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Shares of Zynerba Pharmaceuticals (NASDAQ: ZYNE) were up 6.3% as of 11:03 a.m. EDT on Tuesday after rising as much as 11.5% earlier in the session. The gains appear to be the result of Roth Capital analyst Jerry Isaacson initiating coverage of Zynerba with a buy rating and a price target of $36, which reflected a 211% premium above the stock's closing price on Monday.
One analyst's positive opinion on Zynerba isn't all that significant in the grand scheme of things. However, it is important for investors to understand what's behind the optimism.
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Zynerba's lead pipeline candidate is Zygel, a cannabidiol (CBD) gel that's being evaluated in a phase 3 clinical study for treating Fragile X syndrome (FXS). Roth Capital's Isaacson, though, thinks that there are even bigger opportunities for Zygel in other indications.
The biotech currently has three phase 2 clinical studies of Zygel under way. One is evaluating the CBD drug in treating developmental and epileptic encephalopathies (DEE), which include rare and ultra-rare epilepsy syndromes where patients can experience seizures, behavioral disturbances, and brain electrical activity abnormalities. The other phase 2 studies focus on autism spectrum disorders in pediatric patients and adult refractory focal epilepsy.
In addition, Zynerba plans to initiate another phase 2 study in the second quarter. This study will evaluate Zygel in treating 22q deletion syndrome, the most common gene deletion syndrome, affecting up to 81,000 patients in the U.S.
The main thing to watch now is how Zygel performs in clinical studies. Zynerba anticipates reporting top-line data from the pivotal FXS study later this year. If all goes well, the biotech could file for U.S. regulatory approval for Zygel in the FXS indication in the first half of 2020.
Results from Zynerba's phase 2 studies shouldn't be too far off, either. The company expects to announce top-line data through week 26 from the DEE study in the third quarter of 2019. Zynerba should report results from its 22q study in the first half of 2020.
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