Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of central nervous system (CNS) disorders, today announced the recent receipt of a request from the U.S. Food and Drug Administration (FDA) for additional information related to the Company’s proposed Phase 3 program for ZX008 prior to the FDA declaring Zogenix’s Investigational New Drug Application (IND) effective. Zogenix has responded with the requested information required to initiate the clinical program. ZX008 previously received orphan drug designation from the FDA, and is expected to enter Phase 3 clinical studies during the fourth quarter of 2015 for the treatment of Dravet syndrome, a rare and debilitating form of epilepsy that begins in infancy.
The FDA’s specific information requests are related to normative ranges for echocardiograms being conducted during the course of the pediatric Phase 3 program, and an amended Phase 3 study protocol to reflect a required follow-up echocardiogram 3 to 6 months after patients discontinue treatment with ZX008.
“We are confident that we have adequately addressed the FDA’s information requests and look forward to receiving their response shortly,” said Stephen Farr, Ph.D., President and CEO ofZogenix. “Importantly, our expected ZX008 clinical development timeline remains unchanged, including the expectation that the Phase 3 program will begin in the fourth quarter of 2015. We will provide further regulatory updates as appropriate.” (Original Source)
Shares of Zogenix are trading down 10.35% to $12.30 in after-hours trading. 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 $16.31 and its 200-day moving average is $15.02.
On the ratings front, Zogenix has been the subject of a number of recent research reports. In a report issued on October 2, Brean Murray Carret analyst Difei Yang reiterated a Buy rating on ZGNX, with a price target of $28, which implies an upside of 105.3% from current levels. Separately, on August 11, William Blair’s Tim Lugo maintained 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 1.0% and -12.6% respectively. Yang has a success rate of 39.4% and is ranked #1848 out of 3788 analysts, while Lugo has a success rate of 29.2% and is ranked #3676.
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 68.6% above where the stock opened today.
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.