Intra-Cellular Therapies Inc. - ITCI STOCK NEWS

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).

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.