GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) investors cheer the announcement that the drug maker achieved positive results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex® (cannabidiol or CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy.
GW Pharmaceuticals shares reacted to the news, rising nearly 12% in early trading.
In this trial, Epidiolex, when added to the patient’s current treatment, achieved the primary endpoint for both dose levels with high statistical significance. During the treatment period, patients taking Epidiolex 20mg/kg/day achieved a median reduction in monthly drop seizures of 42 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0047), and patients taking Epidiolex 10mg/kg/day achieved a median reduction in monthly drop seizures of 37 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0016).
This trial follows the announcement in June 2016 of positive results in the first pivotal Phase 3 trial of Epidiolex for the treatment of seizures associated with LGS, and the March 2016 announcement of positive results in the treatment of seizures associated with Dravet syndrome. GW expects to submit a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in the first half of 2017.
“The positive outcome in this second trial of Epidiolex in patients with Lennox-Gastaut syndrome demonstrates the effectiveness of this product in this particularly difficult to treat, childhood-onset epilepsy,” stated Orrin Devinsky, M.D., of New York University Langone Medical Center’s Comprehensive Epilepsy Center and principal investigator in the trial. “The data from the Epidiolex Dravet and LGS studies offers the prospect of an FDA-approved CBD medicine that shows both clinically meaningful seizure reduction and a consistent safety and tolerability profile. I believe Epidiolex has the potential to become an important new option within the field of treatment-resistant epilepsy.”
“Today brings great news for the Lennox-Gastaut Syndrome community,” said Christina SanInocencio, Executive Director of the Lennox-Gastaut Syndrome Foundation. “The announcement of a second set of positive results with Epidiolex is exciting as they offer much needed hope for patients and their families living with this debilitating condition where new treatment options are desperately needed.”
“The Epilepsy Foundation is thrilled to learn about the recent preliminary results for an innovative new therapy from GW for LGS. LGS in so many cases is extremely difficult to treat, and is an incredible challenge for children and families. We feel a tremendous sense of urgency to stop seizures, and believe that the pursuit of new therapies offers hope to individuals who have no currently available therapy to effectively stop their seizures. The Epilepsy Foundation will continue to be a champion for GW’s efforts to pursue this innovative new therapy as studies progress. We thank GW and all our partners who invest in a better tomorrow for people with epilepsy,” stated Philip Gattone, President and Chief Executive Officer of the Epilepsy Foundation.
“We are very pleased to report this second positive Phase 3 trial in seizures associated with Lennox-Gastaut Syndrome. This is the third positive Phase 3 trial for Epidiolex reported in 2016. All three trials provide GW with robust evidence to support the efficacy and safety of Epidiolex. This latest trial also shows that Epidiolex likely has an effective dose range, allowing for dose flexibility to address individual patient needs. These compelling results make us more determined than ever to make this important new medicine available to patients who suffer from these treatment-resistant childhood-onset epilepsies,” stated Justin Gover, GW’s Chief Executive Officer. (Original Source)
On the ratings front, GWPH stock has been the subject of a number of recent research reports. In a report issued on September 23, Morgan Stanley analyst Andrew Berens reiterated a Buy rating on GWPH, with a price target of $152, which represents a potential upside of 41% from where the stock is currently trading. Separately, on September 7, Cantor ‘s Elemer Piros reiterated a Buy rating on the stock and has a price target of $165.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Andrew Berens and Elemer Piros have a total average return of 9.8% and 12.6% respectively. Berens has a success rate of 68% and is ranked #453 out of 4183 analysts, while Piros has a success rate of 49% and is ranked #463.
The street is mostly Bullish on GWPH stock. Out of 7 analysts who cover the stock, 6 suggest a Buy rating and one recommends to Sell the stock. The 12-month average price target assigned to the stock is $130.50, which represents a potential upside of 21.3% from where the stock is currently trading.
GW Pharmaceuticals Plc engages in the business of discovering, developing and commercializing novel therapeutics from proprietary cannabinoid product platform in a broad range of disease areas. The company operates through the following segments: Commercial, Sativex Research & Development and Pipeline Research & Development. The Commercial segment promotes Sativex through strategic collaborations with major pharmaceutical companies for the currently approved indication of spasticity due to multiple sclerosis. The Sativex Research & Development segment seeks to maximize the potential of Sativex through the development of new indications. The Pipeline Research & Development segment seeks to develop cannabinoid medications other than Sativex, which are using the Group’s proprietary cannabinoid technology platform.