Zogenix, Inc. (NASDAQ:ZGNX), a pharmaceutical company developing therapies for the treatment of central nervous system (CNS) disorders, announced receipt of Fast Track designation from the U.S. Food and Drug Administration (FDA) for the development program for the Company’s investigational product, ZX008, as a treatment of seizures associated with Dravet syndrome, a rare and catastrophic form of childhood epilepsy.
“The FDA granting Fast Track designation provides important support as we advance the development program for ZX008 in Dravet syndrome towards a potential approval as quickly as possible,” said Stephen Farr, Ph.D., Chief Executive Officer of Zogenix. “We recently initiated our first Phase 3 clinical trial in the U.S., and the second trial, primarily to be conducted in Europe, is expected to begin this quarter.”
The FDA’s Fast Track program was established to facilitate the development and expedite the review of drugs with the potential to treat serious conditions and address unmet medical needs. Companies that receive Fast Track designation are provided the opportunity for more frequent interactions with the FDA during clinical development and are eligible for accelerated approval and/or priority review, if relevant criteria are met. Additionally, companies that receive Fast Track designation are allowed to submit completed sections of their New Drug Application (NDA) for the drug on a rolling basis, resulting in the potential for an expedited FDA review process. (Original Source)
Shares of Zogenix closed last Friday at $10.51 . 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 $13.51 and its 200-day moving average is $15.46.
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 166.4% 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 -18.3% and 2.2% respectively. Yang has a success rate of 19.5% and is ranked #3549 out of 3582 analysts, while Felt has a success rate of 36.3% and is ranked #765.
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 118.8% 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.