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 announced the acceptance of supplemental new drug applications (sNDAs) for CAPLYTA for treating bipolar depression, with a PDUFA action date of December 17, 2021. In Q1 2021, total revenues surged to $15.9 million, with net product revenues from CAPLYTA at $15.6 million, compared to $1.1 million and $0.9 million in Q1 2020, respectively. The company introduced ITI-1284 ODT-SL, a new deuterated form of lumateperone. R&D expenses slightly decreased to $15.1 million, while SG&A expenses increased to $52.6 million. The net loss for Q1 was $52.7 million.
Intra-Cellular Therapies, a biopharmaceutical firm focused on CNS disorders, announced that CEO Sharon Mates will present at two investor conferences. The first presentation will be at the Bank of America 2021 Healthcare Conference on May 11 at 5:00 PM ET, followed by the 2021 RBC Capital Markets Global Healthcare Conference on May 18 at 9:10 AM ET. Archived webcasts will be available on their website. The company utilizes Nobel prize-winning research to develop innovative therapies for psychiatric and neurological conditions.
Intra-Cellular Therapies (Nasdaq: ITCI) announced a conference call on May 10, 2021, at 8:30 a.m. ET to discuss its financial results for Q1 2021. The call will provide a corporate update and detailed financials for the quarter ended March 31, 2021. Investors can access the call via phone or through a live and archived webcast on the company's website. Intra-Cellular Therapies develops therapeutics for CNS disorders based on innovative intracellular research.
Intra-Cellular Therapies (Nasdaq: ITCI) announced that the FDA has accepted its supplemental New Drug Applications (sNDAs) for lumateperone, aimed at treating bipolar depression as both a monotherapy and adjunctive therapy. The target action date set by the FDA is December 17, 2021. The sNDAs are based on two successful Phase 3 studies (Study 402 and Study 404) demonstrating favorable safety and tolerability of lumateperone. This treatment addresses a significant unmet need, as bipolar depression currently has limited FDA-approved options.
Intra-Cellular Therapies announces a webcast on May 4, 2021, at 2:00 p.m. EDT, featuring Dr. Roger McIntyre discussing clinical data on lumateperone for mood disorders. The presentations at the American Psychiatric Association Annual Meeting from May 1-3, 2021, will cover lumateperone's efficacy in treating bipolar depression and its safety profile. Approximately 11 million adults in the U.S. suffer from bipolar disorders, highlighting a critical need for effective treatments like CAPLYTA (lumateperone), currently indicated for schizophrenia.
Intra-Cellular Therapies (Nasdaq: ITCI) has nominated Sir Michael Rawlins as a new independent director and Joel S. Marcus for re-election to its Board of Directors for the 2021 annual meeting on June 21, 2021. Sir Michael, former chairman of MHRA, brings extensive regulatory experience to aid in the anticipated approval of CAPLYTA for bipolar depression. The current board member, Dr. Christopher Alafi, will complete his term at this meeting. This strategic move underscores the company’s commitment to growth and effective governance.
Intra-Cellular Therapies (Nasdaq: ITCI) presented promising preclinical results on its PDE1 inhibitor, lenrispodun, at the AACR 2021 Virtual Annual Meeting. The studies indicate its potential to enhance anti-tumor effects when combined with PD-1 checkpoint inhibitors in colorectal cancer. Key findings revealed that lenrispodun decreased tumor-associated macrophages and increased natural killer cells, leading to reduced tumor volumes and improved survival rates in mouse models. The company is exploring lenrispodun for conditions like Parkinson's disease and heart failure, highlighting its broad therapeutic potential.
Intra-Cellular Therapies reported Q4 2020 net product revenues for CAPLYTA at $12.4 million, up 77% from Q3. Full year 2020 revenues reached $22.5 million, with a net loss of $227.0 million or $3.23 per share. R&D expenses decreased by 26% to $65.8 million, while SG&A expenses surged to $186.4 million. The company submitted supplemental new drug applications for CAPLYTA to treat bipolar depression and initiated pivotal studies for major depressive disorder. Total cash and investments were $658.8 million at year-end, signaling strong liquidity.
Intra-Cellular Therapies (Nasdaq: ITCI) announced the expansion of its pipeline with ITI-1284, a deuterated form of lumateperone, delivered as an orally disintegrating tablet (ODT-SL) for sublingual administration. Phase 1 studies in healthy volunteers, including those over 65, showed safety and rapid absorption. The company plans to develop ITI-1284 ODT-SL for treating behavioral disturbances in dementia and certain depressive disorders in the elderly. No serious adverse events were reported, with mild effects observed in the elderly cohort.
Intra-Cellular Therapies (ITCI) has submitted Supplemental New Drug Applications (sNDAs) to the FDA for CAPLYTA (lumateperone) targeting bipolar I and II depressive episodes. This treatment could potentially be the first FDA-approved option for bipolar depression as both monotherapy and adjunctive therapy. Positive results from two Phase 3 studies indicate a favorable safety profile with low rates of adverse events. The FDA's decision is anticipated in the second half of 2021, addressing a significant need in a market of approximately 11 million affected adults in the U.S.
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