Zogenix, Inc. (NASDAQ: ZGNX) is having an overwhelmingly strong start to the trading session in the pre-market this morning, and for good reason. The company reported overwhelmingly positive clinical data surrounding its epilepsy drug. Of course, this led to excitement among investors, sending the stock toward the top. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:11), ZGNX is trading at $31.80 per share after a gain of $146.99% thus far today.
Zogenix Skyrockets On Solid Clinical Data
As mentioned above, Zogenix is having an incredible day in the market today after reporting positive top-line results from its first Phase 3 clinical trial surrounding ZX008. The treatment is designed for Drevet syndrome, a severe form of epilepsy. In the press release, the company said that the study met its primary objective of demonstrating that at a dose of 0.8 mg/kg/day, is superior to placebo as adjunctive therapy in the treatment of Dravet syndrome in children and young adults.
ZGNX said that the treatment did show a significant improvement compared to the placebo, not only in the primary endpoint, but in all secondary endpoints as well. A key finding was that the treatment showed meaningful reductions in seizure frequency and longest seizure-free interval. In a statement, Joseph Sullivan M.D., director of the Pediatric Epilepsy Center in UCSF Benioff Children’s Hospital San Francisco, and Principal Investigator of Study 1 in the United States, had the following to offer:
“Dravet syndrome is a rare, but catastrophic form of epilepsy that can be devastating for patients and their families… These results are truly exciting and demonstrate, in a large multicenter controlled trial, the impressive efficacy of low-dose fenfluramine for patients with Dravet syndrome. If approved, ZX008 could play an important role in treating this devastating condition.”
The above statement was followed up by Stephen J. Farr, Ph.D., President and CEO at ZGNX, had the following to offer…
“On behalf of everyone at Zogenix, I would like to extend my sincere appreciation to the patients, families and investigators involved in this study. We are extremely pleased with the top-line efficacy and safety results from Study 1 which reinforce the potential of ZX008 to be an important new treatment for seizure control in children with Dravet syndrome. We look forward to presenting further data in future publications and at medical conferences… We expect top-line results from our second pivotal Phase 3 trial, Study 1504, which is nearing full enrollment, in the first half of 2018. We remain on track to submit applications for regulatory approvals in the U.S. and Europe in the second half of 2018.”
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will be keeping a close eye on ZGNX. In particular, we’re interested in following the company’s ongoing work surrounding ZX008 and excited to see future results as the treatment seems to be overwhelmingly positive thus far. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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