Investors Light Up GW Pharma After Epidiolex Meets Primary Endpoint; Stock Crosses $100

GW Pharmaceuticals PLC- ADR GWPH's Epidiolex met primary endpoint in the phase three pivotal trial results for the treatment of Lennox-Gastaut Syndrome. The primary endpoint was achieved with superior statistical significance demonstrating that Epidiolex treatment reduces drop seizures compared to the placebo.

In the pre-market on Monday, the stock traded up 20 percent at $100.

GW Pharmaceuticals said that the study followed the disclosure in March last about positive results in a pivotal Phase 3 study of Epidiolex for the treatment of Dravet syndrome. The company pointed out that its Epidiolex has Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for LGS and Dravet syndrome treatment.

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The company's CEO, Justin Gover, commented, "We are delighted to announce positive results in this Phase 3 trial of Epidiolex in patients with Lennox-Gastaut syndrome, and particularly pleased that this result is consistent with our recent Phase 3 pivotal data for Epidiolex in Dravet syndrome. We believe that this result further demonstrates that Epidiolex offers the potential to be a new effective therapy within the field of treatment-resistant childhood-onset epilepsies. We now look forward to advancing Epidiolex towards the submission of an NDA with the FDA in the first half of 2017."

Similarly, Director of the Comprehensive Epilepsy Center at Ann & Robert H. Lurie Children's Hospital of Chicago, Linda Laux, reacted, "From a physician's perspective, the positive outcome in this trial of Epidiolex in patients with Lennox-Gastaut syndrome is very exciting. Lennox-Gastaut syndrome begins in early childhood, is particularly difficult to treat, and the vast majority of patients do not obtain an adequate response from existing therapies."

He continued, "These data show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in this highly treatment-resistant population together with an acceptable safety and tolerability profile, which is consistent with my previous clinical experience with Epidiolex. I am excited about the prospect of Epidiolex being made available on prescription in the future and believe it has the potential to make an important difference to the lives of many patients."