Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of central nervous system (CNS) disorders, today announced the initiation of the first Phase 3 clinical trial for the Company’s lead product candidate, ZX008, as an adjunctive treatment of seizures in children with Dravet syndrome.

“We are extremely pleased to have advanced the ZX008 program to the start of the Phase 3 trial. It is an important step toward making this potentially breakthrough treatment available to Dravet patients and their families,” said Gail M. Farfel, Ph.D., Chief Development Officer of Zogenix.

The Phase 3 program for ZX008 includes 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.  In addition to the U.S. Phase 3 study, a second multi-national study, which will be conducted primarily in Europe, is expected to initiate in the first quarter of 2016. The primary endpoint of both studies is 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.

“We are eager to begin this clinical trial as a potential new treatment option for children with Dravet syndrome,” said Dr. Joseph Sullivan, Associate Professor of Neurology & Pediatrics at University of California, San Francisco (UCSF), Director of the UCSF Pediatric Epilepsy Center and Principal Investigator of the North American ZX008 trial. “Effective treatment options for this catastrophic epilepsy syndrome are quite limited. The data generated so far for ZX008 have been encouraging. We look forward to seeing results from the Phase 3 clinical trial.” (Original Source)

Shares of Zogenix closed last Friday at $10.96, down $0.42 or -3.69%. ZGNX has a 1-year high of $21.65 and a 1-year low of $9.36. The stock’s 50-day moving average is $14.17 and its 200-day moving average is $15.54.

On the ratings front, Zogenix has been the subject of a number of recent research reports. In a report issued on December 15, Brean Murray Carret analyst Difei Yang reiterated a Buy rating on ZGNX, with a price target of $28, which represents a potential upside of 155.5% from where the stock is currently trading. Separately, on November 13, Oppenheimer’s Akiva Felt assigned a Buy rating to the stock and has a price target of $23.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Difei Yang and Akiva Felt have a total average return of -13.5% and 6.3% respectively. Yang has a success rate of 26.6% and is ranked #3553 out of 3610 analysts, while Felt has a success rate of 39.8% and is ranked #365.

The street is mostly Bullish on ZGNX stock. Out of 4 analysts who cover the stock, 3 suggest a Buy rating and one recommends to Hold the stock. The 12-month average price target assigned to the stock is $23.00, which implies an upside of 109.9% from current levels.

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.