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|ITEM 8.01|| |
On February 22, 2021, Intra-Cellular Therapies, Inc. (the “Company”) announced it recently submitted supplemental New Drug Applications (“sNDAs”) to the U.S. Food and Drug Administration (the “FDA”) for lumateperone for the treatment of depressive episodes associated with bipolar I or II disorder both as monotherapy and as adjunctive therapy in adults. The Company anticipates an FDA target action date for the sNDAs in the second-half of 2021.
The Company’s press release announcing the submission of the sNDAs is filed as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.
|ITEM 9.01|| |
Financial Statements and Exhibits.
|99.1||Press release dated February 22, 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.|
|Lawrence J. Hineline|
|Senior Vice President of Finance, Chief Financial Officer, Treasurer and Assistant Secretary|
Date: February 22, 2021