GW Pharma Explodes on Positive Late-Stage Results

By Chris Lange Updated Jan 13, 11:59AM EST · Published Mar 14, 8:40AM EDT

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GW Pharma Explodes on Positive Late-Stage Results — © Thinkstock

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%.
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Orrin Devinsky M.D. of New York University Langone Medical Center’s Comprehensive Epilepsy Center commented:

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.

About the Author Chris Lange →

Chris Lange is a writer for 24/7 Wall St., based in Houston. He has covered financial markets over the past decade with an emphasis on healthcare, tech, and IPOs. During this time, he has published thousands of articles with insightful analysis across these complex fields. Currently, Lange's focus is on military and geopolitical topics.

Lange's work has been quoted or mentioned in Forbes, The New York Times, Business Insider, USA Today, MSN, Yahoo, The Verge, Vice, The Intelligencer, Quartz, Nasdaq, The Motley Fool, Fox Business, International Business Times, The Street, Seeking Alpha, Barron’s, Benzinga, and many other major publications.

A graduate of Southwestern University in Georgetown, Texas, Lange majored in business with a particular focus on investments. He has previous experience in the banking industry and startups.