GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) is aiming for an EMA marketing green light for Epidiolex, its lead cannabidiol or CBD product candidate, designed adjunctively to treat seizures correlated with two incredibly formidable childhood-onset epilepsy conditions: Lennox-Gastaut syndrome (LGS) and Dravet syndrome, both forms highly resistant to treatment.
Today, this biotech player disclosed a new submission; a Marketing Authorization Application (MAA) sent to the European Medicines Agency (EMA), a key stride forward in maximizing the global potential of GW’s cannabinoid treatment option for patients tackling these severe syndromes.
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Notably, GW has secured Orphan Designations from the EMA for Epidiolex for the treatment of LGS, Dravet syndrome, and recently, West syndrome and Tuberous Sclerosis Complex. In October 2017, GW completed the submission of its rolling Epidiolex New Drug Application (NDA) to the United States Food and Drug Administration (FDA), also for seizures associated with LGS and Dravet syndrome. This NDA has been accepted by the FDA for Priority Review.
“This MAA submission marks another major milestone for the Epidiolex program and is an important next step toward providing this potential new treatment option globally,” stated Justin Gover, CEO of GW Pharmaceuticals. “GW is committed to making Epidiolex available to patients in Europe that struggle with the burden of living with LGS and Dravet syndrome, both very difficult to treat and devastating conditions. We continue to build a commercial infrastructure in Europe in anticipation of future approval and launch.”
The MAA for Epidiolex is supported by data from three Phase 3 safety and efficacy studies, each of which met their primary endpoint. Epidiolex was generally well tolerated in these trials. The MAA includes safety data on approximately 1,500 patients, with approximately 400 patients on continuous therapy for more than one year. Approximately 26% of the Epidiolex patients from the Phase 3 pivotal program came from European sites. Beyond pivotal safety and efficacy data, the MAA includes a comprehensive clinical pharmacology, pre-clinical and toxicology package.
Shares of GW Pharmaceuticals plc closed yesterday at $134.95, down $-1.45 or -1.06%. GWPH has a 1-year high of $140.52 and a 1-year low of $92.65. The stock’s 50-day moving average is $124.10 and its 200-day moving average is $110.88.
On the ratings front, GW Pharmaceuticals has been the subject of a number of recent research reports. In a report issued on December 14, Goldman Sachs analyst Salveen Richter upgraded GWPH to Buy, with a price target of $174, which implies an upside of 29% from current levels. Separately, on December 4, Cantor Fitzgerald’s Elemer Piros reiterated a Buy rating on the stock and has a price target of $208.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Salveen Richter and Elemer Piros have a yearly average return of 33.2% and a loss of -9.1% respectively. Richter has a success rate of 66% and is ranked #183 out of 4735 analysts, while Piros has a success rate of 43% and is ranked #4613.
Sentiment on the street is mostly bullish on GWPH stock. Out of 4 analysts who cover the stock, 4 suggest a Buy rating . The 12-month average price target assigned to the stock is $175, which represents a potential upside of 30% from where the stock is currently trading.
GW Pharmaceuticals Plc is a biopharmaceutical company, which engages in the discovery, development, and commercialization of novel therapeutics from proprietary cannabinoid product platform in a broad range of disease areas. It operates through the following segments: Commercial, Sativex Research and Development, and Pipeline Research and Development. The Commercial segment distributes and sells the commercial products and promotes Sativex through collaborations with pharmaceutical companies for the currently approved indication of spasticity due to multiple sclerosis. The Sativex Research and Development segment seeks to maximize the potential of Sativex through the development of new indications. The Pipeline Research and Development segment seeks to develop cannabinoid medications other than Sativex, which are using the proprietary cannabinoid technology platform.