Health and Healthcare

GW Pharma Explodes on Positive Late-Stage Results

Chris Lange

Published: March 14, 2016 8:40 am

Last Updated: January 13, 2020 11:59 am

GW Pharmaceuticals PLC (NASDAQ: GWPH) led the bulls out of the gate on Monday morning on news of positive late-stage study results. The company announced the positive results of the first pivotal Phase 3 study of its investigational medicine Epidiolex (cannabidiol) for the treatment of Dravet syndrome.

In this study, Epidiolex achieved the primary endpoint of a significant reduction in convulsive seizures assessed over the entire treatment period compared with the placebo. Epidiolex has both Orphan Drug Designation and Fast Track Designation from the U.S. Food and Drug Administration (FDA) in the treatment of Dravet syndrome, a rare and debilitating type of epilepsy for which there are currently no treatments approved in the United States.

The primary efficacy endpoint was a comparison between Epidiolex and placebo, measuring the percentage change in the monthly frequency of convulsive seizures. Ultimately, patients taking Epidiolex achieved a median reduction in monthly convulsive seizures of 39% compared with a reduction on placebo of 13%.

The results of this Epidiolex pivotal trial are important and exciting as they represent the first placebo-controlled evidence to support the safety and efficacy of pharmaceutical cannabidiol in children with Dravet syndrome, one of the most severe and difficult-to-treat types of epilepsy. These data demonstrate that Epidiolex delivers clinically important reductions in seizure frequency together with an acceptable safety and tolerability profile, providing the epilepsy community with the prospect of an appropriately standardized and tested pharmaceutical formulation of cannabidiol being made available by prescription in the future.

So far in 2016, GW Pharma has underperformed the broad markets, with the stock down about 45% (prior to Monday’s move). Over the past 52 weeks, the stock is down 55%.

Shares closed Friday up 5% at $38.46, with a consensus analyst price target of $133.00 and a 52-week trading range of $35.83 to $133.98. Following the release of the results, the stock shot up 123% at $85.80 in early trading indications Monday.