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 biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders. Company communications emphasize that it is founded on Nobel Prize-winning research into intracellular mechanisms and that this science underpins its work on complex psychiatric and neurologic diseases. News about ITCI often centers on its approved product CAPLYTA (lumateperone) and its expanding clinical pipeline.
Investors and observers following ITCI news will see updates on CAPLYTA, an oral, once-daily atypical antipsychotic approved in adults for the treatment of schizophrenia and for depressive episodes associated with bipolar I or II disorder (bipolar depression) as monotherapy and as adjunctive therapy with lithium or valproate. Recent company announcements have highlighted financial results driven by CAPLYTA net product sales, as well as clinical and regulatory milestones such as a supplemental New Drug Application (sNDA) submitted to the U.S. Food and Drug Administration for adjunctive treatment of major depressive disorder (MDD).
ITCI news flow also includes detailed clinical trial readouts and conference presentations. The company has reported positive Phase 3 data from Studies 501 and 502 evaluating lumateperone as adjunctive therapy in MDD, Phase 3 results in the prevention of relapse in schizophrenia, and multiple late-stage trials in bipolar disorder, pediatric populations, and other CNS indications. Additional updates cover progress in the ITI-1284-ODT-SL program in generalized anxiety disorder and Alzheimer’s disease-related psychosis and agitation, the PDE1 inhibitor program with lenrispodun (ITI-214) in Parkinson’s disease and ITI-1020 in oncology, and the ITI-1500 non-hallucinogenic neuroplastogen program.
Another important category of ITCI news involves corporate and strategic developments. Intra-Cellular Therapies and Johnson & Johnson have announced a definitive agreement under which Johnson & Johnson will acquire all outstanding shares of Intra-Cellular Therapies, with the transaction subject to regulatory and stockholder approvals. Legal and intellectual property news, including a settlement of CAPLYTA patent litigation with Sandoz, also features in company disclosures. For investors tracking ITCI, this news page aggregates earnings announcements, clinical data, regulatory submissions, patent settlements, and acquisition-related updates in one place.
Intra-Cellular Therapies (ITCI) reported strong financial results for Q4 and full-year 2024. CAPLYTA net product sales reached $199.2 million in Q4 2024, showing 51% growth compared to Q4 2023. Full-year 2024 CAPLYTA sales were $680.5 million, up 47% year-over-year.
The FDA accepted the supplemental New Drug Application (sNDA) for lumateperone as adjunctive treatment for major depressive disorder (MDD). The company expanded its field sales force in anticipation of potential MDD approval. R&D expenses increased to $236.1 million in 2024 from $180.1 million in 2023, while SG&A expenses rose to $504.5 million from $409.9 million.
The company's cash position strengthened to $1.0 billion by end of 2024, up from $499.7 million in 2023. ITCI initiated 10 late-stage clinical trials in 2024, including six Phase 3 lumateperone trials and four ITI-1284 trials.
Johnson & Johnson (JNJ) has announced the acquisition of Intra-Cellular Therapies (ITCI) for $132.00 per share in cash, totaling approximately $14.6 billion. The acquisition includes CAPLYTA® (lumateperone), an FDA-approved treatment for bipolar I and II depression and schizophrenia in adults.
CAPLYTA® has potential peak year sales exceeding $5 billion and is currently under FDA review for adjunctive treatment in major depressive disorder (MDD). The drug demonstrated statistically significant improvement in depressive symptoms in Phase 3 trials. The acquisition also includes ITI-1284, a Phase 2 compound being studied for generalized anxiety disorder and Alzheimer's disease-related conditions.
The transaction is expected to close later in 2025, subject to regulatory approvals and ITCI stockholder approval. JNJ plans to fund the acquisition through a combination of cash and debt while maintaining its capital allocation priorities.
Johnson & Johnson (JNJ) has announced the acquisition of Intra-Cellular Therapies for $132.00 per share in cash, totaling approximately $14.6 billion. The acquisition includes CAPLYTA® (lumateperone), an FDA-approved treatment for bipolar I and II depression and schizophrenia in adults.
CAPLYTA® has potential peak year sales exceeding $5 billion and is currently under FDA review for major depressive disorder (MDD) treatment. The drug demonstrated significant improvement in depressive symptoms in Phase 3 trials as an adjunctive treatment to antidepressants.
The deal also includes ITI-1284, a Phase 2 compound being studied for generalized anxiety disorder and Alzheimer's disease-related conditions. The transaction is expected to close later this year, subject to regulatory approvals and stockholder approval.
Intra-Cellular Therapies (ITCI) has reached a settlement agreement with Sandoz Inc. regarding patent litigation over CAPLYTA® (lumateperone), their CNS disorder therapeutic product. The litigation arose from Sandoz's submission of an Abbreviated New Drug Application seeking approval for a generic version of CAPLYTA in the United States.
Under the settlement terms, Sandoz will be permitted to begin selling generic versions of CAPLYTA on July 1, 2040, or earlier under certain circumstances. The agreement will be submitted to the U.S. Federal Trade Commission and Department of Justice for review. Similar patent litigation against other parties remains ongoing in the U.S. District Court for the District of New Jersey.
Intra-Cellular Therapies (Nasdaq: ITCI), a biopharmaceutical company specializing in central nervous system (CNS) disorders therapeutics, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. The company's CEO and Chairman, Sharon Mates, Ph.D., will deliver a presentation on Monday, January 13, 2025, at 11:15 a.m. PT in San Francisco.
Interested parties can access both the live and archived versions of the presentation through the 'Events & Presentations' section of the company's website at www.intracellulartherapies.com. Attendees are advised to log in 5-10 minutes before the presentation to complete registration and software installation if necessary.
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).
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