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): February 1, 2013
HYPERION THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Charter)
| | | | |
| Delaware | | 001-35614 | | 61-1512713 |
(State or Other Jurisdiction of Incorporation) | | (Commission File Number) | | (I.R.S. Employer Identification No.) |
601 Gateway Boulevard, Suite 200
South San Francisco, California 94080
(Address of principal executive offices, zip code)
Registrant’s telephone number, including area code: (650) 745-7802
(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)) |
On February 1, 2013, Hyperion Therapeutics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has approved Ravicti™ (glycerol phenylbutyrate) for the treatment of Urea Cycle Disorders in adult and pediatric patients two years of age and older. The drug is expected to be commercially available to physicians and patients by the end of April 2013. A copy of the press release is filed as Exhibit 99.2 to this Current Report and is incorporated herein by reference.
The Company is filing the risk factors for the purpose of updating and superseding the risk factor disclosure contained in its prior public filings, including those discussed under the caption “Risk Factors” in its Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2012, which was filed with the SEC on November 7, 2012. The updated risk factors are filed as Exhibit 99.2 to this Current Report and are incorporated herein by reference.
| Item 9.01. | Financial Statements and Exhibits. |
(d) Exhibits.
| | |
Exhibit Number | | Description |
| |
| 99.1 | | Press Release, dated February 1, 2013 |
| |
| 99.2 | | Risk Factors |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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Dated: February 1, 2013 | | Hyperion Therapeutics, Inc. |
| | |
| | By: | | /s/ Jeffrey S. Farrow |
| | | | Jeffrey S. Farrow |
| | | | Chief Financial Officer |
EXHIBIT INDEX
| | |
Exhibit No. | | Description |
| |
| 99.1 | | Press Release, dated February 1, 2013 |
| |
| 99.2 | | Risk Factors |
