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 (Nasdaq: ITCI) has announced that Sharon Mates, Ph.D., CEO and Chairman, will present at the SVB Leerink 10th Annual Global Healthcare Conference on February 26, 2021, at 10:00 am ET. The event can be accessed live and recorded via the company's Investor Relations page. Intra-Cellular Therapies focuses on developing therapeutics for central nervous system disorders, drawing on Nobel Prize-winning research to create innovative treatments for psychiatric and neurologic diseases.
Intra-Cellular Therapies (Nasdaq: ITCI) announced a conference call on February 25, 2021, at 8:30 a.m. ET to discuss its financial results for the quarter and year ending December 31, 2020. Investors can access the call by dialing 1-(844) 835-6563 (U.S.) or 1-(970) 315-3916 (international), using conference ID 8499868. The call will also be available as a live and archived webcast on the company's website under the Investor Relations section.
Intra-Cellular Therapies (Nasdaq: ITCI) published positive results from the CAPLYTA clinical trial (ITI-007-303) in patients with stable schizophrenia. The 6-week study demonstrated that CAPLYTA, administered at 42 mg, was well-tolerated with minimal metabolic and extrapyramidal symptoms. Patients experienced stability in schizophrenia symptoms, with low adverse events such as somnolence (6.6%) and headache (5.3%). Notably, mean cholesterol and weight levels decreased during treatment. The findings support CAPLYTA's safety and efficacy, offering valuable insights for clinicians in managing schizophrenia.
Intra-Cellular Therapies (Nasdaq:ITCI) announced that CEO Sharon Mates, Ph.D., will present at the 39th Annual J.P. Morgan Healthcare Conference on January 12, 2021, at 9:10 AM ET. The conference will be accessible via a live and archived webcast on the company's website, requiring registration 5-10 minutes prior to the event.
Intra-Cellular Therapies focuses on developing therapeutics for central nervous system disorders, leveraging Nobel prize-winning research to create innovative treatments for complex psychiatric and neurologic diseases.
Intra-Cellular Therapies has initiated clinical programs for its long-acting injectable formulation of lumateperone and the novel compound ITI-333 for opioid use disorder.
The LLAI formulation is designed for once monthly administration to maintain therapeutic levels in patients with schizophrenia. The Phase 1 study will assess its pharmacokinetics and safety.
ITI-333 aims to treat opioid use disorder with a unique mechanism, showing promise without the safety concerns associated with traditional opioids.
Intra-Cellular Therapies (Nasdaq: ITCI) presented promising findings regarding lumateperone at the 59th Annual Meeting of the American College of Neuropsychopharmacology.
Results from a Phase 3 trial showed significant antidepressant effects of lumateperone in patients with bipolar depression, achieving a p-value of p<.0001 on the Montgomery-Åsberg Depression Rating Scale.
Additional data indicated substantial improvements in depression symptoms among patients with schizophrenia and comorbid depression, with a mean reduction of 4.8 points on the Calgary Depression Scale after one year of treatment.
Intra-Cellular Therapies (Nasdaq:ITCI) announced that CEO Sharon Mates, Ph.D., will participate in a fireside chat at the Evercore ISI 3rd Annual HealthCONx Conference on December 2, 2020, at 9:15 AM ET. Investors can access the live and archived webcast on the company’s Investor Relations website. Intra-Cellular Therapies is a biopharmaceutical firm focusing on developing innovative treatments for central nervous system disorders, leveraging insights from Nobel prize-winning research.
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) reported positive topline results from Study 402, a Phase 3 trial assessing lumateperone for bipolar depression. The company plans to submit a supplemental NDA to the FDA early 2021. CAPLYTA demonstrated robust commercial performance with a 280% increase in prescriptions from Q2 to Q3 2020. Clinical expansion includes trials in Major Depressive Disorder (MDD) and mixed features of bipolar depression. The third quarter net product sales reached $7.4 million, while the net loss was $55.2 million, a significant increase from $34.9 million in Q3 2019.
Intra-Cellular Therapies (Nasdaq: ITCI) announced a conference call scheduled for November 9, 2020, at 8:30 a.m. ET to discuss financial results for Q3 2020 and provide a corporate update. Investors can join the call by dialing 1-(844) 835-6563 (international: 1-(970) 315-3916) using conference ID 1859956. The call will also be available via a webcast on their website's Investor Relations section. Intra-Cellular Therapies focuses on developing treatments for central nervous system disorders based on Nobel Prize-winning research.
Intra-Cellular Therapies (Nasdaq:ITCI) announces the promotion of Dr. Suresh Durgam to Chief Medical Officer, effective immediately. Dr. Andrew Satlin will leave the position on October 28, 2020, for another opportunity. Dr. Durgam has extensive experience in neuropsychiatric drug development and has successfully led clinical programs for lumateperone, addressing schizophrenia and bipolar depression. He previously contributed to the approval of cariprazine and boasts over 23 years in clinical research, enhancing the company's R&D strategy for CNS disorders.
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