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 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.
Intra-Cellular Therapies (Nasdaq: ITCI) has announced the appointment of Sanjeev Narula as Executive Vice President and Chief Financial Officer, effective August 12, 2024. Narula, who brings extensive experience from his roles at Viatris, Pfizer, American Express, and Xerox India, will succeed Lawrence Hineline, who is retiring but will remain as a consultant to ensure a smooth transition. Dr. Sharon Mates, ITCI's Chairman and CEO, expressed excitement about Narula joining the leadership team as the company continues its rapid growth. Narula's background includes serving as CFO of Viatris and holding various financial leadership positions at Pfizer over 16 years.
Intra-Cellular Therapies (ITCI) reported strong Q2 2024 results, with CAPLYTA net product sales reaching $161.3 million, a 46% increase year-over-year. Total prescriptions for CAPLYTA grew 36% compared to Q2 2023. The company raised its 2024 CAPLYTA sales guidance to $650-$680 million.
ITCI announced positive Phase 3 results for lumateperone as an adjunctive therapy for major depressive disorder (MDD), with an sNDA submission planned for H2 2024. The company also initiated patient enrollment in Phase 2 studies for ITI-1284 in generalized anxiety disorder and Alzheimer's-related psychosis.
Despite strong sales growth, ITCI reported a net loss of $16.2 million for Q2 2024, an improvement from the $42.8 million loss in Q2 2023. The company ended the quarter with a strong cash position of $1.025 billion.
Intra-Cellular Therapies (Nasdaq: ITCI), a biopharmaceutical company specializing in central nervous system (CNS) disorder treatments, has announced a conference call and webcast for August 7, 2024, at 8:30 a.m. Eastern Time. The event will provide a corporate update and discuss financial results for the quarter ending June 30, 2024.
Participants can join the call via phone by using the provided registration link. The webcast will be accessible through the company's website under the Investor Relations section. Interested parties are advised to log in 5-10 minutes early to complete the registration process and install any necessary software.
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.
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.