission and response rates, as well as anxiety symptoms, with CAPLYTA compared to placebo. Specifically, Study 501 showed a response rate of 45.6% vs. 24.0% for placebo, and a remission rate of 25.9% vs. 13.6% for placebo. Study 502 reported a response rate of 40.1% vs. 25.3% for placebo, and a remission rate of 25.0% vs. 13.5% for placebo. Additionally, a post-hoc analysis from Study 403 indicated that CAPLYTA significantly improved anhedonia symptoms in patients with MDD and bipolar depression with mixed features.
Pooled safety data from Studies 501 and 502 confirmed a favorable safety profile, with common adverse reactions including dizziness, dry mouth, somnolence, nausea, and fatigue. CAPLYTA also showed low risks of extrapyramidal and motor symptoms.
Intra-Cellular Therapies (ITCI) has submitted a supplemental New Drug Application (sNDA) to the FDA for CAPLYTA as an adjunctive therapy for Major Depressive Disorder (MDD). The submission is supported by two positive Phase 3 studies (501 and 502) showing significant efficacy with MADRS score improvements of 4.9 and 4.5 points versus placebo. The studies demonstrated a favorable safety profile with minimal metabolic and weight impacts. If approved, CAPLYTA would be indicated for three major psychiatric conditions affecting over 30 million US adult patients. Common side effects included dizziness, dry mouth, somnolence/sedation, nausea, and fatigue.
Intra-Cellular Therapies (Nasdaq: ITCI), a biopharmaceutical company specializing in CNS disorder therapeutics, has announced their CEO Sharon Mates will present at three major investor conferences in December 2024. The presentations are scheduled for: the Evercore 7th Annual HealthCONx Conference on December 3 at 10:50 a.m. ET in Miami, the Citi 2024 Global Healthcare Conference on December 4 at 3:15 p.m. ET in Miami, and the Piper Sandler 36th Annual Healthcare Conference on December 5 at 11:30 a.m. ET in New York. Live and archived webcasts will be available on the company's website.
Intra-Cellular Therapies (ITCI) announced presentations of pivotal studies evaluating lumateperone (CAPLYTA) as an adjunctive therapy for major depressive disorder (MDD). Studies 501 and 502 demonstrated robust efficacy with significant separation from placebo in the Montgomery–Åsberg Depression Rating Scale (MADRS) total score, showing 4.9 and 4.5 points difference respectively, with effect sizes of 0.61 and 0.56. The results were supported by strong performance in both CGI-S and QIDS-SR scales. The drug showed a favorable metabolic, weight, and movement disorder profile, positioning CAPLYTA as a potential leading treatment option for mood disorders.
Intra-Cellular Therapies (ITCI) announced positive results from Study 304, evaluating CAPLYTA (lumateperone) for preventing schizophrenia relapse. The trial demonstrated significantly longer time to relapse in patients treated with lumateperone compared to placebo (p=0.0002), with only 16.4% of lumateperone patients relapsing versus 38.6% in the placebo group. The treatment showed a 63% reduction in relapse risk versus placebo. The drug was generally well-tolerated, with headache being the most common adverse event occurring at ≥5% and twice the placebo rate. The study also met its key secondary endpoint of time to all-cause discontinuation (p=0.0007).
Intra-Cellular Therapies reported strong Q3 2024 financial results with CAPLYTA net product sales reaching $175.2 million, a 39% increase from Q3 2023. Total prescriptions grew 38% year-over-year. The company raised its 2024 CAPLYTA sales guidance to $665-685 million. Despite revenue growth, the company reported a net loss of $26.3 million. A key development includes plans to submit an sNDA for lumateperone as adjunctive treatment for major depressive disorder in Q4 2024, following successful FDA pre-submission meeting. The company expanded its sales force by 150 representatives and maintains a strong cash position of $1.0 billion.
Intra-Cellular Therapies (Nasdaq: ITCI), a biopharmaceutical company focused on CNS disorder therapeutics, has announced a conference call and live webcast for October 30, 2024, at 8:30 a.m. Eastern Time. The event will provide a corporate update and discuss the company's financial results for Q3 2024, ending September 30.
Participants can join the call by phone using a provided registration link. The webcast will be accessible under the 'Events & Presentations' section of the company's website. Attendees are advised to log in 5-10 minutes early to register and install any necessary software.
Intra-Cellular Therapies (Nasdaq: ITCI) announced presentations of lumateperone data at the 37th European College of Neuropsychopharmacology (ECNP) Congress in Milan, Italy. The presentations include results from Study 501, evaluating lumateperone 42 mg as an adjunctive therapy to antidepressants for Major Depressive Disorder (MDD), and post-hoc analyses from Study 403 focusing on patients with MDD or bipolar depression with mixed features and anxious distress.
In Study 501, lumateperone met the primary endpoint with a 4.9-point reduction in MADRS total score versus placebo (p<0.0001). It also met key secondary endpoints and showed a favorable safety profile. Study 502 similarly demonstrated positive results. Study 403 analyses highlighted lumateperone's efficacy in patients with anxious distress and mixed features, showing significant improvements in depression symptoms and severity.
Intra-Cellular Therapies (Nasdaq: ITCI), a biopharmaceutical company focused on CNS disorders, has announced its participation in three upcoming investor conferences. Sharon Mates, Ph.D., CEO and Chairman, will present at:
- Morgan Stanley 22nd Annual Global Healthcare Conference on September 4, 2024, at 10:00 a.m. ET
- Baird's 2024 Global Healthcare Conference on September 11, 2024, at 11:25 a.m. ET
- 2024 Cantor Global Healthcare Conference on September 18, 2024, at 10:55 a.m. ET
All conferences will take place in New York, NY. Live and archived webcasts of the presentations will be available on the company's website under the Investors section.
Intra-Cellular Therapies (Nasdaq: ITCI), a biopharmaceutical company specializing in CNS disorder therapeutics, has announced its participation in the Canaccord Genuity 44th Annual Growth Conference. Sharon Mates, Ph.D., the company's CEO and Chairman, is scheduled to present on Tuesday, August 13, 2024, at 12:00 p.m. ET in Boston, MA.
Investors and interested parties can access the live and archived webcast of the presentation through the company's website at www.intracellulartherapies.com under the 'Events & Presentations' section in Investor Relations. Attendees are advised to log in 5-10 minutes early to register and install any necessary software for viewing the presentation.
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