Marijuana stocks have been heating up and we have continued to remain bullish on the biotech side of the sector.
Biotech cannabis investments offer investors significant growth potential and today, Zynerba Pharmaceuticals (ZYNE) is exemplifying this possibility.
After the biotech cannabis firm reported back-to-back negative top line clinical trial results, many investors pushed Zynerba aside for dead.
This morning, the shares are up more than 90% in the pre-market after the biotech firm reported positive data for one of its clinical trials.
Zynerba Shares Jump on Positive Data
Zynerba announced positive top line results from an open label exploratory Phase 2 FAB-C clinical trial evaluating ZYN002 CBD gel in pediatric and adolescent patients with Fragile X syndrome (FXS).
The study successfully met its primary endpoint, achieving a 46% improvement in the total score of Anxiety, Depression, and Mood Scale (ADAMS) at week twelve compared to baseline.
ZYN002 also achieved clinically meaningful improvements in all measures of the Aberrant Behavior Checklist for Fragile X (ABC-FXS), which address the key symptoms of FXS including social avoidance, temper tantrums, repetitive movements, and hyperactivity.
Plans to Meet with the FDA in 2018
With these data, Zynerba expects to meet with the FDA in the first half of 2018 with the goal of moving quickly into a pivotal Phase 2/3 program in pediatric and adolescent patients with FXS in 2018. The FDA has granted Zynerba the Orphan Drug designation for the use of CBD as treatment of patients with FXS.
ZYN002 was shown to be very well tolerated, and the safety profile was consistent with previously released data from clinical trials. 2 patients discontinued due to worsening of pre-existing eczema. 4 other patients experienced an adverse event. No adverse events were considered severe.
Zynerba Chairman and CEO Armando Anido said, “We are thrilled with the positive clinical results of ZYN002 in the FAB-C trial; it is a major step forward for the hundreds of thousands of patients worldwide with Fragile X who currently have no approved therapeutic options to treat their symptoms. The clinically meaningful improvements in Fragile X symptoms and the excellent tolerability seen in the FAB-C trial are compelling. These data will allow us to discuss the pathway to approval in a meeting with the FDA, which we expect to take place during the first half of 2018. I want to thank the patients, families, physicians, study coordinators, and the Zynerba team for their support of this important study.”
A Stock to Watch
Zynerba is trading significantly higher after this news and the shares are up more than 90% in the pre-market. While many have been cautious with ZYNE, we have held strong and are glad with this decision.
The shares dropped more than 60% after the biotech firm reported negative data in back-to-back trials and we viewed this as an undervalued opportunity.
We are favorable on this climb and Zynerba is a stock to watch!