This morning, GW Pharmaceuticals (GWPH) announced that EPIDIOLEX (cannabidiol) oral solution has been transferred to Schedule V, the lowest restriction classification, by the U.S. Drug Enforcement Administration (DEA). EPIDIOLEX, which was approved by the FDA in June for the treatment of seizures associated with Lennox-Gastaut syndrome or Dravet syndrome in patients two years of age or older, is the first prescription pharmaceutical formulation of highly-purified, plant-derived cannabidiol.
Cantor analyst Elemer Piros commented, “Following the FDA approval of Epidiolex in June, the DEA had up to 90 days to issue an interim final rule regarding the rescheduling of Epidiolex. Epidiolex was previously a Schedule I drug prior to being rescheduled to Schedule V. Schedule V drugs are the lowest ranked class, with “a low potential for abuse relative to substances listed in Schedule IV”. We expected this decision given that the FDA Advisory Committee has highlighted Epidiolex as a drug with limited abuse potential, as evidenced by three pivotal studies. We believe the rescheduling classification is the best possible outcome for the company. With this final box checked off, GW Pharmaceuticals will prepare for the U.S. launch within the next six weeks. During the last earnings call, the company announced it had completed the hiring of the U.S. sales team, with two national directors, eight regional managers, and 66 neurology account managers to target ~5,000 total physicians.”
As such, Piros reiterates an Overweight rating on GWPH, with a price target of $211, which implies an upside of 21% from current levels. (To watch Piros’ track record, click here)
Wall Street agrees with Piros that this cannabinoid-based drug maker is one to watch, as TipRanks analytics exhibit GWPH as a Strong Buy. Out of 6 analysts polled in the last 12 months, all 6 are bullish on GW Pharmaceuticals stock. With a return potential of 9.5%, the stock’s consensus target price stands at $190.33. (See GWPH’s price targets and analyst ratings on TipRanks)