GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) investors will be smiling to hear the drug maker’s good news today: FDA acceptance for filing with Priority Review of GWPH’s NDA for the company’s investigational seizure treatment Epidiolex (cannabidiol or CBD). The asset was designed to tackle two rare as well as challenging to treat conditions of childhood-onset epilepsy, Lennox-Gastaut syndrome (LGS) and Dravet syndrome.
Worthy of note, the new year could prove to be a big year for this biotech player, considering the PDUFA (Prescription Drug User Fee Act) goal date for completion of the FDA review of the Epidiolex NDA is June 27, 2018.
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Priority Review status is designated for drugs that may offer major advances in treatment or provide a treatment where no adequate therapies exist. The granting of Priority Review for the Epidiolex NDA accelerates the timing of the FDA review of the application compared to a standard review.
In its acceptance letter, the FDA has stated that it is currently planning to hold an advisory committee meeting to discuss this application.
“We are pleased with the FDA’s acceptance of our NDA filing with Priority Review, an action that underscores the unmet need in the LGS and Dravet syndrome populations,” said Justin Gover, GW’s Chief Executive Officer. “We look forward to working with the FDA during the review process to support the case for approval of Epidiolex so as to provide a much needed new treatment option for patients that suffer from these highly treatment-resistant conditions of childhood-onset epilepsy.”
GW Pharmaceuticals stock is currently trading up 0.44% to $137.00, or up $0.60 in pre-market trading Thursday. 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 $123.41 and its 200-day moving average is $110.70.
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 represents a potential upside of 28% from where the stock is currently trading. 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 33.1% and a loss of -9.4% respectively. Richter has a success rate of 66% and is ranked #183 out of 4735 analysts, while Piros has a success rate of 42% and is ranked #4620.
Overall, 4 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 $175 which is 28.3% above where the stock closed yesterday.
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.