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, Inc. (Nasdaq: ITCI) will hold a conference call on November 3, 2022, at 8:30 a.m. ET to discuss its financial results for the quarter ending September 30, 2022. This call aims to provide a corporate update and invite stakeholders to participate via a registration link. Interested parties can access the live and archived webcast through the Investor Relations section of the company's website. Intra-Cellular Therapies specializes in developing treatments for central nervous system disorders, leveraging innovative insights from cellular research.
Intra-Cellular Therapies reported a significant revenue growth of 178% in total revenues for Q2 2022, reaching $55.6 million, up from $20.0 million in Q2 2021. CAPLYTA net product revenues were $55.1 million, a 190% increase year-over-year and 58% over Q1 2022. Key metrics include a 225% rise in new prescriptions compared to Q2 2021. However, net loss escalated to $86.6 million from $68.7 million in the prior year. Cash reserves stood at $679.2 million as of June 30, 2022.
Intra-Cellular Therapies (Nasdaq: ITCI) announced a conference call on August 9, 2022, at 8:30 a.m. ET to discuss the financial results for Q2 2022 and provide a corporate update. Interested parties can join the call by dialing 1-(877) 407-8291 or accessing the webcast on the company's website. Intra-Cellular Therapies focuses on developing therapeutics for CNS disorders, utilizing innovative research to create solutions for complex psychiatric and neurologic diseases.
Intra-Cellular Therapies (ITCI) has presented new data regarding lumateperone (CAPLYTA) at the 2022 ISBD virtual conference. Key highlights include efficacy findings from Study 404, demonstrating significant improvements in depression scores (MADRS) and quality of life metrics in patients with bipolar depression. Lumateperone's favorable metabolic profile was also emphasized, showing stabilization of metabolic syndrome rates compared to placebo. Dr. Suresh Durgam expressed satisfaction with the positive feedback from the medical community regarding the drug's efficacy and safety.
Intra-Cellular Therapies reported strong first-quarter 2022 results, highlighting a 120% revenue increase to $35 million compared to Q1 2021. CAPLYTA (lumateperone) saw a remarkable prescription growth, with new prescriptions up 300% post-approval for bipolar depression, and total prescriptions rising 63% from Q4 2021. Net product revenues for CAPLYTA reached $34.8 million, a 123% year-over-year increase. However, a net loss of $72.1 million was reported, up from $52.7 million in the prior year, alongside escalating R&D and SG&A expenses.
Intra-Cellular Therapies (Nasdaq: ITCI) announced a conference call on May 10, 2022, at 8:30 a.m. ET to discuss its financial results for Q1 2022, ending March 31. The company focuses on developing therapeutics for central nervous system disorders, leveraging Nobel prize-winning research to create innovative treatments for psychiatric and neurologic diseases. Interested parties can join via phone or webcast, with dial-in details provided for participants.
Intra-Cellular Therapies has received FDA approval for two new dosage strengths of CAPLYTA (lumateperone): 10.5 mg and 21 mg. These adapt dosage recommendations for patients on moderate or strong CYP3A4 inhibitors and those with moderate to severe hepatic impairment. CAPLYTA is indicated for the treatment of schizophrenia and bipolar depression, demonstrating efficacy with a favorable safety profile. The new dosages will be available mid-2022, further enhancing the medicine's accessibility for specific patient populations.
Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) announced the appointment of E. Rene Salas to its Board of Directors, where he will also serve on the audit committee. With over 35 years in financial and life sciences advisory roles, Salas brings valuable experience, having previously worked at Ernst & Young, LLP and served as CFO of Wellstat, LLC. His expertise is expected to support Intra-Cellular's growth and mission to develop innovative CNS therapies, enhancing operational oversight and strategic direction.
Intra-Cellular Therapies, a biopharmaceutical company focused on CNS disorders, announced that CEO Sharon Mates will present at the 21st Annual Needham Virtual Healthcare Conference on April 12, 2022, at 11:00 am ET. The presentation will be accessible live and archived on the company's website under the Investor Relations section. The company's innovative treatments are based on Nobel prize-winning research aimed at understanding cell interactions. For more details, visit www.intracellulartherapies.com.
Intra-Cellular Therapies received FDA approval for CAPLYTA® (lumateperone) as the first treatment for bipolar depression in adults. In Q4 2021, the company reported total revenues of $25.7 million, a 106% increase year-over-year, with CAPLYTA net product revenues at $25.5 million. For the full year, total revenues reached $83.8 million, up 267%. Despite strong revenue growth, the net loss for 2021 was $284.1 million, reflecting increased R&D and SG&A expenses. CAPLYTA prescriptions rose 15% in Q4 compared to Q3 2021, showcasing strong demand.