Wired News – FDA Approved Intra-Cellular’s Rolling NDA Submission for Lumateperone for Schizophrenia
Stock Monitor: Concordia Intl. Post Earnings Reporting
LONDON, UK / ACCESSWIRE / March 15, 2018 / Active-Investors.com has just released a free research report on Intra-Cellular Therapies, Inc. (NASDAQ: ITCI) (“Intra-Cellular”). If you want access to this report all you need to do is sign up now by clicking the following link www.active-investors.com/registration-sg/?symbol=ITIC as the Company's latest news hit the wire. On March 13, 2018, Intra-Cellular announced that the Company and the US Food and Drug Administration (FDA) have agreed on the content and timing of a rolling New Drug Application (NDA) submission seeking approval of lumateperone for the treatment of schizophrenia. The Company plans to complete its NDA submission by mid-2018. Register today and get access to over 1,000 Free Research Reports by joining our site below:
www.active-investors.com/registration-sg
Active-Investors.com is currently working on the research report for Concordia International Corp. (NASDAQ: CXRX), which also belongs to the Healthcare sector as the Company Intra-Cellular Therapies. Do not miss out and become a member today for free to access this upcoming report at:
www.active-investors.com/registration-sg/?symbol=CXRX
Active-Investors.com is focused on giving you timely information and the inside line on companies that matter to you. This morning, Intra-Cellular Therapies most recent news is on our radar and our team decided to put out a fantastic report on the company that is now available for free below:
www.active-investors.com/registration-sg/?symbol=ITCI
Intra-Cellular Looks Forward to Initiating its Rolling NDA Submission
Dr. Sharon Mates, Chairman and CEO of Intra-Cellular Therapies, stated that the Company is pleased with the outcome of its pre-NDA meeting and looks forward to initiating its rolling NDA submission.
Dr. Sharon added that the Company has made significant progress in the advancement of lumateperone and its mission to provide better treatment options for patients suffering from neuropsychiatric conditions.
FDA Granted Fast Track Designation for Lumateperone for Treatment of Schizophrenia
In November 2017, the FDA granted Fast Track designation for lumateperone for the treatment of schizophrenia. Intra-Cellular requested Fast Track designation for lumateperone based on clinical evidence that lumateperone has the potential to address the unmet medical need for the treatment of schizophrenia with significant improvements on several clinically significant safety parameters, including with respect to metabolic, motor, and cardiovascular issues associated with many currently available antipsychotic agents.
The FDA's Fast Track designation is designed to facilitate the development and expedite the review of drug candidates to treat serious and life-threatening conditions. Fast Track designation may allow for more frequent meetings and communications with the FDA to discuss a drug candidate's development plans and review process.
FDA Approved Drug for Treatment of Schizophrenia
In June 2017, the FDA approved Alkermes PLC's two-month ARISTADA® (aripiprazole lauroxil) extended-release injectable suspension for the treatment of schizophrenia. ARISTADA® is now FDA-approved in four doses and three dosing duration options (441 mg, 662 mg, or 882 mg once monthly, 882 mg once every six weeks and 1064 mg once every two months) and can be initiated at any dose or interval, offering an unprecedented range of flexibility to patients and healthcare providers.
About Schizophrenia
Schizophrenia is a mental disorder characterized by abnormal social behavior and failure to understand reality. Common symptoms include false beliefs, unclear or confused thinking, hearing voices that others do not, reduced social engagement and emotional expression, and a lack of motivation. Existing treatments, while helpful for reducing the positive symptoms of schizophrenia, do not provide broad symptom control across other symptom domains and are limited in their use due to side effects.
About Lumateperone
Lumateperone, Intra-Cellular's lead product candidate, is a first-in-class molecule that provides selective and simultaneous modulation of serotonin, dopamine, and glutamate, three neurotransmitter pathways implicated in severe mental illness. Unlike existing schizophrenia treatments, lumateperone is a dopamine receptor phosphoprotein modulation (DPPM), acting as a pre-synaptic partial agonist and post-synaptic antagonist at D2 receptors. This mechanism, along with potent interactions at 5-HT2A receptors, serotonin transporters, and D1 receptors with indirect glutamatergic modulation, contributes to the efficacy of ITI-007 across a broad array of symptoms, with improved psychosocial function and favorable tolerability. This compound has the potential to benefit patients suffering from a range of neuropsychiatric and neurodegenerative diseases.
