trending Market Intelligence /marketintelligence/en/news-insights/trending/ZkKAxt0qRTTOFizc2h77dQ2 content
Log in to other products

Login to Market Intelligence Platform

 /


Looking for more?

Contact Us

Request a Demo

You're one step closer to unlocking our suite of comprehensive and robust tools.

Fill out the form so we can connect you to the right person.

If your company has a current subscription with S&P Global Market Intelligence, you can register as a new user for access to the platform(s) covered by your license at Market Intelligence platform or S&P Capital IQ.

  • First Name*
  • Last Name*
  • Business Email *
  • Phone *
  • Company Name *
  • City *
  • We generated a verification code for you

  • Enter verification Code here*

* Required

In This List

Intra-Cellular to provide more data for US FDA application of schizophrenia drug

Gauging Supply Chain Risk In Volatile Times

S&P Global Market Intelligence

Cannabis: Hashing Out a Budding Industry

Segment

IFRS 9 Impairment How It Impacts Your Corporation And How We Can Help

The Market Intelligence Platform


Intra-Cellular to provide more data for US FDA application of schizophrenia drug

Intra-Cellular Therapies Inc. said the U.S. Food and Drug Administration has agreed to let the company submit additional information regarding its new drug application for lumateperone to treat schizophrenia.

The FDA classified the planned submission as a major amendment to the application and extended the review period by three months. The U.S. regulator plans to make a decision on the New York-based pharmaceutical company's application by Dec. 27.

The new information will cover findings from previous animal studies that show species-specific differences in the breakdown of the drug. Additionally, Intra-Cellular will analyze animal and human plasma samples from previous studies to confirm that lumateperone goes through different chemical reactions in different species.

Intra-Cellular's application for lumateperone is based on results from 20 clinical studies. The FDA granted a fast-track designation to the drug for treating patients with schizophrenia in November 2017.

The pharmaceutical company is also developing lumateperone as a therapy for bipolar disorder, behavioral disturbances in patients with Alzheimer's disease, depression, and other neuropsychiatric and neurological disorders.

The shares of Intra-Cellular were up 8.39% to $8.85 at 1:49 p.m. on Aug. 5.