ZYNE stock has been making big moves this year and has gained almost 430% since the year began. In fact, Zynerba Pharmaceuticals (NASADAQ:ZYNE)’s stock has doubled over the past month alone amid a couple of big developments.
So why such a big rally? Let’s take a look at the company’s recent big developments
Fast Track Designation for Zygel
The biggest news for ZYNE stock investors was on May 06, when the FDA had granted Zygel, Zynerba’s CBD gel, a Fast Track Designation in treating Fragile X Syndrome.
Fast Track Designation for the CBD gel will enable the company to work with the FDA on various areas such as the development of clinical design study as well as data identification for purposes of regulatory filing. This will definitely improve chances of receiving priority review which will reduce the time required for FDA approval decision to around six months from 10 months.
However, this does not guarantee approval but it will reduce the possibility that the company’s regulatory filing for Zygel is incomplete if it doesn’t succeed in the clinical trial that is in progress. Data from the study is expected in the second half of 2019 and if results are positive Zynerba will file for Zygel approval in the first half of next year.
ZYNE stock has jumped almost 45% since the FDA’s news.
ZYNE Stock gets $36 PT from Roth Capital
On April. 30, Jerry Isaacson, an analyst at Roth Capital, started coverage on ZYNE’s stock and set a price target of $36, a potential jump of 125% from the current market price.
Isaacson believes that there is much potential in Zynerba’s lead candidate Zygel that is in the third phase of the trial to treat Fragile X syndrome but he also feels it has opportunities in other indications. The company has three-second phase clinical studies for the CBD gel and they are evaluating it in treatment of developmental and epileptic encephalopathies, autism spectrum disorders and adult refractory focal epilepsy.
Zynerba Pharmaceuticals is one of the most promising biotech companies and it is currently conducting trials for an innovative CBD gel. It will be the first patented permeation-enhanced gel with a potential of delivery into the circulatory system through the skin. It enables the delivery of drugs without going through a digestive process.
ZYNE stock is up another 6% and selling at $16.40 in Friday’s session.
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Featured Image: zynerba.com