GW Pharmaceuticals PLC- ADR (NASDAQ:GWPH) announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Cannabidiol (CBD) for use in treating newborn children with neonatal hypoxic-ischemic encephalopathy (NHIE). NHIE is acute or sub-acute brain injury due to asphyxia caused during the birth process and resulting from deprivation of oxygen during birth (hypoxia).
The incidence of NHIE is 1.5 to 2.8 per 1,000 births in the United States, or, 6,500 to 12,000 cases per year. Of these, 35% are expected to die in early life and 30% may suffer from permanent disability. There are currently no FDA-approved medicines specifically indicated for NHIE.
GW has developed an intravenous CBD formulation for use in this patient population. GW held a pre-IND meeting with the FDA and expects to submit an Investigational New Drug Application (IND) in mid-2015 and to commence a Phase 1 trial in the second half of 2015.
GW has been conducting pre-clinical research into the neuroprotective effects of CBD in animal models of NHIE since 2008. Publications from this research have shown that CBD reduces neurologic disability across a range of newborn animal models of brain hypoxia.
“GW continues to explore the opportunity for the development of cannabinoids in rare pediatric conditions characterized by significant unmet need,” stated Justin Gover, GW’s Chief Executive Officer. “This orphan drug designation for cannabidiol for the treatment of newborn children with neonatal hypoxic-ischemic encephalopathy follows several years of pre-clinical evaluation and we look forward to advancing a clinical development program in this important medical condition later this year.” (Original Source)
Shares of GW closed yesterday at $120.77 . GWPH has a 1-year high of $120.98 and a 1-year low of $58.16. The stock’s 50-day moving average is $95.54 and its 200-day moving average is $79.88.
On the ratings front, GW has been the subject of a number of recent research reports. In a report issued on April 22, Piper Jaffray analyst Joshua Schimmer reiterated a Buy rating on GWPH, with a price target of $147, which represents a potential upside of 21.7% from where the stock is currently trading. Separately, on April 14, Leerink Swann’s Joseph Schwartz reiterated a Buy rating on the stock and has a price target of $120.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Joshua Schimmer and Joseph Schwartz have a total average return of 18.4% and 33.7% respectively. Schimmer has a success rate of 70.2% and is ranked #131 out of 3579 analysts, while Schwartz has a success rate of 66.7% and is ranked #46.
GW Pharmaceuticals PLC is engaged in the research, development and commercialisation of cannabinoid prescription medicines to meet patient needs.