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): January 15, 2013
HYPERION THERAPEUTICS, INC.
(Exact Name of Registrant as Specified in Charter)
601 Gateway Boulevard, Suite 200
South San Francisco, California 94080
(Address of principal executive offices, zip code)
Registrants 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):
On January 15, 2013, Hyperion Therapeutics, Inc. (the Company) received a communication from the U.S. Food and Drug Administration (the FDA) advising the Company that it should not to expect to receive a final action by the Prescription Drug User Fee Act (PDUFA) action date of January 23, 2013. The FDA explained it is continuing to work on label and post-marketing requirements in connection with the Companys New Drug Application for Ravicti (glycerol phenylbutyrate) for the treatment of Urea Cycle Disorders. A copy of the press release issued by the Company is furnished as Exhibit 99.1 hereto and is incorporated into this Item 8.01.
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.