UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 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): February 25, 2014
OREXIGEN THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in its Charter)
| Delaware | 001-33415 | 65-1178822 | ||
| (State or Other Jurisdiction | (Commission | (IRS Employer | ||
| of Incorporation) | File Number) | Identification No.) |
| 3344 N. Torrey Pines Ct., Suite 200, La Jolla, CA | 92037 | |
| (Address of Principal Executive Offices) | (Zip Code) |
Registrant’s telephone number, including area code: (858) 875-8600
(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 (see General Instruction A.2. below):
| ¨ | 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 February 25, 2014, Orexigen Therapeutics, Inc. (the “Company” or “Orexigen”) announced that the Company received the Day 120 List of Questions (“LoQs”) regarding its NB32 Marketing Authorization Application from the European Medicines Agency’s Committee for Medicinal Products for Human Use. The Day 120 LoQs are consistent with issues raised by the United States Food and Drug Administration during the course of NB32 development and the initial review of the New Drug Application for NB32, such as manufacturing and quality, non-clinical studies, dosing regimen, and, most significantly, cardiovascular safety.
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.
| OREXIGEN THERAPEUTICS, INC. | ||||
| Date: February 25, 2014 | By: | /s/ Joseph P. Hagan | ||
| Name: | Joseph P. Hagan | |||
| Title: | Chief Business Officer | |||