Intra-Cellular Therapies Inc. - ITCI STOCK NEWS

Intra-Cellular Therapies announced FDA approval for CAPLYTA, the first treatment for depressive episodes associated with bipolar I and II disorder. CAPLYTA is approved as both monotherapy and adjunctive therapy with lithium or valproate. This approval is based on two positive Phase 3 studies showing significant improvements over placebo. Bipolar disorder affects about 11 million adults in the U.S., highlighting a significant unmet medical need. CAPLYTA offers a favorable safety and tolerability profile, making it a crucial treatment option for patients.

Intra-Cellular Therapies (Nasdaq:ITCI) announces the passing of Director Richard Lerner, MD, who contributed significantly to science and medicine. Dr. Lerner served on the board since 2002 and was influential in the company's mission to develop therapies for CNS disorders. His accolades include the Wolf Prize and membership in prestigious scientific academies. The company's leadership, including CEO Sharon Mates, expressed deep sadness and condolences to his family. Intra-Cellular Therapies focuses on innovative treatments for complex psychiatric and neurologic diseases, founded on Nobel Prize-winning research.

Intra-Cellular Therapies reported a remarkable 200% increase in total revenues for Q3 2021, totaling $22.2 million, driven by strong sales of CAPLYTA, which achieved $21.6 million in net product revenues. The company has completed its sales force expansion in preparation for the bipolar depression launch, pending FDA approval with a target date of December 17, 2021. Additionally, CAPLYTA's total prescriptions rose by 15% over the previous quarter. However, the net loss for Q3 grew to $76.9 million compared to $55.2 million a year ago.

Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) will host a conference call on November 9, 2021, at 8:30 a.m. ET to discuss its financial results for Q3 2021 and provide a corporate update. Investors can access the call via phone or through a live webcast available on the company’s investor relations website. Intra-Cellular Therapies focuses on developing treatments for central nervous system disorders using innovative, research-backed methods.

Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) announced a Virtual Event on October 20, 2021, from 1:00 p.m. to 4:00 p.m. ET, focusing on its development programs for lumateperone, ITI-1284, PDE1 inhibitors, and ITI-333. The event will be accessible via a webcast on the company's Investor Relations page. Intra-Cellular Therapies specializes in therapeutics for CNS disorders, leveraging Nobel prize-winning research to develop innovative treatments for psychiatric and neurologic diseases.

Intra-Cellular Therapies (Nasdaq: ITCI) will host a virtual event on October 20, 2021, from 12:30 to 3:30 p.m. ET. The event will focus on the company’s pipeline, including lumateperone, ITI-1284, PDE1 inhibitors, and ITI-333. Presentations will be made by management and key opinion leaders. Interested parties can access the live and archived webcast via the Investor Relations section of the company's website. This event aims to provide insights into the innovative treatments being developed for CNS disorders.

Intra-Cellular Therapies announced positive results from its Phase 3 trial for lumateperone (42 mg) in treating major depressive episodes linked to bipolar I and II disorders. The study, involving 381 patients, indicated a significant reduction in depressive symptoms compared to placebo (MADRS score difference -4.6, P<0.0001). Lumateperone demonstrated a favorable safety profile, with adverse events similar to placebo. These findings support the drug's supplemental NDA currently under FDA review, with a target action date of December 17, 2021, positioning lumateperone as a potential new treatment for bipolar depression.

Intra-Cellular Therapies, Inc. (Nasdaq: ITCI) announced that CEO Sharon Mates, Ph.D., will present at the 2021 Cantor Virtual Global Healthcare Conference on September 28, 2021, at 10:40 am ET. Investors can access the live and archived webcast in the Investor Relations section of the company's website. Intra-Cellular Therapies focuses on developing therapeutics for central nervous system disorders, leveraging groundbreaking research to create innovative treatments for complex psychiatric and neurologic diseases.

Intra-Cellular Therapies highlights favorable findings from recent studies on lenrispodun (ITI-214), a PDE1 inhibitor, published in several medical journals. These studies indicate lenrispodun is well-tolerated in heart failure patients, enhances cardiac contractility, and improves vascular function in aging models. The research suggests lenrispodun may offer a safer alternative for heart failure treatment by increasing cAMP and cGMP levels. Its potential spans various diseases, including Parkinson's. The promising results could be significant for future clinical applications and therapies.