Intra-Cellular Therapies Inc. - ITCI STOCK NEWS

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.

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.