ITCI Intra-Cellular Therapies
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 3, 2021
Intra-Cellular Therapies, Inc.
(Exact name of registrant as specified in its charter)
Commission File Number: 001-36274
(State or other jurisdiction
430 East 29th Street
New York, NY 10016
(Address of principal executive offices, including zip code)
(Registrant’s telephone number, including area code)
(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))
Securities registered pursuant to Section 12(b) of the Act:
Title of each class
Name of each exchange on which registered
|Common Stock||ITCI||The Nasdaq Global Select Market|
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
On May 3, 2021, Intra-Cellular Therapies, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (the “FDA”) has accepted for review the Company’s supplemental New Drug Applications (“sNDAs”) for lumateperone for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy with lithium or valproate. The FDA has assigned a Prescription Drug User Fee Act target action date of December 17, 2021 for the applications.
The Company’s press release announcing the FDA’s acceptance for review of the Company’s sNDAs is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
Financial Statements and Exhibits.
|99.1||Press release dated May 3, 2021|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document)|
The press release may contain hypertext links to information on our website. The information on our website is not incorporated by reference into this Current Report on Form 8-K and does not constitute a part of this Form 8-K.
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.|
/s/ Lawrence J. Hineline
|Lawrence J. Hineline|
|Senior Vice President of Finance, Chief Financial Officer, Treasurer and Assistant Secretary|
Date: May 3, 2021