Form 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

Form 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): December 9, 2015

 

 

Intra-Cellular Therapies, Inc.

(Exact name of registrant as specified in its charter)

 

 

Commission File Number: 001-36274

 

Delaware   36-4742850

(State or other jurisdiction

of incorporation)

 

(IRS Employer

Identification No.)

430 East 29th Street

New York, New York 10016

(Address of principal executive offices, including zip code)

(212) 923-3344

(Registrant’s telephone number, including area code)

Not applicable

(Former name or former address, if changed since last report)

 

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

 

¨ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

¨ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

¨ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

¨ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 

 


ITEM 8.01 Other Events.

On December 9, 2015, Intra-Cellular Therapies, Inc. (the “Company”) announced additional data from the first Phase 3 clinical trial of its lead drug candidate, ITI-007 (ITI 007-301), and the ITI-007 Positron Emission Tomography (“PET”) study in patients with schizophrenia.

The Company’s press release announcing additional data from the PET study and the Phase 3 clinical trial of ITI-007-301, and the related posters presented at the 54th Annual Meeting of the American College of Neuropsychopharmacology, are filed as Exhibits 99.1, 99.2 and 99.3, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

 

ITEM 9.01 Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

Number

  

Description

99.1    Press release dated December 9, 2015
99.2    Poster presentation, entitled “Clinical Development of ITI-007 for the Treatment of Schizophrenia”
99.3    Poster presentation, entitled “Further Characterizing Brian Receptor Occupancy with ITI-007: Results from a Positron Emission Tomography (PET) Study in Patients with Schizophrenia”


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

INTRA-CELLULAR THERAPIES, INC.
By:  

/s/ Lawrence J. Hineline

  Lawrence J. Hineline
  Vice President of Finance, Chief Financial Officer, Treasurer and Assistant Secretary

Date: December 10, 2015