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ZGNX > SEC Filings for ZGNX > Form 8-K on 30-May-2012All Recent SEC Filings

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Form 8-K for ZOGENIX, INC.


30-May-2012

Other Events


Item 8.01 Other Events.

On May 30, 2012, Zogenix, Inc. (the "Company" or "Zogenix") submitted an investigational new drug ("IND") application to the U.S. Food & Drug Administration (the "FDA") for Relday™, which is a combination of the Company's DosePro® needle-free, subcutaneous drug delivery system plus a proprietary, subcutaneous once-monthly formulation of risperidone for treating schizophrenia. Initial clinical trials are currently planned to begin in the second half of the year, with results expected by year-end.

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Zogenix cautions you that statements included in this report that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming," "designed" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding the potential for, and timing of, clinical trials for Relday and the timing of the results of such trials. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: the uncertainties associated with the clinical development and regulatory approval of product candidates such as Relday, including the timing and outcome of the FDA's review of the IND for Relday; difficulties in identifying, negotiating, executing and carrying out strategic transactions relating to Relday; and other risks described in Zogenix's filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.


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