ZOGENIX, INC. (NASDAQ:ZGNX) Files An 8-K Results of Operations and Financial Condition

ZOGENIX, INC. (NASDAQ:ZGNX) Files An 8-K Results of Operations and Financial Condition
Item 2.02Results of Operations and Financial Condition.

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On February28, 2019, Zogenix, Inc. issued a press release announcing its financial results for the fourth quarterand full-year endedDecember31, 2018. A copy of this press release is attached hereto as Exhibit 99.1.

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this Current Report on Form 8-K.

Item 9.01Financial Statements and Exhibits.

(d) Exhibits.

Exhibit

Number

Exhibit Description

Press Release dated February 28, 2019

ZOGENIX, INC. Exhibit
EX-99.1 2 a20181231erex-991.htm EXHIBIT 99.1 Exhibit Exhibit 99.1Zogenix Provides Corporate Update and Reports Fourth Quarterand Full-Year 2018 Financial Results•Completed rolling submission of an NDA to the U.S. FDA and an MAA to the EMA for FINTEPLA® for the treatment of seizures associated with Dravet syndrome in February 2019◦EMA has accepted MAA for review; outcome of the MAA review by the EMA expected in Q1 2020◦Notice regarding FDA acceptance of NDA filing and notification of PDUFA target date expected in next several weeks•Continued to advance enrollment of global Phase 3 trial of FINTEPLA for the treatment of Lennox-Gastaut syndrome (Study 1601)•Presented data from nine abstracts,…
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About ZOGENIX, INC. (NASDAQ:ZGNX)

Zogenix, Inc. is a pharmaceutical company engaged in developing and commercializing central nervous system (CNS) therapies that address specific clinical needs for people living with orphan and other CNS disorders in requirement of treatment alternatives. The Company’s areas of focus are epilepsy and schizophrenia. Its lead product candidate, ZX008, is a low-dose fenfluramine. The Company is also engaged in the development of Relday, which is a long-acting injectable formulation of risperidone indicated for the treatment of symptoms of schizophrenia and bipolar disorder in adults and teenagers 13 years of age and older. The Company is also engaged in manufacturing Sumavel DosePro (sumatriptan injection), a needle-free delivery system, which it sells to Endo Ventures Bermuda Limited and Endo Ventures Limited. Its DosePro technology is a drug delivery system designed for self-administration of a pre-filled, single dose of liquid drug, subcutaneously, without a needle.

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