0001193125-19-255262.txt : 20190926 0001193125-19-255262.hdr.sgml : 20190926 20190926082410 ACCESSION NUMBER: 0001193125-19-255262 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 12 CONFORMED PERIOD OF REPORT: 20190926 ITEM INFORMATION: Other Events FILED AS OF DATE: 20190926 DATE AS OF CHANGE: 20190926 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ZOGENIX, INC. CENTRAL INDEX KEY: 0001375151 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 205300780 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34962 FILM NUMBER: 191115612 BUSINESS ADDRESS: STREET 1: 5959 HORTON STREET, SUITE 500 CITY: EMERYVILLE STATE: CA ZIP: 94608 BUSINESS PHONE: (510) 550-8300 MAIL ADDRESS: STREET 1: 5959 HORTON STREET, SUITE 500 CITY: EMERYVILLE STATE: CA ZIP: 94608 FORMER COMPANY: FORMER CONFORMED NAME: ZOGENIX INC DATE OF NAME CHANGE: 20060911 8-K 1 d811477d8k.htm 8-K 8-K
false 0001375151 0001375151 2019-09-26 2019-09-26

 

 

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): September 26, 2019

 

ZOGENIX, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

  

001-34962

 

20-5300780

(State or Other Jurisdiction

of Incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

     

5959 Horton Street, Suite 500, Emeryville, CA

  

94608

(Address of Principal Executive Offices)

  

(Zip Code)

Registrant’s telephone number, including area code: (510) 550-8300

(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:

☐ 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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

  

Trading

Symbol

  

Name of each exchange

on which registered

Common Stock, par value $0.001 per share

  

ZGNX

  

The Nasdaq Global Market

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 September 26, 2019, Zogenix, Inc. (the “Company”), a global pharmaceutical company developing rare disease therapies, announced that it has resubmitted its New Drug Application (“NDA”) for FINTEPLA® (ZX008, fenfluramine) for the treatment of seizures associated with Dravet syndrome to the U.S. Food and Drug Administration (“FDA”).

The NDA is based on data from two 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 24 months. The Company is also investigating FINTEPLA in Lennox-Gastaut syndrome (“LGS”), another rare childhood-onset epilepsy, for which a Phase 3 trial is ongoing and top-line data are anticipated in the first quarter of 2020.

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 Company’s belief that it addressed the issues cited in the FDA’s refusal to file letter and subsequent guidance through the resubmission process; the potential for FINTEPLA, if approved, to provide an important new treatment option for patients and families living with Dravet syndrome; and the potential timing of top-line data the on-going Phase 3 trial of FINTEPLA in patients with LGS. These statements are based on the Company’s current beliefs and expectations. 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 refuse to accept the resubmitted NDA and may issue an additional refusal to file letter; the FDA may disagree that the existing safety and efficacy data is sufficient to approve the NDA; the FDA may require the Company to conduct the additional chronic toxicity studies noted in the Refusal to File letter, dated April 3, 2019, or other studies or information in connection with its review of the NDA; the timing of the data from Study 1601 of FINTEPLA in patients suffering from LGS could be delayed; the results of Study 1601 may differ from the results of prior clinical studies in LGS or may demonstrate adverse safety data compared to the prior Phase 3 clinical trials of FINTEPLA; the FDA may not agree with the Company’s interpretation of the results of the clinical trials of FINTEPLA; later developments with the FDA that may be inconsistent with feedback received at prior meetings with the FDA; additional data from the Company’s ongoing studies may contradict or undermine the data submitted in the NDA for FINTEPLA; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA; 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: September 26, 2019

 

 

By:

 

/s/ Michael P. Smith

 

 

Name:

 

Michael P. Smith

 

 

Title:

 

Executive Vice President, Chief Financial
Officer, Treasurer and Secretary

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Document and Entity Information
Sep. 26, 2019
Cover [Abstract]  
Amendment Flag false
Entity Central Index Key 0001375151
Document Type 8-K
Document Period End Date Sep. 26, 2019
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

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