Zogenix, Inc. (NASDAQ: ZGNX) is flying in the pre-market hours this morning, and for good reason. The company announced positive results from a pivotal clinical trial. Of course, the news led to excitement among investors who are sending the stock screaming for the top. Today, we’ll talk about:
- The clinical results;
- what we’re seeing from ZGNX; and
- what we’ll be watching for ahead.
ZGNX Announces Positive Clinical Results
As mentioned above, Zogenix is having an overwhelmingly strong start to the trading session this morning after the company announced positive clinical results. In a press release issued early this morning, the company reported top-line results from its second confirmatory Phase 3 study of an investigational drug known as ZX008. ZX008 is a treatment designed for children and young adults that are suffering from a severe type of epillepsy known as Dravet Syndrome.
In the release, ZGN said that the results were consistent with those reported in the first pivotal Phase 3 study and that the trial successfully met its primary endpoint as well as key secondary endpoints. Ultimately, the treatment, at a dose of 0.5 mg/kg/day proved to be superior to placebo when added to a stiripentol regimen.
During the study, patients who were given ZX008 showed a 54.7% greater reduction in mean monthly convulsive seizures when compared to placebo. Also, the mean reduction in monthly convulsive seizure frequency came to 62.7% in the ZX008 group compared to 1.2% in the placebo group. Also, when it comes to the secondary endpoints, clinically meaningful reductions in seizure frequency and longest seizure-free interval, the treatment showed overwhelmingly promising results. Finally, the company said that the treatment proved through the trial to be safe and well tolerated. In a statement, Stephen J. Farr, Ph.D., President and CEO at ZGNX, had the following to offer:
I would like to extend my gratitude to the patients, families and investigators involved in Study 1504… Based on these highly compelling top-line results from both of our pivotal studies, we are now focused on submitting applications for regulatory approvals in the U.S. and Europe in the fourth quarter of 2018. We are excited about ZX008’s potential to have a major impact in the treatment of patients with Dravet syndrome and their families.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to work in the market is that it’s important to keep an eye on the news. After all, the news moves the market. In the case of Zogenix, the news proved to be overwhelmingly positive. After all, these positive results will likely lead to a New Drug Application with the FDA, bringing the treatment one step closer to commerialization phases. So, it comes as no surprise to see that excited investors are sending the stock on a run for the top. Of course, our partners at Trade Ideas were the first to alert us to the gains. Currently (8:54), ZGNX is trading at $57.80 per share after a gain of $11.50 per share or 24.84% thus far today.
Stop wasting your time! Start finding winning trades in minutes with Trade Ideas!
What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on ZGNX. In particular, we’re interested in following the story surrounding the company’s continued work to bring ZX008 to market following the overwhelmingly promising results that were released. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
Never Miss The News Again
Do you want real-time, actionable news delivered to your inbox? Join the CNA Finance mailing list below!