UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, DC 20549
FORM
CURRENT REPORT
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933(§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
| Item 8.01. | Other Events. |
On February 27, 2020, Zogenix, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) has extended the review period for the New Drug Application (“NDA”) for FINTEPLA® for the treatment of seizures associated with Dravet syndrome. The new Prescription Drug User Fee Act (“PDUFA”) target action date has been extended by three months to June 25, 2020.
The extension allows the FDA time to review additional data submitted by Zogenix in response to a recent information request from the FDA. The FDA determined that the submission of this information constituted a major amendment to the NDA, resulting in this extension of the PDUFA goal date by three months.
The NDA for FINTEPLA was originally accepted for filing in November 2019 under the FDA’s Priority Review program with a six-month review period, and is based on data from two positive pivotal Phase 3 trials in Dravet syndrome and an interim analysis from an ongoing open-label extension study, which included 232 patients treated for up to 21 months.
Forward-Looking Statements
The Company 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 include the timing and results of any decision regarding the NDA from FDA. The inclusion of forward-looking statements should not be regarded as a representation by the Company 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 the Company’s business, including, without limitation: the FDA may not agree with the Company’s interpretation of results from its clinical trials; the FDA may request additional data in connection with its review of the NDA; the potential for the FDA to further delay the PDUFA target action date related to the Dravet syndrome NDA due to the FDA’s internal resource constraints or other reasons; additional data from the Company’s ongoing studies may contradict or undermine the data submitted in the Dravet syndrome NDA for FINTEPLA or reported for LGS; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could result in recalls or product liability claims; and other risks described in the Company’s public periodic filings with the U.S. Securities & Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and the Company 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.
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.
| ZOGENIX, INC. | ||||||
| Date: February 27, 2020 |
By: |
/s/ Michael P. Smith | ||||
| Name: |
Michael P. Smith | |||||
| Title: |
Executive Vice President, Chief Financial Officer, Treasurer and Secretary | |||||
Document and Entity Information |
Feb. 27, 2020 |
|---|---|
| Cover [Abstract] | |
| Amendment Flag | false |
| Entity Central Index Key | 0001375151 |
| Document Type | 8-K |
| Document Period End Date | Feb. 27, 2020 |
| Entity Registrant Name | ZOGENIX, INC. |
| Entity Incorporation State Country Code | DE |
| Entity File Number | 001-34962 |
| Entity Tax Identification Number | 20-5300780 |
| Entity Address, Address Line One | 5959 Horton Street |
| Entity Address, Address Line Two | Suite 500 |
| Entity Address, City or Town | Emeryville |
| Entity Address, State or Province | CA |
| Entity Address, Postal Zip Code | 94608 |
| City Area Code | (510) |
| Local Phone Number | 550-8300 |
| Written Communications | false |
| Soliciting Material | false |
| Pre Commencement Tender Offer | false |
| Pre Commencement Issuer Tender Offer | false |
| Security 12b Title | Common Stock, par value $0.001 per share |
| Trading Symbol | ZGNX |
| Security Exchange Name | NASDAQ |
| Entity Emerging Growth Company | false |