About Intra-Cellular Therapies, Inc.
Founded in 2002 and headquartered in New York City, New York, Intra-Cellular Therapies is a biopharmaceutical company developing novel drugs for the treatment of neuropsychiatric and neurodegenerative diseases. The Company is also utilizing its phosphodiesterase (PDE) platform and other proprietary chemistry platforms to develop drugs for the treatment of central nervous system (CNS) and other disorders.
Stock Performance Snapshot
March 14, 2018 - At Wednesday's closing bell, Intra-Cellular Therapies' stock advanced 5.68%, ending the trading session at $25.49.
Volume traded for the day: 895.55 thousand shares, which was above the 3-month average volume of 529.75 thousand shares.
Stock performance in the last month – up 50.56%; previous three-month period – up 71.42%; past twelve-month period – up 72.58%; and year-to-date - up 76.04%
After yesterday's close, Intra-Cellular Therapies' market cap was at $1.32 billion.
The stock is part of the Healthcare sector, categorized under the Biotechnology industry.
Active-Investors:
Active-Investors (A-I) produces regular sponsored and non-sponsored reports, articles, stock market blogs, and popular investment newsletters covering equities listed on NYSE and NASDAQ and Canadian stocks. A-I has two distinct and independent departments. One department produces non-sponsored analyst certified content generally in the form of press releases, articles and reports covering equities listed on NYSE and NASDAQ and the other produces sponsored content (in most cases not reviewed by a registered analyst), which typically consists of compensated investment newsletters, articles and reports covering listed stocks and micro-caps. Such sponsored content is outside the scope of procedures detailed below.
A-I has not been compensated; directly or indirectly; for producing or publishing this document.
PRESS RELEASE PROCEDURES:
The non-sponsored content contained herein has been prepared by a writer (the "Author") and is fact checked and reviewed by a third-party research service company (the "Reviewer") represented by a credentialed financial analyst [for further information on analyst credentials, please email info@active-investors.com. Rohit Tuli, a CFA® charterholder (the "Sponsor"), provides necessary guidance in preparing the document templates. The Reviewer has reviewed and revised the content, as necessary, based on publicly available information which is believed to be reliable. Content is researched, written and reviewed on a reasonable-effort basis. The Reviewer has not performed any independent investigations or forensic audits to validate the information herein. The Reviewer has only independently reviewed the information provided by the Author according to the procedures outlined by A-I. A-I is not entitled to veto or interfere in the application of such procedures by the third-party research service company to the articles, documents or reports, as the case may be. Unless otherwise noted, any content outside of this document has no association with the Author or the Reviewer in any way.
NO WARRANTY
A-I, the Author, and the Reviewer are not responsible for any error which may be occasioned at the time of printing of this document or any error, mistake or shortcoming. No liability is accepted whatsoever for any direct, indirect or consequential loss arising from the use of this document. A-I, the Author, and the Reviewer expressly disclaim any fiduciary responsibility or liability for any consequences, financial or otherwise arising from any reliance placed on the information in this document. Additionally, A-I, the Author, and the Reviewer do not (1) guarantee the accuracy, timeliness, completeness or correct sequencing of the information, or (2) warrant any results from use of the information. The included information is subject to change without notice.
NOT AN OFFERING
This document is not intended as an offering, recommendation, or a solicitation of an offer to buy or sell the securities mentioned or discussed, and is to be used for informational purposes only. Please read all associated disclosures and disclaimers in full before investing. Neither A-I nor any party affiliated with us is a registered investment adviser or broker-dealer with any agency or in any jurisdiction whatsoever. To download our report(s), read our disclosures, or for more information, visit http://active-investors.com/legal-disclaimer/.
CONTACT
For any questions, inquiries, or comments reach out to us directly. If you're a company we are covering and wish to no longer feature on our coverage list contact us via email and/or phone between 09:30 EDT to 16:00 EDT from Monday to Friday at:
Email: info@active-investors.com
Phone number: 73 29 92 6381
Office Address: 6, Jalan Kia Peng, Kuala Lumpur, 50450 Kuala Lumpur, Wilayah Persekutuan Kuala Lumpur, Malaysia
CFA® and Chartered Financial Analyst® are registered trademarks owned by CFA Institute.
SOURCE: Active-Investors
