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Why GW Pharmaceuticals Dropped 14% In September
What: This emerging biotechnology company is researching a slate of marijuana derived medicine. Sativex for multiple sclerosis spasticity is already approved in the EU. Cannabidiol for schizophrenia phase 2 results were released September 15, but future development of this therapy is uncertain. Cannabidiol results for treating epilepsy coming soon. Shares dropped 14.1% in September.
So What: GW Pharmaceuticals is attempting to create medical marijuana therapies across various indications. A study in evaluating THC (Sativex) in cancer pain failed to meet its endpoint earlier this year. In September, results from a phase 2 study of CBD in schizophrenia failed to impress. Failed to achieve statistical significance in primary endpoints. Future development pathway unclear. .
So what continued… THC study evaluating Sativex in cancer pain. The first of 3 studies failed to outperform placebo. Two other studies are underway. One designed similarly to the failed trial was supposed to read-out results in Q2, but is now expected to read-out by year end. A second study designed slightly differently was slated to read out by year end.
So what continued… CBD trial in schizophrenia. CBD patients report a 20% greater improvement on a key positive symptoms psychiatric scale at a rate that is greater than placebo. Not statistically significant at improving cognition and responses on a negative symptoms scale. Company shifting of endpoints increases skepticism. Future plans may include pediatric research.
Now what: Trial results this year increase pressure for positive results in epilepsy. Phase 3 trials underway for Epidiolex (CBD) in Dravet syndrome and Lennox-Gastaut syndrome. Both are rare childhood diseases with a significant unmet need. Trial results anticipated in Q1 2016.
Now what continued: Significant opportunity exists in target markets. Efficacy results have been lackluster this year. Potential for multiple trial data in the next six months. Likely to be binary events that could significantly affect shares. This is a high risk/reward stock suitable only for speculative investors. Avoid or underweight until positive efficacy results add conviction to medical marijuana thesis.
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