Intra-Cellular Therapies Inc. - ITCI STOCK NEWS

Intra-Cellular Therapies (ITCI) reported strong second-quarter results, achieving total revenues of $20 million, a significant increase from $1.9 million year-over-year. Net product revenues for CAPLYTA rose to $19 million, up 22% from the prior quarter. The company is awaiting FDA action on its supplemental new drug applications (sNDAs) for bipolar depression, with a target date of December 17, 2021. The enrollment for the Phase 3 clinical trial of lumateperone as an adjunctive treatment for major depressive disorder has begun. However, the net loss for the quarter was $68.7 million.

Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) will host a conference call on August 9, 2021, at 8:30 a.m. ET to discuss its financial results for Q2 2021. The call can be accessed via phone or online, with a specific conference ID provided. The company specializes in developing treatments for CNS disorders based on Nobel Prize-winning research.

Intra-Cellular Therapies (Nasdaq: ITCI) announced the publication of a pooled analysis evaluating the safety and tolerability of lumateperone (42 mg), a treatment for schizophrenia. The analysis included 1,073 patients across three randomized, double-blind, placebo-controlled trials. Findings indicate that lumateperone's safety profile is comparable to placebo, with treatment-emergent adverse events (TEAEs) similar in incidence. Notable outcomes include low discontinuation rates due to TEAEs (0.5%) and minimal changes in weight and metabolic parameters. The publication highlights lumateperone as a favorable treatment for schizophrenia.

Intra-Cellular Therapies, a biopharmaceutical company focused on CNS disorders, announced that Dr. Sharon Mates, CEO and Chairman, will present at two investor conferences. The first is the Jefferies Virtual Healthcare Conference on June 2 at 11:30 am ET, followed by the Goldman Sachs 42nd Annual Global Healthcare Conference on June 10 at 1:20 pm ET. Live and archived webcasts will be available on the company’s website. Intra-Cellular leverages Nobel prize-winning research to develop treatments for complex psychiatric and neurologic diseases.

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.