Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of central nervous system (CNS) disorders, today announced that the U.S. Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application for Zogenix’s lead product candidate, ZX008, as an adjunctive treatment of seizures in children with Dravet syndrome.  The active IND now allows the Company to initiate its planned Phase 3 program for ZX008.

“We are pleased to have reached agreement with the FDA to proceed into Phase 3 clinical development, and are now focused on initiating the U.S.-based pivotal clinical trial for ZX008 prior to year-end, which would position us well to generate top-line results in 2016,” said Stephen J. Farr, Ph.D., President and CEO.  “This is a significant milestone for Zogenix, as we believe ZX008 has the potential to provide Dravet patients and their families with an important treatment option for this catastrophic form of intractable epilepsy that begins in infancy.”

The Phase 3 program for ZX008 will consist of two randomized, double-blind placebo-controlled studies that will include two dose levels of ZX008 (0.2 mg/kg/day and 0.8 mg/kg/day, up to a maximum daily dose of 30 mg), as well as placebo.  Zogenix intends to enroll 105 subjects in each of the two studies, with 35 patients in each treatment arm.  One study will be conducted primarily in the U.S. and Canada, and the other will be a multi-national study, conducted primarily in Europe. The primary endpoint will be the change in frequency of convulsive seizures as compared to placebo. The key secondary endpoints include 40% and 50% responder analyses and convulsive seizure-free interval. (Original Source)

Shares of Zogenix closed last Friday at $13.39, down $0.26 or -1.90%. ZGNX has a 1-year high of $21.65 and a 1-year low of $8.64. The stock’s 50-day moving average is $13.50 and its 200-day moving average is $15.43.

On the ratings front, Zogenix has been the subject of a number of recent research reports. In a report issued on November 11, Brean Murray Carret analyst Difei Yang maintained a Buy rating on ZGNX, with a price target of $28, which represents a potential upside of 109.1% from where the stock is currently trading. Separately, on November 10, William Blair’s Tim Lugo reiterated a Hold rating on the stock .

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Difei Yang and Tim Lugo have a total average return of -3.8% and -6.8% respectively. Yang has a success rate of 39.3% and is ranked #3199 out of 3618 analysts, while Lugo has a success rate of 33.3% and is ranked #3305.

Overall, one research analyst has assigned a Hold rating and 3 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $23.00 which is 71.8% above where the stock closed last Friday.

Zogenix Inc is a pharmaceutical company engaged in commercializing & developing therapies that address clinical needs for people living with pain-related and CNS disorders that needs treatment alternatives to help return to normal daily functioning.