GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) announced additional positive Epidiolex® (cannabidiol or CBD) Phase 3 data in poster presentations at the 70th Annual Meeting of the American Epilepsy Society. These data are from the positive pivotal Phase 3 study of Epidiolex in Dravet syndrome and the first pivotal Phase 3 study of Epidiolex in Lennox-Gastaut syndrome (LGS), both reported earlier this year.
“We are pleased to present key findings from two pivotal Phase 3 studies of Epidiolex and believe these additional positive data reinforce the robust nature of the results achieved in two of the most difficult-to-treat epilepsy patient populations,” stated Justin Gover, GW’s Chief Executive Officer. “We are making very good progress toward a NDA submission to the FDA as well as preparations for commercial launch and look forward to the opportunity to make this important new medicine available to patients as quickly as possible.”
Highlights of Findings in Both Phase 3 Studies:
- Each pivotal Phase 3 study achieved the primary endpoint demonstrating a statistically significant difference between Epidiolex and placebo in seizure frequency reduction during the 14 week treatment period.
- In the 12-week maintenance period (excluding the initial dose escalation), the treatment effect increased for patients receiving Epidiolex and showed a greater level of statistical significance compared with placebo.
- Caregivers of patients receiving Epidiolex were significantly more likely to report an improvement in overall condition.
- A consistent separation between Epidiolex and placebo across all response rates was seen. In the LGS study, the drop seizure responder analysis showed a statistically significant separation between Epidiolex and placebo at the 50 percent seizure reduction threshold.
- Epidiolex efficacy was established relatively early in treatment.
- Epidiolex was generally well tolerated.
“These placebo-controlled studies demonstrate that Epidiolex provides clinically meaningful reductions in seizure frequency together with an acceptable safety and tolerability profile,” stated Orrin Devinsky, M.D., of New York University Langone Medical Center’s Comprehensive Epilepsy Center and Principal Investigator of the Dravet syndrome trial. “The epilepsy community has been eagerly anticipating the presentation of this high quality scientific data from the Epidiolex program at the American Epilepsy Society. My colleagues and I are excited at the future prospect of prescribing an appropriately standardized and tested pharmaceutical formulation of cannabidiol.”
“Dravet syndrome and Lennox-Gastaut syndrome are diagnosed in early childhood and represent some of the most difficult types of epilepsy to treat. Nearly all patients continue to have uncontrolled seizures and other medical needs throughout their lifetime. These trial results show that Epidiolex offers much needed new hope for children and their families,” stated Elizabeth Thiele, MD, PhD, Director of Pediatric Epilepsy at the Massachusetts General Hospital, Professor of Neurology at the Harvard Medical School and Principal Investigator of the LGS trial. “I very much look forward to the day when Epidiolex is available as a new prescription option for my patients.” (Original Source)
Shares of GW Pharmaceuticals are currently trading at $113.43, up $1.11 or 0.99%. GWPH has a 1-year high of $137.88 and a 1-year low of $35.83. The stock’s 50-day moving average is $124.63 and its 200-day moving average is $97.76.
On the ratings front, GWPH stock has been the subject of a number of recent research reports. In a report issued on November 21, Goldman Sachs analyst Salveen Richter maintained a Buy rating on GWPH, with a price target of $185, which implies an upside of 65% from current levels. Separately, on November 16, Leerink Swann’s Paul Matteis reiterated a Buy rating on the stock.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Salveen Richter and Paul Matteis have a yearly average return of 29.2% and 7.2% respectively. Richter has a success rate of 68% and is ranked #86 out of 4240 analysts, while Matteis has a success rate of 52% and is ranked #603.
Overall, 6 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $172.50 which is 53.6% above where the stock closed last Friday.
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.